Pt. 882 21 CFR Ch. I (4–1–01 Edition)
subpart E of part 807 of this chapter 882.1900 Evoked response auditory stimu- subject to the limitations in § 880.9. lator. 882.1925 Ultrasonic scanner calibration test [63 FR 59718, Nov. 5, 1998] block. 882.1950 Tremor transducer. PART 882—NEUROLOGICAL DEVICES Subparts C–D [Reserved] Subpart E—Neurological Surgical Devices Subpart A—General Provisions 882.4030 Skull plate anvil. Sec. 882.4060 Ventricular cannula. 882.1 Scope. 882.4100 Ventricular catheter. 882.3 Effective dates of requirement for pre- 882.4125 Neurosurgical chair. market approval. 882.4150 Scalp clip. 882.9 Limitations of exemptions from sec- 882.4175 Aneurysm clip applier. tion 510(k) of the Federal Food, Drug, 882.4190 Clip forming/cutting instrument. and Cosmetic Act (the act). 882.4200 Clip removal instrument. 882.4215 Clip rack. Subpart B—Neurological Diagnostic 882.4250 Cryogenic surgical device. Devices 882.4275 Dowel cutting instrument. 882.4300 Manual cranial drills, burrs, 882.1020 Rigidity analyzer. trephines, and their accessories. 882.1030 Ataxiagraph. 882.4305 Powered compound cranial drills, 882.1200 Two-point discriminator. burrs, trephines, and their accessories. 882.1240 Echoencephalograph. 882.4310 Powered simple cranial drills, 882.1275 Electroconductive media. burrs, trephines, and their accessories. 882.1310 Cortical electrode. 882.4325 Cranial drill handpiece (brace). 882.1320 Cutaneous electrode. 882.4360 Electric cranial drill motor. 882.1330 Depth electrode. 882.4370 Pneumatic cranial drill motor. 882.1340 Nasopharyngeal electrode. 882.4400 Radiofrequency lesion generator. 882.1350 Needle electrode. 882.4440 Neurosurgical headrests. 882.1400 Electroencephalograph. 882.4460 Neurosurgical head holder (skull 882.1410 Electroencephalograph electrode/ clamp). lead tester. 882.4500 Cranioplasty material forming in- 882.1420 Electroencephalogram (EEG) signal strument. spectrum analyzer. 882.4525 Microsurgical instrument. 882.1430 Electroencephalograph test signal 882.4535 Nonpowered neurosurgical instru- generator. ment. 882.1460 Nystagmograph. 882.4545 Shunt system implantation instru- 882.1480 Neurological endoscope. ment. 882.1500 Esthesiometer. 882.4560 Stereotaxic instrument. 882.1525 Tuning fork. 882.4600 Leukotome. 882.1540 Galvanic skin response measure- 882.4650 Neurosurgical suture needle. ment device. 882.4700 Cottonoid paddie. 882.1550 Nerve conduction velocity measure- 882.4725 Radiofrequency lesion probe. ment device. 882.4750 Skull punch. 882.1560 Skin potential measurement de- 882.4800 Self-retaining retractor for neuro- vice. surgery. 882.1570 Powered direct-contact tempera- 882.4840 Manual rongeur. ture measurement device. 882.4845 Powered rongeur. 882.1610 Alpha monitor. 882.4900 Skullplate screwdriver. 882.1620 Intracranial pressure monitoring device. Subpart F—Neurological Therapeutic 882.1700 Percussor. Devices 882.1750 Pinwheel. 882.1790 Ocular plethysmograph. 882.5030 Methyl methacrylate for 882.1825 Rheoencephalograph. aneurysmorrhaphy. 882.1835 Physiological signal amplifier. 882.5050 Biofeedback device. 882.1845 Physiological signal conditioner. 882.5070 Bite block. 882.1855 Electroencephalogram (EEG) te- 882.5150 Intravascular occluding catheter. lemetry system. 882.5175 Carotid artery clamp. 882.1870 Evoked response electrical stimu- 882.5200 Aneurysm clip. lator. 882.5225 Implanted malleable clip. 882.1880 Evoked response mechanical stimu- 882.5235 Aversive conditioning device. lator. 882.5250 Burr hole cover. 882.1890 Evoked response photic stimulator. 882.5275 Nerve cuff.
