§884.4100. Endoscopic electrocautery and accessories.
21 C.F.R. § 884.4100
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:
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.
Notes, amendments, and revision history
Amendments
[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.
Amendments
[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]