HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS

K962185 · CooperVision, Inc. · LPL · Dec 17, 1996 · Ophthalmic

Device Facts

• Record ID: K962185
• Device Name: HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The HYDRASOFT (East) lens is intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes.

Device Story

Hydrasoft (East) soft contact lens; spherical or toric design; composed of methafilcon B (hydroxyethylmethacrylate and methacrylic acid copolymer). Device functions as refractive medium on cornea to focus light on retina. Used by patients for vision correction. Manufactured via alternate process; equivalent to predicate Hydrasoft lenses.

Clinical Evidence

Bench testing only. Evaluated water content, light transmittance, refractive index, and mechanical properties per 1994 FDA guidance. Biocompatibility assessed via systemic injection and cytotoxicity testing.

Technological Characteristics

Material: methafilcon B (hydroxyethylmethacrylate and methacrylic acid copolymer). Form: spherical or toric soft contact lens. Function: refractive medium. Manufacturing: alternate polymerization process.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and non-aphakic patients with non-diseased eyes.

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

• Hydrasoft (K962185)
• Hydrasoft Toric (K962185)

Submission Summary (Full Text)

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K962185
CoperVision

DEC 17 1996

East Coast Office
200 WillowBrook Office Park
Fairport, New York 14450
[phone]
[phone]
Fax [phone]

West Coast Office
10 Faraday
Irvine, California 92718
[phone]
[phone]
Fax [phone]

J. 510(k) SUMMARY
Page 1 of 2

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

2. Contact Person:
Bernard Hallatt
Phone: [phone]
FAX: [phone]

3. Date Summary Prepared: May 1, 1996

4. Name of Device:
- Trade Name: Hydrasoft (East)
- Common Name: Soft Contact Lens
- Classification Name: Soft (hydrophilic) Contact Lens (Per 21 CFR § 886.5925)

5. Legally Marketed Device: Hydrasoft® and Hydrasoft® Toric (methafilcon B)

6. Description of Device:
The HYDRASOFT (East) (methafilcon B) Soft (hydrophilic) Contact lens is available as a spherical or astigmatic (toric) lens. The lens material, methafilcon B, is a random copolymer of hydroxyethylmethacrylate and methacrylic acid.

When placed on the cornea in its hydrated state the HYDRASOFT (East) Contact Lens act as a refracting medium to focus light rays on the retina.

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510(k) SUMMARY (Cont'd)
Page 2 of 2

7. Intended Use:

The HYDRASOFT (East) lens is intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes.

8. Technological Characteristics:

The technological characteristics of the HYDRASOFT (East) spherical lens and HYDRASOFT TORIC (East) Lens are the same as the predicate device, Hydrasoft® and Hydrasoft® Toric.

9. Summary of Non-Clinical Tests:

Physical and chemical properties testing was performed on lenses made using the alternate manufacturing method and polymerization process as called or 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 the Systemic Injection Test and Cytotoxicity Test along with company data incorporated by reference to an identical manufacturing process for tetrafilcon A lenses.

10. Conclusion:

The determination of substantial equivalence is based on the results of non-clinical testing. Review of the all test data demonstrates methafilcon B lenses manufactured with the alternate manufacturing method and polymerization process are equivalent to the currently marketed Hydrasoft® and Hydrasoft® Toric contact lenses. The Hydrasoft (East) and Hydrasoft Toric (East) contact lenses have the same design, indication and directions for use as the Hydrasoft® and Hydrasoft® Toric contact lenses. CooperVision, Inc. concludes, therefore, that the Hydrasoft (East) and Hydrasoft Toric (East) contact lenses are substantially equivalent to the Hydrasoft® and Hydrasoft® Toric contact lenses.

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