TETRAFILCON A

K990606 · CooperVision, Inc. · LPL · Mar 15, 1999 · Ophthalmic

Device Facts

• Record ID: K990606
• Device Name: TETRAFILCON A
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Tetrafilcon A lenses are intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in not-aphakic persons with non-diseased eyes.

Device Story

Tetrafilcon A soft hydrophilic contact lenses; hemispherical shells; spherical or astigmatic designs. Material: hydrophilic random terpolymer of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone, and methylmethacrylate; divinylbenzene cross-linked. Optional handling tint using C.I. Reactive Blue 163 dye chemically bound in-monomer. Placed on cornea by patient; acts as refracting medium to focus light on retina. Corrects refractive ametropia. Daily wear use.

Clinical Evidence

Bench testing only. Evaluated water content, light transmittance, refractive index, and mechanical properties per May 1994 FDA 510(k) guidance. Toxicity assessed via cytotoxicity, ocular irritation, and acute systemic studies.

Technological Characteristics

Hydrophilic random terpolymer of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone, and methylmethacrylate; divinylbenzene cross-linked. In-monomer tinting using C.I. Reactive Blue 163. Hemispherical shell form factor. Daily wear modality.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and astigmatism in non-aphakic persons with non-diseased eyes. Standard lenses for astigmatism ≤ 2.50D. Toric lenses for astigmatism up to 9.00D, spherical range -20.00 to +12.00D.

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.

Submission Summary (Full Text)

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3/15/99

K 990606

#### 510(K) Summary

1. Submitter

| 's Name: | CooperVision, Inc. |
|----------|-----------------------|
| | 711 North Road |
| | Scottsville, NY 14546 |
| | Phone: [phone] |
| | FAX: [phone] |

- 2. Contact person:
Bonnie Tsymbal Phone: [phone] FAX:

### 3. Date Summary Prepared:

### 4. Name of Device:

| Trade Name: | Preference® standard<br>Preference® Toric<br>Cooper HT™<br>Cooper Toric™<br>CV 43™<br>Vantage™<br>Vantage™ Accents |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft Contact Lens |
| Classification Code: | 86LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| 5. Legally Marketed Device: | Same as Trade Name |

### 6. Description of Device:

All tetrafilcon A Soft (hydrophilic Contact Lenses are hemispherical shells and are available as a spherical or astigmatic lens. When place on the cornea, the hydrated lens acts as a refracting medium to focus light rays on the retina.

The lens material is a hydrophilic random terpolymer of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone and methylmethacrylate joined in a three dimensional network of terpolymer chains by divinylbenzene cross links.

When produced with a handling tint, the dye C.I. Reactive Blue 163 is chemically bound to the polymer to impart a light blue tint on the lens. The handling tint increases the visibility of the lens when not worn on the eye.

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## 510(k) Summary (continued)

#### 7. Intended Use:

Tetrafilcon A lenses are intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in not-aphakic persons with non-diseased eyes.

## 8. Technological Characteristics:

The technological characteristics of tetrafilcon A lenses manufactured with a in-monomer tint are the same as the predicate device tinted after hydration.

## 9. Summary of Non-Clinical Tests:

Physical and chemical testing was performed on the lenses made by Aspect using an in-monomer tint as called for in the May 1994 Premarket Notification (510(k) Guidance Document for Daily Wear Contact Lenses. Water content, light transmittance, refractive index and mechanical properties were tested. Toxicity was determined by Cytotoxicity, Ocular Irritation Study and Acute Systemic Study.

## 10. Conclusion:

The determination of substantial equivalence is based in the results if non-clinical testing. Review of all test data demonstrates that tetrafilcon A lenses manufactured at Aspect Vision, Ltd. with an in-monomer tint, are equivalent to the predicated post-hydration tinted lenses. The in-monomer tinted lenses have the same design, indication and directions for use. CooperVision, Inc. concludes, therefore, that the in-monomer tinted lenses are substantially equivalent to the post-hydration tinted lenses.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that features a stylized human figure with three lines extending upwards, resembling a bird in flight. The emblem is a symbol representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Ms. Bonnie Tsymbal Regulatory Associate COOPERVISION, Inc. 711 North Road Scottsville, New York 14546

Re: K990606

Trade Name: The Preference ® Standard, CooperClear ™, CV43 ™, Vantage ® and Vantage ® Accents, (tetrafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (Spherical and Toric, Clear and Handling Tint with In- Monomer-Tinting Process, Cast-molded) Regulatory Class: II Product Code: 86 LPL Dated: February 22, 1999 Received: February 23, 1999

Dear Ms. Tsymbal:

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 - Ms. Bonnie Tsymbal

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl 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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Image /page/4/Picture/0 description: The image shows the CooperVision logo. The logo consists of the word "CooperVision" in a stylized font, with the "C" in "Cooper" being a double circle. To the right of the wordmark is a black square containing a white stylized eye shape.

711 North Road Scottsville New York 14546 [phone] Fax [phone]

# Indications for Use Statement

K990666 510(k) Number:

Device Name:

Preference® standard Preference Toric™ Cooper Toric™ CooperHTTM CV 43mm Vantage® Vantage® Accents

#### Indications for Use:

The Preference® standard, CooperHT™, CooperHT™, CV 43™, Vantage® and Vantage® Accents (tetrafilcon A) Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lenses can be worn by persons who exhibit astigmatism of 2.50 diopters or less that does not interfere with visual acuity.

The PreferenceToric™ and Cooper Toric™ hydrophilic contact lenses are indicated for daily wear use by not-aphakic persons with non-diseased eyes that are myopic or hyperopic, who exhibit astigmatism up to 9.00 diopters and can obtain satisfactory visual acuity, in a spherical range of -20.00 to +12.00.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-the-Counter Use

Eis
(Division Sign-Off)
Division of Ophthalmic Devices

510(k) Number K990606