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(b) Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses (1) Identification. A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(2) Classification. Class III.

(3) Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See $ 884.3. (53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48440, Nov. 20, 1990; 66 FR 46953, Sept. 10, 2001)

or other uses-(1) Identification. A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for use as the sole diagnostic screening tool for detection of breast cancer or other uses is a nonelectrically powered or an AC-powered device applied to the skin that displays the color patterns of heat sensitive cholesteric liquid crystals that respond to temperature variations of the surface of the body. This generic type of device may include image display and recording equipment, patient and equipment supports, a means to ensure thermal contact between the patient's skin and the liquid crystals, component parts, and accessories.

(2) Classification. Class III.

(3) Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments. May 28. 1976. an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.

(53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48441, Nov. 20, 1990; 66 FR 46953, Sept. 10, 2001]

8884.2982 Liquid crystal thermo

graphic system. (a) A nonelectrically powered or an ACpowered liquid crystal thermographic system intended for adjunctive use in diagnostic screening for detection of breast cancer or other uses-(1) Identification. A nonelectrically powered or an AC-Powered liquid crystal thermographic system intended for use as an adjunct to physical palpation or mammography in diagnostic screening for detection of breast cancer or other uses is a nonelectrically powered or an AC-powered device applied to the skin that displays the color patterns of heat sensitive cholesteric liquid crystals that respond to temperature variations of the surface of the body. This generic type of device may include patient and equipment supports, a means to ensure thermal contact between the patient's skin and the liquid crystals, component parts, and accessories.

(2) Classification. Class I (general controls).

(b) A nonelectrically powered or an ACpowered liquid crystal thermographic system intended for use alone in diagnostic screening for detection of breast cancer

8884.2990 Breast lesion documentation

system. (a) Identification. A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination.

(b) Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See $ 884.1(e) for the availability of this guidance document. [68 FR 44415, Aug. 27, 2003]

Subpart D-Obstetrical and Gynecological Prosthetic Devices $ 884.3200 Cervical drain.

(a) Identification. A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic surgery.

(b) Classification. Class II (performance standards).

$ 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 Requiregina to support the pelvic organs and is used to treat conditions such as uter

ments for Safety, ine prolapse (falling down of uterus),

(3) American National Standards In

stitute/American Association for Meduterine retroposition (backward displacement), or gynecologic hernia.

ical Instrumentation's HF-18, 1993,

“Electrosurgical Devices,". (b) Classification. Class II (perform

(4) Labeling: ance standards).

(i) Indication: For female tubal steri8884.3650 Fallopian tube prosthesis. lization, and

(ii) Instructions for use: (a) Identification. A fallopian tube

(A) Destroy at least 2 centimeters of prosthesis is a device designed to main

the fallopian tubes, tain the patency (openness) of the fal

(B) Use a cut or undampened sinuslopian tube and is used after recon

oidal waveform, structive surgery.

(C) Use a minimum power of 25 watts, (b) Classification. Class II (perform

and ance standards).

(D) For devices with ammeters: con$884.3900 Vaginal stent.

tinue electrode activation for 5 seconds

after the visual endpoint (tissue (a) Identification. A vaginal stent is a

blanching) is reached or current flow device used to enlarge the vagina by ceases indicating adequate tissue destretching, or to support the vagina

struction. and to hold a skin graft after reconstructive 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.

31, 2000) ance standards).

$ 884.4120 Gynecologic electrocautery Subpart E-Obstetrical and

and accessories. Gynecological Surgical Devices (a) Identification. A gynecologic

electrocautery is a device designed to 8884.4100 Endoscopic electrocautery

destroy tissue with high temperatures and accessories.

by tissue contact with an electrically (a) Identification. An endoscopic heated probe. It is used to excise cerelectrocautery is a device used to per- vical lesions, perform biopsies, or treat form female sterilization under chronic cervicitis under direct visual endoscopic observation. It is designed observation. This generic type of deto coagulate fallopian tube tissue with vice may include the following accesa probe heated by low-voltage energy sories: an electrical generator, a probe, This generic type of device may in- and electrical cables. clude the following accessories: elec (b) Classification. Class II (performtrical generators, probes, and electrical ance standards). cables.

