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in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to rheoencephalograph that was in commercial distribution before May 28, 1976. Any other rheoencephalograph shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

8882.1880 Evoked response mechan

ical stimulator. (a) Identification. An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring patient's evoked response.

(b) Classification. Class II (performance standards).

a

[44 FR 51730–51778, Sept. 4, 1979, as amended 8882.1890 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 (a) Identification. A physiological sig

or to apply a brief light stimulus to a nal amplifier is a general purpose de

patient's eye for use in evoked response vice used to electrically amplify sig

measurements or for electroencephanals derived from various physiological

logram (EEG) activation. sources (e.g., the electroencepha

(b) Classification. Class II (performlogram).

ance standards). (b) Classification. Class II (perform

8882.1900 Evoked response auditory ance standards).

stimulator. 8882.1845 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 elecintegrator or differentiator used to troencephalogram activation. modify physiological signals for re- (b) Classification. Class II (performcording and processing.

ance standards). (b) Classification. Class II (perform

8882.1925 Ultrasonic scanner calibra. ance standards).

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 notificaby means of radio or telephone trans- tion procedures in subpart E of part 807 mission systems.

of this chapter. (b) Classification. Class II (perform

[44 FR 51730–51778, Sept. 4, 1979, as amended ance standards).

at 59 FR 63011, Dec. 7, 1994) 8 882.1870 Evoked

response electrical stimulator.

8 882.1950 Tremor transducer. (a) Identification. An evoked response

(a) Identification. A tremor transelectrical 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

eases. tient by means of skin electrodes for the purpose of measuring the evoked (b) Classification. Class II (performresponse.

ance standards). (b) Classification. Class II (performance standards).

Subparts C-D [Reserved)

Subpart E-Neurological Surgical

Devices

(b) Classification. Class II (performance standards).

8 882.4030 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)

$882.4175 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).

$ 882.4060 Ventricular cannula.

(a) Identification. A ventricular 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)

$ 882.4190 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]

8 882.4200 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)

$ 882.4100 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]

8 882.4215 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)

8 882.4250 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).

8882.4150 Scalp clip.

(a) Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.

8882.4275 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).

8882.4360 Electric cranial drill motor.

(a) Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

(b) Classification. Class II (performance standards). 8882.4370 Pneumatic cranial drill

motor. (a) Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

(b) Classification. Class II (performance standards). $ 882.4400 Radiofrequency lesion gen

erator. (a) Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

(b) Classification. Class II (performance standards).

8 882.4305 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).

$ 882.4310 Powered simple cranial

drills, burrs, trephines, and their

accessories. (a) Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

(b) Classification. Class II (performance standards).

8 882.4440 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). 8882.4500 Cranioplasty material form.

ing instrument. (a) Identification. A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials.

8 882.4325 Cranial drill handpiece

(brace). (a) Identification. A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on 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 61 FR 1123, Jan. 16, 1996)

(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]

$ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).

8882.4525 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)

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$882.4535 Nonpowered neurosurgical

instrument. (a) Identification. А nonpowered 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)

$ 882.4650 Neurosurgical suture

dle. (a) Identification. A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.

(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.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 198965 FR 2319, Jan. 14, 2000]

8882.4700 Cottonoid paddie.

(a) Identification. A cottonoid paddie is a cotton pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

(b) Classification. Class II (performance standards).

8882.4545 Shunt system implantation

instrument. (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)

8882.4725 Radiofrequency lesion

probe. (a) Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

(b) Classification. Class II (performance standards).

$ 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)

Subpart F-Neurological

Therapeutic Devices $ 882.5030 Methyl methacrylate for

aneurysmorrhaphy. (a) Identification. Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip.

(b) Classification. Class II (performance standards).

8882.4800 Self-retaining retractor for

neurosurgery. (a) Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

(b) Classification. Class II (performance standards).

8882.4840 Manual rongeur.

(a) Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

(b) Classification. Class II (performance standards).

$ 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]

8882.4845 Powered rongeur.

(a) Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.

(b) Classification. Class II (performance standards).

8882.5070 Bite block.

(a) Identification. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.

(b) Classification. Class II (performance standards).

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8882.5150 Intravascular occluding

catheter. (a) Identification. An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.

(b) Classification. Class III (premarket approval).

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