Subpart E-Neurological Surgical Devices § 882.4030 Skull plate anvil. (a) Identification. A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994] § 882.4060 Ventricular cannula. Identification. A ventricular (a) cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle. (b) Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. [44 FR 51730-51778, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000] § 882.4100 Ventricular catheter. (a) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance standards). § 882.4125 Neurosurgical chair. (a) Identification. A neurosurgical chair is an operating room chair used to position and support a patient during neurosurgery. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] § 882.4150 Scalp clip. (a) Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp. (b) Classification. Class II (performance standards). § 882.4175 Aneurysm clip applier. (a) Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips. (b) Classification. Class II (performance standards). § 882.4190 Clip forming/cutting instru ment. (a) Identification. A clip forming/cutting instrument is a device used by the physician to make tissue clips from wire stock. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] § 882.4200 Clip removal instrument. (a) Identification. A clip removal instrument is a device used to remove surgical clips from the patient. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] § 882.4215 Clip rack. (a) Identification. A clip rack is a device used to hold or store surgical clips during surgery. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 59 FR 63012, Dec. 7, 1994] § 882.4250 Cryogenic surgical device. (a) Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site. (b) Classification. Class II (performance standards). § 882.4275 Dowel cutting instrument. (a) Identification. A dowel cutting instrument is a device used to cut dowels of bone for bone grafting. (b) Classification. Class II (performance standards). § 882.4300 Manual cranial drills, burrs, trephines, and their accessories (a) Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull. (b) Classification. Class II (performance standards). § 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories. (a) Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain. (b) Classification. Class II (performance standards). § 882.4440 Neurosurgical headrests. (a) Identification. A neurosurgical headrest is a device used to support the patient's head during a surgical procedure. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] § 882.4460 Neurosurgical head holder (skull clamp). (a) Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures. (b) Classification. Class II (performance standards). § 882.4500 Cranioplasty material forming instrument. (a) Identification. A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] § 882.4525 Microsurgical instrument. (a) Identification. A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] § 882.4535 Nonpowered neurosurgical instrument. nonpowered (a) Identification. A neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] (a) Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin. (b) Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. [44 FR 51730-51778, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000] § 882.4750 Skull punch. (a) Identification. A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under § 882.4305. [44 FR 51730-51778, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000] § 882.5050 Biofeedback device. (a) Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to §882.9. [44 FR 51730-51778, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998] |