OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S

K011577 · Ocu-Ease Optical Products, Inc. · LPL · Jun 19, 2001 · Ophthalmic

Device Facts

• Record ID: K011577
• Device Name: OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S
• Applicant: Ocu-Ease Optical Products, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity. The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or notaphakic persons with non-diseased eyes that are myopic or hyperopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity. The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity. The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity. The lens may be disinfected with chemical (not heat) disinfection system.

Device Story

Soft contact lenses fabricated from methafilcon A (hydrophilic co-polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate); lathe-cut manufacturing. Hydrated state (55% water) conforms to corneal curvature to provide refractive correction. Used by patients for daily wear; prescribed by eye care professionals. Lenses require chemical (non-heat) disinfection. Benefits include visual acuity correction for refractive errors.

Clinical Evidence

Bench testing only. No clinical data presented. Equivalence established through comparison of physical properties (water content, Dk value, refractive index, specific gravity, light transmission) and material composition to predicate devices.

Technological Characteristics

Hydrophilic methafilcon A polymer; 55% water content; Dk=18x10^-11 @ 35°C; refractive index 1.4153; specific gravity 1.090 g/cc; light transmission >95%; Phthalocyanine Blue pigment; lathe-cut manufacturing; chemical disinfection required.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and astigmatism in aphakic or not-aphakic persons with non-diseased eyes; includes presbyopic correction for aspherical models. Contraindicated for 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

• Horizon 55 (methafilcon A) Sphere, Toric, Progressive, Progressive Toric (K992010)

Reference Devices

• BENZ - MF (methafilcon A) (K980418)
• BENZ - MF (methafilcon A) (K003861)

Submission Summary (Full Text)

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510(k) Premarket Notification Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear (clear or tinted)

# cu-Lase ptical Products, Inc.

629 Tennent Avenue Pinole, California 94564 Telephone: [phone] (NAT'L) 800-521-8984 Facsimile: 800-OCU-EASE · e-mail: [e-mail] visit us on the web: www.ocuease.com

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Assianed 510(k) Number:

K011577

Applicant Information: Date Prepared:

Name: Address:

Contact Person:

Phone/Fax Number:

Device Information:

Device Classification:

Classification Number:

Classification Name:

Device Trade Name:

May 10, 2001

Ocu-Ease Optical Products, Inc. 629 Tennent Avenue Pinole, CA. 94564

Charles R. Vermette President OR Kelli Wayne

Phone: [phone] Fax: [phone]

Class II

LPL

Lenses, Soft Contact, Daily Wear

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear (Clear and Tinted, lathe-cut)

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510(k) Premarket Notification

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear (clear or tinted)

SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

#### Equivalent Devices:

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens for Daily Wear is substantially equivalent to the predicate device(s) identified below in terms of intended use and design.

Predicate Device:

Horizon 55 (methafilcon A) Sphere, Toric, Progressive, Progressive Toric 510(k) #K992010 Manufactured By: Westcon Contact Lens

#### Device Description:

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are fabricated from methafilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly bevond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eve. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The ionic lens material (methafilcon A) is a hydrophilic co-polymer of 2hydroxvethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 55% water by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution.

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510(k) Premarket Notification

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear (clear or tinted)

#### SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are available as a spherical, toric, aspheric and toric aspheric design.

The physical properties of the lens are:

Refractive Index Light Transmission Specific Gravity Water Content Color Pigment Name Oxygen Permeability

1.4153 greater than 95% T 1.090 g/cc ર્ રેજી Phthalocyanine Blue Dk=18x10-11 @ 35°C

#### Intended Use:

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.

The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or notaphakic persons with non-diseased eyes that are myopic or hyperopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eves that are mvopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity.

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510(k) Premarket Notification

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear (clear or tinted)

#### SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.

The lens may be disinfected with chemical (not heat) disinfection system.

#### Substantial Equivalence:

The new device will be manufactured according to specified process controls and a Quality Management System certified to CGMP guidelines currently in place. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Ocu-Ease Optical Products, Inc. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ - MF (methafilcon A), 510k #K980418 and K003861. Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.

The following matrix illustrates that the production method, lens function and material of the Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear is substantially equivalent to the predicate device. In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device.

