1 (b) Classification. Class II (performance standards). $882.5550 Central nervous 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). $882.5800 Cranial stimulator. (a) Identification. 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] $882.5810 External functional neuromuscular 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). $882.5820 Implanted cerebellar stimulator. (a) Identification. An implanted cerebellar stimulator is a device used to stimulate electrically a patient's cere bellar 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 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 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 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. an [44 FR 51730-51778, Sept. 4, 1979 and 49 FR 26574, June 28, 1984] § 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] §882.5840 Implanted intracerebral/ subcortical stimulator for pain relief. (a) Identification. An implanted intracerebral/subcortical stimulator 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 the 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 implanted stimulator an intracerebral/subcortical for pain relief that was in commercial distribution before May 28, 1976. Any other implanted intracerebral/subcortical 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] § 882.5850 Implanted spinal cord stimulator 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 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. [44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996] I i 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 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] $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 pa=tient 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). $882.5880 Implanted spinal cord stimulator 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). (a) therapy An Identification. 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] § 882.5950 Artificial embolization device. (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). 8882.5970 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] PART 884-OBSTETRICAL AND GYNECOLOGICAL DEVICES Subpart A-General Provisions Sec. 884.1 Scope. 884.3 Effective dates of requirement for premarket approval. 884.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). Subpart B-Obstetrical and Gynecological 884.1040 Viscometer for cervical mucus. 884.6180 Reproductive media and supplements. 884.6190 Assisted reproductive microscopes and microscope accessories. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. SOURCE: 45 FR 12684-12720, Feb. 26, 1980, unless otherwise noted. Subpart A-General Provisions §884.1 Scope. (a) This part sets forth the classification of obstetrical and gynecological devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, a obstetrical and gynecological device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. [52 FR 17740, May 11, 1987] § 884.3 Effective dates of_requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. 407 |