(a) 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.
(b) Classification. Class II. The special controls for this device are:
(1) FDA's:
(i) ``Use of International Standard ISO 10993 `Biological Evaluation of Medical Devices--Part 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 Equipment--Part 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. [45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]