21 CFR §884.4100

1. (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.
2. (b)Classification. Class II. The special controls for this device are:
   1. (1)FDA's:
      1. (i)“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
      2. (ii)“510(k) Sterility Review Guidance 2/12/90 (K-90),” and
      3. (iii)“Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),”
   2. (2)International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,”
   3. (3)American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,”
   4. (4)Labeling:
      1. (i)Indication: For female tubal sterilization, and
      2. (ii)Instructions for use:
         1. (A)Destroy at least 2 centimeters of the fallopian tubes,
         2. (B)Use a cut or undampened sinusoidal waveform,
         3. (C)Use a minimum power of 25 watts, and
         4. (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.