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not have adapters, connectors, chan- do not have adapters, connectors, channels, do not have portals for nels, or do not have portals for electrosurgical, laser, or other power electrosurgical, laser, or other power sources. Such culdoscope accessory in- sources. Such hysteroscope accessory struments include: lens cleaning brush, instruments include: lens cleaning biopsy brush, clip applier (without brush, cannula (without trocar or clips), applicatorcannula (without valves), clamp hemostat/grasper, trocar or valves), ligature carrier/nee- rette, instrument guide, forceps, disdle holder, clamp hemostat/grasper, cu- sector, mechanical (noninflatable), and rette, instrument guide, ligature pass- scissors. The devices subject to this ing and knotting instrument, suture paragraph (b)(2) are exempt from the needle (without suture), retractor, me- premarket notification procedures in chanical (noninflatable), snare, stylet, subpart E of part 807 of this chapter. forceps, dissector, mechanical (non-inflatable) scissors, and suction/irriga

(45 FR 12684–12720, Feb. 26, 1980, as amended

at 61 FR 1123, Jan. 16, 1996] tion probe. The devices subject to this paragraph (b)(2) are exempt from the

8884.1700 Hysteroscopic insufflator. premarket notification procedures in subpart E of part 807 of this chapter.

(a) Identification. A hysteroscopic

insufflator is a device designed to dis(45 FR 12684–12720, Feb. 26, 1980, as amended

tend the uterus by filling the uterine at 61 FR 1123, Jan. 16, 1996)

cavity with a liquid or gas to facilitate 8884.1660 Transcervical endoscope

viewing with a hysteroscope. (amnioscope) and accessories.

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

formance standards). (a) Identification. A transcervical en

(2) Class I for tubing and tubing/filter doscope is a device designed to permit

fits which only include accessory indirect viewing of the fetus and

struments which are not used to effect amniotic sac by means of an open tube

intrauterine access e.g. hysteroscopic introduced into the uterus through the

introducer sheaths, etc.; and single-use cervix. The device may be used to vis

tubing kits used for only intrauterine ualize the fetus or amniotic fluid and

insufflation. The devices subject to this to sample fetal blood or amniotic fluid.

paragraph (b)(2) are exempt from the This generic type of device may in

premarket notification procedures in clude obturators, instruments used

subpart E of part 807 of this chapter. through an operating channel, light sources and cables, and component (45 FR 12684-12720, Feb. 26, 1980, as amended parts.

at 61 FR 1124, Jan. 16, 1996] (b) Classification. Class II (performance standards).

8884.1720 Gynecologic laparoscope

and accessories. 8884.1690 Hysteroscope and

(a) Identification. A gynecologic sories.

laparoscope is a device used to permit (a) Identification. A hysteroscope is a direct viewing of the organs within the device used to permit direct viewing of peritoneum by a telescopic system inthe cervical canal and the uterine cav- troduced through the abdominal wall. ity by a telescopic system introduced It is used to perform diagnostic and into the uterus through the cervix. It is surgical procedures on the female genused to perform diagnostic and surgical ital organs. This generic type of device procedures other than sterilization. may include: Trocar and cannula, inThis generic type of device may in- struments used through an operating clude obturators and sheaths, instru- channel, scope preheater, light source ments used through an operating chan- and cables, and component parts. nel, scope preheaters, light sources and (b) Classification. (1) Class II (percables, and component parts.

formance standards). (b) Classification. (1) Class II (per- (2) Class I for gynecologic formance standards).

laparoscope accessories that are not (2) Class I for hysteroscope acces- part of a specialized instrument or desories that are not part of a specialized vice delivery system, do not have instrument or device delivery system; adapters, connector channels, or do not

acces

have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparoscope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996)

interfaces for other equipment, and power supplies and component parts.

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

(c) Date PMA or notice of completion of 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 October 3, 2000, for any obstetric data analyzer described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has been found, on or before October 3, 2000, to be substantially equivalent to an obstetric data analyzer described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other obstetric data analyzer described in paragraph (a) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [65 FR 41332, July 5, 2000)

8884.1730 Laparoscopic insufflator.

(a) Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

(b) Classification. (1) Class II (performance standards).

