Neurological

Neurological

Neurology is an area of medicine concerned with the anatomy, functions, and disorders of the nervous system. The FDA regulates neurological devices under CFR Title 21 Part 882, and the devices are categorized into three subparts.

Neurological Diagnostic Devices

Neurological Diagnostic Devices

Rigidity analyzer.

§882.1020
Rigidity analyzer.
Identification. A rigidity analyzer is a device for quantifying the extent of the rigidity of a patient's limb to determine the effectiveness of drugs or other treatments.
Classification. Class II (performance standards).

Ataxiagraph.

§882.1030
Ataxiagraph.
Identification. An ataxiagraph is a device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed.
Classification. Class I (general controls).

Two-point discriminator.

§882.1200
Two-point discriminator.
Identification. A two-point discriminator is a device with points used for testing a patient's touch discrimination.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

Echoencephalograph.

§882.1240
Echoencephalograph.
Identification. An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head.
Classification. Class II (performance standards).

Electroconductive media.

§882.1275
Electroconductive media.
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.
Classification. Class II (performance standards).

Cortical electrode.

§882.1310
Cortical electrode.
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.
Classification. Class II (performance standards).

Cutaneous electrode.

§882.1320
Cutaneous electrode.
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Classification. Class II (performance standards).

Depth electrode.

§882.1330
Depth electrode.
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.
Classification. Class II (performance standards).

Nasopharyngeal electrode.

§882.1340
Nasopharyngeal electrode.
Identification. A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.
Classification. Class II (performance standards).

Needle electrode.

§882.1350
Needle electrode.
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.
Classification. Class II (performance standards).

Electroencephalograph.

§882.1400
Electroencephalograph.
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification. Class II (performance standards).

Electroencephalograph electrode/lead tester.

§882.1410
Electroencephalograph electrode/lead tester.
Identification. An electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Electroencephalogram (EEG) signal spectrum analyzer.

§882.1420
Electroencephalogram (EEG) signal spectrum analyzer.
Identification. An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal.
Classification. Class I (general controls).

Electroencephalograph test signal generator.

§882.1430
Electroencephalograph test signal generator.
Identification. An electroencephalograph test signal generator is a device used to test or calibrate an electroencephalograph.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Neuropsychiatric interpretive electroencephalograph assessment aid.

§882.1440
Neuropsychiatric interpretive electroencephalograph assessment aid.
Identification. The neuropsychiatric interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. The neuropsychiatric interpretive EEG assessment aid is used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.
Classification. Class II (special controls). The special controls for this device are: (1) The technical parameters of the device, hardware and software, must be fully characterized and must demonstrate a reasonable assurance of safety and effectiveness. (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. (ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification and software design specification. Appropriate software verification, validation, and hazard analysis must be performed. (2) The device parts that contact the patient must be demonstrated to be biocompatible. (3) The device must be designed and tested for electrical safety, electromagnetic compatibility, thermal, and mechanical safety. (4) Clinical performance testing must demonstrate the accuracy, precision, reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs). (5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value, and negative predictive value per the device intended use. Repeatability of measurements must be demonstrated using interclass correlation coefficients and illustrated by qualitative scatter plot(s). (6) The device design must include safeguards to prevent use of the device as a stand-alone diagnostic. (7) The labeling must include the following information: (i) A warning that the device is not to be used as a stand-alone diagnostic. (ii) A detailed summary of the clinical performance testing, including any adverse events and complications. (iii) The qualifications and training requirements for device users including technicians and clinicians. (iv) The intended use population and the intended use environment. (v) Any instructions technicians should convey to patients regarding the collection of EEG data. (vi) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway. (vii) Where appropriate, validated methods and instructions for reprocessing of any reusable components.

Brain injury adjunctive interpretive electroencephalograph assessment aid.

§882.1450
Brain injury adjunctive interpretive electroencephalograph assessment aid.
Identification. A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.
Classification. Class II (special controls). The special controls for this device are: (1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information: (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. (ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed. (2) The device parts that contact the patient must be demonstrated to be biocompatible. (3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety. (4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs). (5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use. (6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output (e.g., use in appropriate patient population, or for appropriate clinical decision). (7) The labeling and training information must include: (i) A warning that the device is not to be used as a stand-alone diagnostic. (ii) A detailed summary of the clinical performance testing, including any adverse events and complications. (iii) The intended use population and the intended use environment. (iv) Any instructions technicians should convey to patients regarding the collection of EEG data. (v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway. (vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result.

