PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS

K980649 · CooperVision, Inc. · LPL · May 13, 1998 · Ophthalmic

Device Facts

• Record ID: K980649
• Device Name: PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: May 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Preference® standard, CooperClear™, CV 43™, Vantage® and Vantage® Accents (tetrafilcon A) Hydrophilic Contact Lenses are intended for use as a daily wear lens for the correction of visual acuity by not-aphakic persons with non-diseased eyes that are myopic or hyperopic, who exhibit astigmatism of 2.50 diopters or less that does not interfere with visual acuity. Preference Toric™ 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.

Device Story

Tetrafilcon A hydrophilic contact lenses; hemispherical shells; placed on cornea to focus light on retina. Material: hydrophilic random terpolymer of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone, and methylmethacrylate; cross-linked with divinylbenzene. Available as spherical or astigmatic (toric) lenses. Optional handling or enhancement tints using C.I. Reactive Blue 163, Yellow 86, and Red 22. Used by patients for daily wear to correct visual acuity. Prescribed by eye care professionals.

Clinical Evidence

Bench testing only. Testing included water content, light transmittance, refractive index, and mechanical properties. Biocompatibility testing included cytotoxicity, ocular irritation, and acute systemic toxicity studies.

Technological Characteristics

Hydrophilic random terpolymer of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone, and methylmethacrylate; cross-linked with divinylbenzene. Hemispherical shell form factor. Available with handling or enhancement tints (C.I. Reactive Blue 163, Yellow 86, Red 22).

Indications for Use

Indicated for daily wear correction of myopia or hyperopia in non-aphakic persons with non-diseased eyes. Preference standard/CooperClear/CV 43/Vantage models indicated for astigmatism ≤ 2.50D. Preference Toric/Cooper Toric models indicated for astigmatism up to 9.00D and 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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MAY | 3 1998

# G. 510(K) Summary (page 1 of 2)

2.

1. Submitter's Name:

Contact Person:

CooperVision, Inc. 711 North Road Scottsville, NY 14546 Phone: [phone] FAX:

Bonnie Tsymbal Phone: [phone] FAX: [phone]

3. Date Summary Prepared: February 18, 1998

- 4. Name of Device:
- Trade Name: .

Preference® standard Preference Toric™ Cooper Toric™ CooperClear™ CooperHT™ CV 43TM Vantage® Vantage® Accents

- Common Name: .
- . Classification Name:

Soft Contact Lens

Soft Hydrophilic Contact Lens (Per 21 CFR §886.5925)

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 placed 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.

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- K980649

- 6. Description of Device (continued)
When produced with a handling or enhancement tint, the lens is coupled with one or more of three dye moieties through the use of varying combinations and concentrations of C.I. Reactive Blue 163, Yellow 86, and Red 22. Lenses with a handling tint are tinted blue on the surface of the lens. The handling tint increases the visibility of the lens when not worn on the eye. Lenses tinted wit an enhancement tint are tinted on the anterior surface in the shape of an iris. The enhancement tint colors available are Sky Blue, Turquoise, Violet Blue, Spring Green, Auburn and Misty Brown.

## Intended Use:

The Preference® standard CooperClear™, CV 43™, Vantage® and Vantage® Accents
tetrafilcon A) Hydrophilic Contact Lenses are intended for use as a daily wear lens for the correction of visual aculty by not-aphakic persons with non-diseased eyes that are myopic or borrouber of visual adulty by The uphane por who exhibit astigmatism of 2.50 diopters or les that does not interfere with visual acuity.

Preference Toric™ and Cooper Toric™ Hydrophilic Contact Lenses are indicated for daily se by not-aphakic persons with non-diseased eyes that are myopic or hyperopic, who astigmatism up to 9.00 Diopters and can obtain satisfactory visual acuity, in 20100 to 103000

# 8. Technological Characteristics:

The technological characteristics of tetrafilcon A lenses manufactured at Aspect Vision, Ltd. are the same as the predicate device manufactured at Scottsville.

- 9. Summary of Non-Clinical Tests:
Physical and chemical properties testing was performed on lenses made by Aspect using the alternate manufacturing method as called for in the May 1994 Permarket 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 Toxicity Study.

- 10. Conclusion:
The determination of substantial equivalence is based on the results of non-clinical testing. Review of all test data demonstrates tetrafilcon A lenses manufactured at Aspect Vision, Ltd. are equivalent to the currently marketed tetrafilcon A lenses manufactured by CooperVision. Inc. The lenses manufactured at Apsect have the same design, indication and directions for use. CooperVision, Inc. concludes, therefore, that the tetrafilcon A lenses manufactured by Aspect are substantially equivalent to the tetrafilcon A lenses manufactured at Scottsville.

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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted with flowing lines to suggest movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1998

Mrs. Bonnie Tsymbal Regulatory Associate Cooper Vision 711 North Road Scottsville, NY 14546

Re: K980649

Trade Name: Preference ® standard, Preference Toric ™, Cooper Toric, ™CooperClear ™ CooperHT ™,CV 43 ™, Vantage ® and Vantage ®Accents (tetrafilcon A) Hydrophilic Contact Lenses for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: February 18, 1998 Received: February 19, 1998

Dear Mrs. 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

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### Page 2 - Mrs. Bonnie Tsymbal

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.

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- _ 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,

David R. Wipple
for A. Ralph Rosenthal, M.D.

A. Ralph Rosenthal, 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. The "C" in Cooper is made up of two circles, one inside the other. To the right of the word "CooperVision" is a black square with a white eye-like symbol inside.

Scottsville, Ne v York 14546 [phone] Fax [phone]

# Indications for Use Statement

K980649 510(k) Number:

Device Name:

Preference® standard Preference Toric™ Cooper Toric™ CooperClear™ CooperHT™ CV 43TM Vantage® Vantage® Accents

#### Indications for Use:

The Preference® standard, CooperHTM, CooperHTM, CV 43™, Vantage® and Vantage® Accents (tetrafilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual accity by nowabnake 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 Preference Toric ™ and Cooper Toric™ hydrophilic contact lenses are indicated for daily wear use by not anhake 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ V

Over-the-Counter Use_

smletts

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K980649

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