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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 cranioplasty plate. Regulations are to chapter I of title 21, 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- lator. tion 520(g)(2) of the act). An approval 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. 882.5950 Artificial embolization device. enactment date of the amendments, or 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, 360j, 371. FDA must promulgate a regulation 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 described by the section title and iden- device. If FDA promulgates a regula- tification provisions of a regulation in tion under section 515(b) of the act re- this part, but shall state why the de- quiring premarket approval for a de- vice is substantially equivalent to vice, section, 501(f)(1)(A) of the act ap- other devices, as required by § 807.87. plies to the device. (c) To avoid duplicative listings, a (b) Any new, not substantially equiv- neurological device that has two or alent, device introduced into commer- more types of uses (e.g., used both as a cial distribution on or after May 28,
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1976, including a device formerly mar- entific technology than a legally mar- keted that has been substantially al- keted device in that generic type of de- tered, is classified by statute (section vice; e.g., a surgical instrument cuts 513(f) of the act) into class III without tissue with a laser beam rather than any grace period and FDA must have with a sharpened metal blade, or an in issued an order approving a PMA or de- vitro diagnostic device detects or iden- claring completed a PDP for the device tifies infectious agents by using before the device is commercially dis- deoxyribonucleic acid (DNA) probe or tributed unless it is reclassified. If nucleic acid hybridization technology FDA knows that a device being com- rather than culture or immunoassay mercially distributed may be a ‘‘new’’ technology; or device as defined in this section be- (c) The device is an in vitro device cause of any new intended use or other that is intended: reasons, FDA may codify the statutory (1) For use in the diagnosis, moni- classification of the device into class toring, or screening of neoplastic dis- III for such new use. Accordingly, the eases with the exception of regulation for such a class III device immunohistochemical devices; states that as of the enactment date of (2) For use in screening or diagnosis the amendments, May 28, 1976, the de- of familial or acquired genetic dis- vice must have an approval under sec- orders, including inborn errors of me- tion 515 of the act before commercial tabolism; distribution. (3) For measuring an analyte that [52 FR 17739, May 11, 1987] serves as a surrogate marker for screening, diagnosis, or monitoring § 882.9 Limitations of exemptions from life-threatening diseases such as ac- section 510(k) of the Federal Food, quired immune deficiency syndrome Drug, and Cosmetic Act (the act). (AIDS), chronic or active hepatitis, tu- The exemption from the requirement berculosis, or myocardial infarction or of premarket notification (section to monitor therapy; 510(k) of the act) for a generic type of (4) For assessing the risk of cardio- class I or II device is only to the extent vascular diseases; that the device has existing or reason- (5) For use in diabetes management; ably foreseeable characteristics of (6) For identifying or inferring the commercially distributed devices with- identity of a microorganism directly in that generic type or, in the case of from clinical material; in vitro diagnostic devices, only to the extent that misdiagnosis as a result of (7) For detection of antibodies to using the device would not be associ- microorganisms other than ated with high morbidity or mortality. immunoglobulin G (IgG) or IgG assays Accordingly, manufacturers of any when the results are not qualitative, or commercially distributed class I or II are used to determine immunity, or the device for which FDA has granted an assay is intended for use in matrices exemption from the requirement of other than serum or plasma; premarket notification must still sub- (8) For noninvasive testing as defined mit a premarket notification to FDA in § 812.3(k) of this chapter; and before introducing or delivering for in- (9) For near patient testing (point of troduction into interstate commerce care). for commercial distribution the device [65 FR 2319, Jan. 14, 2000] when: (a) The device is intended for a use different from the intended use of a le- Subpart B—Neurological gally marketed device in that generic Diagnostic Devices type of device; e.g., the device is in- tended for a different medical purpose, § 882.1020 Rigidity analyzer. or the device is intended for lay use (a) Identification. A rigidity analyzer where the former intended use was by is a device for quantifying the extent of health care professionals only; the rigidity of a patient’s limb to de- (b) The modified device operates termine the effectiveness of drugs or using a different fundamental sci- other treatments.
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(b) Classification. Class II (perform- § 882.1310 Cortical electrode. ance standards). (a) Identification. A cortical electrode is an electrode which is temporarily § 882.1030 Ataxiagraph. placed on the surface of the brain for (a) Identification. An ataxiagraph is a stimulating the brain or recording the device used to determine the extent of brain’s electrical activity. ataxia (failure of muscular coordina- (b) Classification. Class II (perform- tion) by measuring the amount of ance standards). swaying of the body when the patient is standing erect and with eyes closed. § 882.1320 Cutaneous electrode. (b) Classification. Class I (general con- (a) Identification. A cutaneous elec- trols). trode is an electrode that is applied di- rectly to a patient’s skin either to § 882.1200 Two-point discriminator. record physiological signals (e.g., the (a) Identification. A two-point dis- electroencephalogram) or to apply electrical stimulation. criminator is a device with points used (b) Classification. Class II (perform- for testing a patient’s touch discrimi- ance standards). nation. (b) Classification. Class I (general con- § 882.1330 Depth electrode. trols). The device is exempt from the (a) Identification. A depth electrode is premarket notification procedures in an electrode used for temporary stimu- subpart E of part 807 of this chapter lation of, or recording electrical sig- subject to § 882.9. The device is also ex- nals at, subsurface levels of the brain. empt from the current good manufac- (b) Classification. Class II (perform- turing practice regulations in part 820 ance standards). of this chapter, with the exception of § 820.180 of this chapter, with respect to § 882.1340 Nasopharyngeal electrode. general requirements concerning (a) Identification. A nasopharyngeal records, and § 820.198 of this chapter, electrode is an electrode which is tem- with respect to complaint files. porarily placed in the nasopharyngeal region for the purpose of recording [44 FR 51730–51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. electrical activity. 14, 2000] (b) Classification. Class II (perform- ance standards). § 882.1240 Echoencephalograph. § 882.1350 Needle electrode. (a) Identification. An (a) Identification. A needle electrode echoencephalograph is an ultrasonic is a device which is placed scanning device (including A-scan, B- subcutaneously to stimulate or to scan, and doppler systems) that uses record electrical signals. noninvasive transducers for measuring (b) Classification. Class II (perform- intracranial interfaces and blood flow ance standards). velocity to and in the head. (b) Classification. Class II (perform- § 882.1400 Electroencephalograph. ance standards). (a) Identification. An electroencephalograph is a device used § 882.1275 Electroconductive media. to measure and record the electrical (a) Identification. Electroconductive activity of the patient’s brain obtained media are the conductive creams or by placing two or more electrodes on gels used with external electrodes to the head. reduce the impedance (resistance to al- (b) Classification. Class II (perform- ternating current) of the contact be- ance standards). tween the electrode surface and the § 882.1410 Electroencephalograph elec- skin. trode/lead tester. (b) Classification. Class II (perform- (a) Identification. An ance standards). electroencephalograph electrode/lead
