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(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (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 January 29, 1987 for any transabdominal amnioscope (fetoscope) and accessories that was in commercial distribution before May 28, 1976, or that has on or before January 29, 1987 been found to be substantially equivalent to a transabdominal amnioscope (fetoscope) and accessories that was in commercial distribution before May 28, 1976. Any other transabdominal amnioscope (fetoscope) and accessories shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [45 FR 1268412720, Feb. 26, 1980, as amended at 51 FR 39845, Oct. 31, 1986]

sources. Such culdoscope accessory instruments include: 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, subject to the limitations in $884.9.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001]

8884.1630 Colposcope.

(a) Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

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

$884.1660 Transcervical endoscope

(amnioscope) and accessories. (a) Identification. A transcervical endoscope is a device designed to permit direct viewing of the fetus and amniotic sac by means of an open tube introduced into the uterus through the cervix. The device may be used to visualize the fetus or amniotic fluid and to sample fetal blood or amniotic fluid. This generic type of device may include obturators, instruments used through an operating channel, light sources and cables, and component parts.

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

$ 884.1640 Culdoscope and accessories.

(a) Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.

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

(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, chan nels, or do not have portals for electrosurgical, laser, or other power

$ 884.1690 Hysteroscope and acces.

sories. (a) Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

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

(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 8884.9. [45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001)

part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope 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, subject to the limitations in 8 884.9. [45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, 2001]

$ 884.1700 Hysteroscopic insufflator.

(a) Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

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

(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 8884.9. (45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, 2001)

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 that are not used to effect intraabdominal

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, subject to the limitations in $ 884.9. [45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001]

$ 884.1720 Gynecologic laparoscope

and accessories. (a) Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

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

(2) Class I forgynecologic laparoscope accessories that are not

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 rec- separate fetal heart signals from maommendations for labor management ternal heart signals by analyzing elecand clinical interventions. This generic trocardiographic signals (electrical potype of device may include signal anal- tentials generated during contraction ysis and display equipment, electronic and relaxation of heart muscle) obinterfaces for other equipment, and tained from the maternal abdomen power supplies and component parts. with external electrodes. This generic

(b) Classification: Class III (premarket type of device may include an alarm approval).

that signals when the heart rate (c) Date PMA or notice of completion of crosses a preset threshold. This generic PDP is required. A PMA or a notice of type of device includes the "fetal completion of a PDP is required to be cardiotachometer (with sensors)" and filed with the Food and Drug Adminis- the “fetal electrocardiographic montration on or before October 3, 2000, for itor." any obstetric data analyzer described (b) Classification. Class II (performin paragraph (a) of this section that ance standards). was in commercial distribution before May 28, 1976, or that has been found, on $884.2620 Fetal or before October 3, 2000, to be substan electroencephalographic monitor. tially equivalent to an obstetric data (a) Identification. A fetal analyzer described in paragraph (a) of electroencephalographic monitor is a this section that was in commercial device used to detect, measure, and distribution before May 28, 1976. Any record in graphic form (by means of other obstetric data analyzer described one or more electrodes placed in paragraph (a) of this section shall transcervically on the fetal scalp durhave an approved PMA or declared ing labor) the rhythmically varying completed PDP in effect before being electrical skin potentials produced by placed in commercial distribution.

the fetal brain. [65 FR 41332, July 5, 2000)

(b) Classification. Class III (premarket

approval). 8884.2225 Obstetric-gynecologic ultra (c) Date PMA or notice of completion of sonic imager.

a PDP is required. A PMA or a notice of (a) Identification. An obstetric completion of a PDP is required to be gynecologic ultrasonic imager is a de

filed with the Food and Drug Adminisvice designed to transmit and receive

tration on or before December 26, 1996 ultrasonic energy into and from a fe for any fetal electroencephalographic male patient by pulsed echoscopy. This monitor that was in commercial disdevice is used to provide a visual rep tribution before May 28, 1976, or that resentation of some physiological or has, on or before December 26, 1996 artificial structure, or of a fetus, for di- been found to be substantially equivaagnostic purposes during a limited pe lent to a fetal electroencephalographic riod of time. This generic type of de monitor in commercial distribution bevice may include the following: signal fore May 28, 1976. Any other fetal analysis and display equipment, elec electroencephalographic monitor shall tronic interfaces for other equipment, have an approved PMA or a declared

lent and equipment supports. cou- completed PDP in effect before being pling gel, and component parts. This placed in commercial distribution. generic type of device does not include 145 FR 12684_12720. Feb. 26. 1980. as amended devices used to monitor the changes in at 52 FR 17741, May 11, 1987; 61 FR 50708, Sept. some physiological condition over long 27, 1996] periods of time.

