§ 880.6990 21 CFR Ch. I (4–1–99 Edition)
§ 880.6990 Infusion stand. 882.1825 Rheoencephalograph. 882.1835 Physiological signal amplifier. (a) Identification. The infusion stand 882.1845 Physiological signal conditioner. is a stationary or movable stand in- 882.1855 Electroencephalogram (EEG) te- tended to hold infusion liquids, infu- lemetry system. sion accessories, and other medical de- 882.1870 Evoked response electrical stimu- vices. lator. (b) Classification. Class I (general con- 882.1880 Evoked response mechanical stimu- lator. trols). The device is exempt from the 882.1890 Evoked response photic stimulator. premarket notification procedures in 882.1900 Evoked response auditory stimu- subpart E of part 807 of this chapter lator. subject to the limitations in § 880.9. 882.1925 Ultrasonic scanner calibration test block. [63 FR 59718, Nov. 5, 1998] 882.1950 Tremor transducer. PART 882—NEUROLOGICAL Subparts C–D [Reserved] DEVICES Subpart E—Neurological Surgical Devices Subpart A—General Provisions 882.4030 Skull plate anvil. 882.4060 Ventricular cannula. Sec. 882.4100 Ventricular catheter. 882.1 Scope. 882.4125 Neurosurgical chair. 882.3 Effective dates of requirement for pre- 882.4150 Scalp clip. market approval. 882.4175 Aneurysm clip applier. 882.9 Limitations of exemptions from sec- 882.4190 Clip forming/cutting instrument. tion 510(k) of the Federal Food, Drug, 882.4200 Clip removal instrument. and Cosmetic Act (the act). 882.4215 Clip rack. 882.4250 Cryogenic surgical device. Subpart B—Neurological Diagnostic 882.4275 Dowel cutting instrument. Devices 882.4300 Manual cranial drills, burrs, trephines, and their accessories. 882.1020 Rigidity analyzer. 882.4305 Powered compound cranial drills, 882.1030 Ataxiagraph. burrs, trephines, and their accessories. 882.1200 Two-point discriminator. 882.4310 Powered simple cranial drills, 882.1240 Echoencephalograph. burrs, trephines, and their accessories. 882.1275 Electroconductive media. 882.4325 Cranial drill handpiece (brace). 882.1310 Cortical electrode. 882.4360 Electric cranial drill motor. 882.1320 Cutaneous electrode. 882.4370 Pneumatic cranial drill motor. 882.1330 Depth electrode. 882.4400 Radiofrequency lesion generator. 882.1340 Nasopharyngeal electrode. 882.4440 Neurosurgical headrests. 882.1350 Needle electrode. 882.4460 Neurosurgical head holder (skull 882.1400 Electroencephalograph. clamp). 882.1410 Electroencephalograph electrode/ 882.4500 Cranioplasty material forming in- lead tester. strument. 882.1420 Electroencephalogram (EEG) signal 882.4525 Microsurgical instrument. spectrum analyzer. 882.4535 Nonpowered neurosurgical instru- 882.1430 Electroencephalograph test signal ment. generator. 882.4545 Shunt system implantation instru- 882.1460 Nystagmograph. ment. 882.1480 Neurological endoscope. 882.4560 Stereotaxic instrument. 882.1500 Esthesiometer. 882.4600 Leukotome. 882.1525 Tuning fork. 882.4650 Neurosurgical suture needle. 882.1540 Galvanic skin response measure- 882.4700 Cottonoid paddie. ment device. 882.4725 Radiofrequency lesion probe. 882.1550 Nerve conduction velocity measure- 882.4750 Skull punch. ment device. 882.4800 Self-retaining retractor for neuro- 882.1560 Skin potential measurement de- surgery. vice. 882.4840 Manual rongeur. 882.1570 Powered direct-contact tempera- 882.4845 Powered rongeur. ture measurement device. 882.4900 Skullplate screwdriver. 882.1610 Alpha monitor. 882.1620 Intracranial pressure monitoring Subpart F—Neurological Therapeutic device. Devices 882.1700 Percussor. 882.1750 Pinwheel. 882.5030 Methyl methacrylate for 882.1790 Ocular plethysmograph. aneurysmorrhaphy.
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882.5050 Biofeedback device. described by the section title and iden- 882.5070 Bite block. tification provisions of a regulation in 882.5150 Intravascular occluding catheter. this part, but shall state why the de- 882.5175 Carotid artery clamp. vice is substantially equivalent to 882.5200 Aneurysm clip. 882.5225 Implanted malleable clip. other devices, as required by § 807.87. 882.5235 Aversive conditioning device. (c) To avoid duplicative listings, a 882.5250 Burr hole cover. neurological device that has two or 882.5275 Nerve cuff. more types of uses (e.g., used both as a 882.5300 Methyl methacrylate for diagnostic device and as a therapeutic cranioplasty. device) is listed only in one subpart. 882.5320 Preformed alterable cranioplasty (d) References in this part to regu- plate. latory sections of the Code of Federal 882.5330 Preformed nonalterable Regulations are to chapter I of title 21, cranioplasty plate. 882.5360 Cranioplasty plate fastener. unless otherwise noted. 882.5500 Lesion temperature monitor. [52 FR 17739, May 11, 1987] 882.5550 Central nervous system fluid shunt and components. § 882.3 Effective dates of requirement 882.5800 Cranial electrotheraphy stimulator. for premarket approval. 882.5810 External functional neuromuscular stimulator. A device included in this part that is 882.5820 Implanted cerebellar stimulator. classified into class III (premarket ap- 882.5830 Implanted diaphragmatic/phrenic proval) shall not be commercially dis- nerve stimulator. tributed after the date shown in the 882.5840 Implanted intracerebral/subcortical regulation classifying the device unless stimulator for pain relief. the manufacturer has an approval 882.5850 Implanted spinal cord stimulator under section 515 of the act (unless an for bladder evacuation. exemption has been granted under sec- 882.5860 Implanted neuromuscular stimu- tion 520(g)(2) of the act). An approval lator. 882.5870 Implanted peripheral nerve stimu- under section 515 of the act consists of lator for pain relief. FDA’s issuance of an order approving 882.5880 Implanted spinal cord stimulator an application for premarket approval for pain relief. (PMA) for the device or declaring com- 882.5890 Transcutaneous electrical nerve pleted a product development protocol stimulator for pain relief. (PDP) for the device. 882.5900 Preformed craniosynostosis strip. (a) Before FDA requires that a device 882.5910 Dura substitute. commercially distributed before the 882.5940 Electroconvulsive therapy device. enactment date of the amendments, or 882.5950 Artificial embolization device. 882.5960 Skull tongs for traction. a device that has been found substan- 882.5970 Cranial orthosis. tially equivalent to such a device, has an approval under section 515 of the act AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, FDA must promulgate a regulation 360j, 371. under section 515(b) of the act requir- SOURCE: 44 FR 51730–51778, Sept. 4, 1979, un- ing such approval, except as provided less otherwise noted. in paragraph (b) of this section. Such a regulation under section 515(b) of the Subpart A—General Provisions act shall not be effective during the grace period ending on the 90th day § 882.1 Scope. after its promulgation or on the last (a) This part sets forth the classifica- day of the 30th full calendar month tion of neurological devices intended after the regulation that classifies the for human use that are in commercial device into class III is effective, which- distribution. ever is later. See section 501(f)(2)(B) of (b) The identification of a device in a the act. Accordingly, unless an effec- regulation in this part is not a precise tive date of the requirement for pre- description of every device that is, or market approval is shown in the regu- will be, subject to the regulation. A lation for a device classified into class manufacturer who submits a pre- III in this part, the device may be com- market notification submission for a mercially distributed without FDA’s device under part 807 may not show issuance of an order approving a PMA merely that the device is accurately or declaring completed a PDP for the