Nystagmograph.

§882.1460
Nystagmograph.
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
Classification. Class II (performance standards).

Computerized cognitive assessment aid.

§882.1470
Computerized cognitive assessment aid.
Identification. The computerized cognitive assessment aid is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an interpretation of the current level of cognitive function. The computerized cognitive assessment aid is used only as an assessment aid to determine level of cognitive functioning for which there exists other valid methods of cognitive assessment and does not identify the presence or absence of clinical diagnoses. The computerized cognitive assessment aid is not intended as a stand-alone or adjunctive diagnostic device.
Classification. Class II (special controls). The special control(s) for this device are: (1) The technical parameters of the device's hardware and software must be fully characterized and be accompanied by appropriate non-clinical testing: (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. (ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed. (2) The device must be designed and tested for electrical safety. (3) The labeling must include: (i) A summary of any testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function. The summary of testing must include the following, if available: Any expected or observed adverse events and complications; any performance measurements including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) per the devices intended use; a description of the repeatability of measurements; a description of how the cut-off values for categorization of measurements were determined; and a description of the construct validity of the device. (ii) A warning that the device does not identify the presence or absence of clinical diagnoses. (iii) A warning that the device is not a stand-alone diagnostic. (iv) The intended use population and the intended use environment. (v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.

Computerized cognitive assessment aid for concussion.

§882.1471
Computerized cognitive assessment aid for concussion.
Identification. The computerized cognitive assessment aid for concussion is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. It is not intended as a stand-alone diagnostic device.
Classification. Class II (special controls). The special controls for this device are: (1) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. (2) Clinical performance data must be provided that demonstrates how the device functions as an interpretation of the current level of cognitive function in an individual that has recently received an injury that causes concern about a possible concussion. The testing must: (i) Evaluate device output and clinical interpretation. (ii) Evaluate device test-retest reliability of the device output. (iii) Evaluate construct validity of the device cognitive assessments. (iv) Describe the construction of the normative database, which includes the following: (A) How the clinical workup was completed to establish a normal population, including the establishment of inclusion and exclusion criteria. (B) Statistical methods and model assumptions used. (3) The labeling must include: (i) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function in a patient that has recently received an injury that causes concern about a possible concussion. The summary of testing must include the following: (A) Device output and clinical interpretation. (B) Device test-retest reliability of the device output. (C) Construct validity of the device cognitive assessments. (D) A description of the normative database, which includes the following: (1) How the clinical workup was completed to establish a normal population, including the establishment of inclusion and exclusion criteria. (2) How normal values will be reported to the user. (3) Representative screen shots and reports that will be generated to provide the user results and normative data. (4) Statistical methods and model assumptions used. (5) Whether or not the normative database was adjusted due to differences in age and gender. (ii) A warning that the device should only be used by health care professionals who are trained in concussion management. (iii) A warning that the device does not identify the presence or absence of concussion or other clinical diagnoses. (iv) A warning that the device is not a stand-alone diagnostic. (v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.

Neurological endoscope.

§882.1480
Neurological endoscope.
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.
Classification. Class II (performance standards).

Esthesiometer.

§882.1500
Esthesiometer.
Identification. An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

Tuning fork.

§882.1525
Tuning fork.
Identification. A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Galvanic skin response measurement device.

§882.1540
Galvanic skin response measurement device.
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.
Classification. Class II (performance standards).

Nerve conduction velocity measurement device.

§882.1550
Nerve conduction velocity measurement device.
Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.
Classification. Class II (performance standards).

Skin potential measurement device.

§882.1560
Skin potential measurement device.
Identification. A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.
Classification. Class II (performance standards).

Evoked photon image capture device.

§882.1561
Evoked photon image capture device.
Identification. An evoked photon image capture device is a prescription, electrically powered device intended for use as a noninvasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 882.9.

Powered direct-contact temperature measurement device.

§882.1570
Powered direct-contact temperature measurement device.
Identification. A powered direct-contact temperature measurement device is a device which contains a power source and is used to measure differences in temperature between two points on the body.
Classification. Class II (performance standards).

Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.

§882.1580
Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
Identification. A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.
Classification. Class II (special controls). The special controls for this device are: (1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information: (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. (ii) Software, including any proprietary algorithm(s) used by the device to achieve its intended use, must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) The device must be designed and tested for electrical, thermal, and mechanical safety and electromagnetic compatibility (EMC). (4) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for monitoring for seizure-related activity in the intended population and for the intended use setting. Performance measurements must include positive percent agreement and false alarm rate. (5) Training must be provided for intended users that includes information regarding the proper use of the device and factors that may affect the collection of the physiologic data. (6) The labeling must include health care professional labeling and patient-caregiver labeling. The health care professional and the patient-caregiver labeling must include the following information: (i) A detailed summary of the clinical performance testing, including any adverse events and complications. (ii) Any instructions technicians and clinicians should convey to patients and caregivers regarding the proper use of the device and factors that may affect the collection of the physiologic data. (iii) Instructions to technicians and clinicians regarding how to set the device threshold to achieve the intended performance of the device.

Alpha monitor.

§882.1610
Alpha monitor.
Identification. An alpha monitor is a device with electrodes that are placed on a patient's scalp to monitor that portion of the electroencephalogram which is referred to as the alpha wave.
Classification. Class II (performance standards).

Intracranial pressure monitoring device.

§882.1620
Intracranial pressure monitoring device.
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.
Classification. Class II (performance standards).

Cranial motion measurement device.

§882.1630
Cranial motion measurement device.
Identification. A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.
Classification. Class II (special controls). The special controls for this device are: (1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information: (i) Hardware specifications must be provided. Additionally, verification and validation testing as well as a hazard analysis must be performed. (ii) Software must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Additionally, software verification and validation testing as well as a hazard analysis must be performed. (2) The device parts that contact the patient must be demonstrated to be biocompatible. (3) The device must be designed and tested for electrical, thermal, and mechanical safety, and electromagnetic compatibility (EMC). (4) Clinical performance testing must demonstrate the accuracy, precision, stability, and repeatability of measuring cranial motion per the intended use in the intended use environment. (5) The labeling must include: (i) The intended use population and the intended use environment. (ii) Instructions for technicians to convey to patients regarding the collection of cranial acceleration data to ensure device measurement accuracy, precision, stability, and repeatability. (iii) Information allowing clinicians to understand potential sources of variability in the measurement to help recognize and identify changes in the measurement.

Percussor.

§882.1700
Percussor.
Identification. A percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Pinwheel.

§882.1750
Pinwheel.
Identification. A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9.

Ocular plethysmograph.

§882.1790
Ocular plethysmograph.
Identification. An ocular plethysmograph is a device used to measure or detect volume changes in the eye produced by pulsations of the artery, to diagnose carotid artery occlusive disease (restrictions on blood flow in the carotid artery).
Classification. Class III (premarket approval).

Rheoencephalograph.

§882.1825
Rheoencephalograph.
Identification. A rheoencephalograph is a device used to estimate a patient's cerebral circulation (blood flow in the brain) by electrical impedance methods with direct electrical connections to the scalp or neck area.
Classification. Class III (premarket approval).

Physiological signal amplifier.

§882.1835
Physiological signal amplifier.
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).
Classification. Class II (performance standards).

Physiological signal conditioner.

§882.1845
Physiological signal conditioner.
Identification. A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.
Classification. Class II (performance standards).

Electroencephalogram (EEG) telemetry system.

§882.1855
Electroencephalogram (EEG) telemetry system.
Identification. An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems.
Classification. Class II (performance standards).

Evoked response electrical stimulator.

§882.1870
Evoked response electrical stimulator.
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.
Classification. Class II (performance standards).

Evoked response mechanical stimulator.

§882.1880
Evoked response mechanical stimulator.
Identification. An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response.
Classification. Class II (performance standards).

Evoked response photic stimulator.

§882.1890
Evoked response photic stimulator.
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.
Classification. Class II (performance standards).

Evoked response auditory stimulator.

§882.1900
Evoked response auditory stimulator.
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
Classification. Class II (performance standards).

Ultrasonic scanner calibration test block.

