eCFR Reference Browser

---

title: "21 CFR §884.4100"

source: "https://www.ecfr.gov/current/title-21/section-884.4100"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "884"

part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"

subpart_code: "E"

subpart_subject: "Obstetrical and Gynecological Surgical Devices"

section_number: "884.4100"

section_subject: "Endoscopic electrocautery and accessories."

cfr_reference: "21 CFR 884.4100"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§884.4100 - Endoscopic electrocautery and accessories.