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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 (general con- sure that an adequate contact is made trols). The device is exempt from the between the electrode and the skin. premarket notification procedures in (b) Classification. Class I. The device subpart E of part 807 of this chapter is exempt from the premarket notifica- subject to § 882.9. The device is also ex- tion procedures in subpart E of part 807 empt from the current good manufac- of this chapter. turing practice regulations in part 820 of this chapter, with the exception of [44 FR 51730–51778, Sept. 4, 1979, as amended § 820.180 of this chapter, with respect to at 61 FR 1123, Jan. 16, 1996] general requirements concerning § 882.1420 Electroencephalogram records, and § 820.198 of this chapter, (EEG) signal spectrum analyzer. with respect to complaint files. (a) Identification. An electroencepha- [44 FR 51730–51778, Sept. 4, 1979, as amended logram (EEG) signal spectrum analyzer at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. is a device used to display the fre- 14, 2000] quency content or power spectral den- § 882.1525 Tuning fork. sity of the electroencephalogram (EEG) signal. (a) Identification. A tuning fork is a (b) Classification. Class I (general con- mechanical device which resonates at a trols). given frequency and is used to diagnose hearing disorders and to test for vibra- § 882.1430 Electroencephalograph test tory sense. signal generator. (b) Classification. Class I. The device (a) Identification. An is exempt from the premarket notifica- electroencephalograph test signal gen- tion procedures in subpart E of part 807 erator is a device used to test or cali- of this chapter. The device is also ex- brate an electroencephalograph. empt from the current good manufac- (b) Classification. Class I. The device turing practice regulations in part 820 is exempt from the premarket notifica- of this chapter, with the exception of tion procedures in subpart E of part 807 § 820.180, with respect to general re- of this chapter. quirements concerning records, and § 820.198, with respect to complaint [44 FR 51730–51778, Sept. 4, 1979, as amended files. at 59 FR 63011, Dec. 7, 1994] [44 FR 51730–51778, Sept. 4, 1979, as amended § 882.1460 Nystagmograph. at 54 FR 25051, June 12, 1989] (a) Identification. A nystagmograph is § 882.1540 Galvanic skin response a device used to measure, record, or measurement device. visually display the involuntary move- (a) Identification. A galvanic skin re- ments (nystagmus) of the eyeball. sponse measurement device is a device (b) Classification. Class II (perform- used to determine autonomic responses ance standards). as psychological indicators by meas- uring the electrical resistance of the § 882.1480 Neurological endoscope. skin and the tissue path between two (a) Identification. A neurological en- electrodes applied to the skin. doscope is an instrument with a light (b) Classification. Class II (perform- source used to view the inside of the ance standards). ventricles of the brain. (b) Classification. Class II (perform- § 882.1550 Nerve conduction velocity ance standards). measurement device. (a) Identification. A nerve conduction § 882.1500 Esthesiometer. velocity measurement device is a de- (a) Identification. An esthesiometer is vice which measures nerve conduction a mechanical device which usually con- time by applying a stimulus, usually to sists of a single rod or fiber which is a patient’s peripheral nerve. This de- held in the fingers of the physician or vice includes the stimulator and the
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electronic processing equipment for of this chapter. The device is also ex- measuring and displaying the nerve empt from the current good manufac- conduction time. turing practice regulations in part 820 (b) Classification. Class II (perform- of this chapter, with the exception of ance standards). § 820.180, with respect to general re- quirements concerning records, and § 882.1560 Skin potential measurement § 820.198, with respect to complaint device. files. (a) Identification. A skin potential [44 FR 51730–51778, Sept. 4, 1979, as amended measurement device is a general diag- at 54 FR 25051, June 12, 1989; 59 FR 63011, Dec. nostic device used to measure skin 7, 1994] voltage by means of surface skin elec- trodes. § 882.1750 Pinwheel. (b) Classification. Class II (perform- (a) Identification. A pinwheel is a de- ance standards). vice with sharp points on a rotating § 882.1570 Powered direct-contact tem- wheel used for testing pain sensation. perature measurement device. (b) Classification. Class I (general con- trols). The device is exempt from the (a) Identification. A powered direct- premarket notification procedures in contact temperature measurement de- subpart E of part 807 of this chapter vice is a device which contains a power subject to § 882.9. source and is used to measure dif- ferences in temperature between two [44 FR 51730–51778, Sept. 4, 1979, as amended points on the body. at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. (b) Classification. Class II (perform- 14, 2000] ance standards). § 882.1790 Ocular plethysmograph. § 882.1610 Alpha monitor. (a) Identification. An ocular (a) Identification. An alpha monitor is plethysmograph is a device used to a device with electrodes that are measure or detect volume changes in placed on a patient’s scalp to monitor the eye produced by pulsations of the that portion of the electroencepha- artery, to diagnose carotid artery oc- logram which is referred to as the clusive disease (restrictions on blood alpha wave. flow in the carotid artery). (b) Classification. Class II (perform- (b) Classification. Class III (premarket ance standards). approval). (c) Date PMA or notice of completion of § 882.1620 Intracranial pressure moni- a PDP is required. No effective date has toring device. been established of the requirement for (a) Identification. An intracranial premarket approval. See § 882.3. pressure monitoring device is a device [44 FR 51730–51778, Sept. 4, 1979, as amended used for short-term monitoring and re- at 52 FR 17739, May 11, 1987] cording of intracranial pressures and pressure trends. The device includes § 882.1825 Rheoencephalograph. the transducer, monitor, and inter- (a) Identification. A connecting hardware. rheoencephalograph is a device used to (b) Classification. Class II (perform- estimate a patient’s cerebral circula- ance standards). tion (blood flow in the brain) by elec- trical impedance methods with direct § 882.1700 Percussor. electrical connections to the scalp or (a) Identification. A percussor is a neck area. small hammerlike device used by a (b) Classification. Class III (premarket physician to provide light blows to a approval). body part. A percussor is used as a di- (c) Date PMA or notice of completion of agnostic aid during physical examina- a PDP is required. A PMA or a notice of tions. completion of a PDP is required to be (b) Classification. Class I. The device filed with the Food and Drug Adminis- is exempt from the premarket notifica- tration on or before December 26, 1996 tion procedures in subpart E of part 807 for any rheoencephalograph that was