(2) Class I for tubing and tubing/filter kits which include accessory instruments which are not used to effect intra-abdominal access, Verres needles etc.; and single-use tubing kits used for only intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996)

§ 884.2225 Obstetric-gynecologic ultra

sonic imager. (a) Identification. An obstetricgynecologic ultrasonic imager is a device designed to transmit and receive ultrasonic energy into and from a female patient by pulsed echoscopy. This device is used to provide a visual representation of some physiological or artificial structure, or of a fetus, for diagnostic purposes during a limited period of time. This generic type of device may include the following: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, coupling gel, and component parts. This generic type of device does not include devices used to monitor the changes in some physiological condition over long periods of time.

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

Subpart C-Obstetrical and Gyne

cological Monitoring Devices

8884.2050 Obstetric data analyzer.

(a) Identification. An obstetric data analyzer (fetal status data analyzer) is a device used during labor to analyze electronic signal data obtained from fetal and maternal monitors. The obstetric data analyzer provides clinical diagnosis of fetal status and recommendations for labor management and clinical interventions. This generic type of device may include signal analysis and display equipment, electronic

8 884.2600 Fetal cardiac monitor.

(a) Identification. A fetal cardiac monitor is a device used to ascertain fetal heart activity during pregnancy and labor. The device is designed to separate fetal heart signals from maternal heart signals by analyzing electrocardiographic signals (electrical potentials generated during contraction

(a)

more

and relaxation of heart muscle) ob- equipment supports, and other compotained from the maternal abdomen nent parts. with external electrodes. This generic (b) Classification. Class II (performtype of device may include an alarm ance standards). that signals when the heart rate crosses a preset threshold. This generic 8884.2660 Fetal ultrasonic monitor type of device includes the “fetal

and accessories. cardiotachometer (with sensors)" and

(a) Identification. A fetal ultrasonic the “fetal electrocardiographic mon

monitor is a device designed to transitor."

mit and receive ultrasonic energy into (b) Classification. Class II (perform- and from the pregnant woman, usually ance standards).

by means of continuous wave (doppler)

echoscopy. The device is used to rep8884.2620 Fetal

resent some physiological condition or electroencephalographic monitor.

characteristic in a measured value over Identification. A fetal a period of time (e.g., perinatal monielectroencephalographic monitor is a toring during labor) or in an immedevice used to detect, measure, and diately perceptible form (e.g., use of record in graphic form (by means of the ultrasonic stethoscope). This geone or

electrodes placed neric type of device may include the transcervically on the fetal scalp dur- following accessories: signal analysis ing labor) the rhythmically varying and display equipment, electronic electrical skin potentials produced by interfaces for other equipment, patient the fetal brain.

and equipment supports, and compo(b) Classification. Class III (premarket nent parts. This generic type of device approval).

does not include devices used to image (c) Date PMA or notice of completion of some relatively unchanging physioa PDP is required. A PMA or a notice of logical structure or interpret a physiocompletion of a PDP is required to be logical condition, but does include defiled with the Food and Drug Adminis- vices which may be set to alarm autotration on or before December 26, 1996 matically at a predetermined threshold for any fetal electroencephalographic value. monitor that was in commercial dis- (b) Classification. Class II (performtribution before May 28, 1976, or that ance standards). has, on or before December 26, 1996 been found to be substantially equiva- $ 884.2675 Fetal scalp. circular (spiral) lent to a fetal electroencephalographic

electrode and applicator. monitor in commercial distribution be

(a) Identification. A fetal scalp cirfore May 28, 1976. Any other fetal

cular (spiral) electrode and applicator electroencephalographic monitor shall is a device used to obtain a fetal elechave an approved PMA or a declared trocardiogram during labor and delivcompleted PDP in effect before being

ery. It establishes electrical contact placed in commercial distribution.

between fetal skin and an external [45 FR 12684–12720, Feb. 26, 1980, as amended

monitoring device by a shallow subat 52 FR 17741, May 11, 1987; 61 FR 50708, Sept.

cutaneous puncture of fetal scalp tis27, 1996]

sue with a curved needle or needles.

This generic type of device includes 8 884.2640 Fetal phonocardiographic nonreusable spiral electrodes and reusmonitor and accessories.

able circular electrodes. (a) Identification. A fetal (b) Classification. Class II (performphonocardiographic monitor is a device ance standards). designed to detect, measure, and record fetal heart sounds electronically, in

8884.2685 Fetal scalp clip electrode graphic form, and noninvasively, to as

and applicator. certain fetal condition during labor. (a) Identification. A fetal scalp clip This generic type of device includes the electrode and applicator is a device defollowing accessories: signal analysis signed to establish electrical contact and display equipment, patient and between fetal skin and an external monitoring device by means of pinch- sure transducer, support straps, and ing skin tissue with a nonreusable clip. other patient and equipment supports. This device is used to obtain a fetal (b) Classification. Class II (performelectrocardiogram. This generic type of ance standards). device may include a clip electrode applicator.