Signed: Charles R. Vermette, President Date: 05/10/2001

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510(k) Premarket Notification

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone 5 Spherical, Torio, Tim Lono 10) Soft Contact Lenses for Daily Wear

(clear or tinted)

## SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

## Substantial Equivalence Matrix

| | Characteristic | Ocu-Flex 55 Spherical,<br>Toric, Thin Zone Toric,<br>Aspherical, Toric<br>Aspherical and Thin Zone<br>Toric Aspherical<br>(methafilcon A) Soft<br>Contact Lenses | Predicate Device:<br>Westcon Horizon 55 (methafilcon<br>A) Soft Contact Lens |
|-----|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | PRODUCTION<br>METHOD | Lathe-cut | Lathe-cut |
| 2.) | LENS FUNCTION | Refractive medium that<br>focuses light rays from near<br>and distant objects on the<br>retina, while compensating<br>for refractive error | Refractive medium that focuses<br>light rays from near and distant<br>objects on the retina, while<br>compensating for refractive error |
| 3.) | INDICATION | Correction of visual acuity in<br>aphakic and not-aphakic<br>persons with non-diseased<br>eyes with myopia, hyperopia<br>and astigmatism | Correction of visual acuity in<br>aphakic and not-aphakic persons<br>with non-diseased eyes with<br>myopia, hyperopia and astigmatism |
| 3.) | MATERIAL | hydrophilic (methafilcon A) | hydrophilic (methafilcon A) |
| 4.) | WATER CONTENT | 55% | 55% |
| 5.) | Dk Value | $Dk=18x10^{-11}$ @ 35°C | $Dk=18x10^{-11}$ @ 35°C |

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The profiles are stacked on top of each other, creating a sense of unity and collaboration.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2001

Mr. Charles R. Vermette President Ocu-Ease Optical Products, Inc. 629 Tennent Avenue Pinole, California 94564

Re: K011577

Ne: Your Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical, Toric Aspherical and Thin Zone Toric Asperhical (methafilcon A) Soft Contact Lenses (Clear & Tinted, Lathe-cut from Lens Blank) Regulation Number: 886.5925 Regulatory Class: II Product Code: LPL Dated: May 10, 2001 Received: May 22, 2001

Dear Mr. Vermette:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your occared he 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 the cliactified 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 (Itch). Tou may, thereford mailier in of the Act include requirements for annual registration, I to: - 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 ( Femailtons 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 periodic Q inspections, and 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

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## Page 2 - Mr. Charles R. Vermette

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 nodication. The I DA miding of various 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 IT you desire specific active ror your stic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please 574-6415. Additionally, for questions on [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information Misoranding of reletence to premarket in an obtained from the Division of Small Manufacturers on your responsibilités under the 1123 -2041 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
A. Ralph 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

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#### Ocu-Ease Optical Products, Inc. 510(k) Premarket Notification Ocu-Flex 55 Spherical, Toric, Tronic, Aspherical, Toric Aspherical and Thin Zone 15 Sphencal, 1 one, 1 the filtion A) Soft Contact Lenses for Daily Wear (clear or tinted)

# INDICATIONS FOR USE STATEMENT

Page 1 of 1

#### Device Name:

## Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical, d-riex 35 Spherical (methafilcon A) Soft Contact Lenses (Clear & Tinted, Lathe-cut from Lens Blank)

#### INDICATIONS FOR USE:

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin The Ocu-Flex 55 Sphencal, Tonc, Thin Lond Lenses are indicated for daily wear for the Zone Tone Asphencal (methallion) A) Ook Oonliae Lendo are Massan Property.
correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.

The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual aculty in aprakte of not-apilanc with the may with the contribution of 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic persons with indicated for daily wear for the correction of visual douly in application of 4.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual aculty in aphake of not uphants poleone which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methaticon A) Soft The Ocu-Flex 35 Tollo Asphencal and Thin London in the Contrity in aphakic or not-aphakic on not-aphakic Contact Lens is indicated for daily wear for the one one and/or presbyopic and is intended persons will non-diseased eyes that are infopted of types in therfere with visual acuity.

The lens may be disinfected with a chemical (not heat) disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Ophthalmic Devices

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Daniel W. C. Brown, Ph.D.

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Numberional Format 1-2-96) K011577