HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR

K021977 · Contamac, Ltd. · HQD · Sep 12, 2002 · Ophthalmic

Device Facts

• Record ID: K021977
• Device Name: HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
• Applicant: Contamac, Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: Sep 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The Contamac Hybrid FS (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and low level corneal toricity up to 2.00D) in aphakic or not-aphakic persons with nondiseased eyes. The lens may be disinfected using chemical disinfection only. The Contamac Hybrid FS Toric (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism where a spherical lens does not neutralize any residual over-refraction) in aphakic or not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfection only.

Device Story

Contamac Hybrid FS (hybufocon A) is a rigid gas permeable (RGP) contact lens designed for daily wear. It corrects refractive errors including myopia, hyperopia, and astigmatism in aphakic or non-aphakic patients. The lens is intended for use in non-diseased eyes and requires chemical disinfection. It functions as a standard optical corrective device worn directly on the cornea.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: hybufocon A (fluorosilicone acrylate). Type: Rigid Gas Permeable (RGP) contact lens. Form factor: Spherical and Toric designs. Disinfection: Chemical only.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia, hyperopia, and corneal toricity/astigmatism) in aphakic or non-aphakic persons with non-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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP 1 2 2002

Contamac Ltd c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127

Re: K021977

Trade/Device Name: Contamac Hybrid FS (hybufocon A) RGP Contact Lenses for Daily Wear (Spherical and Toric, Clear and Tinted) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: August 23, 2002 Received: August 26, 2002

Dear Mr. Walls:

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. Kevin Walls, RAC

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/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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## 510(k) Number (if known): K021977

- Device Name: Hybrid FS (hybufocon A) RGP Contact Lens for Daily Wear Hybrid FS Toric (hybufocon A) RGP Contact Lens for Daily Wear
- Indications for Use: The Contamac Hybrid FS (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and low level corneal toricity up to 2.00D) in aphakic or not-aphakic persons with nondiseased eyes. The lens may be disinfected using chemical disinfection only.

The Contamac Hybrid FS Toric (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism where a spherical lens does not neutralize any residual over-refraction) in aphakic or not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfection only.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)