Food and Drug Administration, HHS § 882.4460 nervous tissue by the application of ex- (b) Classification. Class I (general con- treme cold to the selected site. trols). 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 subject to the limitations in § 882.9. § 882.4275 Dowel cutting instrument. [44 FR 51730–51778, Sept. 4, 1979, as amended (a) Identification. A dowel cutting in- at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July strument is a device used to cut dowels 25, 2001] of bone for bone grafting. (b) Classification. Class II (perform- § 882.4360 Electric cranial drill motor. ance standards). (a) Identification. An electric cranial drill motor is an electrically operated § 882.4300 Manual cranial drills, burrs, power source used with removable ro- trephines, and their accessories tating surgical cutting tools or drill (a) Identification. Manual cranial bits on a patient’s skull. drills, burrs, trephines, and their acces- (b) Classification. Class II (perform- sories are bone cutting and drilling in- ance standards). struments that are used without a power source on a patient’s skull. § 882.4370 Pneumatic cranial drill motor. (b) Classification. Class II (perform- ance standards). (a) Identification. A pneumatic cranial drill motor is a pneumatically operated § 882.4305 Powered compound cranial power source used with removable ro- drills, burrs, trephines, and their tating surgical cutting tools or drill accessories. bits on a patient’s skull. (a) Identification. Powered compound (b) Classification. Class II (perform- cranial drills, burrs, trephines, and ance standards). their accessories are bone cutting and drilling instruments used on a pa- § 882.4400 Radiofrequency lesion gen- erator. tient’s skull. The instruments employ a clutch mechanism to disengage the (a) Identification. A radiofrequency le- tip of the instrument after penetrating sion generator is a device used to the skull to prevent plunging of the tip produce lesions in the nervous system into the brain. or other tissue by the direct applica- (b) Classification. Class II (perform- tion of radiofrequency currents to se- ance standards). lected sites. (b) Classification. Class II (perform- § 882.4310 Powered simple cranial ance standards). drills, burrs, trephines, and their accessories. § 882.4440 Neurosurgical headrests. (a) Identification. Powered simple cra- (a) Identification. A neurosurgical nial drills, burrs, trephines, and their headrest is a device used to support the accessories are bone cutting and drill- patient’s head during a surgical proce- ing instruments used on a patient’s dure. skull. The instruments are used with a (b) Classification. Class I (general con- power source but do not have a clutch trols). The device is exempt from the mechanism to disengage the tip after premarket notification procedures in penetrating the skull. subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 882.9. ance standards). [44 FR 51730–51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July § 882.4325 Cranial drill handpiece 25, 2001] (brace). (a) Identification. A cranial drill hand- § 882.4460 Neurosurgical head holder piece (brace) is a hand holder, which is (skull clamp). used without a power source, for drills, (a) Identification. A neurosurgical burrs, trephines, or other cutting tools head holder (skull clamp) is a device that are used on a patient’s skull. used to clamp the patient’s skull to 439 VerDate Nov<24>2008 08:24 Apr 27, 2010 Jkt 220072 PO 00000 Frm 00449 Fmt 8010 Sfmt 8010 Y:\SGML\220072.XXX 220072 erowe on DSK5CLS3C1PROD with CFR § 882.4500 21 CFR Ch. I (4–1–10 Edition) hold head and neck in a particular po- § 882.4545 Shunt system implantation sition during surgical procedures. instrument. (b) Classification. Class II (perform- (a) Identification. A shunt system im- ance standards). plantation instrument is an instru- ment used in the implantation of cere- § 882.4500 Cranioplasty material form- ing instrument. brospinal fluid shunts, and includes tunneling instruments for passing (a) Identification. A cranioplasty ma- shunt components under the skin. terial forming instrument is a roller (b) Classification. Class I (general con- used in the preparation and forming of trols). When made only of surgical cranioplasty (skull repair) materials. grade stainless steel, the device is ex- (b) Classification. Class I (general con- empt from the premarket notification trols). The device is exempt from the procedures in subpart E of part 807 of premarket notification procedures in this chapter subject to § 882.9. subpart E of part 807 of this chapter subject to the limitations in § 882.9. [44 FR 51730–51778, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000] [44 FR 51730–51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July § 882.4560 Stereotaxic instrument. 25, 2001] (a) Identification. A stereotaxic in- § 882.4525 Microsurgical instrument. strument is a device consisting of a rigid frame with a calibrated guide (a) Identification. A microsurgical in- mechanism for precisely positioning strument is a nonpowered surgical in- probes or other devices within a pa- strument used in neurological micro- tient’s brain, spinal cord, or other part surgery procedures. of the nervous system. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in subpart E of part 807 of this chapter § 882.4600 Leukotome. subject to the limitations in § 882.9. (a) Identification. A leukotome is a [44 FR 51730–51778, Sept. 4, 1979, as amended device used to cut sections out of the at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July brain. 25, 2001] (b) Classification. Class I (general con- trols). The device is exempt from the § 882.4535 Nonpowered neurosurgical premarket notification procedures in instrument. subpart E of part 807 of this chapter (a) Identification. A nonpowered subject to the limitations in § 882.9. neurosurgical instrument is a hand in- strument or an accessory to a hand in- [44 FR 51730–51778, Sept. 4, 1979, as amended strument used during neurosurgical at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] procedures to cut, hold, or manipulate tissue. It includes specialized chisels, § 882.4650 Neurosurgical suture nee- osteotomes, curettes, dissectors, ele- dle. vators, forceps, gouges, hooks, surgical (a) Identification. A neurosurgical su- knives, rasps, scissors, separators, ture needle is a needle used in suturing spatulas, spoons, blades, blade holders, during neurosurgical procedures or in blade breakers, probes, etc. the repair of nervous tissue. (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 882.9. subject to § 882.9. [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; 66 FR 38808, July at 54 FR 25051, June 12, 198965 FR 2319, Jan. 25, 2001] 14, 2000] 440 VerDate Nov<24>2008 08:24 Apr 27, 2010 Jkt 220072 PO 00000 Frm 00450 Fmt 8010 Sfmt 8010 Y:\SGML\220072.XXX 220072 erowe on DSK5CLS3C1PROD with CFR.