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device. If FDA promulgates a regula- for a use different from the intended tion under section 515(b) of the act re- use of a preamendments device to quiring premarket approval for a de- which it had been determined to be vice, section, 501(f)(1)(A) of the act ap- substantially equivalent; e.g., the de- plies to the device. vice is intended for a different medical (b) Any new, not substantially equiv- purpose, or the device is intended for alent, device introduced into commer- lay use where the former intended use cial distribution on or after May 28, was by health care professionals only; 1976, including a device formerly mar- or keted that has been substantially al- (2) The modified device operates tered, is classified by statute (section using a different fundamental sci- 513(f) of the act) into class III without entific technology than that in use in any grace period and FDA must have the device before May 28, 1976; e.g., a issued an order approving a PMA or de- surgical instrument cuts tissue with a claring completed a PDP for the device laser beam rather than with a sharp- before the device is commercially dis- ened metal blade, or an in vitro diag- tributed unless it is reclassified. If nostic device detects or identifies in- FDA knows that a device being com- fectious agents by using a mercially distributed may be a ‘‘new’’ deoxyribonucleic acid (DNA) probe or device as defined in this section be- nucleic acid hybridization technology cause of any new intended use or other rather than culture or immunoassay reasons, FDA may codify the statutory technology. classification of the device into class (b) The exemption from the require- III for such new use. Accordingly, the ment of premarket notification for a regulation for such a class III device generic type of class II device applies states that as of the enactment date of only to those class II devices that have the amendments, May 28, 1976, the de- existing or reasonably foreseeable vice must have an approval under sec- characteristics of commercially dis- tion 515 of the act before commercial tributed devices within that generic distribution. type, or, in the case of in vitro diag- [52 FR 17739, May 11, 1987] nostic devices, for which a misdiag- nosis, as a result of using the device, § 882.9 Limitations of exemptions from would not be associated with high mor- section 510(k) of the Federal Food, bidity or mortality. A class II device Drug, and Cosmetic Act (the act). for which FDA has granted an exemp- (a) The Food and Drug Administra- tion from the requirement of pre- tion’s (FDA’s) decision to grant an ex- market notification must still submit emption from the requirement of pre- a premarket notification when: market notification (section 510(k) of (1) The device is intended for a use the act) for a generic type of class I de- different from the intended use of a le- vice is based upon the existing and rea- gally marketed device in that generic sonably foreseeable characteristics of type of device; e.g., the device is in- commercially distributed devices with- tended for a different medical purpose, in that generic type. Because FDA can- or the device is intended for lay use not anticipate every change in in- where the former intended use was by tended use or characteristic that could health care professionals only; or significantly affect a device’s safety or (2) The modified device operates effectiveness, manufacturers of any using a different fundamental sci- commercially distributed class I device entific technology than a legally mar- for which FDA has granted an exemp- keted device in that generic type of de- tion from the requirement of pre- vice; e.g., a surgical instrument cuts market notification must still submit tissue with a laser beam rather than a premarket notification to FDA before with a sharpened metal blade, or an in introducing or delivering for introduc- vitro diagnostic device detects or iden- tion into interstate commerce for com- tifies infectious agents by using mercial distribution the device when: deoxyribonucleic acid (DNA) probe or (1) The device is intended for a use nucleic acid hybridization technology different from its intended use before rather than culture or immunoassay May 28, 1976, or the device is intended technology; or
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(3) The device is an in vitro device § 882.1200 Two-point discriminator. that is intended: (a) Identification. A two-point dis- (i) For use in the diagnosis, moni- criminator is a device with points used toring, or screening of neoplastic dis- for testing a patient’s touch discrimi- eases with the exception of nation. immunohistochemical devices; (b) Classification. Class I. If the device (ii) For use in screening or diagnosis is made of the same material (single, of familial and acquired genetic dis- surgical-grade, stainless steel alloy) orders, including inborn errors of me- that was used in the device before May tabolism; 28, 1976, the device is exempt from the (iii) For measuring an analyte that premarket notification procedures in serves as a surrogate marker for subpart E of part 807 of this chapter. screening, diagnosis, or monitoring The device is also exempt from the cur- life-threatening diseases such as ac- rent good manufacturing practice regu- quired immune deficiency syndrome lations in part 820 of this chapter, with (AIDS), chronic or active hepatitis, tu- the exception of § 820.180, with respect berculosis, or myocardial infarction or to general requirements concerning to monitor therapy; records, and § 820.198, with respect to (iv) For assessing the risk of cardio- complaint files. vascular diseases; (v) For use in diabetes management; [44 FR 51730–51778, Sept. 4, 1979, as amended (vi) For identifying or inferring the at 54 FR 25051, June 12, 1989] identity of a microorganism directly § 882.1240 Echoencephalograph. from clinical material; (vii) For detection of antibodies to (a) Identification. An microorganisms other than echoencephalograph is an ultrasonic immunoglobulin G (IgG) and IgG as- scanning device (including A-scan, B- says when the results are not quali- scan, and doppler systems) that uses tative, or are used to determine immu- noninvasive transducers for measuring nity, or the assay is intended for use in intracranial interfaces and blood flow matrices other than serum or plasma; velocity to and in the head. (viii) For noninvasive testing; and (b) Classification. Class II (perform- (ix) For near patient testing (point of ance standards). care). § 882.1275 Electroconductive media. [54 FR 25051, June 12, 1989, as amended at 63 (a) Identification. Electroconductive FR 59229, Nov. 3, 1998] media are the conductive creams or gels used with external electrodes to Subpart B—Neurological reduce the impedance (resistance to al- Diagnostic Devices ternating current) of the