§882.1925
Ultrasonic scanner calibration test block.
Identification. An ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Near Infrared (NIR) Brain Hematoma Detector.

§882.1935
Near Infrared (NIR) Brain Hematoma Detector.
Identification. A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Classification. Class II (special controls). The special controls for this device are: (1) The sale, distribution, and use of this device are restricted to prescription use in accordance with 801.109 of this chapter; (2) The labeling must include specific instructions and the clinical training needed for the safe use of this device; (3) Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics; (4) Performance data should validate accuracy and precision and safety features; (5) Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and, (6) Appropriate software verification, validation, and hazard analysis should be performed.

Tremor transducer.

§882.1950
Tremor transducer.
Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.
Classification. Class II (performance standards).

Neurological Surgical Device

Neurological Surgical Device

Skull plate anvil.

§882.4030
Skull plate anvil.
Identification. A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Ventricular cannula.

§882.4060
Ventricular cannula.
Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.
Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9.

Ventricular catheter.

§882.4100
Ventricular catheter.
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.
Classification. Class II (performance standards).

Neurosurgical chair.

§882.4125
Neurosurgical chair.
Identification. A neurosurgical chair is an operating room chair used to position and support a patient during neurosurgery.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Scalp clip.

§882.4150
Scalp clip.
Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.
Classification. Class II (performance standards).

Aneurysm clip applier.

§882.4175
Aneurysm clip applier.
Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.
Classification. Class II (performance standards).

Clip forming/cutting instrument.

§882.4190
Clip forming/cutting instrument.
Identification. A clip forming/cutting instrument is a device used by the physician to make tissue clips from wire stock.
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

Clip removal instrument.

§882.4200
Clip removal instrument.
Identification. A clip removal instrument is a device used to remove surgical clips from the patient.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Clip rack.

§882.4215
Clip rack.
Identification. A clip rack is a device used to hold or store surgical clips during surgery.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Cryogenic surgical device.

§882.4250
Cryogenic surgical device.
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.
Classification. Class II (performance standards).

Dowel cutting instrument.

§882.4275
Dowel cutting instrument.
Identification. A dowel cutting instrument is a device used to cut dowels of bone for bone grafting.
Classification. Class II (performance standards).

Manual cranial drills, burrs, trephines, and their accessories

§882.4300
Manual cranial drills, burrs, trephines, and their accessories
Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.
Classification. Class II (performance standards).

Powered compound cranial drills, burrs, trephines, and their accessories.

§882.4305
Powered compound cranial drills, burrs, trephines, and their accessories.
Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.
Classification. Class II (performance standards).

Powered simple cranial drills, burrs, trephines, and their accessories.

§882.4310
Powered simple cranial drills, burrs, trephines, and their accessories.
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.
Classification. Class II (performance standards).

Cranial drill handpiece (brace).

§882.4325
Cranial drill handpiece (brace).
Identification. A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Electric cranial drill motor.

§882.4360
Electric cranial drill motor.
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.
Classification. Class II (performance standards).

Pneumatic cranial drill motor.

§882.4370
Pneumatic cranial drill motor.
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.
Classification. Class II (performance standards).

Radiofrequency lesion generator.

§882.4400
Radiofrequency lesion generator.
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.
Classification. Class II (performance standards).

Neurosurgical headrests.

§882.4440
Neurosurgical headrests.
Identification. A neurosurgical headrest is a device used to support the patient's head during a surgical procedure.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Neurosurgical head holder (skull clamp).

§882.4460
Neurosurgical head holder (skull clamp).
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.
Classification. Class II (performance standards).

Cranioplasty material forming instrument.

§882.4500
Cranioplasty material forming instrument.
Identification. A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Microsurgical instrument.

§882.4525
Microsurgical instrument.
Identification. A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Nonpowered neurosurgical instrument.

§882.4535
Nonpowered neurosurgical instrument.
Identification. A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Shunt system implantation instrument.

§882.4545
Shunt system implantation instrument.
Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.
Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9.

Stereotaxic instrument.

§882.4560
Stereotaxic instrument.
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification. Class II (performance standards).

Leukotome.

§882.4600
Leukotome.
Identification. A leukotome is a device used to cut sections out of the brain.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Neurosurgical suture needle.

§882.4650
Neurosurgical suture needle.
Identification. A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9.