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in commercial distribution before May § 882.1880 Evoked response mechan- 28, 1976, or that has, on or before De- ical stimulator. cember 26, 1996 been found to be sub- (a) Identification. An evoked response stantially equivalent to a mechanical stimulator is a device used rheoencephalograph that was in com- to produce a mechanical stimulus or a mercial distribution before May 28, series of mechanical stimuli for the 1976. Any other rheoencephalograph purpose of measuring a patient’s shall have an approved PMA or a de- clared completed PDP in effect before evoked response. being placed in commercial distribu- (b) Classification. Class II (perform- tion. ance standards). [44 FR 51730–51778, Sept. 4, 1979, as amended § 882.1890 Evoked response photic at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. stimulator. 27, 1996] (a) Identification. An evoked response § 882.1835 Physiological signal ampli- photic stimulator is a device used to fier. generate and display a shifting pattern or to apply a brief light stimulus to a (a) Identification. A physiological sig- patient’s eye for use in evoked response nal amplifier is a general purpose de- measurements or for electroencepha- vice used to electrically amplify sig- nals derived from various physiological logram (EEG) activation. sources (e.g., the electroencepha- (b) Classification. Class II (perform- logram). ance standards). (b) Classification. Class II (perform- § 882.1900 Evoked response auditory ance standards). stimulator. § 882.1845 Physiological signal condi- (a) Identification. An evoked response tioner. auditory stimulator is a device that (a) Identification. A physiological sig- produces a sound stimulus for use in nal conditioner is a device such as an evoked response measurements or elec- integrator or differentiator used to troencephalogram activation. modify physiological signals for re- (b) Classification. Class II (perform- cording and processing. ance standards). (b) Classification. Class II (perform- ance standards). § 882.1925 Ultrasonic scanner calibra- tion test block. § 882.1855 Electroencephalogram (a) Identification. An ultrasonic scan- (EEG) telemetry system. ner calibration test block is a block of (a) Identification. An electroencepha- material with known properties used to logram (EEG) telemetry system con- calibrate ultrasonic scanning devices sists of transmitters, receivers, and (e.g., the echoencephalograph). other components used for remotely (b) Classification. Class I. The device monitoring or measuring EEG signals is exempt from the premarket notifica- by means of radio or telephone trans- tion procedures in subpart E of part 807 mission systems. of this chapter. (b) Classification. Class II (perform- ance standards). [44 FR 51730–51778, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994] § 882.1870 Evoked response electrical stimulator. § 882.1950 Tremor transducer. (a) Identification. An evoked response (a) Identification. A tremor trans- electrical stimulator is a device used ducer is a device used to measure the to apply an electrical stimulus to a pa- degree of tremor caused by certain dis- tient by means of skin electrodes for eases. the purpose of measuring the evoked (b) Classification. Class II (perform- response. ance standards). (b) Classification. Class II (perform- ance standards). Subparts C–D [Reserved] 400
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Subpart E—Neurological Surgical (b) Classification. Class II (perform- Devices ance standards).
§ 882.4030 Skull plate anvil. § 882.4175 Aneurysm clip applier. (a) Identification. A skull plate anvil (a) Identification. An aneurysm clip is a device used to form alterable skull applier is a device used by the surgeon plates in the proper shape to fit the for holding and applying intracranial curvature of a patient’s skull. aneurysm clips. (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. § 882.4190 Clip forming/cutting instru- ment. [44 FR 51730–51778, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994] (a) Identification. A clip forming/cut- ting instrument is a device used by the § 882.4060 Ventricular cannula. physician to make tissue clips from (a) Identification. A ventricular wire stock. cannula is a device used to puncture (b) Classification. Class I. The device the ventricles of the brain for aspira- is exempt from the premarket notifica- tion or for injection. This device is fre- tion procedures in subpart E of part 807 quently referred to as a ventricular of this chapter. needle. [44 FR 51730–51778, Sept. 4, 1979, as amended (b) Classification. Class I (general con- at 59 FR 63012, Dec. 7, 1994] trols). When made only of surgical grade stainless steel, the device is ex- § 882.4200 Clip removal instrument. empt from the premarket notification (a) Identification. A clip removal in- procedures in subpart E of part 807 of strument is a device used to remove this chapter subject to § 882.9. surgical clips from the patient. [44 FR 51730–51778, Sept. 4, 1979, as amended (b) Classification. Class I. The device at 65 FR 2319, Jan. 14, 2000] is exempt from the premarket notifica- tion procedures in subpart E of part 807 § 882.4100 Ventricular catheter. of this chapter. (a) Identification. A ventricular cath- eter is a device used to gain access to [44 FR 51730–51778, Sept. 4, 1979, as amended the cavities of the brain for injection at 59 FR 63012, Dec. 7, 1994] of material into, or removal of mate- § 882.4215 Clip rack. rial from, the brain. (b) Classification. Class II (perform- (a) Identification. A clip rack is a de- ance standards). vice used to hold or store surgical clips during surgery. § 882.4125 Neurosurgical chair. (b) Classification. Class I. The device (a) Identification. A neurosurgical is exempt from the premarket notifica- chair is an operating room chair used tion procedures in subpart E of part 807 to position and support a patient dur- of this chapter. ing neurosurgery. [44 FR 51730–51778, Sept. 4, 1979, as amended (b) Classification. Class I. The device at 54 FR 25051, June 12, 1989; 59 FR 63012, Dec. is exempt from the premarket notifica- 7, 1994] tion procedures in subpart E of part 807 of this chapter. § 882.4250 Cryogenic surgical device. [44 FR 51730–51778, Sept. 4, 1979, as amended (a) Identification. A cryogenic sur- at 59 FR 63012, Dec. 7, 1994] gical device is a device used to destroy nervous tissue or produce lesions in § 882.4150 Scalp clip. nervous tissue by the application of ex- (a) Identification. A scalp clip is a treme cold to the selected site. plastic or metal clip used to stop bleed- (b) Classification. Class II (perform- ing during surgery on the scalp. ance standards).