contact be- tween the electrode surface and the § 882.1020 Rigidity analyzer. skin. (a) Identification. A rigidity analyzer (b) Classification. Class II (perform- is a device for quantifying the extent of ance standards). the rigidity of a patient’s limb to de- termine the effectiveness of drugs or § 882.1310 Cortical electrode. other treatments. (a) Identification. A cortical electrode (b) Classification. Class II (perform- is an electrode which is temporarily ance standards). placed on the surface of the brain for stimulating the brain or recording the § 882.1030 Ataxiagraph. brain’s electrical activity. (a) Identification. An ataxiagraph is a (b) Classification. Class II (perform- device used to determine the extent of ance standards). ataxia (failure of muscular coordina- tion) by measuring the amount of § 882.1320 Cutaneous electrode. swaying of the body when the patient (a) Identification. A cutaneous elec- is standing erect and with eyes closed. trode is an electrode that is applied di- (b) Classification. Class I (general con- rectly to a patient’s skin either to trols). record physiological signals (e.g., the
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electroencephalogram) or to apply § 882.1420 Electroencephalogram electrical stimulation. (EEG) signal spectrum analyzer. (b) Classification. Class II (perform- (a) Identification. An electroencepha- ance standards). logram (EEG) signal spectrum analyzer is a device used to display the fre- § 882.1330 Depth electrode. quency content or power spectral den- (a) Identification. A depth electrode is sity of the electroencephalogram an electrode used for temporary stimu- (EEG) signal. lation of, or recording electrical sig- (b) Classification. Class I (general con- nals at, subsurface levels of the brain. trols). (b) Classification. Class II (perform- ance standards). § 882.1430 Electroencephalograph test signal generator. § 882.1340 Nasopharyngeal electrode. (a) Identification. An electroencephalograph test signal gen- (a) Identification. A nasopharyngeal erator is a device used to test or cali- electrode is an electrode which is tem- brate an electroencephalograph. porarily placed in the nasopharyngeal (b) Classification. Class I. The device region for the purpose of recording is exempt from the premarket notifica- electrical activity. tion procedures in subpart E of part 807 (b) Classification. Class II (perform- of this chapter. ance standards). [44 FR 51730–51778, Sept. 4, 1979, as amended § 882.1350 Needle electrode. at 59 FR 63011, Dec. 7, 1994] (a) Identification. A needle electrode § 882.1460 Nystagmograph. is a device which is placed (a) Identification. A nystagmograph is subcutaneously to stimulate or to a device used to measure, record, or record electrical signals. visually display the involuntary move- (b) Classification. Class II (perform- ments (nystagmus) of the eyeball. ance standards). (b) Classification. Class II (perform- ance standards). § 882.1400 Electroencephalograph. (a) Identification. An § 882.1480 Neurological endoscope. electroencephalograph is a device used (a) Identification. A neurological en- to measure and record the electrical doscope is an instrument with a light activity of the patient’s brain obtained source used to view the inside of the by placing two or more electrodes on ventricles of the brain. the head. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). § 882.1500 Esthesiometer. § 882.1410 Electroencephalograph elec- (a) Identification. An esthesiometer is trode/lead tester. a mechanical device which usually con- (a) Identification. An sists of a single rod or fiber which is electroencephalograph electrode/lead held in the fingers of the physician or tester is a device used for testing the other examiner and which is used to impedance (resistance to alternating determine whether a patient has tac- current) of the electrode and lead sys- tile sensitivity. tem of an electroencephalograph to as- (b) Classification. Class I. If the device sure that an adequate contact is made is composed entirely of a single mate- between the electrode and the skin. rial, the device is exempt from the pre- market notification procedures in sub- (b) Classification. Class I. The device part E of part 807 of this chapter. The is exempt from the premarket notifica- device is also exempt from the current tion procedures in subpart E of part 807 good manufacturing practice regula- of this chapter. tions in part 820 of this chapter, with [44 FR 51730–51778, Sept. 4, 1979, as amended the exception of § 820.180, with respect at 61 FR 1123, Jan. 16, 1996] to general requirements concerning
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records, and § 820.198, with respect to (b) Classification. Class II (perform- complaint files. ance standards).
[44 FR 51730–51778, Sept. 4, 1979, as amended § 882.1570 Powered direct-contact tem- at 54 FR 25051, June 12, 1989] perature measurement device. § 882.1525 Tuning fork. (a) Identification. A powered direct- (a) Identification. A tuning fork is a contact temperature measurement de- mechanical device which resonates at a vice is a device which contains a power given frequency and is used to diagnose source and is used to measure dif- hearing disorders and to test for vibra- ferences in temperature between two tory sense. points on the body. (b) Classification. Class I. The device (b) Classification. Class II (perform- is exempt from the premarket notifica- ance standards). tion procedures in subpart E of part 807 of this chapter. The device is also ex- § 882.1610 Alpha monitor. empt from the current good manufac- (a) Identification. An alpha monitor is turing practice regulations in part 820 a device with electrodes that are of this chapter, with the exception of placed on a patient’s scalp to monitor § 820.180, with respect to general re- that portion of the electroencepha- quirements concerning records, and logram which is referred to as the § 820.198, with respect to complaint alpha wave. files. (b) Classification. Class II (perform- [44 FR 51730–51778, Sept. 4, 1979, as amended ance standards). at 54 FR 25051, June 12, 1989] § 882.1620 Intracranial pressure moni- § 882.1540 Galvanic skin response toring device. measurement device. (a) Identification. An intracranial (a) Identification. A galvanic skin re- pressure monitoring device is a device sponse measurement device is a device used for short-term monitoring and re- used to determine autonomic responses cording of intracranial pressures and as psychological indicators by meas- pressure trends. The device includes uring the electrical resistance of the the transducer, monitor, and inter- skin and the tissue path between two connecting hardware. electrodes applied to the skin. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). § 882.1700 Percussor. § 882.1550 Nerve conduction velocity measurement device. (a) Identification. A percussor is a small hammerlike device used by a (a) Identification. A nerve conduction physician to provide light blows to a velocity measurement device is a de- body part. A percussor is used as a di- vice which measures nerve conduction agnostic aid during physical examina- time by applying a stimulus, usually to tions. a patient’s peripheral nerve. This de- vice includes the stimulator and the (b) Classification. Class I. The device electronic processing equipment for is exempt from the premarket notifica- measuring and displaying the nerve tion procedures in subpart E of part 807 conduction time. of this chapter. The device is also ex- (b) Classification. Class II (perform- empt from the current good manufac- ance standards). turing practice regulations in part 820 of this chapter, with the exception of § 882.1560 Skin potential measurement § 820.180, with respect to general re- device. quirements concerning records, and (a) Identification. A skin potential § 820.198, with respect to complaint measurement device is a general diag- files. nostic device used to measure skin [44 FR 51730–51778, Sept. 4, 1979, as amended voltage by means of surface skin elec- at 54 FR 25051, June 12, 1989; 59 FR 63011, Dec. trodes. 7, 1994]
