Lapas attēli
PDF
ePub

(b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 8886.9. (55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 65 FR 2321, Jan. 14, 2000]

8886.3600 Intraocular lens.

(a) Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See 8 886.3. 8886.3800 Scleral shell.

(a) Identification. A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximalcornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $886.9. (52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]

8 886.4100 Radiofrequency

electrosurgical cautery apparatus. (a) Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

(b) Classification. Class II.

8 886.4115 Thermal cautery unit.

(a) Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.

(b) Classification. Class II.

$886.4150 Vitreous aspiration and cut

ting instrument. (a) Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.

(b) Classification. Class II.

8 886.3920 Aqueous shunt.

(a) Identification. An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neurovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.

(b) Classification. Class II. The special controls for this device are FDA's:

(1) “Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,'

(2) "510(k) Sterility Review Guidance of 2/12/90 (K90-1)," and

(3) “Aqueous Shunts—510(k) Submissions." [65 FR 17147, Mar. 31, 2000)

8 886.4170 Cryophthalmic unit.

(a) Identification. A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be ACpowered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.

(b) Classification. Class II.

Subpart E-Surgical Devices $886.4070 Powered corneal burr.

(a) Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.

8 886.4230 Ophthalmic knife test drum.

(a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files. (52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988)

8 886.4250 Ophthalmic electrolysis

unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy ocular hair follicles by applying a galvanic electrical current.

(b) Classification. Class I for the battery-powered device. Class II for the AC-powered device. The battery-powered Class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994)

8886.4280 Intraocular pressure meas.

uring device. (a) Identification. An intraocular pressure measuring device is a manual or AC-powered device intended to measure intraocular pressure. Also included are any devices found by FDA to be substantially equivalent to such devices. Accessories for the device may include calibrators or recorders. The device is intended for use in the diagnosis of glaucoma.

(b) Classification. Class III.

(c) Date PMA or notice of completion of PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See $ 886.3. 8886.4300 Intraocular lens guide.

(a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

(b) Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $ 886.9. (52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000)

$886.4270 Intraocular gas.

(a) Identification. An intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure on a detached retina.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See 8886.3.

$ 886.4275 Intraocular fluid.

(a) Identification. An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See 8886.3.

8886.4335 Operating headlamp.

(a) Identification. An operating headlamp is an AC-powered or batterypowered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

(b) Classification. Class I for the battery-powered device. Class II for the AC-powered device. The battery powered-device is exempt from the premarket notification procedures in part 807, subpart E of this chapter. (55 FR 48443, Nov. 20, 1990)

$ 886.4350 Manual ophthalmic surgical

instrument. (a) Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical (b) Classification. Class II.

procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, corneasclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome ophthalmic manual trephine.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 60 FR 15872, Mar. 28, 1995) 8886.4360 Ocular surgery irrigation

device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994)

$ 886.4392 Nd:YAG laser for posterior

capsulotomy and peripheral

iridotomy. (a) Identification. The Nd:YAG laser for posterior capsulotomy and peripheral iridotomy consists of a modelocked or Q-switched solid state Nd:YAG laser intended for disruption of the posterior capsule or the iris via optical breakdown. The Nd:YAG laser generates short pulse, low energy, high power, coherent optical radiation. When the laser output is combined with focusing optics, the high irradiance at the target causes tissue disruption via optical breakdown. A visible aiming system is utilized to target the invisible Nd:YAG laser radiation on or in close proximity to the target tissue.

(b) Classification. Class II (special controls). Design Parameters: Device must emit a laser beam with the following parameters: wavelength = 1064 nanometers; spot size = 50 to 100 micros; pulse width = 3 to 30 nanoseconds; output energy per pulse 0.5 to 15 millijoules (mJ); repetition rate = 1 to 10 pulses; and total energy = 20 to 120 mJ.

or

[65 FR 6894, Feb. 11, 2000)

$ 886.4400 Electronic metal locator.

(a) Identification. An electronic metal locator is an AC-powered device with probes intended to locate metallic foreign bodies in the eye or eye socket.

(b) Classification. Class II. $ 886.4440 AC-powered magnet. (a) Identification. An

An AC-powered magnet is an AC-powered device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

(b) Classification. Class II.

