Prosthetic (polymacon) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Device Description

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearence of lanses which are designed to fit over the corneal surface of the lenses are made by modifying the uncolored polymacon cast molded lens by affixing a colored pigment on that portion of the front surface that corresponds to the iris. The colored pigments consist of: carbazole violet, chromium oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide black, phthalocyanine blue and titanium dioxide. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopla (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power that is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

AI/ML Overview

The provided text describes a 510(k) submission for a Prosthetic (polymacon) Hydrophilic Contact Lens for Daily Wear. This document focuses on the substantial equivalence of the new device to a predicate device and its performance testing related to toxicology and material properties. It does not contain information about acceptance criteria and studies in the context of AI/ML device performance metrics like sensitivity, specificity, or reader studies.

Therefore, the following points cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: The document does not specify acceptance criteria in terms of accuracy metrics (e.g., sensitivity, specificity, AUC) or numerical performance results for such metrics. It states the results of toxicology testing were "non toxic" and that "respective extracts did not contain leachable color or significant levels of residual monomers," but these are qualitative statements, not quantitative performance metrics against defined acceptance criteria typically seen in AI/ML device evaluations.
Sample size used for the test set and the data provenance: Not applicable, as no test set as understood in AI/ML context is described. The "Performance Testing of Contact Lens" mentions "lenses were loaded with the following eleven pigments," but this refers to the components of the product itself for toxicology and leachability testing, not a dataset for evaluating an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not described. The document is about the material equivalence and safety of a physical contact lens.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm described.
The type of ground truth used: For toxicology and leachability, the "ground truth" would be the standard laboratory assays and their established thresholds for toxicity and chemical detection. However, this is not a ground truth for diagnostic or prognostic performance as would be relevant for an AI/ML device.
The sample size for the training set: Not applicable, as no training set for an AI/ML model is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary of Device Performance (based on provided text):

The document states:

"The results of toxicology testing (cytotoxicity, acute systemic toxicity and acute ocular irritation) have demonstrated that the subject lens is non toxic."
"Furthermore, the results of residual monomer and color leachability testing demonstrate that the respective extracts did not contain leachable color or significant levels of residual monomers."
The physical, optical, and chemical properties are "equivalent to those of the FREQUENCY 38 (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) from Aspect Vision Care, Ltd." because the base lens is the same.

In conclusion, the provided text describes the regulatory submission for a physical medical device (contact lens) and not an AI/ML-driven device. Therefore, the questions related to AI/ML device acceptance criteria, study design, and performance metrics cannot be answered from this document.

Summary

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JAN 2 1 1999

K 984259

510 (k) Summary

SUBMITTER:

Submitted on behalf of:

Manufacturer:

CL-TINTERS

Address:

Hovlaamotie 7 Fin-00380 Helsinki Finland

Phone:

358 9340 5066

CONTACT PERSON:

Martin S. Knopf

DATE SUMMARY PREPARED: November 20, 1998

TRADE NAME: Prosthetic (polymacon) Hydrophilic Contact Lens for Dally Wear (clear and tinted)

COMMON NAME: contact lens

SUBSTANTIALLY EQUIVALENT TO:

Prosthetic (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to Aspect Vision Care, Ltd.'s FREQUENCY 38 (polymacon) Hydrophilic Confact Lens for Daily Wear (clear and tinted) currently marketed in the U.S.

Prosthetic (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are substantially equivalent to the indications for use of Aspect Vision Care, Ltd.'s FREQUENCY 38 (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) pursuant to K971049. The only addition to these indications are that the subject lens is also indicated to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for management of conditions such as corneal, iris or lens abnormalities. In addition, Aspect Vision Care. Ltd. will produce the dry cast molded lenses at the same manufacturing location as the predicate devices. These lenses are subsequently processed by CL-TINTERS to incorporate the pigments (i.e., listed color additives) to produce their unique tinting patterns.

This lens is in Group 1, non-ionic, low water content polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994. The physical, optical, and chemical properties of the Prosthetic (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the

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Aspect Vision Care, Ltd. FREQUENCY 38 (polymacon) Soft Contact Lens for Daily Wear (clear and tinted).

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

Device Name: Prosthetic (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)

Prosthetic (polymacon) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for management of conditions such as corneal, ins or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, ambiyopia or extreme photophobia.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Performance Testing of Contact Lens

Lenses were loaded with the following eleven pigments (i.e., listed color additives):

Carbazole violet, chromium oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide black, phthalocyanine blue and titanium dioxide.

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The results of toxicology testing (cytotoxicity, acute systemic toxicity and acute ocular irritation) have demonstrated that the subject lens is non toxic. Furthermore, the results of residual monomer and color leachability testing demonstrate that the respective extracts did not contain leachable color or significant levels of residual monomers.

The physical optical, and chemical properties of the Prosthetic (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the FREQUENCY 38 (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) from Aspect Vision Care, Ltd. since this lens is provided to CL-TINTERS by Aspect Vision Care, Ltd.

PARAMETERS AVAILABLE:

PROSTHETIC™ (polymacon) Hydrophilic Contact Lens (clear and tinted)

Powers:	+8.00 to -8.00D
Center Thickness:	0.08 mm
Diameter:	14.5 mm
Base Curve:	8.7 mm

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1999

Mr. Martin S. Knopf President and CEO KNOPF ASSOCIATES, INC. 6 Shadowbrook Drive Colts Neck, New Jersey 07722

Re: K984259

Trade Name: PROSTHETIC (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) Regulatory Class: II Product Code: 86 LPL Dated: December 15, 1998 Received: December 21, 1998

Dear Mr. Knopf:

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 prìor 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. Martin S. Knopf

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,

A Ralph 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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INDICATIONS STATEMENT

Device Name: Prosthetic (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)

Prosthetic (polymacon) Hydrophillc Contact Lens (clear and tinfed) is indicated for daily wear to r toomedic (parymoon) . The eye, including ocular masking, either in sighted or enmarked of aller the uppen. Deceded contact lens for management of conditions such as comeal, iris or lens abnormalities. The lens may also be prescribed for the correction of oomedia ametropia (myopia and hyperopia) in aphakic and not-aphakic persons that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

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

NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use__

BRrick

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number 1984259

(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.