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§ 882.1750 Pinwheel. being placed in commercial distribu- tion. (a) Identification. A pinwheel is a de- vice with sharp points on a rotating [44 FR 51730–51778, Sept. 4, 1979, as amended wheel used for testing pain sensation. at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. (b) Classification. Class I. If the device 27, 1996] is made of the same material (single, surgical-grade, stainless steel alloy) § 882.1835 Physiological signal ampli- fier. that was used in the device before May 28, 1976, and it is manually operated, (a) Identification. A physiological sig- the device is exempt from the pre- nal amplifier is a general purpose de- market notification procedures in sub- vice used to electrically amplify sig- part E of part 807 of this chapter. nals derived from various physiological sources (e.g., the electroencepha- [44 FR 51730–51778, Sept. 4, 1979, as amended logram). at 54 FR 25051, June 12, 1989] (b) Classification. Class II (perform- § 882.1790 Ocular plethysmograph. ance standards). (a) Identification. An ocular § 882.1845 Physiological signal condi- plethysmograph is a device used to tioner. measure or detect volume changes in (a) Identification. A physiological sig- the eye produced by pulsations of the nal conditioner is a device such as an artery, to diagnose carotid artery oc- integrator or differentiator used to clusive disease (restrictions on blood modify physiological signals for re- flow in the carotid artery). cording and processing. (b) Classification. Class III (premarket (b) Classification. Class II (perform- approval). ance standards). (c) Date PMA or notice of completion of a PDP is required. No effective date has § 882.1855 Electroencephalogram been established of the requirement for (EEG) telemetry system. premarket approval. See § 882.3. (a) Identification. An electroencepha- [44 FR 51730–51778, Sept. 4, 1979, as amended logram (EEG) telemetry system con- at 52 FR 17739, May 11, 1987] sists of transmitters, receivers, and other components used for remotely § 882.1825 Rheoencephalograph. monitoring or measuring EEG signals (a) Identification. A by means of radio or telephone trans- rheoencephalograph is a device used to mission systems. estimate a patient’s cerebral circula- (b) Classification. Class II (perform- tion (blood flow in the brain) by elec- ance standards). trical inpedance methods with direct electrical connections to the scalp or § 882.1870 Evoked response electrical neck area. stimulator. (b) Classification. Class III (premarket (a) Identification. An evoked response approval). electrical stimulator is a device used (c) Date PMA or notice of completion of to apply an electrical stimulus to a pa- a PDP is required. A PMA or a notice of tient by means of skin electrodes for completion of a PDP is required to be the purpose of measuring the evoked filed with the Food and Drug Adminis- response. tration on or before December 26, 1996 (b) Classification. Class II (perform- for any rheoencephalograph that was ance standards). in commercial distribution before May 28, 1976, or that has, on or before De- § 882.1880 Evoked response mechan- cember 26, 1996 been found to be sub- ical stimulator. stantially equivalent to a (a) Identification. An evoked response rheoencephalograph that was in com- mechanical stimulator is a device used mercial distribution before May 28, to produce a mechanical stimulus or a 1976. Any other rheoencephalograph series of mechanical stimuli for the shall have an approved PMA or a de- purpose of measuring a patient’s clared completed PDP in effect before evoked response.
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(b) Classification. Class II (perform- (b) Classification. Class I. The device ance standards). is exempt from the premarket notifica- tion procedures in subpart E of part 807 § 882.1890 Evoked response photic of this chapter. stimulator. [44 FR 51730–51778, Sept. 4, 1979, as amended (a) Identification. An evoked response at 59 FR 63011, Dec. 7, 1994] photic stimulator is a device used to generate and display a shifting pattern § 882.4060 Ventricular cannula. or to apply a brief light stimulus to a (a) Identification. A ventricular patient’s eye for use in evoked response cannula is a device used to puncture measurements or for electroencepha- the ventricles of the brain for aspira- logram (EEG) activation. tion or for injection. This device is fre- (b) Classification. Class II (perform- quently referred to as a ventricular ance standards). needle. § 882.1900 Evoked response auditory (b) Classification. Class I (general con- stimulator. trols). (a) Identification. An evoked response § 882.4100 Ventricular catheter. auditory stimulator is a device that (a) Identification. A ventricular cath- produces a sound stimulus for use in eter is a device used to gain access to evoked response measurements or elec- the cavities of the brain for injection troencephalogram activation. of material into, or removal of mate- (b) Classification. Class II (perform- rial from, the brain. ance standards). (b) Classification. Class II (perform- § 882.1925 Ultrasonic scanner calibra- ance standards). tion test block. § 882.4125 Neurosurgical chair. (a) Identification. An ultrasonic scan- ner calibration test block is a block of (a) Identification. A neurosurgical material with known properties used to chair is an operating room chair used calibrate ultrasonic scanning devices to position and support a patient dur- (e.g., the echoencephalograph). ing neurosurgery. (b) Classification. Class I. The device (b) Classification. Class I. The device is exempt from the premarket notifica- is exempt from the premarket notifica- tion procedures in subpart E of part 807 tion procedures in subpart E of part 807 of this chapter. of this chapter. [44 FR 51730–51778, Sept. 4, 1979, as amended [44 FR 51730–51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] at 59 FR 63011, Dec. 7, 1994]
§ 882.1950 Tremor transducer. § 882.4150 Scalp clip. (a) Identification. A tremor trans- (a) Identification. A scalp clip is a ducer is a device used to measure the plastic or metal clip used to stop bleed- degree of tremor caused by certain dis- ing during surgery on the scalp. eases. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). § 882.4175 Aneurysm clip applier. (a) Identification. An aneurysm clip Subparts C–D [Reserved] applier is a device used by the surgeon for holding and applying intracranial Subpart E—Neurological Surgical aneurysm clips. Devices (b) Classification. Class II (perform- ance standards). § 882.4030 Skull plate anvil. (a) Identification. A skull plate anvil § 882.4190 Clip forming/cutting instru- is a device used to form alterable skull ment. plates in the proper shape to fit the (a) Identification. A clip forming/cut- curvature of a patient’s skull. ting instrument is a device used by the