Neurosurgical paddie.

§882.4700
Neurosurgical paddie.
A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Classification. Class II (performance standards).

Radiofrequency lesion probe.

§882.4725
Radiofrequency lesion probe.
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.
Classification. Class II (performance standards).

Skull punch.

§882.4750
Skull punch.
Identification. A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under 882.4305.

Self-retaining retractor for neurosurgery.

§882.4800
Self-retaining retractor for neurosurgery.
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.
Classification. Class II (performance standards).

Manual rongeur.

§882.4840
Manual rongeur.
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.
Classification. Class II (performance standards).

Powered rongeur.

§882.4845
Powered rongeur.
Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.
Classification. Class II (performance standards).

Skullplate screwdriver.

§882.4900
Skullplate screwdriver.
Identification. A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Neurological Therapeutic Devices

Neurological Therapeutic Devices

Methyl methacrylate for aneurysmorrhaphy.

§882.5030
Methyl methacrylate for aneurysmorrhaphy.
Identification. Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip.
Classification. Class II (performance standards).

Biofeedback device.

§882.5050
Biofeedback device.
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to 882.9.

Bite block.

§882.5070
Bite block.
Identification. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.
Classification. Class II (performance standards).

Intravascular occluding catheter.

§882.5150
Intravascular occluding catheter.
Identification. An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.
Classification. Class III (premarket approval).

Carotid artery clamp.

§882.5175
Carotid artery clamp.
Identification. A carotid artery clamp is a device that is surgically placed around a patient's carotid artery (the principal artery in the neck that supplies blood to the brain) and has a removable adjusting mechanism that protrudes through the skin of the patient's neck. The clamp is used to occlude the patient's carotid artery to treat intracranial aneurysms (balloonlike sacs formed on blood vessels) or other intracranial vascular malformations that are difficult to attach directly by reducing the blood pressure and blood flow to the aneurysm or malformation.
Classification. Class II (performance standards).

Aneurysm clip.

§882.5200
Aneurysm clip.
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.
Classification. Class II (performance standards).

Implanted malleable clip.

§882.5225
Implanted malleable clip.
Identification. An implanted malleable clip is a bent wire or staple that is forcibly closed with a special instrument to occlude an intracranial blood vessel or aneurysm (a balloonlike sac formed on a blood vessel), stop bleeding, or hold tissue or a mechanical device in place in a patient.
Classification. Class II (performance standards).

Aversive conditioning device.

§882.5235
Aversive conditioning device.
Identification. An aversive conditioning device is an instrument used to administer an electrical shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics.
Classification. Class II (performance standards).

Burr hole cover.

§882.5250
Burr hole cover.
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.
Classification. Class II (performance standards).

Nerve cuff.

§882.5275
Nerve cuff.
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).
Classification. Class II (performance standards).

Methyl methacrylate for cranioplasty.

§882.5300
Methyl methacrylate for cranioplasty.
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.
Classification. Class II (performance standards).

Preformed alterable cranioplasty plate.

§882.5320
Preformed alterable cranioplasty plate.
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.
Classification. Class II (performance standards).

Preformed nonalterable cranioplasty plate.

§882.5330
Preformed nonalterable cranioplasty plate.
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.
Classification. Class II (performance standards).

Cranioplasty plate fastener.

§882.5360
Cranioplasty plate fastener.
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.
Classification. Class II (performance standards).

Lesion temperature monitor.

§882.5500
Lesion temperature monitor.
Identification. A lesion temperature monitor is a device used to monitor the tissue temperature at the site where a lesion (tissue destruction) is to be made when a surgeon uses a radiofrequency (RF) lesion generator and probe.
Classification. Class II (performance standards).

Central nervous system fluid shunt and components.

§882.5550
Central nervous system fluid shunt and components.
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.
Classification. Class II (performance standards).

Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.

§882.5600
Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.
Classification. Class II (special controls). The special controls for this device are: (1) The patient contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including: (i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces. (ii) Mechanical testing to evaluate the radial forces exerted by the device. (iii) Non-clinical testing to verify the dimensions of the device. (iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions. (v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized. (vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions. (vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions. (3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device. (4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life. (5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure. (6) The labeling must include: (i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size. (ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature. (iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events. (iv) A shelf life.

