OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.

K070628 · Contamac, Ltd. · HQD · May 1, 2007 · Ophthalmic

Device Facts

• Record ID: K070628
• Device Name: OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
• Applicant: Contamac, Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: May 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following peneterating keratoplasty or refractive (e.g. LASIK) surgery. 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.

Device Story

OPTIMUM GP is a lathe-cut, rigid gas permeable (RGP) contact lens composed of a methacrylate copolymer. Available in clear or tinted versions, with optional Benzophenone UV blocker. Prescribed by eyecare practitioners for daily wear in patients with irregular corneal conditions. Lens requires cleaning and disinfection via chemical (non-heat) systems. Provides vision correction for patients with keratoconus, pellucid marginal degeneration, or post-surgical corneal irregularities. Benefits include improved visual acuity through rigid lens optics and high oxygen permeability (Dk values ranging from 26 to 125).

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of physical/chemical properties (refractive index, light transmission, wetting angle, specific gravity, and oxygen permeability) against predicate devices.

Technological Characteristics

Rigid gas permeable methacrylate copolymer (Methyl methacrylate, Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, Methacrylic acid, Ethylene Glycol Dimethacrylate). Lathe-cut form factor. Oxygen permeability (Dk) 26-125 x 10^-11. UV blocker: 2,2'-Dihydroxy-4,4'dimethoxybenzophenone. FDA Group 3 (Fluoro Silicone Acrylate).

Indications for Use

Indicated for patients with otherwise non-diseased eyes requiring rigid gas permeable lenses for management of irregular corneal conditions, including keratoconus, pellucid marginal degeneration, or post-penetrating keratoplasty or refractive (e.g., LASIK) surgery.

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

• Boston ES (enflufocon A), Boston EO (enflufocon B), and Boston XO (hexafocon A) Rigid Gas Permeable Contact Lenses (K053124)
• Dyna Intra-Limbal Lens (K020006)

Submission Summary (Full Text)

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# K070628

# 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.

#### The assigned 510(k) number is:

### Applicant information:

| Date Prepared: | February 15, 2007 |
|------------------------|--------------------------------------------------------------------|
| Name: | CONTAMAC Ltd. |
| Address | Bearwalden Business Park |
| Saffron Walden | |
| Essex England CB11 4JX | |
| Contact Person: | Robert McGregor |
| Phone number: | 44-1799 542 000 |
| US Agent: | Medvice Consulting, Inc. |
| Martin Dalsing | |
| Phone number | [phone] |
| Fax number | [phone] |
| Device Information: | |
| Device Classification: | Class II |
| Classification Number: | HQD |
| Classification Name: | Lenses, Rigid Gas Permeable, Daily Wear |
| Trade Name: | OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear<br>Contact Lens. |
| Purpose of 510(k): | Additional Indications for Use. |

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#### Equivalent Devices:

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens is substantially equivalent to the following predicate devices.

#### PREDICATE DEVICES

Predicate device manufacturer:

Device name:

- 1.) Polymer Technology
1400 North Goodman Street Rochester. NY 14603

and the Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses 510(k) #K053124

Boston ES® (enflufocon A), Boston EO (enflufocon B),

- 2.) Lens Dynamics 14998 W. 6th Avenue, Suite 830 Golden, CO 80401
Dyna Intra-Limbal Lens 510(k) #K020006

#### Device Description:

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

The Safety and Efficacy and description of the OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens was demonstrated in 510(k) K0033594.

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens is a rigid gas permeable methacrylate copolymer of Methvi methacrylate. 1.1.3.3.3 - Hexafluoroisopropyl Methacrylate. Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrviic acid cross-linked with Ethylene Glycol Dimethacrylate.

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens are available have as lathe cut contact lenses in clear and tinted versions. 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 - 315mm and 95% in the UVA range of 316 - 380nm.

