OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES

K081178 · Contamac, Ltd. · HQD · Oct 9, 2008 · Ophthalmic

Device Facts

• Record ID: K081178
• Device Name: OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
• Applicant: Contamac, Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: Oct 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Rigid Gas Permeable (RGP) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not aphakic persons with non-diseased eyes, The lenses may be disinfected using a chemical disinfection system only.

Device Story

Optimum HR-1.51 (hirafocon A) and Optimum HR-1.53 (hirafocon B) are rigid gas permeable (RGP) contact lenses. Designed for daily wear to correct refractive errors including myopia, hyperopia, astigmatism, and presbyopia. Used by patients with non-diseased eyes, both aphakic and non-aphakic. Lenses require chemical disinfection systems. Prescribed by eye care professionals to improve visual acuity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid gas permeable contact lens materials: hirafocon A and hirafocon B. Designed for daily wear. Requires chemical disinfection.

Indications for Use

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

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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OCT 0 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Contamac Ltd. c/o Martin Dalsing Official Correspondent of Contamac, Ltd. Medvice Consulting, Inc. 806 Kimball Avenue Grand Junction CO 81501

Re: K081178

Trade/Device Name: Optimum HR-1.51 (hirafocon A) and Optimum HR-1.53 (hirafocon B) Daily Wear Contact Lens

Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: September 18, 2008 Received: September 19, 2008

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Egerkins, mD

Malvina B. Evdelman, 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

510(k) Number:

K081178

Device Name:

OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Daily Wear Contact Lenses.

INDICATIONS FOR USE:

The OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Rigid Gas Permeable (RGP) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not aphakic persons with non-diseased eyes, The lenses may be disinfected using a chemical disinfection system only.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use or (Per 21 CFR 801.109) Stional Format 1-2-96)