The Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lens 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.

Device Description

The Cooper Prosthetic Lens (polymacon) Soft (hydrophilic) Contact Lenses are available as spherical lenses. The lens material, polymacon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) which is cross linked with ethyleneglycol dimethacrylate. When hydrated, the lens consists of 62.0% HEMA and 38.0% water by weight when immersed in normal saline. The lenses are made by modifying the uncolored polymacon 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 brown, iron oxide black, phthalocyanine blue, and titanium oxide. Cooper Prosthetic Lenses are hemispherical shells with the following dimensions: Diameter: 14.0mm to 15.0mm, Base Curve: 8.0mm to 9.5mm, Center Thickness: 0.05mm to 0.40mm (varies with power), Lens Powers: -20.00 to +20.00D. The physical/optical properties of the Cooper Prosthetic Lenses are: Refractive Index: 1.43, Light Transmittance: >90% (open pupil), Surface Character: Hydrophilic, Water Content: 38%, Oxygen Permeability: 8.0 x 10-11 (cm2/sec) (ml O2/ml x mmHg) at 35°C (Fatt method for determination of oxygen permeability).

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens. It does not contain a study that proves the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity, as would typically be found for AI/imaging-based medical devices.

Instead, this submission seeks to establish substantial equivalence to previously cleared predicate devices. The "acceptance criteria" are implied by demonstrating that the new device's material properties, indications for use, and manufacturing processes are equivalent to those of the predicate devices, and that it does not raise any new questions of safety or effectiveness.

Here's an analysis of the information provided, addressing the requested points where applicable:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Cooper Prosthetic UK Lathed Base - New Device)
Material: Polymacon	Polymacon
Material Classification: Hydrophilic Lens Group 1	Hydrophilic Lens Group 1
Indications for Use: 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. Also for correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit astigmatism up to 2.00 diopters, or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.	Matches the predicate indications exactly.
Water Content: 38% (Predicate K984259)	38%
Water Content: 38.6% (Predicate K010126)	38% (Slight difference from one predicate, but still considered substantially equivalent given the broad range of contact lens specifications).
Light Transmittance: >97% (Predicate K984259)	>97%
Light Transmittance: >95% (Predicate K010126)	>97% (Exceeds this predicate's requirement).
Dk (Oxygen Permeability): 8.0 x 10^-11^	8.0 x 10^-11^
Refractive Index: 1.43	1.43
Powers: -20.00 to +20.00 D	-20.00 to +20.00 D
Colorants: Matches predicate list	Matches predicate list (carbazole violet, chromium oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide brown, iron oxide black, phthalocyanine blue, and titanium oxide).
Tint Process: Pad Printing, Post Lens Forming	Pad Printing, Post Lens Forming
Manufacturing Method: Lathe Cut (Predicate K010126)	Lathe Cut (Matches this predicate).
Manufacturing Method: Cast Molded (Predicate K984259)	The new device is Lathe Cut, while one predicate is Cast Molded. However, since another predicate (K010126) is also Lathe Cut, this difference is implicitly accepted as not raising new safety/effectiveness concerns.
Toxicology: Non-toxic, in compliance with specifications	Toxicology testing (Ocular Irritation, Cytotoxicity, Systemic Toxicity) demonstrated the subject lens is non-toxic. An Monomer Extractable Study showed residual 2-HEMA and EGDMA levels in compliance with specifications and equivalent to the current product.

Study Details (Based on Provided Document)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not report a specific clinical "test set" or data provenance for performance evaluation in the way an AI/imaging device would.
- For the Monomer Extractable Study, samples were analyzed to determine residual levels, but the sample size is not specified. This was likely a laboratory-based study on manufactured units.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This submission relies on substantial equivalence to predicate devices, not on a clinical performance study with expert-adjudicated ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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 is a contact lens, not an AI-powered diagnostic tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (contact lens), not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is the established safety and effectiveness of the predicate devices, as determined by their prior FDA clearance (K984259 and K010126). The current device's physical, chemical, and biological properties are compared against these predicates, and toxicology testing confirms non-toxicity and compliance with specifications.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model. The relevant "data" would be the manufacturing controls and material specifications consistently achieved during production, which are compared to the predicate's characteristics.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Conclusion:

This 510(k) submission for the Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens is a substantial equivalence submission. It explicitly states: "It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens. This determination was based on the following: Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens has demonstrated to be substantially equivalent to the predicate Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens (K984259) and (K010126)."

