Endoscopic electrocautery and accessories.

§884.4100
Endoscopic electrocautery and accessories.
Identification. An endoscopic electrocautery is a device used to perform female sterilization under endoscopic observation. It is designed to coagulate fallopian tube tissue with a probe heated by low-voltage energy. This generic type of device may include the following accessories: electrical generators, probes, and electrical cables.
Classification. Class II. The special controls for this device are: (1) FDA's: (i) Use of International Standard ISO 10993 Biological Evaluation of Medical DevicesPart I: Evaluation and Testing, (ii) 510(k) Sterility Review Guidance 2/12/90 (K-90), and (iii) Guidance (Guidelines) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories), (2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, Medical Electrical EquipmentPart 1: General Requirements for Safety, (3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, Electrosurgical Devices, (4) Labeling: (i) Indication: For female tubal sterilization, and (ii) Instructions for use: (A) Destroy at least 2 centimeters of the fallopian tubes, (B) Use a cut or undampened sinusoidal waveform, (C) Use a minimum power of 25 watts, and (D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.