(b) Classification. Class II. The special $884.4150 Bipolar endoscopic coagucontrols for this device are:

lator-cutter and accessories. (1) FDA's:

(a) Identification. A bipolar (i) “Use of International Standard endoscopic coagulator-cutter is a deISO 10993 ‘Biological Evaluation of vice used to perform female sterilizaMedical Devices-Part I: Evaluation tion and other operative procedures and Testing,' "'.

under endoscopic observation. It de(ii) “510(k) Sterility Review Guidance stroys tissue with high temperatures 2/12/90 (K-90)," and

by directing a high frequency electrical (iii) “Guidance ("Guidelines') for current through tissue between two Evaluation of Laproscopic Bipolar and electrical contacts of a probe. This geThermal Coagulators (and Acces- neric type of device may include the sories),”

following accessories: an electrical generator, probes, and electrical ca- plate. This generic type of device does bles.

not include devices used to perform fe(b) Classification. Class II. The special male sterilization under hysteroscopic controls for this device are:

observation. (1) FDA's:

(b) Classification. Class II (perform(i) "Use of International Standard ance standards). ISO 10993 "Biological Evaluation of Medical Devices—Part 1: Evaluation $884.4250 Expandable cervical dilator. and Testing,'"

(a) Identification. An expandable cer(ii) “510(k) Sterility Review Guidance

vical dilator is an instrument with two 2/12/90 (K-90)," and

handles and two opposing blades used (iii) “Guidance ("Guidelines') for

manually to dilate (stretch open) the Evaluation of Laproscopic Bipolar and

cervical os. Thermal Coagulators (and Acces

(b) Classification. Class III (premarket sories)." (2) International Electrotechnical

approval). ational Electrotechnical Commission's IEC 60601-1-AM2 (1995

(c) Date PMA or notice of completion of 03), Amendment 2, “Medical Electrical

a PDP is required. A PMA or a notice of

completion of a PDP is required to be Equipment- Part 1: General Require

filed with the Food and Drug Adminisments for Safety,".

tration on or before December 26, 1996 (3) American National Standards Institute/American Association for Med

for any expandable cervical dilator

that was in commercial distribution ical Instrumentation's HF-18, 1993,

before May 28, 1976, or that has, on or "Electrosurgical Devices,”

before December 26, 1996 been found to (4) Labeling: (i) Indication: For female tubal steri

be substantially equivalent to an exlization, and

pandable cervical dilator that was in

commercial distribution before May 28, (ii) Instructions for use: (A) Destroy at least 2 centimeters of

1976. Any other expandable cervical dithe fallopian tubes,

lator shall have an approved PMA or a (B) Use a cut or undampened sinus

declared completed PDP in effect beoidal waveform,

fore being placed in commercial dis(C) Use a minimum power of 25 watts,

tribution. and

[45 FR 12684-12720, Feb. 26, 1980, as amended (D) For devices with ammeters: con- at 52 FR 17741, May 11, 1987; 61 FR 50708, Sept. tinue electrode activation for 5 seconds 27, 1996) after the visual endpoint (tissue blanching) is reached or current flow

8884.4260 Hygroscopic Laminaria cerceases indicating adequate tissue de

vical dilator. struction.

(a) Identification. A hygroscopic Lam

inaria cervical dilator is a device de(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar.

signed to dilate (stretch open) the cer31, 2000)

vical os by cervical insertion of a con

ical and expansible material made from 8884.4160 Unipolar endoscopic coagu the root of a seaweed (Laminaria lator-cutter and accessories.

digitata or Laminaria japonica). The de(a) Identification. A unipolar vice is used to induce abortion. endoscopic coagulator-cutter is a de (b) Classification. Class II (performvice designed to destroy tissue with ance standards). high temperatures by directing a high frequency electrical current through

$884.4270 Vibratory cervical dilators. the tissue between an energized probe (a) Identification. A vibratory cervical and a grounding plate. It is used in fe dilator is a device designed to dilate male sterilization and in other opera- the cervical os by stretching it with a tive procedures under endoscopic obser power-driven vibrating probe head. The vation. This generic type of device may device is used to gain access to the include the following accessories: an uterus or to induce abortion, but is not electrical generator, probes and elec- to be used during labor when a viable trical cables, and a patient grounding fetus is desired or anticipated.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any vibratory cervical dilator that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a vibratory cervical dilator that was in commercial distribution before May 28, 1976. Any other vibratory cervical dilator shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (45 FR 12684–12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, 1996)

8884.4340 Fetal vacuum extractor.

(a) Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.

(b) Classification. Class II (performance standards).

