ROSE K POST GRAFT LENS

K013646 · Rose K International , Ltd. · HQD · May 30, 2002 · Ophthalmic

Device Facts

• Record ID: K013646
• Device Name: ROSE K POST GRAFT LENS
• Applicant: Rose K International , Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: May 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The Rose K Post Graft Rigid Gas Permeable Contact Lens (hexafocon A), and Rose K Post Graft Rigid Gas Permeable Contact Lens (enflufocon B) are indicated for the correction of refractive error in patients with keratoconus or post-penetrating keratoplasty (post-graft) in aphakic or non-aphakic eyes. The lenses may be disinfected using a chemical disinfection system.

Device Story

Rose K Post Graft Rigid Gas Permeable Contact Lenses are custom-designed lenses for patients with irregular corneal surfaces due to keratoconus or post-graft surgery. Lenses are manufactured from hexafocon A or enflufocon B materials. Used by eye care professionals to provide visual correction for refractive errors in aphakic or non-aphakic patients. Lenses are worn on the eye; cleaned and disinfected by the patient using standard chemical disinfection systems. Benefit includes improved visual acuity for patients with complex corneal geometries.

Clinical Evidence

No clinical data provided; substantial equivalence is based on material and design characteristics.

Technological Characteristics

Rigid gas permeable contact lenses composed of hexafocon A or enflufocon B. Designed for daily wear. Chemical disinfection required.

Indications for Use

Indicated for correction of refractive error in patients with keratoconus or post-penetrating keratoplasty (post-graft) in aphakic or non-aphakic 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 3 0 2002

Mr. Ian Jennings Rose K. International, LTD 60 St. Andrews TCE Hamilton, New Zealand

Re: K013646

Trade/Device Name: Rose K Post Graft Rigid Gas Permeable Contact Lens (hexafocon A or enflufocon B)

Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: May 14, 2002 Received: May 16, 2002

Dear Mr. Jennings:

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 aso button in all encreates) of the Medical Device Amendments, or to devices that provision in they 20, 1978, and cordance 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 rr your de rive to such additional controls. Existing major regulations affecting your device can be finar of subject to sten acant 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. Ian Jennings

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotes with are way of substantial equivalence of your device of your device to a legally promated nodicate 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 vours,

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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## Name and Address of Company

P.O. Box 9307 HAMILTON NEW ZEALAND. ROSE K INTERNATIONAL LTD Indications for Use Statement

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K013646 |
| Device Name: | THE ROSE K POST GRAFT (hexaforon A or Enflufocon B)RIGID GAS PERMEABLE CONTACT LENS |

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510(k) Number K013646