8884.2730 Home uterine activity mon. (b) Classification. Class III (premarket

itor. approval).

(a) Identification. A home uterine ac(c) Date PMA or notice of completion of tivity monitor (HUAM) is an electronic a PDP is required. A PMA or a notice of system for at home antepartum meascompletion of a PDP is required to be urement of uterine contractions, data filed with the Food and Drug Adminis- transmission by telephone to a clinical tration on or before December 26, 1996 setting, and for receipt and display of for any fetal scalp clip electrode and the uterine contraction data at the applicator that was in commercial dis- clinic. The HUAM system comprises a tribution before May 28, 1976, or that tocotransducer, an at-home recorder, a has, on or before December 26, 1996 modem, and a computer and monitor been found to be substantially equiva- that receive, process, and display data. lent to a fetal scalp clip electrode and

This device is intended for use in applicator that was in commercial dis- women with a previous preterm delivtribution before May 28, 1976. Any ery to aid in the detection of preterm other fetal scalp clip electrode and ap- labor. plicator shall have an approved PMA or (b) Classification. Class II (special a declared completed PDP in effect be- controls); guidance document (Class II fore being placed in commercial dis- Special Controls Guidance for Home tribution.

Uterine Activity Monitors). [45 FR 12684–12720, Feb. 26, 1980, as amended

[66 FR 14076, Mar. 9, 2001] at 52 FR 17741, May 11, 1987; 61 FR 50708, Sept. EFFECTIVE DATE NOTE: At 66 FR 14076, Mar. 27, 1996)

9, 2001, $884.2730 was added to subpart C of

part 884, effective Apr. 9, 2001. 8884.2700 Intrauterine pressure mon. itor and accessories.

$884.2740 Perinatal monitoring system (a) Identification. An intrauterine and accessories. pressure monitor is a device designed (a) Identification. A perinatal monito detect and measure intrauterine and toring system is a device used to show amniotic fluid pressure with a catheter graphically the relationship between placed transcervically into the uterine maternal labor and the fetal heart rate cavity. The device is used to monitor by means of combining and coordiintensity, duration, and frequency of nating uterine contraction and fetal uterine contractions during labor. This heart monitors with appropriate disgeneric type of device may include the plays of the well-being of the fetus durfollowing accessories: signal analysis ing pregnancy, labor, and delivery. and display equipment, patient and This generic type of device may inequipment supports, and component clude any of the devices subject to parts.

$8 884.2600, 884.2640, 884.2660, 884.2675, (b) Classification. Class II (perform- 884.2700, and 884.2720. This generic type ance standards).

of device may include the following ac

cessories: Central monitoring system $884.2720 External uterine contrac- and remote repeaters, signal analysis tion monitor and accessories.

and display equipment, patient and (a) Identification. An external uterine equipment supports, and component contraction monitor (i.e.,

parts. tokodynamometer) is a device used to (b) Classification. Class II (performmonitor the progress of labor. It meas- ance standards). ures the duration, frequency, and relative pressure of uterine contractions

$884.2900 Fetal stethoscope. with a transducer strapped to the ma- (a) Identification. A fetal stethoscope ternal abdomen. This generic type of is a device used for listening to fetal device may include an external pres- heart sounds. It is designed to transmit

the

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]

the fetal heart sounds not only through sound channels by air conduction, but also through the user's head by tissue conduction into the user's ears. It does not use ultrasonic energy. This device is designed to eliminate noise interference commonly caused by handling conventional stethoscopes.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. 8884.2960 Obstetric ultrasonic trans

ducer and accessories. (a) Identification. An obstetric ultrasonic transducer is a device used to apply ultrasonic energy to, and to receive ultrasonic energy from, the body in conjunction with an obstetric monitor or imager. The device converts electrical signals into ultrasonic energy, and vice versa, by means of an assembly distinct from an ultrasonic generator. This generic type of device may include the following accessories: coupling gel, preamplifiers, amplifiers, signal conditioners with their power supply, connecting cables, and component parts. This generic type of device does not include devices used to generate the ultrasonic frequency electrical signals for application.

(b) Classification. Class II (performance standards). 8884.2980 Telethermographic system.

(a) Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses-(1) Identification. A telethermographic system for adjunctive diagnostic screening 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 I.

(b) Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses-(1) Identification. A telethermographic

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.

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

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