§ 884.4150 - Bipolar endoscopic coagulator-cutter and accessories.

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Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.

Classification. Class II. The special controls for this device are:

FDA's:

“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”

“510(k) Sterility Review Guidance 2/12/90 (K-90),” and

“Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),”

International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,”

American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,”

Labeling:

Indication: For female tubal sterilization, and

Instructions for use:

Destroy at least 2 centimeters of the fallopian tubes,

Use a cut or undampened sinusoidal waveform,

Use a minimum power of 25 watts, and

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.

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§ 884.4120 - Gynecologic electrocautery and accessories.

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§ 884.4160 - Unipolar endoscopic coagulator-cutter and accessories.