8884.4520 Obstetric-gynecologic gen.

eral manual instrument. (a) Identification. An obstetricgynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

(1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes.

(2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

(3) A metal vaginal speculum is a metal instrument used to expose the interior interior of the vagina.

(4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord.

(5) A uterine clamp is an instrument used to hold the uterus by compression.

(6) A uterine packer is an instrument used to introduce dressing into the uterus or vagina.

(7) A vaginal applicator is an instrument used to insert medication into the vagina.

(8) A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back the tissue.

(9) A gynecological fibroid hook is an instrument used to exert traction upon a fibroid.

(10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.

(b) Classification. Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in $ 884.9.

$ 884.4400 Obstetric forceps.

(a) Identification. An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.

(b) Classification. Class II (performance standards).

$ 884.4500 Obstetric fetal destructive

instrument. (a) Identification. An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery of a dead or anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast, craniotribe, and destructive hook.

(b) Classification. Class II (performance standards).

[45 FR 12684-12720, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, 2001]

$884.4530 Obstetric-gynecologic spe

cialized manual instrument. (a) Identification. An obstetricgynecologic specialized manual instrument is one of a group of devices used

during obstetric-gynecologic proce- (15) A uterine tenaculum is a hookdures to perform manipulative diag- like instrument used to seize and hold nostic and surgical functions (e.g., di- the cervix or fundus. lating, grasping, measuring, and scrap (16) An internal pelvimeter is an ining), where structural integrity is the strument used within the vagina to chief criterion of device performance. measure the diameter and capacity of This type of device consists of the fol- the pelvis. lowing:

(17) A nonmetal vaginal speculum is (1) An amniotome is an instrument a nonmetal instrument used to expose used to rupture the fetal membranes. the interior of the vagina. (2) A circumcision clamp is an instru

(18) A fiberoptic nonmetal vaginal ment used to compress the foreskin of speculum is a nonmetal instrument, the penis during circumcision of a male

with fiberoptic light, used to expose infant.

and illuminate the interior of the va(3) An umbilical clamp is an instru

gina. ment used to compress the umbilical

(b) Classification. (1) Class II (percord.

formance standards). (4) A uterine curette is an instrument

(2) Class I for the amniotome, uterine used to scrape and remove material

curette, cervical dilator (fixed-size boufrom the uterus.

gies), cerclage needle, IUD remover,

uterine sound, and gynecological bi(5) A fixed-size cervical dilator is any

opsy forceps. The devices subject to of a series of bougies of various sizes used to dilate the cervical os by

this paragraph (b)(2) are exempt from

the premarket notification procedures stretching the cervix.

in subpart E of part 807 of this chapter, (6) A uterine elevator is an instru

subject to the limitations in $884.9. ment inserted into the uterus used to lift and manipulate the uterus.

[45 FR 12684-12720, Feb. 26, 1980, as amended (7) A gynecological surgical forceps is

at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July

25, 2001) an instrument with two blades and handles used to pull, grasp, or com- 8884.4550 Gynecologic surgical laser. press during gynecological examination.

(a) Identification. A gynecologic sur(8) A cervical cone knife is a cutting

gical laser is a continuous wave carbon instrument used to excise and remove

dioxide laser designed to destroy tissue

thermally or to remove tissue by raditissue from the cervix.

ant light energy. The device is used (9) A gynecological cerclage needle is

only in conjunction with a colposcope a looplike instrument used to suture

as part of a gynecological surgical systhe cervix.

tem. A colposcope is a magnifying lens (10) A hook-type contraceptive intra

system used to examine the vagina and uterine device (IUD) remover is an in

cervix. strument used to remove an IUD from

(b) Classification. Class II (performthe uterus.

ance standards). (11) A gynecological fibroid screw is an instrument used to hold onto a fi- $884.4900 Obstetric table and accesbroid.

sories. (12) A uterine sound is an instrument

(a) Identification. An obstetric table is used to determine the depth of the a device with adjustable sections deuterus by inserting it into the uterine signed to support a patient in the varcavity.

ious positions required during obstetric (13) A cytological cervical spatula is and gynecologic procedures. This gea blunt instrument used to scrape and neric type of device may include the remove cytological material from the following accessories: patient equipsurface of the cervix or vagina.

ment, support attachments, and cabi(14) A gynecological biopsy forceps is nets for warming instruments and disan instrument with two blades and posing of wastes. handles used for gynecological biopsy (b) Classification. Class II (performprocedures.

ance standards).

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