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§ 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. (b) Classification. Class II (perform- § 882.4305 Powered compound cranial drills, burrs, trephines, and their ance standards). accessories. § 882.4400 Radiofrequency lesion gen- (a) Identification. Powered compound erator. cranial drills, burrs, trephines, and (a) Identification. A radiofrequency le- their accessories are bone cutting and sion generator is a device used to drilling instruments used on a pa- produce lesions in the nervous system tient’s skull. The instruments employ or other tissue by the direct applica- a clutch mechanism to disengage the tion of radiofrequency currents to se- tip of the instrument after penetrating lected sites. the skull to prevent plunging of the tip into the brain. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). § 882.4440 Neurosurgical headrests. § 882.4310 Powered simple cranial (a) Identification. A neurosurgical drills, burrs, trephines, and their headrest is a device used to support the accessories. patient’s head during a surgical proce- (a) Identification. Powered simple cra- dure. nial drills, burrs, trephines, and their (b) Classification. Class I. The device accessories are bone cutting and drill- is exempt from the premarket notifica- ing instruments used on a patient’s tion procedures in subpart E of part 807 skull. The instruments are used with a of this chapter. power source but do not have a clutch [44 FR 51730–51778, Sept. 4, 1979, as amended mechanism to disengage the tip after at 59 FR 63012, Dec. 7, 1994] penetrating the skull. (b) Classification. Class II (perform- § 882.4460 Neurosurgical head holder ance standards). (skull clamp). (a) Identification. A neurosurgical § 882.4325 Cranial drill handpiece head holder (skull clamp) is a device (brace). used to clamp the patient’s skull to (a) Identification. A cranial drill hand- hold head and neck in a particular po- piece (brace) is a hand holder, which is sition during surgical procedures. used without a power source, for drills, (b) Classification. Class II (perform- burrs, trephines, or other cutting tools ance standards). that are used on a patient’s skull. (b) Classification. Class I. The device § 882.4500 Cranioplasty material form- is exempt from the premarket notifica- ing instrument. tion procedures in subpart E of part 807 (a) Identification. A cranioplasty ma- of this chapter. terial forming instrument is a roller [44 FR 51730–51778, Sept. 4, 1979, as amended used in the preparation and forming of at 61 FR 1123, Jan. 16, 1996] cranioplasty (skull repair) materials.
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(b) Classification. Class I. The device § 882.4560 Stereotaxic instrument. is exempt from the premarket notifica- (a) Identification. A stereotaxic in- tion procedures in subpart E of part 807 strument is a device consisting of a of this chapter. rigid frame with a calibrated guide [44 FR 51730–51778, Sept. 4, 1979, as amended mechanism for precisely positioning at 59 FR 63012, Dec. 7, 1994] probes or other devices within a pa- tient’s brain, spinal cord, or other part § 882.4525 Microsurgical instrument. of the nervous system. (a) Identification. A microsurgical in- (b) Classification. Class II (perform- strument is a nonpowered surgical in- ance standards). strument used in neurological micro- surgery procedures. § 882.4600 Leukotome. (b) Classification. Class I. The device (a) Identification. A leukotome is a is exempt from the premarket notifica- device used to cut sections out of the tion procedures in subpart E of part 807 brain. 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] tion procedures in subpart E of part 807 of this chapter. § 882.4535 Nonpowered neurosurgical [44 FR 51730–51778, Sept. 4, 1979, as amended instrument. at 59 FR 63012, Dec. 7, 1994] (a) Identification. A nonpowered neurosurgical instrument is a hand in- § 882.4650 Neurosurgical suture nee- strument or an accessory to a hand in- dle. strument used during neurosurgical (a) Identification. A neurosurgical su- procedures to cut, hold, or manipulate ture needle is a needle used in suturing tissue. It includes specialized chisels, during neurosurgical procedures or in osteotomes, curettes, dissectors, ele- the repair of nervous tissue. vators, forceps, gouges, hooks, surgical (b) Classification. Class I (general con- knives, rasps, scissors, separators, trols). The device is exempt from the spatulas, spoons, blades, blade holders, premarket notification procedures in blade breakers, probes, etc. subpart E of part 807 of this chapter (b) Classification. Class I. The device subject to § 882.9. is exempt from the premarket notifica- tion procedures in subpart E of part 807 [44 FR 51730–51778, Sept. 4, 1979, as amended of this chapter. at 54 FR 25051, June 12, 198965 FR 2319, Jan. 14, 2000] [44 FR 51730–51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] § 882.4700 Cottonoid paddie. (a) Identification. A cottonoid paddie § 882.4545 Shunt system implantation instrument. is a cotton pad used during surgery to protect nervous tissue, absorb fluids, or (a) Identification. A shunt system im- stop bleeding. plantation instrument is an instru- (b) Classification. Class II (perform- ment used in the implantation of cere- ance standards). brospinal fluid shunts, and includes tunneling instruments for passing § 882.4725 Radiofrequency lesion shunt components under the skin. probe. (b) Classification. Class I (general con- (a) Identification. A radiofrequency le- trols). When made only of surgical sion probe is a device connected to a grade stainless steel, the device is ex- radiofrequency (RF) lesion generator empt from the premarket notification to deliver the RF energy to the site procedures in subpart E of part 807 of within the nervous system where a le- this chapter subject to § 882.9. sion is desired. [44 FR 51730–51778, Sept. 4, 1979, as amended (b) Classification. Class II (perform- at 65 FR 2319, Jan. 14, 2000] ance standards).