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physician to make tissue clips from § 882.4305 Powered compound cranial wire stock. drills, burrs, trephines, and their (b) Classification. Class I. The device accessories. is exempt from the premarket notifica- (a) Identification. Powered compound tion procedures in subpart E of part 807 cranial drills, burrs, trephines, and of this chapter. their accessories are bone cutting and [44 FR 51730–51778, Sept. 4, 1979, as amended drilling instruments used on a pa- at 59 FR 63012, Dec. 7, 1994] tient’s skull. The instruments employ a clutch mechanism to disengage the § 882.4200 Clip removal instrument. tip of the instrument after penetrating the skull to prevent plunging of the tip (a) Identification. A clip removal in- into the brain. strument is a device used to remove (b) Classification. Class II (perform- surgical clips from the patient. ance standards). (b) Classification. Class I. The device is exempt from the premarket notifica- § 882.4310 Powered simple cranial tion procedures in subpart E of part 807 drills, burrs, trephines, and their of this chapter. accessories. [44 FR 51730–51778, Sept. 4, 1979, as amended (a) Identification. Powered simple cra- at 59 FR 63012, Dec. 7, 1994] nial drills, burrs, trephines, and their accessories are bone cutting and drill- § 882.4215 Clip rack. ing instruments used on a patient’s (a) Identification. A clip rack is a de- skull. The instruments are used with a vice used to hold or store surgical clips power source but do not have a clutch during surgery. mechanism to disengage the tip after (b) Classification. Class I. The device penetrating the skull. (b) Class II (perform- is exempt from the premarket notifica- Classification. ance standards). tion procedures in subpart E of part 807 of this chapter. § 882.4325 Cranial drill handpiece [44 FR 51730–51778, Sept. 4, 1979, as amended (brace). at 54 FR 25051, June 12, 1989; 59 FR 63012, Dec. (a) Identification. A cranial drill hand- 7, 1994] piece (brace) is a hand holder, which is used without a power source, for drills, § 882.4250 Cryogenic surgical device. burrs, trephines, or other cutting tools (a) Identification. A cryogenic sur- that are used on a patient’s skull. gical device is a device used to destroy (b) Classification. Class I. The device nervous tissue or produce lesions in is exempt from the premarket notifica- nervous tissue by the application of ex- tion procedures in subpart E of part 807 treme cold to the selected site. of this chapter. (b) Classification. Class II (perform- [44 FR 51730–51778, Sept. 4, 1979, as amended ance standards). at 61 FR 1123, Jan. 16, 1996]
§ 882.4275 Dowel cutting instrument. § 882.4360 Electric cranial drill motor. (a) Identification. A dowel cutting in- (a) Identification. An electric cranial strument is a device used to cut dowels drill motor is an electrically operated of bone for bone grafting. power source used with removable ro- (b) Classification. Class II (perform- tating surgical cutting tools or drill ance standards). bits on a patient’s skull. (b) Classification. Class II (perform- § 882.4300 Manual cranial drills, burrs, ance standards). trephines, and their accessories (a) Identification. Manual cranial § 882.4370 Pneumatic cranial drill drills, burrs, trephines, and their acces- motor. sories are bone cutting and drilling in- (a) Identification. A pneumatic cranial struments that are used without a drill motor is a pneumatically operated power source on a patient’s skull. power source used with removable ro- (b) Classification. Class II (perform- tating surgical cutting tools or drill ance standards). bits on a patient’s skull.
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(b) Classification. Class II (perform- tion procedures in subpart E of part 807 ance standards). of this chapter.
§ 882.4400 Radiofrequency lesion gen- [44 FR 51730–51778, Sept. 4, 1979, as amended erator. at 59 FR 63012, Dec. 7, 1994] (a) Identification. A radiofrequency le- § 882.4535 Nonpowered neurosurgical sion generator is a device used to instrument. produce lesions in the nervous system (a) Identification. A nonpowered or other tissue by the direct applica- neurosurgical instrument is a hand in- tion of radiofrequency currents to se- strument or an accessory to a hand in- lected sites. strument used during neurosurgical (b) Classification. Class II (perform- procedures to cut, hold, or manipulate ance standards). tissue. It includes specialized chisels, osteotomes, curettes, dissectors, ele- § 882.4440 Neurosurgical headrests. vators, forceps, gouges, hooks, surgical (a) Identification. A neurosurgical knives, rasps, scissors, separators, headrest is a device used to support the spatulas, spoons, blades, blade holders, patient’s head during a surgical proce- blade breakers, probes, etc. dure. (b) Classification. Class I. The device (b) Classification. Class I. The device is exempt from the premarket notifica- is exempt from the premarket notifica- tion procedures in subpart E of part 807 tion procedures in subpart E of part 807 of this chapter. of this chapter. [44 FR 51730–51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] [44 FR 51730–51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] § 882.4545 Shunt system implantation instrument. § 882.4460 Neurosurgical head holder (skull clamp). (a) Identification. A shunt system im- plantation instrument is an instru- (a) Identification. A neurosurgical ment used in the implantation of cere- head holder (skull clamp) is a device brospinal fluid shunts, and includes used to clamp the patient’s skull to tunneling instruments for passing hold head and neck in a particular po- shunt components under the skin. sition during surgical procedures. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). ance standards). § 882.4560 Stereotaxic instrument. § 882.4500 Cranioplasty material form- ing instrument. (a) Identification. A stereotaxic in- strument is a device consisting of a (a) Identification. A cranioplasty ma- rigid frame with a calibrated guide terial forming instrument is a roller mechanism for precisely positioning used in the preparation and forming of probes or other devices within a pa- cranioplasty (skull repair) materials. tient’s brain, spinal cord, or other part (b) Classification. Class I. The device of the nervous system. is exempt from the premarket notifica- (b) Classification. Class II (perform- tion procedures in subpart E of part 807 ance standards). of this chapter. § 882.4600 Leukotome. [44 FR 51730–51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] (a) Identification. A leukotome is a device used to cut sections out of the § 882.4525 Microsurgical instrument. brain. (a) Identification. A microsurgical in- (b) Classification. Class I. The device strument is a nonpowered surgical in- is exempt from the premarket notifica- strument used in neurological micro- tion procedures in subpart E of part 807 surgery procedures. of this chapter. (b) Classification. Class I. The device [44 FR 51730–51778, Sept. 4, 1979, as amended is exempt from the premarket notifica- at 59 FR 63012, Dec. 7, 1994]
