The Prosthetic (hefilcon A) Soft Contact Lens is indicated for daily wear to enhance or alter the appearance of the eve. including ocular masking, in sighted or non-sighted eyes, that may require a prosthetic contact lens for the cosmetic management of corneal, iris, scleral or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or non-aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with a chemical disinfection system.

Device Description

The Prosthetic (hefilcon A)Soft Lens is a partially or totally white opaque lens that is painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye. The approved pigment, titanium dioxide, is incorporated into the lens matrix as the white opaquing agent. Lenses are printed or painted by skilled artists to a eye care practitioners specifications with approved reactive dyes. The opaquing agent and colorants are permanent and are not leached from a lens.

AI/ML Overview

The provided text is a 510(k) summary for a contact lens, focusing on its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving device performance against such criteria in the manner requested. Specifically:

A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance metrics or acceptance criteria.
Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is about a contact lens and does not involve AI or human readers for diagnostic interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document states that the device is "substantially equivalent" to predicate devices, which implies that it meets similar safety and effectiveness standards, but it does not detail specific performance studies of the Prosthetic (hefilcon A) Soft Lens itself against defined acceptance criteria.

Summary

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Nov 1 8 1999

510(k) #K992950

510(k) SUMMARY

Applicant Information:

Date Prepared: August 26, 1999

Submitted by: Prosthetic Soft Lens Company 2890 South Tejon Street Englewood, CO 80110

Contact Person: Phone: Fax: Email:

William Hoffman 303-789-0933 303-789-4506 lagado@lagado.net

Device Information:

Trade Name:	Prosthetic (hefilcon A) Soft Lens
Classification Name:	Lens, Soft Contact, Daily Wear
Class and Number:	Class II, LPL

Substantially Equivalent to:

(1) Prosthetic (polymacon) Hydrophilic Contact Lens, K984259
(2) Classic Prosthetic (polymacon), K983053

(3) Oxylens tinted Prosthetic (hioxifilcon B), K983278

Device Description:

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1999

Mr. William Hoffman President Prosthetic Soft Lens Corporation 2890 South Tejon Street Englewood, CO 80110

Re: K992950 Trade Name: Prosthetic (hefilcon A) Soft Contact Lens Product Code: 86 LPL Dated: September 8, 1999 Received: September 14, 1999

Dear Mr. Hoffman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. William Hoffman

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ARalph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) NUMBER (IF KNOWN): K992950

DEVICE NAME: Prosthetic (hefilcon A) Soft Contact Lens

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W.C. Brown

510(k) Number ..

ion Sign-Off)
ion of Ophthalmic Devices
) Number: K992950

Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.