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

• K Number: K962185
• Device Name: HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
• Manufacturer: COOPERVISION, INC.
• Date Cleared: 1996-12-17 ( 194 days)
• Product Code: LPL
• Regulation Number: 886.5925
• Type: Traditional
• Panel: Ophthalmic
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 notaphakic persons with non-diseased eyes.

Device Description

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.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it relates to a medical device's diagnostic performance. Instead, the document is a 510(k) summary for a contact lens, focusing on its substantial equivalence to a legally marketed predicate device based on manufacturing processes and material properties.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, expert involvement, or statistical analyses for diagnostic performance.

The document mainly discusses:

• Device Name: HYDRASOFT (East) (methafilcon B) Soft (hydrophilic) Contact lens
• Intended Use: Daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in aphakic and notaphakic persons with non-diseased eyes.
• Technological Characteristics: Stated to be the same as the predicate device, Hydrasoft® and Hydrasoft® Toric.
• Non-Clinical Tests: Physical and chemical properties testing (water content, light transmittance, refractive index, mechanical properties) and toxicity tests (Systemic Injection Test and Cytotoxicity Test). These tests were performed to establish equivalence to the predicate device due to an alternate manufacturing method and polymerization process, not to evaluate diagnostic performance.
• Conclusion: Substantial equivalence is based on the results of non-clinical testing demonstrating that lenses manufactured with the alternate method are equivalent to currently marketed Hydrasoft® and Hydrasoft® Toric contact lenses, having the same design, indication, and directions for use.

In summary, the provided text does not offer the type of information requested about diagnostic device acceptance criteria and performance studies.

Summary

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sion of

K962185

DEC 17 1996

510 (k) SUMMARY J. Page 1 of 2

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]

Submitter's Name: 1.

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

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

May 1, 1996 3 . Date Summary Prepared:

Name of Device: 4 .

• Hydrasoft (East) · Trade Name:
• Soft Contact Lens · Common Name:
• Soft (hydrophilic) Contact Lens · Classification Name: (Per 21 CFR § 886.5925)
• Legally Marketed Device: Hydrasoft and Hydrasoft® Toric 5 . (methafilcon B)

6 . Description of Device:

The HYDRASOFT (East) (methafilcon B) Soft (hydrophilic) Contact lens is available as a spherical or astigmatic The lens material, methafilcon B, is a (toric) lens. hydroxyethylmethacrylate and copolymer of random 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) SUMNARY (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 notaphakic 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 a 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 Cytotoxcity Test along with company data incorproceded by reference to an identical manufacturing process for
ferrafilizion A lenses.

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 HydrasoftR Toric contact lenses.

Regulation Number and Section

N/A