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§ 882.4650 Neurosurgical suture nee- gery involving the skull or spinal col- dle. umn. (a) Identification. A neurosurgical su- (b) Classification. Class II (perform- ture needle is a needle used in suturing ance standards). during neurosurgical procedures or in the repair of nervous tissue. § 882.4845 Powered rongeur. (b) Classification. Class I. If the device (a) Identification. A powered rongeur is made of the same material (single, is a powered instrument used for cut- surgical-grade, stainless steel alloy) ting or biting bone during surgery in- that was used in the device before May volving the skull or spinal column. 28, 1976, the device is exempt from the (b) Classification. Class II (perform- premarket notification procedures in ance standards). subpart E of part 807 of this chapter. § 882.4900 Skullplate screwdriver. [44 FR 51730–51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989] (a) Identification. A skullplate screw- driver is a tool used by the surgeon to § 882.4700 Cottonoid paddie. fasten cranioplasty plates or skullplates to a patient’s skull by (a) Identification. A cottonoid paddie screws. is a cotton pad used during surgery to protect nervous tissue, absorb fluids, or (b) Classification. Class I. The device stop bleeding. is exempt from the premarket notifica- tion procedures in subpart E of part 807 (b) Classification. Class II (perform- of this chapter. ance standards). [44 FR 51730–51778, Sept. 4, 1979, as amended § 882.4725 Radiofrequency lesion at 59 FR 63012, Dec. 7, 1994] probe. (a) Identification. A radiofrequency le- Subpart F—Neurological sion probe is a device connected to a Therapeutic Devices radiofrequency (RF) lesion generator to deliver the RF energy to the site § 882.5030 Methyl methacrylate for within the nervous system where a le- aneurysmorrhaphy. sion is desired. (a) Identification. Methyl methacry- (b) Classification. Class II (perform- late for aneurysmorrhaphy (repair of ance standards). aneurysms, which are balloonlike sacs formed on blood vessels) is a self-cur- § 882.4750 Skull punch. ing acrylic used to encase and reinforce (a) Identification. A skull punch is a intracranial aneurysms that are not device used to punch holes through a amenable to conservative manage- patient’s skull to allow fixation of ment, removal, or obliteration by an- cranioplasty plates or bone flaps by eurysm clip. wire or other means. (b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). § 882.5050 Biofeedback device. § 882.4800 Self-retaining retractor for (a) Identification. A biofeedback de- neurosurgery. vice is an instrument that provides a (a) Identification. A self-retaining re- visual or auditory signal corresponding tractor for neurosurgery is a self-lock- to the status of one or more of a pa- ing device used to hold the edges of a tient’s physiological parameters (e.g., wound open during neurosurgery. brain alpha wave activity, muscle ac- (b) Classification. Class II (perform- tivity, skin temperature, etc.) so that ance standards). the patient can control voluntarily these physiological parameters. § 882.4840 Manual rongeur. (b) Classification. Class II (special (a) Identification. A manual rongeur is controls). The device is exempt from a manually operated instrument used the premarket notification procedures for cutting or biting bone during sur- in subpart E of part 807 of this chapter
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when it is a prescription battery pow- (balloonlike sacs formed on blood ves- ered device that is indicated for relax- sels) or other intracranial vascular ation training and muscle reeducation malformations that are difficult to at- and prescription use, subject to § 882.9. tach directly by reducing the blood pressure and blood flow to the aneu- [44 FR 51730–51778, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998] rysm or malformation. (b) Classification. Class II (perform- § 882.5070 Bite block. ance standards). (a) Identification. A bite block is a de- § 882.5200 Aneurysm clip. vice inserted into a patient’s mouth to protect the tongue and teeth while the (a) Identification. An aneurysm clip is patient is having convulsions. a device used to occlude an (b) Classification. Class II (perform- intracranial aneurysm (a balloonlike ance standards). sac formed on a blood vessel) to pre- vent it from bleeding or bursting. § 882.5150 Intravascular occluding (b) Classification. Class II (perform- catheter. ance standards). (a) Identification. An intravascular occluding catheter is a catheter with § 882.5225 Implanted malleable clip. an inflatable or detachable balloon tip (a) Identification. An implanted mal- that is used to block a blood vessel to leable clip is a bent wire or staple that treat malformations, e.g., aneurysms is forcibly closed with a special instru- (balloonlike sacs formed on blood ves- ment to occlude an intracranial blood sels) of intracranial blood vessels. vessel or aneurysm (a balloonlike sac (b) Classification. Class III (premarket formed on a blood vessel), stop bleed- approval). ing, or hold tissue or a mechanical de- (c) Date PMA or notice of completion of vice in place in a patient. a PDP is required. A PMA or a notice of (b) Classification. Class II (perform- completion of a PDP is required to be ance standards). filed with the Food and Drug Adminis- tration on or before December 26, 1996 § 882.5235 Aversive conditioning de- for any intravascular occluding cath- vice. eter that was in commercial distribu- (a) Identification. An aversive condi- tion before May 28, 1976, or that has, on tioning device is an instrument used to or before December 26, 1996 been found administer an electrical shock or other to be substantially equivalent to an noxious stimulus to a patient to mod- intravascular occluding catheter that ify undesirable behavioral characteris- was in commercial distribution before tics. May 28, 1976. Any other intravascular (b) Classification. Class II (perform- occluding catheter shall have an ap- ance standards). proved PMA or a declared completed PDP in effect before being placed in § 882.5250 Burr hole cover. commercial distribution. (a) Identification. A burr hole cover is [44 FR 51730–51778, Sept. 4, 1979, as amended a plastic or metal device used to cover at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. or plug holes drilled into the skull dur- 27, 1996] ing surgery and to reattach cranial bone removed during surgery. § 882.5175 Carotid artery clamp. (b) Classification. Class II (perform- (a) Identification. A carotid artery ance standards). clamp is a device that is surgically placed around a patient’s carotid ar- § 882.5275 Nerve cuff. tery (the principal artery in the neck (a) Identification. A nerve cuff is a tu- that supplies blood to the brain) and bular silicone rubber sheath used to en- has a removable adjusting mechanism case a nerve for aid in repairing the that protrudes through the skin of the nerve (e.g., to prevent ingrowth of scar patient’s neck. The clamp is used to oc- tissue) and for capping the end of the clude the patient’s carotid artery to nerve to prevent the formation of treat intracranial aneurysms neuroma (tumors).
