§886.5910 Image intensification vision aid.

(a) Identification. An image intensification vision aid is a battery-powered device intended for use by a patient who has limited dark adaptation or impaired vision to amplify ambient light.

(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]

$886.5915 Optical vision aid.

(a) Identification. An optical vision aid is a device that consists of a magnifying lens with an accompanying ACpowered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail.

(b) Classification. Class I. The ACpowered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The battery-powered 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.

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]

§886.5916 Rigid gas permeable contact lens.

(a) Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

(b) Classification. (1) Class II if the device is intended for daily wear only.

(2) Class III if the device is intended for extended wear.

(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 a device described in paragraph (b)(2) of this section may be commercially distributed. See §886.3.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]

§ 886.5918 Rigid gas permeable contact lens care products.

(a) Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning. conditioning, rinsing, lubricating rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

(b) Classification. Class II (Special Controls) Guidance Document: "Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products."

[62 FR 30987, June 6, 1997]

§ 886.5925 Soft (hydrophilic) contact lens.

(a) Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

(b) Classification. (1) Class II if the device is intended for daily wear only. (2) Class III if the device is intended for extended wear.

(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 a device described in paragraph (b)(2) of this section may be commercially distributed. See §886.3.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]

strained, with an uncemented acetabular component, prosthesis.

888.3340 Hip joint metal/composite semiconstrained cemented prosthesis.

888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

888.3358 Hip joint metal/polymer/metal semi-constrained porous coated

uncemented prosthesis.

888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. 888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis.

888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.

888.3390 Hip joint femoral (hemi-hip) metal/ polymer cemented or uncemented prosthesis.

888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

888.3410 Hip joint metal/polymer semi-constrained resurfacing cemented thesis.

pros

888.3480 Knee joint femorotibial metallic constrained cemented prosthesis. 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis. 888.3580 Knee joint patellar (hemi-knee) me

tallic resurfacing uncemented prosthesis. 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.

888.3650 Shoulder joint metal/polymer nonconstrained cemented prosthesis. 888.3660 Shoulder joint metal/polymer semiconstrained cemented prosthesis. 888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. 888.3690 Shoulder joint humeral (hemishoulder) metallic uncemented prosthesis.

888.3720 Toe joint polymer constrained prosthesis.

888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

888.3750 Wrist joint carpal lunate polymer prosthesis.

888.3760 Wrist joint carpal scaphoid polymer prosthesis.

888.3770 Wrist joint carpal trapezium polymer prosthesis.

888.3780 Wrist joint polymer constrained prosthesis.

888.3790 Wrist joint metal constrained cemented prosthesis.

888.3800 Wrist joint metal/polymer semiconstrained cemented prosthesis. 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.

Subpart E-Surgical Devices

888.4150 Calipers for clinical use.

888.4200 Cement dispenser.

888.4210 Cement mixer for clinical use. 888.4220 Cement monomer vapor evacuator. 888.4230 Cement ventilation tube. 888.4300 Depth gauge for clinical use. 888.4540 Orthopedic manual surgical instrument.

888.4580 Sonic surgical instrument and accessories/attachments.

888.4600 Protractor for clinical use.

(a) This part sets forth the classification of orthopedic devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise a description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by §807.87.

(c) To avoid duplicative listings, an orthopedic device that has two or more types of uses (e.g., used both as a diag nostic device and as a surgical device is listed in one subpart only.

(d) References in this part to regu latory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

§ 888.3 Effective dates of requirement for premarket approval.

A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval

器

(PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act, FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraphs (b) and (c) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivSalent, device introduced into commercial distribution on or after May 28, * 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new" device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

(c) A device identified in a regulation in this part that is classified into class III and that is subject to the transitional provisions of section 520(1) of the act is automatically classified by statute into class III and must have an approval under section 515 of the act before being commercially distributed. Accordingly, the regulation for such a class III transitional device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. §888.5 Resurfacing technique.

Because of resurfacing techniques, certain joint prostheses require far less bone resection than other devices intended to repair or replace the same joint. The amount of bone resection may or may not affect the safety and effectiveness of the implantation of the prosthesis. When a resurfacing technique is used, the name of the prosthesis includes this information.

§ 888.6 Degree of constraint.

Certain joint prostheses provide more constraint of joint movement than others. FDA believes that the degree of constraint is an important factor affecting the safety and effectiveness of orthopedic prostheses. FDA is defining the following standard terms for categorizing the degree of constraint.

(a) A "constrained" joint prosthesis is used for joint replacement and prevents dislocation of the prosthesis in more than one anatomic plane and consists of either a single, flexible, acrossthe-joint component or more than one component linked together or affined.

(b) A "semi-constrained" joint prosthesis is used for partial or total joint replacement and limits translation and rotation of the prosthesis in one or more planes via the geometry of its articulating surfaces. It has no acrossthe-joint linkage.

(c) A "non-constrained" joint prosthesis is used for partial or total joint replacement and restricts minimally prosthesis movement in one or more planes. Its components have no acrossthe-joint linkage.

§ 888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception immunohistochemical devices;

of

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring

life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care).

[65 FR 2321, Jan. 14, 2000]

Subpart B-Diagnostic Devices § 888.1100 Arthroscope.

(a) Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

(b) Classification. (1) Class II (performance standards).

(2) Class I for the following manual arthroscopic instruments: cannulas currettes, drill guides, forceps, gouges. graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches. switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996]

§ 888.1240 AC-powered dynamometer.

(a) Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that