Thermal system for insomnia.

§882.5700
Thermal system for insomnia.
Identification. A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface.
Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate electromagnetic compatibility and electrical safety. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Thermal performance of the device, including maintenance of the target temperature, must be evaluated under simulated use conditions. (ii) Mechanical testing to demonstrate the device can withstand forces under anticipated use conditions. (iii) Mechanical testing to demonstrate the device is resistant to leakage under anticipated use conditions. (4) Software verification, validation, and hazard analysis must be performed. (5) Patient labeling must be provided to convey information regarding safe use of the device, including instructions for assembly.

Cranial electrotherapy stimulator.

§882.5800
Cranial electrotherapy stimulator.
Identification. A cranial electrotherapy stimulator is a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety.
Classification. Class III (premarket approval).

Repetitive transcranial magnetic stimulation system.

§882.5805
Repetitive transcranial magnetic stimulation system.
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.
Classification. Class II (special controls). The special control is FDA's Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System. See 882.1(e) for the availability of this guidance document.

Transcranial magnetic stimulator for headache.

§882.5808
Transcranial magnetic stimulator for headache.
Identification. A transcranial magnetic stimulator device for headache is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electrical currents for the treatment of headache.
Classification. Class II (special controls). The special controls for this device are: (1) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety. (2) Appropriate verification, validation, and hazard analysis must be performed on the device software and firmware. (3) The elements of the device that contact the patient must be assessed to be biocompatible. (4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. This includes full characterization of the magnetic pulse output and resulting magnetic field map. This also includes characterization of the sound level of the device during use. (5) Clinical testing must demonstrate that the device is safe and effective for treating headache in the indicated patient population. (6) The physician and patient labeling must include the following: (i) A summary of the clinical performance testing, including any adverse events and complications. (ii) The intended use population in terms of the types of headaches appropriate for use with the device. (iii) Information on how to report adverse events and device malfunctions. (iv) A diagram or picture depicting the proper placement of the device on the user.

External functional neuromuscular stimulator.

§882.5810
External functional neuromuscular stimulator.
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.
Classification. Class II (performance standards).

Implanted cerebellar stimulator.

§882.5820
Implanted cerebellar stimulator.
Identification. An implanted cerebellar stimulator is a device used to stimulate electrically a patient's cerebellar cortex for the treatment of intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's cerebellum and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification. Class III (premarket approval).

Implanted diaphragmatic/phrenic nerve stimulator.

§882.5830
Implanted diaphragmatic/phrenic nerve stimulator.
Identification. An implanted diaphragmatic/phrenic nerve stimulator is a device that provides electrical stimulation of a patient's phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification. Class III (premarket approval).

Implanted intracerebral/subcortical stimulator for pain relief.

§882.5840
Implanted intracerebral/subcortical stimulator for pain relief.
Identification. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification. Class III (premarket approval).

Implanted spinal cord stimulator for bladder evacuation.

§882.5850
Implanted spinal cord stimulator for bladder evacuation.
Identification. An implanted spinal cord stimulator for bladder evacuation is an electrical stimulator used to empty the bladder of a paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or her bladder by reflex means or by the intermittent use of catheters. The stimulator consists of an implanted receiver with electrodes that are placed on the conus medullaris portion of the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification. Class III (premarket approval).

Implanted neuromuscular stimulator.

§882.5860
Implanted neuromuscular stimulator.
Identification. An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver with electrodes that are placed around a patient's nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. The external transmitter is activated by a switch in the heel in the patient's shoe.
Classification. Class III (premarket approval).

Implanted peripheral nerve stimulator for pain relief.

§882.5870
Implanted peripheral nerve stimulator for pain relief.
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification. Class II (performance standards).

Implanted spinal cord stimulator for pain relief.

§882.5880
Implanted spinal cord stimulator for pain relief.
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification. Class II (performance standards).

Transcutaneous electrical nerve stimulator for pain relief.

§882.5890
Transcutaneous electrical nerve stimulator for pain relief.
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.
Classification. Class II (performance standards).

Transcutaneous electrical nerve stimulator to treat headache.