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(b) Classification. Class II (perform- be made when a surgeon uses a radio- ance standards). frequency (RF) lesion generator and probe. § 882.5300 Methyl methacrylate for (b) Classification. Class II (perform- cranioplasty. ance standards). (a) Identification. Methyl methacry- late for cranioplasty (skull repair) is a § 882.5550 Central nervous system self-curing acrylic that a surgeon uses fluid shunt and components. to repair a skull defect in a patient. At (a) Identification. A central nervous the time of surgery, the surgeon initi- system fluid shunt is a device or com- ates polymerization of the material bination of devices used to divert fluid and forms it into a plate or other ap- propriate shape to repair the defect. from the brain or other part of the cen- (b) Classification. Class II (perform- tral nervous system to an internal de- ance standards). livery site or an external receptacle for the purpose of relieving elevated § 882.5320 Preformed alterable intracranial pressure or fluid volume cranioplasty plate. (e.g., due to hydrocephalus). Compo- (a) Identification. A preformed nents of a central nervous system alterable cranioplasty plate is a device shunt include catheters, valved cath- that is implanted into a patient to re- eters, valves, connectors, and other ac- pair a skull defect. It is constructed of cessory components intended to facili- a material, e.g., tantalum, that can be tate use of the shunt or evaluation of a altered or reshaped at the time of sur- patient with a shunt. gery without changing the chemical (b) Classification. Class II (perform- behavior of the material. ance standards). (b) Classification. Class II (perform- ance standards). § 882.5800 Cranial electrotheraphy stimulator. § 882.5330 Preformed nonalterable cranioplasty plate. (a) Identification. A cranial electrotheraphy stimulator is a device (a) Identification. A preformed nonalterable cranioplasty plate is a de- that applies electrical current to a pa- vice that is implanted in a patient to tient’s head to treat insomnia, depres- repair a skull defect and is constructed sion, or anxiety. of a material, e.g., stainless steel or (b) Classification. Class III (premarket vitallium, that cannot be altered or re- approval). shaped at the time of surgery without (c) Date a PMA or notice of completion changing the chemical behavior of the of a PDP is required. No effective date material. has been established of the require- (b) Classification. Class II (perform- ment for premarket approval. See ance standards). § 882.3. § 882.5360 Cranioplasty plate fastener. [44 FR 51730–51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 60 FR 43969, Aug. (a) Identification. A cranioplasty plate 24, 1995; 62 FR 30457, June 4, 1997] fastener is a screw, wire, or other arti- cle made of tantalum, vitallium, or § 882.5810 External functional neuro- stainless steel used to secure a plate to muscular stimulator. the patient’s skull to repair a skull de- fect. (a) Identification. An external func- (b) Classification. Class II (perform- tional neuromuscular stimulator is an ance standards). electrical stimulator that uses external electrodes for stimulating muscles in § 882.5500 Lesion temperature mon- the leg and ankle of partially paralyzed itor. patients (e.g., after stroke) to provide (a) Identification. A lesion tempera- flexion of the foot and thus improve ture monitor is a device used to mon- the patient’s gait. itor the tissue temperature at the site (b) Classification. Class II (perform- where a lesion (tissue destruction) is to ance standards).
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§ 882.5820 Implanted cerebellar stimu- (c) Date premarket approval application lator. (PMA) or notice of completion of a prod- (a) Identification. An implanted cere- uct development protocol (PDP) is re- bellar stimulator is a device used to quired. A PMA or a notice of comple- stimulate electrically a patient’s cere- tion of a PDP is required to be filed bellar cortex for the treatment of in- with the Food and Drug Administra- tractable epilepsy, spasticity, and some tion on or before July 7, 1986 for any movement disorders. The stimulator implanted diaphragmatic/phrenic nerve consists of an implanted receiver with stimulator that was in commercial dis- electrodes that are placed on the pa- tribution before May 28, 1976, or that tient’s cerebellum and an external has on or before July 7, 1986 been found transmitter for transmitting the stim- to be substantially equivalent to an ulating pulses across the patient’s skin implanted diaphragmatic/phrenic nerve to the implanted receiver. stimulator that was in commercial dis- (b) Classification. Class III (premarket tribution before May 28, 1976. Any approval). other implanted diaphragmatic/phrenic (c) Date premarket approval application nerve stimulator shall have an ap- (PMA) or notice of completion of a prod- proved PMA or a declared completed uct development protocol (PDP) is re- PDP in effect before being placed in quired. A PMA or notice of completion commercial distribution. of a PDP is required to be filed with [44 FR 51730–51778, Sept. 4, 1979, as amended the Food and Drug Administration on at 51 FR 12101, Apr. 8, 1986] or before September 26, 1984. Any im- planted cerebellar stimulator that was § 882.5840 Implanted intracerebral/ not in commercial distribution before subcortical stimulator for pain re- May 28, 1976, or that has not on or be- lief. fore September 26, 1984 been found by (a) Identification. An implanted FDA to be substantially equivalent to intracerebral/subcortical stimulator an implanted cerebellar stimulator for pain relief is a device that applies that was in commercial distribution electrical current to subsurface areas before May 28, 1976 shall have an ap- of a patient’s brain to treat severe in- proved PMA or declared completed tractable pain. The stimulator consists PDP in effect before beginning com- of an implanted receiver with elec- mercial distribution. trodes that are placed within a pa- [44 FR 51730–51778, Sept. 4, 1979 and 49 FR tient’s brain and an external trans- 26574, June 28, 1984] mitter for transmitting the stimu- lating pulses across the patient’s skin § 882.5830 Implanted diaphragmatic/ to the implanted receiver. phrenic nerve stimulator. (b) Classification. Class III (premarket (a) Identification. An implanted dia- approval). phragmatic/phrenic nerve stimulator is (c) Date premarket approval application a device that provides electrical stimu- (PMA) or notice of completion of a prod- lation of a patient’s phrenic nerve to uct development protocol (PDP) is re- contract the diaphragm rhythmically quired. A PMA or a notice of comple- and produce breathing in patients who tion of a PDP is required to be filed have hypoventilation (a state in which with the Food and Drug Administra- an abnormally low amount of air en- tion on or before March 1, 1989, for any ters the lungs) caused by brain stem implanted intracerebral/subcortical disease, high cervical spinal cord in- stimulator for pain relief that was in jury, or chronic lung disease. The stim- commercial distribution before May 28, ulator consists of an implanted re- 1976, or that has on or before March 1, ceiver with electrodes that are placed 1989, been found to be substantially around the patient’s phrenic nerve and equivalent to an implanted an external transmitter for transmit- intracerebral/subcortical stimulator ting the stimulating pulses across the for pain relief that was in commercial patient’s skin to the implanted re- distribution before May 28, 1976. Any ceiver. other implanted intracerebral/subcor- (b) Classification. Class III (premarket tical stimulator for pain relief shall approval). have an approved PMA or a declared