Therefore, the device meets its "acceptance criteria" by demonstrating that its design, materials, manufacturing processes, and intended use are sufficiently similar to legally marketed predicate devices, and that it performs equivalently in terms of physical, optical, and chemical properties, and passes standard toxicology tests. There are no performance outcomes reported in terms of accuracy, sensitivity, or specificity, as those are typical metrics for diagnostic devices, particularly those involving AI.

Summary

{0}------------------------------------------------

K04-2435

Goper Vision &

OCT 2 6 2004

Premarket Notification

Cooper Prosthetic Polymacon

510(k) Summary

1. SUBMITTER:

Submitted on Behalf of:

Company Name: 트
Address: 트
트 Phone:
Fax:

2. CONTACT PERSON:

Company Name: 트
Address: K
트 Phone:
트 Fax:

3. DATE SUMMARY PREPARED:

4. DEVICE IDENTIFICATION:

프 Trade Name:
CooperVision Manufacturing, Ltd. Unit 2, South Point Hamble SO3 4RF Southampton UK 011 44 2380 605200 011 44 2380 605299

Bonnie Tsymbal

CooperVision, Inc. 711 North Road Scottsville, NY 14546 (585) 264-3210 (585) 889-5688

September 7th, 2004

Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens

I Common Name:
트 Classification
Device Classification: 다

Hydrophilic Soft Contact Lens Lenses, Soft Contact, Daily Wear 86LPL Class II (21 CFR 886.5925)

5. DEVICE DESCRIPTION:

{1}------------------------------------------------

GoperVision D

Premarket Notification

Leo Colors Methafilcon A

Cooper Prosthetic Lenses are hemispherical shells with the following dimensions:

Diameter:	14.0mm to 15.0mm
Base Curve:	8.0mm to 9.5mm
Center Thickness:	0.05mm to 0.40mm (varies with power)
Lens Powers:	-20.00 to +20.00D

The physical/optical properties of the Cooper Prosthetic Lenses are:

Refractive Index:	1.43
Light Transmittance:	>90% (open pupil)
Surface Character:	Hydrophilic
Water Content:	38%
Oxygen Permeability:	8.0 x 10-11 (cm2/sec) (ml O2/ml x mmHg) at 35°C(Fatt method for determination of oxygen permeability)

6. INTENDED USE:

The Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens 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 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, amblyopia or extreme photophobia.

{2}------------------------------------------------

7. SUBSTANTIAL EQUIVALENCE:

Characteristic	Cooper ProstheticUK Lathed Base(New Device)	Cooper ProstheticUK Molded BaseK984259	Cooper ProstheticGelflex Lathed BaseK010126
Material	Polymacon	Polymacon	Polymacon
MaterialClassification	Hydrophilic LensGroup 1	Hydrophilic LensGroup 1	Hydrophilic LensGroup 1
Indications for Use	Daily WearTo enhance or alter theapparent color of theeye, including ocularmasking, either insighted or non-sightedeyes that require aprosthetic contact lensfor management ofconditions such ascorneal, iris, or lensabnormalities. The lensmay also be prescribedfor the correction ofrefractive ametropia	Daily WearTo enhance or alter theapparent color of theeye, including ocularmasking, either insighted or non-sightedeyes that require aprosthetic contact lensfor management ofconditions such ascorneal, iris, or lensabnormalities. The lensmay also be prescribedfor the correction ofrefractive ametropia	Daily WearTo enhance or alter theapparent color of theeye, including ocularmasking, either insighted or non-sightedeyes that require aprosthetic contact lensfor management ofconditions such ascorneal, iris, or lensabnormalities. The lensmay also be prescribedfor the correction ofrefractive ametropia
Water Content	38%	38%	38.6%
Light Transmittance	>97%	>97%	>95%
Dk (35° C)	8.0 x 10-11	8.0 x 10-11	8.0 x 10-11
Refractive Index	1.43	1.43	1.43
Powers	-20.00 to +20.00 D	-20.00 to +20.00 D	-20.00 to +20.00 D
Colorants	carbazole violet,chromium oxidegreen,dihydrodinaphtobrown, dihydrodioxoyellow,phthalocyanine green,iron oxide red, ironoxide brown, ironoxide black,phthalocyanine blue,and titanium oxide	carbazole violet,chromium oxidegreen,dihydrodinaphtobrown, dihydrodioxoyellow,phthalocyanine green,iron oxide red, ironoxide brown, ironoxide black,phthalocyanine blue,and titanium oxide	carbazole violet,chromium oxidegreen,dihydrodinaphtobrown, dihydrodioxoyellow.phthalocyanine green,iron oxide red, ironoxide brown, ironoxide black,phthalocyanine blue,and titanium oxide
Tint Process	Pad PrintingPost Lens Forming	Pad PrintingPost Lens Forming	Pad PrintingPost Lens Forming
ManufacturingMethod	Lathe Cut	Cast Molded	Lathe Cut