$886.4370 Keratome.

(a) Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

(b) Classification. Class I. (55 FR 48443, Nov. 20, 1990)

8886.4390 Ophthalmic laser.

(a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

8 886.4445 Permanent magnet.

(a) Identification. A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in part 807, subpart E

er.

of this chapter. The device also is ex- plastic or aluminum eye covering inempt from the current good manufac- tended to protect the eye or retain turing practice regulations in part 820 dressing materials in place. of this chapter, with the exception of (b) Classification. Class I (general con$ 820.180, with respect to general re- trols). When made only of plastic or quirements concerning records, and aluminum, the device is exempt from $ 820.198, with respect to complaint the premarket notification procedures files.

in subpart E of part 807 of this chapter (52 FR 33355, Sept. 2, 1987, as amended at 53

subject to $886.9. When made only of FR 35606, Sept. 14, 1988)

plastic or aluminum, the devices are

exempt from the current good manu8886.4570 Ophthalmic surgical mark- facturing practice regulations in part

820 of this chapter, with the exception (a) Identification. An ophthalmic sur

of $820.180 of this chapter, with respect gical marker is a device intended to

to general requirements concerning mark by use of ink, dye, or indentation

records, and $820.198 of this chapter, the location of ocular or scleral sur

with respect to complaint files. gical manipulation.

(52 FR 33355, Sept. 2, 1987, as amended at 59 (b) Classification. Class I. The device FR 63014, Dec. 7, 1994; 65 FR 2321, Jan. 14, is exempt from the premarket notifica- 2000] tion procedures in subpart E of part 807 of this chapter.

8886.4770 Ophthalmic operating spec

tacles (loupes). (52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7,

(a) Identification. Ophthalmic oper1994)

ating spectacles (loupes) are devices

that consist of convex lenses or lens 8886.4610 Ocular pressure applicator. systems intended to be worn by a sur(a) Identification. An ocular pressure

geon to magnify the surgical site durapplicator is a manual device that con

ing ophthalmic surgery. sists of a sphygmomanometer-type

(b) Classification. Class I. The device squeeze bulb, a dial indicator, a band,

is exempt from the premarket notificaand bellows, intended to apply pressure

tion procedures in part 807, subpart E on the eye in preparation for oph

of this chapter. The device also is exthalmic surgery.

empt from the current good manufac(b) Classification. Class II.

turing practice regulations in part 820

of this chapter, with the exception of 8886.4670 Phacofragmentation system. $820.180, with respect to general re(a)

quirements concerning records, and Identification. phacofrag

A mentation system is an AC-powered de

$ 820.198, with respect to complaint

files. vice with a fragmenting needle intended for use in cataract surgery to (52 FR 33355, Sept. 2, 1987, as amended at 53 disrupt a cataract with ultrasound and FR 35606, Sept. 14, 1988] extract the cataract. (b) Classification. Class II.

8886.4790 Ophthalmic sponge.

(a) Identification. An ophthalmic 8886.4690 Ophthalmic

sponge is a device that is an absorbant photocoagulator.

sponge, pad, or spear made of folded (a) Identification. An ophthalmic gauze, cotton, cellulose, or other matephotocoagulator is an AC-powered de- rial intended to absorb fluids from the vice intended to use the energy from an operative field in ophthalmic surgery. extended noncoherent light source to (b) Classification. Class II. occlude blood vessels of the retina, choroid, or iris.

$886.4855 Ophthalmic instrument (b) Classification. Class II.

table.

(a) Identification. An ophthalmic in8886.4750 Ophthalmic eye shield.

strument table is an AC-powered or (a) Identification. An ophthalmic eye manual device on which ophthalmic inshield is a device that consists of a struments are intended to be placed.

(b) Classification. Class I. The ACpowered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The manual device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

8886.5540 Low-vision magnifier.

(a) Identification. A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files. (52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988)

[blocks in formation]

8 886.5120 Low-power binocular loupe.

(a) Identification. A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files.

8 886.5600 Ptosis crutch.

(a) Identification. A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988)

(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988)

8 886.5420 Contact lens inserter/re.

mover. (a) Identification. A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter. (52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988)

8886.5800 Ophthalmic bar reader.

(a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and

« iepriekšējāTurpināt »