COOPER PROSTHETIC

K042435 · CooperVision, Inc. · LPL · Oct 26, 2004 · Ophthalmic

Device Facts

• Record ID: K042435
• Device Name: COOPER PROSTHETIC
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Cooper Prosthetic Lens is a hydrophilic soft contact lens made of polymacon (HEMA cross-linked with EGDMA). The lens features a colored pigment layer on the front surface to mask iris/corneal/lens abnormalities or alter eye color. It is a lathe-cut hemispherical shell available in various powers (-20.00 to +20.00D). The device is prescribed by eye care professionals for daily wear. It functions as a prosthetic device to improve cosmetic appearance or as an occlusive aid for specific ocular conditions. The lens is hydrated in saline, providing oxygen permeability and refractive correction. It is intended for patients with specific ocular pathologies requiring masking or refractive management.

Clinical Evidence

No clinical data was required. Substantial equivalence was established through bench testing, including toxicology (ocular irritation, cytotoxicity, systemic toxicity) and monomer extractable studies, demonstrating the subject lens is non-toxic and equivalent to predicate devices.

Technological Characteristics

Material: Polymacon (HEMA cross-linked with EGDMA); 38% water content. Dimensions: 14.0-15.0mm diameter, 8.0-9.5mm base curve. Refractive index: 1.43. Oxygen permeability: 8.0 x 10^-11 (cm2/sec)(ml O2/ml x mmHg) at 35°C. Pigments: Carbazole violet, chromium oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red/brown/black, phthalocyanine blue, titanium oxide. Manufacturing: Lathe-cut. Hydrophilic lens group 1.

Indications for Use

Indicated for daily wear in sighted or non-sighted patients requiring prosthetic contact lenses for corneal, iris, or lens abnormalities; correction of refractive ametropia (myopia/hyperopia) in aphakic/not-aphakic persons with astigmatism up to 2.00D; or occlusive therapy for diplopia, amblyopia, or extreme photophobia.

Regulatory Classification

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.

Predicate Devices

• Cooper Prosthetic UK Molded Base (K984259)
• Cooper Prosthetic Gelflex Lathed Base (K010126)

Submission Summary (Full Text)

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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 [phone] [phone]

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:

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.

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# 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<br>(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.

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# 7. SUBSTANTIAL EQUIVALENCE:

| Characteristic | Cooper Prosthetic<br>UK Lathed Base<br>(New Device) | Cooper Prosthetic<br>UK Molded Base<br>K984259 | Cooper Prosthetic<br>Gelflex Lathed Base<br>K010126 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Polymacon | Polymacon | Polymacon |
| Material<br>Classification | Hydrophilic Lens<br>Group 1 | Hydrophilic Lens<br>Group 1 | Hydrophilic Lens<br>Group 1 |
| Indications for Use | Daily Wear<br>To enhance or alter the<br>apparent color of the<br>eye, including ocular<br>masking, either in<br>sighted or non-sighted<br>eyes that require a<br>prosthetic contact lens<br>for management of<br>conditions such as<br>corneal, iris, or lens<br>abnormalities. The lens<br>may also be prescribed<br>for the correction of<br>refractive ametropia | Daily Wear<br>To enhance or alter the<br>apparent color of the<br>eye, including ocular<br>masking, either in<br>sighted or non-sighted<br>eyes that require a<br>prosthetic contact lens<br>for management of<br>conditions such as<br>corneal, iris, or lens<br>abnormalities. The lens<br>may also be prescribed<br>for the correction of<br>refractive ametropia | Daily Wear<br>To enhance or alter the<br>apparent color of the<br>eye, including ocular<br>masking, either in<br>sighted or non-sighted<br>eyes that require a<br>prosthetic contact lens<br>for management of<br>conditions such as<br>corneal, iris, or lens<br>abnormalities. The lens<br>may also be prescribed<br>for the correction of<br>refractive 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,<br>chromium oxide<br>green,<br>dihydrodinaphto<br>brown, dihydrodioxo<br>yellow,<br>phthalocyanine green,<br>iron oxide red, iron<br>oxide brown, iron<br>oxide black,<br>phthalocyanine blue,<br>and titanium oxide | carbazole violet,<br>chromium oxide<br>green,<br>dihydrodinaphto<br>brown, dihydrodioxo<br>yellow,<br>phthalocyanine green,<br>iron oxide red, iron<br>oxide brown, iron<br>oxide black,<br>phthalocyanine blue,<br>and titanium oxide | carbazole violet,<br>chromium oxide<br>green,<br>dihydrodinaphto<br>brown, dihydrodioxo<br>yellow.<br>phthalocyanine green,<br>iron oxide red, iron<br>oxide brown, iron<br>oxide black,<br>phthalocyanine blue,<br>and titanium oxide |
| Tint Process | Pad Printing<br>Post Lens Forming | Pad Printing<br>Post Lens Forming | Pad Printing<br>Post Lens Forming |
| Manufacturing<br>Method | Lathe Cut | Cast Molded | Lathe Cut |

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#### 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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 [phone] Fax: [phone]

# 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)

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510(k) Number.