{3}------------------------------------------------

PRECLINICAL INFORMATION: 8.

The results of toxicology testing, including Ocular Irritation, Cytoxicity and Systemic Toxicity have demonstrated that the subject lens is non-toxic.

An Monomer Extractable Study was conducted to assess the suitability of using an alternative polymacon base lens for Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens. Samples were analyzed to determine the levels of 2-HEMA and EGDMA remaining in the lathe-cut polymacon lens. The test lenses indicated that the levels of residual 2-HEMA and EDGMA found were in compliance with specifications, and equivalent to that seen in the current product..

The physical, optical and chemical properties of the subject lens are equivalent to the predicate device.

9. CLINICAL DATA:

It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens. This determination was based on the following:

Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens has . demonstrated to be substantially equivalent to the predicate Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens (K984259) and (K010126).

10. CONCLUSION:

The information provided in this 510(k) establishes that the Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens is equivalent in optical, chemical and physical properties of the predicate device and does not raise any questions of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate device.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2004

CooperVision, Inc. c/o Ms. Bonnie Tsymbal 711 North Road Scottsville, NY 14546

Re: K042435

K042435
Trade/Device Name: Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lens
Trade/Device Name: Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Hydrophilic Soft Contact Lens Regulatory Class: Class II Product Code: LPL Dated: September 7, 2004 Received: September 8, 2004

Dear Ms. Tsymbal:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematic is substantially equivalent (for the indications for referenced above and nave determined the devices marketed in interstate comments, or to devices that use stated in the encrosure) to iceally many in the Medical Device Amendments, or to devices that prior to May 28, 1976, the enactions with the provisions of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of PMA). You may have been reclassified in accordance with the provice approval application (PMA). You may, Act (Act) that do not require approval of a premail.compossions of the Act. The general therefore, market the device, subject to morements for annual registration, listing of devices, good
controls provisions of the Act include requirements for annual register o controls provisions or the Net morade requirement.
manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Comtrols) or class III (PMA), it If your device is classified (see above) mo Existing major regulations affecting your device can be may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Peacharts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's Issualice of a succession with other requirements of the Act of that FDA has made a determination that your are how rought institutions of the must comply with any rederal statutes and regulations administ it of of of registration and listing of as as as fasth in the all the Act s requirements, meriding, but not miniture to requirements as set forth in the 807); labelling (21 CFR Part 820); and if applicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820); and if applicable (2001) 1958 quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I his icity will anow you to organization of substantial equivalence of your device to a legally premaired 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), please If you desire specific arrant an (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. halpi Rosenthal

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

Enclosure

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the word "CooperVision" in a stylized font. The word is written in black ink on a white background. To the right of the word is a black square with a white circle inside.

Regulatory Affairs 711 North Road Scottsville, NY 14546 (585) 385-6810 Fax: (585) 889-5688

Indication for Use Statement

510(k) Number:

Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lenses Device Name:

Indication for Use:

The Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lens is indicated for The Cooper(8) Prosuleuc (polymacon) Soft (nyarophilo) Son, including ocular masking,
daily wear to enhance or alter the apparent color of the eye, including for dally wear to ennance of alter the upparent color a prosthetic contact lens for either in signted or norraigned eyes that I citis, or lens abormalities. The lens may also
management of conditions such as corneal, iris, or lens and byporopia) in management of conditions such as corneal) inspective ametropia (myopia and hyperopia) in be prescribed for the correction of refree whiles stigmatism up to 2.00 diopters that
aphakic and not-aphakic persons that may exhibit as such as aphakic and not-aphakic persons that may oxhibit assigning and therapy for conditions such as diplopia, amblyopia or extreme photophobia.

X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter (Per 21 CFR 801 Subpart C)

PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

$\mathit{m} \mathcal{L} \mathcal{Q}$

510(k) Number.

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.