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§ 882.4750 Skull punch. Subpart F—Neurological (a) Identification. A skull punch is a Therapeutic Devices device used to punch holes through a patient’s skull to allow fixation of § 882.5030 Methyl methacrylate for aneurysmorrhaphy. cranioplasty plates or bone flaps by wire or other means. (a) Identification. Methyl methacry- (b) Classification. Class I (general con- late for aneurysmorrhaphy (repair of trols). The device is exempt from the aneurysms, which are balloonlike sacs premarket notification procedures in formed on blood vessels) is a self-cur- subpart E of part 807 of this chapter ing acrylic used to encase and reinforce subject to § 882.9. This exemption does intracranial aneurysms that are not not apply to powered compound cranial amenable to conservative manage- ment, removal, or obliteration by an- drills, burrs, trephines, and their acces- eurysm clip. sories classified under § 882.4305. (b) Classification. Class II (perform- [44 FR 51730–51778, Sept. 4, 1979, as amended ance standards). at 65 FR 2319, Jan. 14, 2000] § 882.5050 Biofeedback device. § 882.4800 Self-retaining retractor for neurosurgery. (a) Identification. A biofeedback de- 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 gery involving the skull or spinal col- when it is a prescription battery pow- umn. ered device that is indicated for relax- (b) Classification. Class II (perform- ation training and muscle reeducation and prescription use, subject to § 882.9. ance standards). [44 FR 51730–51778, Sept. 4, 1979, as amended § 882.4845 Powered rongeur. at 63 FR 59229, Nov. 3, 1998] (a) Identification. A powered rongeur is a powered instrument used for cut- § 882.5070 Bite block. ting or biting bone during surgery in- (a) Identification. A bite block is a de- volving the skull or spinal column. vice inserted into a patient’s mouth to (b) Classification. Class II (perform- protect the tongue and teeth while the ance standards). patient is having convulsions. (b) Classification. Class II (perform- § 882.4900 Skullplate screwdriver. ance standards). (a) Identification. A skullplate screw- § 882.5150 Intravascular occluding driver is a tool used by the surgeon to catheter. fasten cranioplasty plates or skullplates to a patient’s skull by (a) Identification. An intravascular screws. occluding catheter is a catheter with an inflatable or detachable balloon tip (b) Classification. Class I. The device that is used to block a blood vessel to is exempt from the premarket notifica- treat malformations, e.g., aneurysms tion procedures in subpart E of part 807 (balloonlike sacs formed on blood ves- of this chapter. sels) of intracranial blood vessels. [44 FR 51730–51778, Sept. 4, 1979, as amended (b) Classification. Class III (premarket at 59 FR 63012, Dec. 7, 1994] approval).
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(c) Date PMA or notice of completion of (b) Classification. Class II (perform- a PDP is required. A PMA or a notice of ance standards). completion of a PDP is required to be filed with the Food and Drug Adminis- § 882.5235 Aversive conditioning de- tration on or before December 26, 1996 vice. for any intravascular occluding cath- (a) Identification. An aversive condi- eter that was in commercial distribu- tioning device is an instrument used to tion before May 28, 1976, or that has, on administer an electrical shock or other or before December 26, 1996 been found noxious stimulus to a patient to mod- to be substantially equivalent to an ify undesirable behavioral characteris- intravascular occluding catheter that tics. was in commercial distribution before (b) Classification. Class II (perform- May 28, 1976. Any other intravascular ance standards). occluding catheter shall have an ap- proved PMA or a declared completed § 882.5250 Burr hole cover. PDP in effect before being placed in (a) Identification. A burr hole cover is commercial distribution. a plastic or metal device used to cover [44 FR 51730–51778, Sept. 4, 1979, as amended or plug holes drilled into the skull dur- at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. ing surgery and to reattach cranial 27, 1996] bone removed during surgery. (b) Classification. Class II (perform- § 882.5175 Carotid artery clamp. ance standards). (a) Identification. A carotid artery clamp is a device that is surgically § 882.5275 Nerve cuff. placed around a patient’s carotid ar- (a) Identification. A nerve cuff is a tu- tery (the principal artery in the neck bular silicone rubber sheath used to en- that supplies blood to the brain) and case a nerve for aid in repairing the has a removable adjusting mechanism nerve (e.g., to prevent ingrowth of scar that protrudes through the skin of the tissue) and for capping the end of the patient’s neck. The clamp is used to oc- nerve to prevent the formation of clude the patient’s carotid artery to neuroma (tumors). treat intracranial aneurysms (b) Classification. Class II (perform- (balloonlike sacs formed on blood ves- ance standards). sels) or other intracranial vascular malformations that are difficult to at- § 882.5300 Methyl methacrylate for tach directly by reducing the blood cranioplasty. pressure and blood flow to the aneu- (a) Identification. Methyl methacry- rysm or malformation. late for cranioplasty (skull repair) is a (b) Classification. Class II (perform- self-curing acrylic that a surgeon uses ance standards). to repair a skull defect in a patient. At the time of surgery, the surgeon initi- § 882.5200 Aneurysm clip. ates polymerization of the material (a) Identification. An aneurysm clip is and forms it into a plate or other ap- a device used to occlude an propriate shape to repair the defect. intracranial aneurysm (a balloonlike (b) Classification. Class II (perform- sac formed on a blood vessel) to pre- ance standards). vent it from bleeding or bursting. (b) Classification. Class II (perform- § 882.5320 Preformed alterable ance standards). cranioplasty plate. (a) Identification. A preformed § 882.5225 Implanted malleable clip. alterable cranioplasty plate is a device (a) Identification. An implanted mal- that is implanted into a patient to re- leable clip is a bent wire or staple that pair a skull defect. It is constructed of is forcibly closed with a special instru- a material, e.g., tantalum, that can be ment to occlude an intracranial blood altered or reshaped at the time of sur- vessel or aneurysm (a balloonlike sac gery without changing the chemical formed on a blood vessel), stop bleed- behavior of the material. ing, or hold tissue or a mechanical de- (b) Classification. Class II (perform- vice in place in a patient. ance standards).
