Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
  • Print
  • Share
  • E-mail
-

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR884.4100]
 See Related Information on Endoscopic electrocautery and accessories. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES

Subpart E - Obstetrical and Gynecological Surgical Devices

Sec. 884.4100 Endoscopic electrocautery and accessories.

(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]

-
-