§882.5891
Transcutaneous electrical nerve stimulator to treat headache.
Identification. A transcutaneous electrical nerve stimulator to treat headache is a device used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety. (3) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (C) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm2, r.m.s.), maximum average current (mA), maximum average power density (W/cm2), and the type of impedance monitoring system must be fully characterized. (4) Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted. (5) Appropriate software verification, validation, and hazard analysis must be performed. (6) Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population. (7) Labeling must include the following: (i) Appropriate contraindications such as not for use in subjects with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator. (ii) Appropriate warnings such as not to apply the device on the neck or chest, not to use the device in the presence of electronic monitoring equipment, not to use in the bath or shower, not to use while sleeping, not to use while driving, not to use while operating machinery. (iii) Appropriate precautions such as the long-term effects of chronic use of the device are unknown. (iv) A summary of the expected risks and benefits of using the device. (v) A summary of the clinical performance data, including information on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications. (vi) Information on how the device operates and the typical sensations experienced during treatment. (vii) A detailed summary of the device technical parameters. (viii) An expiration date/shelf life for the electrodes and the number of times they can be reused. (ix) Disposal instructions.

Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.

§882.5894
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
Identification. A limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is a device intended to alleviate skin reactions associated with insect bites via cutaneous, piezoelectric stimulation at the local site of the bite.
Classification. Class II (special controls). The special controls for this device are: (1) Appropriate testing to characterize the electrical output specifications of the device (i.e., total charge delivered, maximum instantaneous output current, maximum instantaneous output voltage, pulse duration, charge density) must be conducted. (2) Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses. (3) All elements of the device that may contact the patient must be assessed to be biocompatible. (4) Labeling must include: (i) Validated instructions which addresses the following: (A) Identification of areas of the body which are appropriate and not appropriate for contact with the device. (B) Whether use of the device in conjunction with flammable materials (e.g., insect repellent) is appropriate. (C) Use of the device on or near implanted devices. (D) How to identify the correct type of skin condition. (ii) Technical parameters of the device (maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration). (iii) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device. (iv) The anticipated number of device uses prior to failure.

Vibratory counter-stimulation device.

§882.5895
Vibratory counter-stimulation device.
Identification. A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome.
Classification. Class II (special controls). The special controls for this device are: (1) Appropriate analysis/testing must demonstrate electromagnetic compatibility (EMC), electrical safety, and thermal safety. (2) If the device contains software or firmware, appropriate verification, validation, and hazard analysis must be performed. (3) The elements of the device that contact the patient must be assessed to be biocompatible. (4) Non-clinical testing data (including vibration frequency, amplitude, and acceleration) must demonstrate that the device performs as intended under anticipated conditions of use. (5) Labeling must include: (i) Specific information pertinent to use of the device by the intended patient population and the treatment regimen; (ii) Warning to only use the device on normal, intact, clean, healthy skin; (iii) Warning to not use the device if the user has leg skin disorders, such as eczema, psoriasis, cellulitis, non-healing wounds; (iv) Warning to discontinue use if Restless Leg Syndrome symptoms worsen; and (v) Instructions for end users to contact the device manufacturer and MedWatch in case they experience any adverse events when using this device.

Preformed craniosynostosis strip.

§882.5900
Preformed craniosynostosis strip.
Identification. A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.
Classification. Class II (performance standards).

Dura substitute.

§882.5910
Dura substitute.
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain)
Classification. Class II (performance standards).

Electroconvulsive therapy device.

§882.5940
Electroconvulsive therapy device.
Identification. An electroconvulsive therapy device is a device used for treating severe psychiatric disturbances (e.g., severe depression) by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head.
Classification. Class III (premarket approval).

Neurovascular embolization device.

§882.5950
Neurovascular embolization device.
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see 870.3300.
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices. For availability of this guidance document, see 882.1(e).

Skull tongs for traction.

§882.5960
Skull tongs for traction.
Identification. Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.
Classification. Class II (performance standards).

Cranial orthosis.

§882.5970
Cranial orthosis.
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Classification. Class II (special controls) (prescription use in accordance with 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).

Human dura mater.

§882.5975
Human dura mater.
Identification. Human dura mater is human pachymeninx tissue intended to repair defects in human dura mater.
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled Class II Special Controls Guidance Document: Human Dura Mater. See 882.1(e) for the availability of this guidance.