(b) Classification. Class II (perform- $884.2640 Fetal phonocardiographic ance standards).

monitor and accessories.

(a) Identification. A fetal 8884.2600 Fetal cardiac monitor.

phonocardiographic monitor is a device (a) Identification. A fetal cardiac designed to detect, measure, and record monitor is a device used to ascertain fetal heart sounds electronically, in fetal heart activity during pregnancy graphic form, and noninvasively, to asand labor. The device is designed to certain fetal condition during labor.

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This generic type of device includes the signed to establish electrical contact following accessories: signal analysis between fetal skin and an external and display equipment, patient and monitoring device by means of pinchequipment supports, and other compo ing skin tissue with a nonreusable clip. nent parts.

This device is used to obtain a fetal (b) Classification. Class II (perform electrocardiogram. This generic type of ance standards).

device may include a clip electrode ap

plicator. $884.2660 Fetal ultrasonic monitor

(b) Classification. Class III (premarket and accessories.

approval). (a) Identification. A fetal ultrasonic

(c) Date PMA or notice of completion of monitor is a device designed to trans

a PDP is required. A PMA or a notice of mit and receive ultrasonic energy into

completion of a PDP is required to be and from the pregnant woman, usually filed with the Food and Drug Adminisby means of continuous wave (doppler) tration on or before December 26, 1996 echoscopy. The device is used to rep

for any fetal scalp clip electrode and resent some physiological condition or

applicator that was in commercial discharacteristic in a measured value over

tribution before May 28, 1976, or that a period of time (e.g., perinatal moni

has, on or before December 26, 1996 toring during labor) or in an imme been found to be substantially equivadiately perceptible form (e.g., use of

lent to a fetal scalp clip electrode and the ultrasonic stethoscope). This ge

applicator that was in commercial disneric type of device may include the

tribution before May 28, 1976. Any following accessories: signal analysis

other fetal scalp clip electrode and apand display equipment, electronic

plicator shall have an approved PMA or interfaces for other equipment, patient a declared completed PDP in effect beand equipment supports, and compo

fore being placed in commercial disnent parts. This generic type of device

tribution. does not include devices used to image some relatively unchanging physio

[45 FR 12684-12720, Feb. 26, 1980, as amended logical structure or interpret a physio

at 52 FR 17741, May 11, 1987; 61 FR 50708, Sept.

27, 1996) logical condition, but does include devices which may be set to alarm auto

$ 884.2700 Intrauterine pressure monmatically at a predetermined threshold

itor and accessories. value. (b) Classification. Class II (perform

(a) Identification. An intrauterine ance standards).

pressure monitor is a device designed

to detect and measure intrauterine and $884.2675 Fetal scalp circular (spiral) amniotic fluid pressure with a catheter electrode and applicator.

placed transcervically into the uterine (a) Identification. A fetal scalp cir

cavity. The device is used to monitor cular (spiral) electrode and applicator

intensity, duration, and frequency of is a device used to obtain a fetal elec

uterine contractions during labor. This trocardiogram during labor and deliv

generic type of device may include the ery. It establishes electrical contact

following accessories: signal analysis between fetal skin and an external

and display equipment, patient and monitoring device by a shallow sub

equipment supports, and component cutaneous puncture of fetal scalp tis

parts. sue with a curved needle or needles. (b) Classification. Class II (performThis generic type of device includes ance standards). nonreusable spiral electrodes and reusable circular electrodes.

$ 884.2720 External uterine contrac(b) Classification. Class II (perform

tion monitor and accessories. ance standards).

(a) Identification. An external uterine

contraction monitor (i.e., the 8884.2685 Fetal scalp clip electrode tokodynamometer) is a device used to and applicator.

monitor the progress of labor. It meas(a) Identification. A fetal scalp clipures the duration, frequency, and relelectrode and applicator is a device de ative pressure of uterine contractions

with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.

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

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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in $884.9. [45 FR 12684-12720, Feb. 26, 1980, as amended at 66 FR 38809, July 25, 2001)

8884.2730 Home uterine activity mon

itor. (a) Identification. A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions, data transmission by telephone to a clinical setting, and for receipt and display of the uterine contraction data at the clinic. The HUAM system comprises a tocotransducer, an at-home recorder, a modem, and a computer and monitor that receive, process, and display data. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.

(b) Classification. Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors). [66 FR 14076, Mar. 9, 2001)

$884.2960 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 sig. nals for application.

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

8884.2740 Perinatal monitoring system

and accessories. (a) Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may in clude any of the devices subject to $8 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.

(b) Classification. Class II (performance standards). 8884.2900 Fetal stethoscope.

(a) Identification. A fetal stethoscope is a device used for listening to fetal heart sounds. It is designed to transmit

$ 884.2980 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 (general controls).

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