21 C.F.R. § 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
Title 21 - Food and Drugs
(a) 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. (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]
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart E—Obstetrical and Gynecological Surgical Devices
§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
