§ 884.4100. Endoscopic electrocautery and accessories.
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/us/cfr/t21/s§ 884.4100·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]
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§ 884.4100
Endoscopic electrocautery and accessories.
Fed. Reg.×1
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