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| | (roflufocon A) | (roflufocon B) | (roflufocon C) | (roflufocon d) | (roflufocon e) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------|
| Refractive Index | 1.4527 | 1.4454 | 1.4406 | 1.4333 | 1.4332 |
| Light Transmission<br>(clear) | >97% | >97% | >97% | >97% | >97% |
| Light Transmission<br>(tinted) | >90% | >90% | >90% | >90% | >90% |
| Wetting Angle<br>(Dynamic contact<br>receding angle) | 12° | 13° | 6° | 3° | 6° |
| Specific Gravity | 1.189 | 1.181 | 1.178 | 1.166 | 1.155 |
| Oxygen<br>Permeability (Dk)<br>ISO/FATT Method | $26 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $46 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $65 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $100 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $125 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) |
| Visitint lenses<br>contain one or more<br>of the following<br>color additives and<br>conform to:<br>21 CFR Part 73 &<br>74, Subpart D<br>Medical Devices | D & C Green No.<br>6, FD & C Red<br>No. 17 CI Solvent<br>Yellow 18 | D & C Green No.<br>6, FD & C Red<br>No. 17 CI Solvent<br>Yellow 18 | D & C Green No.<br>6, FD & C Red<br>No. 17 CI Solvent<br>Yellow 18 | D & C Green<br>No. 6, FD & C<br>Red No. 17 CI<br>Solvent Yellow<br>18 | D & C Green No.<br>6, FD & C Red<br>No. 17 CI Solvent<br>Yellow 18 |

The physical properties of the OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens are:

#### Indication for Use:

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

#### Substantial Equivalence:

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens is substantially equivalent and does not raise different questions of safety and effectiveness than the predicate device identified previously.

The following comparison table depicts characteristics of the OPTIMUM GP material, as well as the predicate devices.

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| | Characteristics<br>Comparison | OPTIMUM GP | BOSTON ES, EO&<br>XO | Dyna Intra-Limbal<br>Lens | |
|-----|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | New Device | Predicate Device | Predicate Device | |
| 1.) | Indication for Use | The OPTIMUM GP<br>(roflufocon A, B, C, D & E)<br>Daily Wear Contact Lens<br>may be prescribed<br>in otherwise non-diseased<br>eyes that require<br>a rigid gas permeable lens for<br>the management<br>of irregular corneal conditions<br>such as:<br>keratoconus, pellucid<br>marginal degeneration<br>or following penetrating<br>keratoplasty or following<br>refractive (e.g. LASIK)<br>surgery. | The Boston ES®<br>(enflufocon A) , Boston<br>EO® (enflufocon B) and<br>Boston XO® (hexafocon<br>A) RGP contact lenses may<br>be prescribed in otherwise<br>non-diseased eyes that<br>require a rigd contact lens<br>for management of<br>irregular corneal conditions<br>such as keratoconus,<br>pellucid marginal<br>degeneration, or following<br>penetrating keratoplasty or<br>refractive (e.g. LASIK)<br>surgery. | TheDyna Intra-Limbal<br>(enflufocon or hexafocon<br>A) Lens lens may be<br>prescribed in otherwise non<br>diseased eyes that require a<br>rigid contact lens for the<br>management of irregular<br>corneal conditions such as<br>keratoconus, pellucid<br>marginal degeneration or<br>following penetrating<br>keratoplasty. | |
| 2.) | Device and<br>Classification | Class II<br>Daily wear, Rigid Gas<br>Permeable RGP<br>Contact Lens<br>HQD | Class II<br>Daily wear, Rigid Gas<br>Permeable RGP Contact<br>Lens<br>HQD | Class II<br>Daily wear, Rigid Gas<br>Permeable RGP Contact<br>Lens<br>HQD | |
| 3.) | Production<br>Method | Lathe-cut | Lathe-cut | Lathe-cut | |
| 4.) | FDA Group # | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | |
| 5.) | Water Content | <1% | <1% | <1% | |
| 6.) | UV<br>Absorber/Blocker<br>available | YES | YES | YES | |

### Substantial Equivalence Table

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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 consists of a stylized eagle with three lines forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2007

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: K070628

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: HQD Dated: February 15 2007 Received: March 7, 2007

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 (see 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. Eychler SiWD

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

K070628

Device Name:

OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens

#### INDICATIONS FOR USE:

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following peneterating keratoplasty or refractive (e.g. LASIK) surgery.

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.

### (PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 801.109)
or
Over-The-Counter Use **__**

(Optional Format 1-2-96)

Marc Robles
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K070628

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