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§ 882.5330 Preformed nonalterable § 882.5800 Cranial electrotheraphy cranioplasty plate. stimulator. (a) Identification. A preformed (a) Identification. A cranial nonalterable cranioplasty plate is a de- electrotheraphy stimulator is a device vice that is implanted in a patient to that applies electrical current to a pa- repair a skull defect and is constructed tient’s head to treat insomnia, depres- of a material, e.g., stainless steel or sion, or anxiety. (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- (a) Identification. An external func- fect. tional neuromuscular stimulator is an (b) Classification. Class II (perform- electrical stimulator that uses external ance standards). electrodes for stimulating muscles in the leg and ankle of partially paralyzed § 882.5500 Lesion temperature mon- patients (e.g., after stroke) to provide itor. flexion of the foot and thus improve the patient’s gait. (a) Identification. A lesion tempera- (b) Classification. Class II (perform- ture monitor is a device used to mon- ance standards). itor the tissue temperature at the site where a lesion (tissue destruction) is to § 882.5820 Implanted cerebellar stimu- be made when a surgeon uses a radio- lator. frequency (RF) lesion generator and (a) Identification. An implanted cere- probe. bellar stimulator is a device used to (b) Classification. Class II (perform- stimulate electrically a patient’s cere- ance standards). bellar cortex for the treatment of in- tractable epilepsy, spasticity, and some § 882.5550 Central nervous system movement disorders. The stimulator fluid shunt and components. consists of an implanted receiver with (a) Identification. A central nervous electrodes that are placed on the pa- tient’s cerebellum and an external system fluid shunt is a device or com- transmitter for transmitting the stim- bination of devices used to divert fluid ulating pulses across the patient’s skin from the brain or other part of the cen- to the implanted receiver. tral nervous system to an internal de- (b) Classification. Class III (premarket livery site or an external receptacle for approval). the purpose of relieving elevated (c) Date premarket approval application intracranial pressure or fluid volume (PMA) or notice of completion of a prod- (e.g., due to hydrocephalus). Compo- uct development protocol (PDP) is re- nents of a central nervous system quired. A PMA or notice of completion shunt include catheters, valved cath- of a PDP is required to be filed with eters, valves, connectors, and other ac- the Food and Drug Administration on cessory components intended to facili- or before September 26, 1984. Any im- tate use of the shunt or evaluation of a planted cerebellar stimulator that was patient with a shunt. not in commercial distribution before (b) Classification. Class II (perform- May 28, 1976, or that has not on or be- ance standards). fore September 26, 1984 been found by FDA to be substantially equivalent to
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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- tient’s brain and an external trans- [44 FR 51730–51778, Sept. 4, 1979 and 49 FR 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 (c) Date premarket approval application completed PDP in effect before being (PMA) or notice of completion of a prod- placed in commercial distribution. uct development protocol (PDP) is re- [44 FR 51730–51778, Sept. 4, 1979, as amended quired. A PMA or a notice of comple- at 53 FR 48621, Dec. 1, 1988] tion of a PDP is required to be filed with the Food and Drug Administra- § 882.5850 Implanted spinal cord stim- tion on or before July 7, 1986 for any ulator for bladder evacuation. implanted diaphragmatic/phrenic nerve (a) Identification. An implanted spinal stimulator that was in commercial dis- cord stimulator for bladder evacuation tribution before May 28, 1976, or that is an electrical stimulator used to has on or before July 7, 1986 been found empty the bladder of a paraplegic pa- to be substantially equivalent to an tient who has a complete transection implanted diaphragmatic/phrenic nerve of the spinal cord and who is unable to stimulator that was in commercial dis- empty his or her bladder by reflex tribution before May 28, 1976. Any means or by the intermittent use of other implanted diaphragmatic/phrenic catheters. The stimulator consists of nerve stimulator shall have an ap- an implanted receiver with electrodes proved PMA or a declared completed that are placed on the conus medullaris PDP in effect before being placed in portion of the patient’s spinal cord and commercial distribution. an external transmitter for transmit- [44 FR 51730–51778, Sept. 4, 1979, as amended ting the stimulating pulses across the at 51 FR 12101, Apr. 8, 1986] patient’s skin to the implanted re- ceiver. § 882.5840 Implanted intracerebral/ (b) Classification. Class III (premarket subcortical stimulator for pain re- approval). lief. (c) Date PMA or notice of completion of (a) Identification. An implanted a PDP is required. A PMA or a notice of intracerebral/subcortical stimulator completion of a PDP is required to be