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completed PDP in effect before being tient’s nerve and an external trans- placed in commercial distribution. mitter for transmitting the stimu- [44 FR 51730–51778, Sept. 4, 1979, as amended lating pulses across the patient’s skin at 53 FR 48621, Dec. 1, 1988] to the implanted receiver. The external transmitter is activated by a switch in § 882.5850 Implanted spinal cord stim- the heel in the patient’s shoe. ulator for bladder evacuation. (b) Classification. Class III (premarket (a) Identification. An implanted spinal approval). cord stimulator for bladder evacuation (c) Date PMA or notice of completion of is an electrical stimulator used to a PDP is required. No effective date has empty the bladder of a paraplegic pa- been established of the requirement for tient who has a complete transection premarket approval. See § 882.3. of the spinal cord and who is unable to empty his or her bladder by reflex [44 FR 51730–51778, Sept. 4, 1979, as amended means or by the intermittent use of at 52 FR 17740, May 11, 1987] catheters. The stimulator consists of an implanted receiver with electrodes § 882.5870 Implanted peripheral nerve stimulator for pain relief. that are placed on the conus medullaris portion of the patient’s spinal cord and (a) Identification. An implanted pe- an external transmitter for transmit- ripheral nerve stimulator for pain re- ting the stimulating pulses across the lief is a device that is used to stimulate patient’s skin to the implanted re- electrically a peripheral nerve in a pa- ceiver. tient to relieve severe intractable pain. (b) Classification. Class III (premarket The stimulator consists of an inplanted approval). receiver with electrodes that are (c) Date PMA or notice of completion of placed around a peripheral nerve and a PDP is required. A PMA or a notice of an external transmitter for transmit- completion of a PDP is required to be ting the stimulating pulses across the filed with the Food and Drug Adminis- patient’s skin to the implanted re- tration on or before December 26, 1996 ceiver. for any implanted spinal cord stimu- (b) Classification. Class II (perform- lator for bladder evacuation that was ance standards). in commercial distribution before May 28, 1976, or that has, on or before De- § 882.5880 Implanted spinal cord stim- cember 26, 1996 been found to be sub- ulator for pain relief. stantially equivalent to an implanted spinal cord stimulator for bladder (a) Identification. An implanted spinal evacuation that was in commercial dis- cord stimulator for pain relief is a de- tribution before May 28, 1976. Any vice that is used to stimulate elec- other implanted spinal cord stimulator trically a patient’s spinal cord to re- for bladder evacuation shall have an lieve severe intractable pain. The stim- approved PMA or a declared completed ulator consists of an implanted re- PDP in effect before being placed in ceiver with electrodes that are placed commercial distribution. on the patient’s spinal cord and an ex- ternal transmitter for transmitting the [44 FR 51730–51778, Sept. 4, 1979, as amended stimulating pulses across the patient’s at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. skin to the implanted receiver. 27, 1996] (b) Classification. Class II (perform- § 882.5860 Implanted neuromuscular ance standards). stimulator. (a) Identification. An implanted neu- § 882.5890 Transcutaneous electrical nerve stimulator for pain relief. romuscular stimulator is a device that provides electrical stimulation to a pa- (a) Identification. A transcutaneous tient’s peroneal or femoral nerve to electrical nerve stimulator for pain re- cause muscles in the leg to contract, lief is a device used to apply an elec- thus improving the gait in a patient trical current to electrodes on a pa- with a paralyzed leg. The stimulator tient’s skin to treat pain. consists of an implanted receiver with (b) Classification. Class II (perform- electrodes that are placed around a pa- ance standards).
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§ 882.5900 Preformed craniosynostosis mobilize a patient with a cervical spine strip. injury (e.g., fracture or dislocation). (a) Identification. A preformed The device is caliper shaped with tips craniosynostosis strip is a plastic strip that penetrate the skin. It is anchored used to cover bone edges of craniec- to the skull and has a heavy weight at- tomy sites (sites where the skull has tached to it that maintains, by trac- been cut) to prevent the bone from re- tion, the patient’s position. growing in patients whose skull su- (b) Classification. Class II (perform- tures are abnormally fused together. ance standards). (b) Classification. Class II (perform- § 882.5970 Cranial orthosis. ance standards). (a) Identification. A cranial orthosis is § 882.5910 Dura substitute. a device that is intended for medical (a) Identification. A dura substitute is purposes to apply pressure to promi- a sheet or material that is used to re- nent regions of an infant’s cranium in pair the dura mater (the membrane order to improve cranial symmetry surrounding the brain). and/or shape in infants from 3 to 18 (b) Classification. Class II (perform- months of age, with moderate to severe ance standards). nonsynostotic positional plagiocephaly, including infants with § 882.5940 Electroconvulsive therapy plagiocephalic-, brachycephalic-, and device. scaphocephalic-shaped heads. (a) Identification. An (b) Classification. Class II (special electroconvulsive therapy device is a controls) (prescription use in accord- device used for treating severe psy- ance with § 801.109 of this chapter, bio- chiatric disturbances (e.g., severe de- compatibility testing, and labeling pression) by inducing in the patient a (contraindications, warnings, pre- major motor seizure by applying a brief cautions, adverse events, instructions intense electrical current to the pa- for physicians and parents)). tient’s head. [63 FR 40651, July 30, 1998] (b) Classification. Class III (premarket approval). PART 884—OBSTETRICAL AND (c) Date PMA or notice of completion of GYNECOLOGICAL DEVICES a PDP is required. No effective date has been established of the requirement for Subpart A—General Provisions premarket approval. See § 882.3. Sec. [44 FR 51730–51778, Sept. 4, 1979, as amended 884.1 Scope. at 52 FR 17740, May 11, 1987] 884.3 Effective dates of requirement for pre- market approval. § 882.5950 Artificial embolization de- 884.9 Limitations of exemptions from sec- vice. tion 510(k) of the Federal Food, Drug, (a) Identification. An artificial and Cosmetic Act (the act). embolization device is an object that is placed in a blood vessel to permanently Subpart B—Obstetrical and Gynecological obstruct blood flow to an aneurysm or Diagnostic Devices other vascular malformation. 884.1040 Viscometer for cervical mucus. (b) Classification. Class III (premarket 884.1050 Endocervical aspirator. approval). 884.1060 Endometrial aspirator. (c) Date PMA or notice of completion of 884.1100 Endometrial brush. a PDP is required. No effective date has 884.1175 Endometrial suction curette and been established of the requirement for accessories. 884.1185 Endometrial washer. premarket approval. See § 882.3. 884.1300 Uterotubal carbon dioxide [44 FR 51730–51778, Sept. 4, 1979, as amended insufflator and accessories. at 52 FR 17740, May 11, 1987] 884.1425 Perineometer. 884.1550 Amniotic fluid sampler § 882.5960 Skull tongs for traction. (amniocentesis tray). 884.1560 Fetal blood sampler. (a) Identification. Skull tongs for 884.1600 Transabdominal amnioscope traction is an instrument used to im- (fetoscope) and accessories.
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