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

(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 intravascular occluding catheter 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 an intravascular occluding catheter that was in commercial distribution before May 28, 1976. Any other intravascular occluding catheter shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996)

8 882.5235 Aversive conditioning de

vice. (a) Identification. An aversive conditioning device is an instrument used to administer an electrical shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics.

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

8 882.5250 Burr hole cover.

(a) Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

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

8 882.5275 Nerve cuff.

(a) Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).

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

$ 882.5175 Carotid artery clamp.

(a) Identification. A carotid artery clamp is a device that is surgically placed around a patient's carotid artery (the principal artery in the neck that supplies blood to the brain) and has a removable adjusting mechanism that protrudes through the skin of the patient's neck. The clamp is used to occlude the patient's carotid artery to treat intracranial aneurysms (balloonlike sacs formed on blood vessels) or other intracranial vascular malformations that are difficult to attach directly by reducing the blood pressure and blood flow to the aneurysm or malformation.

(b) Classification. Class II (performance standards). 8 882.5200 Aneurysm clip. (a) Identification. An aneurysm clip is

device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.

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

8882.5300 Methyl methacrylate for

cranioplasty (a) Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

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

a

8 882.5225 Implanted malleable clip.

(a) Identification. An implanted malleable clip is a bent wire or staple that is forcibly closed with a special instrument to occlude an intracranial blood vessel or aneurysm (a balloonlike sac formed on a blood vessel), stop bleeding, or hold tissue or a mechanical device in place in a patient.

$ 882.5320 Preformed

alterable cranioplasty plate. (a) Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

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

[blocks in formation]

8882.5800 Cranial electrotheraphy

stimulator. (a) Identification. A cranial electrotheraphy stimulator is a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety.

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

(c) Date a PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See $ 882.3. [44 FR 51730–51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 60 FR 43969, Aug. 24, 1995; 62 FR 30457, June 4, 1997) 8882.5810 External functional neuro

muscular stimulator. (a) Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

(b) Classification. Class II (performance standards). 8 882.5820 Implanted cerebellar stimu

lator. (a) Identification. An implanted cerebellar stimulator is a device used to stimulate electrically a patient's cerebellar cortex for the treatment of intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's cerebellum and external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

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

(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 26, 1984. Any implanted cerebellar stimulator that was not in commercial distribution before May 28, 1976, or that has not on or before September 26, 1984 been found by FDA to be substantially equivalent to

nervous

an

8882.5550 Central

system fluid shunt and components. (a) Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.

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

an implanted cerebellar stimulator that was in commercial distribution before May 28, 1976 shall have an approved PMA or declared completed PDP in effect before beginning commercial distribution. (44 FR 51730-51778, Sept. 4, 1979 and 49 FR 26574, June 28, 1984)

8 882.5830 Implanted diaphragmatic/

phrenic nerve stimulator. (a) Identification. An implanted diaphragmatic/phrenic nerve stimulator is a device that provides electrical stimulation of a patient's phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

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

(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 July 7, 1986 for any implanted diaphragmatic/phrenic nerve stimulator that was in commercial distribution before May 28, 1976, or that has on or before July 7, 1986 been found to be substantially equivalent to an implanted diaphragmatic/phrenic nerve stimulator that was in commercial distribution before May 28, 1976. Any other implanted diaphragmatic/phrenic nerve stimulator shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (44 FR 51730-51778, Sept. 4, 1979, as amended at 51 FR 12101, Apr. 8, 1986)

for pain relief is a device that applies electrical current to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

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

(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 Food and Drug Administration on or before March 1, 1989, for any implanted intracerebral/subcortical stimulator for pain relief that was in commercial distribution before May 28, 1976, or that has on or before March 1, 1989, been found to be substantially equivalent

to an implanted intracerebral/subcortical stimulator for pain relief that was in commercial distribution before May 28, 1976. Any other implanted intracerebral/su cortical stimulator for pain relief shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (44 FR 51730–51778, Sept. 4, 1979, as amended at 53 FR 48621, Dec. 1, 1988)

8 882.5850 Implanted spinal cord stim

ulator for bladder evacuation. (a) Identification. An implanted spinal cord stimulator for bladder evacuation is an electrical stimulator used to empty the bladder of a paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or her bladder by reflex means or by the intermittent use of catheters. The stimulator consists of an implanted receiver with electrodes that are placed on the conus medullaris portion of the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

(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

8882.5840 Implanted intracerebral

subcortical stimulator for pain re

lief. (a) Identification. An implanted intracerebral/subcortical stimulator

194-069 D-01--14

PDP in effect before being placed in commercial distribution. [44 FR 51730–51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 64 FR 18329, Apr, 14, 1999)

filed with the Food and Drug Administration on or before December 26, 1996 for any implanted spinal cord stimulator for bladder evacuation 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 an implanted spinal cord stimulator for bladder evacuation that was in commercial distribution before May 28, 1976. Any other implanted spinal cord stimulator for bladder evacuation shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

8 882.5870 Implanted peripheral nerve

stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an inplanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

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

[44 FR 51730–51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996)

8 882.5880 Implanted spinal cord stim.

ulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

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

8882.5860 Implanted neuromuscular

stimulator. (a) Identification. An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver with electrodes that are placed around a patient's nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. The external transmitter is activated by a switch in the heel in the patient's shoe.

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

(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any implanted neuromuscular stimulator that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an implanted neuromuscular stimulator that was in commercial distribution before May 28, 1976. Any other implanted neuromuscular stimulator shall have an approved PMA or declared completed

8 882.5890 Transcutaneous electrical

nerve stimulator for pain relief. (a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

(b) Classification. Class II (performance standards). 8882.5900 Preformed craniosynostosis

strip. (a) Identification. A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.

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

$ 882.5910 Dura substitute.

(a) Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

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

8 882.5970 Cranial orthosis.

(a) Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic

positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

(b) Classification. Class II (special controls) (prescription use in accordance with $801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)). [63 FR 40651, July 30, 1998]

8 882.5940 Electroconvulsive therapy

device. (a) Identification.

An electroconvulsive therapy device is a device used for treating severe psychiatric disturbances (e.g., severe depression) by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head.

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

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See $ 882.3. (44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987)

PART 884-OBSTETRICAL AND GYNECOLOGICAL DEVICES

Subpart A-General Provisions

Sec. 884.1 Scope. 884.3 Effective dates of requirement for pre

market approval. 884.9 Limitations of exemptions from sec

tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B-Obstetrical and Gynecological

Diagnostic Devices

$ 882.5950 Artificial embolization de

vice. (a) Identification. An artificial embolization device is an object that is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation.

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

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See $882.3. (44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987)

$ 882.5960 Skull tongs for traction.

(a) Identification. Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.

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

884.1040 Viscometer for cervical mucus. 884.1050 Endocervical aspirator. 884.1060 Endometrial aspirator. 884.1100 Endometrial brush. 884.1175 Endometrial suction curette and

accessories. 884.1185 Endometrial washer. 884.1300 Uterotubal carbon dioxide

insufflator and accessories. 884.1425 Perineometer. 884.1550 Amniotic fluid sampler

(amniocentesis tray). 884.1560 Fetal blood sampler. 884.1600 Transabdominal

amnioscope (fetoscope) and accessories. 884.1630 Colposcope. 884.1640 Culdoscope and accessories. 884.1660 Transcervical

endoscope (amnioscope) and accessories. 884.1690 Hysteroscope and accessories. 884.1700 Hysteroscopic insufflator. 884.1720 Gynecologic laparoscope and acces

sories. 884.1730 Laparoscopic insufflator.

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