Subpart E—Obstetrical and Gynecological Surgical Devices

§ 884.2990 21 CFR Ch. I (4–1–10 Edition)

§ 884.2990 Breast lesion documentation Subpart E—Obstetrical and system. Gynecological Surgical Devices (a) Identification. A breast lesion documentation system is a device for use § 884.4100 Endoscopic electrocautery in producing a surface map of the and accessories. breast as an aid to document palpable (a) Identification. An endoscopic breast lesions identified during a clin- electrocautery is a device used to per- ical breast examination. form female sterilization under (b) Classification. Class II (special endoscopic observation. It is designed controls). The special control is FDA’s to coagulate fallopian tube tissue with guidance entitled ‘‘Class II Special a probe heated by low-voltage energy. Controls Guidance Document: Breast This generic type of device may in- Lesion Documentation System.’’ See clude the following accessories: elec- § 884.1(e) for the availability of this trical generators, probes, and electrical guidance document. cables. [68 FR 44415, Aug. 27, 2003] (b) Classification. Class II. The special controls for this device are: Subpart D—Obstetrical and (1) FDA’s: Gynecological Prosthetic Devices (i) ‘‘Use of International Standard ISO 10993 ‘Biological Evaluation of § 884.3200 Cervical drain. Medical Devices—Part I: Evaluation and Testing,’ ’’ (a) Identification. A cervical drain is a (ii) ‘‘510(k) Sterility Review Guidance device designed to provide an exit channel for draining discharge from 2/12/90 (K–90),’’ and the cervix after pelvic surgery. (iii) ‘‘Guidance (‘Guidelines’) for (b) Classification. Class II (perform- Evaluation of Laproscopic Bipolar and ance standards). Thermal Coagulators (and Acces- sories),’’ § 884.3575 Vaginal pessary. (2) International Electrotechnical Commission’s IEC 60601–1–AM2 (1995– (a) Identification. A vaginal pessary is 03), Amendment 2, ‘‘Medical Electrical a removable structure placed in the va- Equipment—Part 1: General Require- gina to support the pelvic organs and is ments for Safety,’’ used to treat conditions such as uterine prolapse (falling down of uterus), (3) American National Standards In- uterine retroposition (backward dis- stitute/American Association for Med- placement), or gynecologic hernia. ical Instrumentation’s HF–18, 1993, (b) Classification. Class II (perform- ‘‘Electrosurgical Devices,’’ ance standards). (4) Labeling: (i) Indication: For female tubal steri- § 884.3650 Fallopian tube prosthesis. lization, and (a) Identification. A fallopian tube (ii) Instructions for use: prosthesis is a device designed to main- (A) Destroy at least 2 centimeters of tain the patency (openness) of the fal- the fallopian tubes, lopian tube and is used after recon- (B) Use a cut or undampened sinus- structive surgery. oidal waveform, (b) Classification. Class II (perform- (C) Use a minimum power of 25 watts, ance standards). and (D) For devices with ammeters: con- § 884.3900 Vaginal stent. tinue electrode activation for 5 seconds (a) Identification. A vaginal stent is a after the visual endpoint (tissue device used to enlarge the vagina by blanching) is reached or current flow stretching, or to support the vagina ceases indicating adequate tissue de- and to hold a skin graft after recon- struction. structive surgery. [45 FR 12684–12720, Feb. 26, 1980, as amended (b) Classification. Class II (perform- at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. ance standards). 31, 2000]

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