[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.4100]

[Page 457]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884_OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
        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 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987; 65 FR 17146, Mar. 31, 2000]