MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES

K062548 · Contamac, Ltd. · HQD · Nov 1, 2006 · Ophthalmic

Device Facts

• Record ID: K062548
• Device Name: MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
• Applicant: Contamac, Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: Nov 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon D, and roflufocon E) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disioner on and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Story

OPTIMUM GP contact lenses are lathe-cut rigid gas permeable (RGP) lenses fabricated from roflufocon (A-E) methacrylate copolymers. Lenses act as a refractive medium to focus light on the retina. Available in spherical, aspheric, bifocal, multifocal, or toric designs; may include visibility tints or Benzophenone UV blockers. Lenses are non-sterile, intended for daily wear, and require chemical disinfection. Eyecare practitioners prescribe lenses for vision correction; patients handle lenses for daily insertion/removal. Plasma surface treatment is applied to reduce contact wetting angles, improving lens surface characteristics. Clinical benefit is the correction of refractive errors in aphakic and non-aphakic patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, specifically measurements of contact angle reduction following plasma surface treatment.

Technological Characteristics

Materials: roflufocon A, B, C, D, E (methacrylate copolymers). Design: Lathe-cut, spherical/aspheric/bifocal/multifocal/toric. Surface: Plasma treated, hydrophobic base. UV blocker: 2,2-Dihydroxy-4,4 dimethoxybenzophenone. FDA Group #3 (Fluoro Silicone Acrylate). Water content: <1%.

Indications for Use

Indicated for daily wear for correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia. Contraindicated for heat disinfection.

Regulatory Classification

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Predicate Devices

• Optimum GP (roflufocon) (K033594)

Submission Summary (Full Text)

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# SPECIAL 510(k) SUMMARY

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.

| The assigned 510(k) number is: | | K062548 | | | | NOV | 1 2006 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------|--|--|-----|--------|
| Applicant information: | | | | | | | |
| Date Prepared: | | August 28th, 2006 | | | | | |
| Submittals Name: | | CONTAMAC Ltd.<br>Bearwalden Business Park<br>Saffron Walden<br>Essex United Kingdom CB11 4JX | | | | | |
| Contact Person: | | | | | | | |
| Medvice Consulting, Inc.<br>Martin Dalsing, Consultant and U.S. Agent for Contamac Ltd.<br>2214 Sanford Drive, B7<br>Grand Junction, CO 81505<br>[phone]<br>Fax #: [phone]<br>E-mail: [e-mail] | | | | | | | |
| Device Information: | | | | | | | |
| Device Classification: | | Class II | | | | | |
| | Classification Number: | | HQD | | | | |
| | Classification Name: | | Daily Wear Rigid Gas Permeable (RGP) Contact Lens | | | | |
| Trade Name: | | OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses | | | | | |

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#### Device Description:

The OPTIMUM GP series of contact lenses are fabricated from the hydrophobic contact lens materials (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon E). When placed on the (fuman cornea, the OPTIMUM GP rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.

OPTIMUM GP Contact Lens for Daily Wear is available with a plasma surface treatment. Lenses are packaged non-sterile and shipped in one of the following GP solutions.

| Solution | Manufacturer |
|----------------|--------------------|
| Boston Simplus | Bausch & Lomb |
| Unique Ph | Alcon |
| Optimum CDS | Lobob Laboratories |

The OPTIMUM GP Contact Lens for Daily Wear are available as lathe cut contact lenses with spherical, aspheric, bifocal, multifocal or toric anterior and/or posterior designs in clear and tinted versions.

The OPTIMUM GP Contact Lens for Daily Wear is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3,3 - Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.

The OPTIMUM GP Contact Lens for Daily Wear incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.

#### UV Blocker

In the OPTIMUM GP Contact Lens with UV Blocker, a Benzophenone UV blocker is used to block UV radiation. The UV Blocker is 2,2 -Dihydroxy-4,4 dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280mm - 315nm and 95% in the UVA range of 316 -380mm.

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## Contamac Ltd. Special 510(k): Manufacturing Process Change, Premarket Notification

The following chart depicts the dramatic reduction in the OPTIMUM GP contact lens wetting angle measurements post plasma surface treatment.

Image /page/2/Figure/2 description: The image is a bar graph titled "% Reduction in Contact Angle after Plasma Surface Treatment". The x-axis shows four different categories: Optimum Classic, Optimum Comfort, Optimum Extra, and Optimum Extreme. The y-axis shows the percent reduction, ranging from 0% to 40%. The bar graph shows that Optimum Classic has a 17% reduction, Optimum Comfort has a 28% reduction, Optimum Extra has a 20% reduction, and Optimum Extreme has a 38% reduction.

#### Unmodified Predicate Devices:

The OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses is substantially equivalent to Contamac Ltd. own unmodified predicate devices:

- 1. Optimum GP (roflufocon ) K033594, Contamac Ltd.
#### INDICATIONS FOR USE:

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon E) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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### Technological Characteristics Comparison:

ﺒﻌﻪ

ु

| Technological<br>Characteristic<br>/Device | Optimum GP<br>(roflufocon) Gas<br>Permeable Contact<br>Lens.<br>Modified Device | Optimum GP<br>(roflufocon) Gas<br>Permeable Contact<br>Lens.<br>Un-Modified Device<br>K033594 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear<br>for the correction of<br>visual acuity in aphakic<br>and not aphakic persons<br>with non-diseased eyes<br>with myopia or<br>hyperopia. | Indicated for daily wear<br>for the correction of<br>visual acuity in aphakic<br>and not aphakic persons<br>with non-diseased eyes<br>with myopia or<br>hyperopia. |
| Functionality | After machining from<br>the optical blank, the<br>contact lenses act as a<br>refractive medium that<br>focus light rays from<br>near and distant objects<br>on the retina. | After machining from<br>the optical blank, the<br>contact lenses act as a<br>refractive medium that<br>focus light rays from<br>near and distant objects<br>on the retina. |
| Indication for<br>Use | Daily wear, Rigid Gas<br>Permeable RGP Contact<br>Lens | Daily wear, Rigid Gas<br>Permeable RGP Contact<br>Lens |
| Production<br>Method | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate |
| USAN name | roflufocon | roflufocon |
| Water Content | <1% | <1% |
| Surface<br>characteristic | hydrophobic | hydrophobic |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

#### NOV 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Contamac Ltd. c/o Mr. Martin Dalsing Medvice Consulting, Inc. Official Correspondent/Consultant and US Agent for Contamac Ltd. 2214 Sanford Dr. Ste. B7 Grand Junction, CO 81505

Re: K062548

Trade/Device Name: OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D and roflufocon E) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lenses Regulatory Class: Class II Product Code: HOD Dated: October 19, 2006 Received: October 20, 2006

Dear Mr. Dalsing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (sec above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Mr. Martin Dalsing

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egdelmin SimD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses. Device Name:

INDICATIONS FOR USE:

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon D, and roflufocon E) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disioner on and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASEDO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

4062548 510(k) Number.

OPTIMUM GP, Daily Wear (Oxygen Permeable) Contact lens