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filed with the Food and Drug Adminis- PDP in effect before being placed in tration on or before December 26, 1996 commercial distribution. for any implanted spinal cord stimu- [44 FR 51730–51778, Sept. 4, 1979, as amended lator for bladder evacuation that was at 52 FR 17740, May 11, 1987; 64 FR 18329, Apr. in commercial distribution before May 14, 1999] 28, 1976, or that has, on or before De- cember 26, 1996 been found to be sub- § 882.5870 Implanted peripheral nerve stantially equivalent to an implanted stimulator for pain relief. spinal cord stimulator for bladder (a) Identification. An implanted pe- evacuation that was in commercial dis- ripheral nerve stimulator for pain re- tribution before May 28, 1976. Any lief is a device that is used to stimulate other implanted spinal cord stimulator electrically a peripheral nerve in a pa- for bladder evacuation shall have an tient to relieve severe intractable pain. approved PMA or a declared completed The stimulator consists of an inplanted PDP in effect before being placed in receiver with electrodes that are commercial distribution. placed around a peripheral nerve and an external transmitter for transmit- [44 FR 51730–51778, Sept. 4, 1979, as amended ting the stimulating pulses across the at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. patient’s skin to the implanted re- 27, 1996] ceiver. (b) Classification. Class II (perform- § 882.5860 Implanted neuromuscular stimulator. ance standards). (a) Identification. An implanted neu- § 882.5880 Implanted spinal cord stim- romuscular stimulator is a device that ulator for pain relief. provides electrical stimulation to a pa- (a) Identification. An implanted spinal tient’s peroneal or femoral nerve to cord stimulator for pain relief is a de- cause muscles in the leg to contract, vice that is used to stimulate elec- thus improving the gait in a patient trically a patient’s spinal cord to re- with a paralyzed leg. The stimulator lieve severe intractable pain. The stim- consists of an implanted receiver with ulator consists of an implanted re- electrodes that are placed around a pa- ceiver with electrodes that are placed tient’s nerve and an external trans- on the patient’s spinal cord and an ex- mitter for transmitting the stimu- ternal transmitter for transmitting the lating pulses across the patient’s skin stimulating pulses across the patient’s to the implanted receiver. The external skin to the implanted receiver. transmitter is activated by a switch in (b) Classification. Class II (perform- the heel in the patient’s shoe. ance standards). (b) Classification. Class III (premarket § 882.5890 Transcutaneous electrical approval). nerve stimulator for pain relief. (c) Date PMA or notice of completion of PDP is required. A PMA or notice of (a) Identification. A transcutaneous completion of a PDP for a device de- electrical nerve stimulator for pain re- scribed in paragraph (b) of this section lief is a device used to apply an elec- trical current to electrodes on a pa- is required to be filed with the Food tient’s skin to treat pain. and Drug Administration on or before (b) Classification. Class II (perform- July 13, 1999 for any implanted neuro- ance standards). muscular stimulator that was in com- mercial distribution before May 28, § 882.5900 Preformed craniosynostosis 1976, or that has, on or before July 13, strip. 1999, been found to be substantially (a) Identification. A preformed equivalent to an implanted neuro- craniosynostosis strip is a plastic strip muscular stimulator that was in com- used to cover bone edges of craniec- mercial distribution before May 28, tomy sites (sites where the skull has 1976. Any other implanted neuro- been cut) to prevent the bone from re- muscular stimulator shall have an ap- growing in patients whose skull su- proved PMA or declared completed tures are abnormally fused together.
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(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 purposes to apply pressure to promi- (a) Identification. A dura substitute is nent regions of an infant’s cranium in a sheet or material that is used to re- order to improve cranial symmetry pair the dura mater (the membrane and/or shape in infants from 3 to 18 surrounding the brain). months of age, with moderate to severe (b) Classification. Class II (perform- nonsynostotic positional ance standards). plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and § 882.5940 Electroconvulsive therapy device. scaphocephalic-shaped heads. (b) Classification. Class II (special (a) Identification. An controls) (prescription use in accord- electroconvulsive therapy device is a ance with § 801.109 of this chapter, bio- device used for treating severe psy- compatibility testing, and labeling chiatric disturbances (e.g., severe de- (contraindications, warnings, pre- pression) by inducing in the patient a cautions, adverse events, instructions major motor seizure by applying a brief for physicians and parents)). intense electrical current to the pa- 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. premarket approval. See § 882.3. 884.1185 Endometrial washer. 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). (a) Identification. Skull tongs for 884.1560 Fetal blood sampler. traction is an instrument used to im- 884.1600 Transabdominal amnioscope mobilize a patient with a cervical spine (fetoscope) and accessories. injury (e.g., fracture or dislocation). 884.1630 Colposcope. The device is caliper shaped with tips 884.1640 Culdoscope and accessories. that penetrate the skin. It is anchored 884.1660 Transcervical endoscope (amnioscope) and accessories. to the skull and has a heavy weight at- 884.1690 Hysteroscope and accessories. tached to it that maintains, by trac- 884.1700 Hysteroscopic insufflator. tion, the patient’s position. 884.1720 Gynecologic laparoscope and acces- (b) Classification. Class II (perform- sories. ance standards). 884.1730 Laparoscopic insufflator.
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