MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS

K972443 · Menicon U.S.A., Inc. · HQD · Aug 22, 1997 · Ophthalmic

Device Facts

• Record ID: K972443
• Device Name: MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS
• Applicant: Menicon U.S.A., Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Aug 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Indications for Use

The Menicon SF-P (melafocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only. The Menicon Z (tisilfocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

Device Story

Menicon SF-P (melafocon A) and Menicon Z (tisilfocon A) are rigid gas permeable (RGP) contact lenses; intended for daily wear correction of refractive errors. This submission introduces a process change from dry storage to wet storage (packaging in BARNES-HIND ComfortCare GP Wetting & Soaking Solution). Lenses are lathe-cut; SF-P is a thermoset copolymer of fluoro-methacrylate, siloxanylmethacrylate, and methacrylic acid; Menicon Z is a thermoset copolymer of fluoro-methacrylate and siloxanylstyrene with UV absorber. Lenses are prescribed by eye care professionals for patients with non-diseased eyes. Wet storage provides convenience and stability for the user. Substantial equivalence is supported by non-clinical stability and microbiology testing of wet-stored lenses and toxicology testing of shipping case plastics.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical stability and microbiology testing of lenses stored wet for 30 days, and toxicology testing of shipping case plastics.

Technological Characteristics

RGP contact lenses. SF-P: thermoset copolymer (fluoro-methacrylate, siloxanylmethacrylate, methacrylic acid). Menicon Z: thermoset copolymer (fluoro-methacrylate, siloxanylstyrene). Both are lathe-cut. Wet storage utilizes BARNES-HIND ComfortCare GP Wetting & Soaking Solution (edetate disodium, chlorhexidine gluconate).

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, presbyopia, and/or astigmatism in aphakic and 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.

Predicate Devices

• Menicon SF-P (melafocon A) Rigid Gas Permeable Contact Lens (dry storage)
• Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lens (dry storage)

Submission Summary (Full Text)

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510(k) Summary Kg12443

AUG 22 1997 Applicant's Name and Address: Menicon Co., Ltd. 21-19. Aoi 3-Chome Naka-ku, Nagoya 460 Japan Phone [phone] 011 81 52 935 1121 Fax

Contact Person:

Cristina M. Schnider, OD, MSc, FAAO Menicon U.S.A. Inc. 333 West Pontiac Way Clovis, CA 93612 Phone [phone] x114 Fax [phone]

Summary Prepared

June 1997

Trade Name:

This process change applies to Menicon Rigid Gas Permeable (RGP) Contact Lenses:

Menicon SF-PTM (melafocon A) Rigid Gas Permeable Contact Lens Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens

Device Generic Name:

melafocon A tisilfocon A

Classification Name:

Contact lens, rigid gas permeable

Common/Usual Name

Fluoro silicone acrylate rigid gas permeable contact lens

Predicate Device:

Menicon SF-P (melafocon A) and Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses under dry storage

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Device Description:

The Menicon SF-P (melafocon A) RGP lens is a thermoset copolymer derived from fluoro-methacrylate, siloxanylmethacrylate and methacrylic acid with water absorbance of less than 0.5% by weight. The lens is available in blue tint. The blue tinted lens contains D&C Green No. 6 as the color additive.

The Menicon Z (tisilfocon A) RGP lens is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene, bound by crosslinking agents. Lens colors available are light blue and violet. The blue lens is tinted with color additive D & C Green No. 6 and the violet lens contains the color additives D & C Green No. 6 and D & C Violet No. 2. Also, UV absorber is added.

Solution used for packaging the Menicon RGP lenses:

BARNES-HIND® ComfortCare® GP WETTING & SOAKING SOLUTION, which contains edetate disodium and chlorhexidine gluconate as preservatives.

Indications for Use:

The Menicon SF-P (melafocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

The Menicon Z (tisilfocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

Substantial Equivalence:

Menicon SF-P and Menicon Z RGP lenses under wet storage for up to 30 days are substantially equivalent to the Menicon SF-P and Menicon Z RGP lenses under dry storage.

The applicant performed non-clinical stability and microbiology testing on the Menicon RGP lenses stored wet for 30 days. This testing in conjunction with toxicology testing on the shipping case plastics supports the claim of substantial equivalence to Menicon RGP lenses shipped and stored in the dry state.

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Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cristina M. Schnider, O.D., M.Sc., F.A.A.O. Director of Professional Relations and Clinical Affairs Menicon USA, Inc. 333 West Pontiac Way Clovis, CA 93612-5613

AUG 22 1997

Re: K972443

> Trade Names: Menicon SF-P™ (melafocon A) Rigid Gas Permeable Contact Lens for Daily Wear (Visibility tinted, Lathe-cut, Wet shipping)

> > Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear (Visibility tinted with UV absorber, Lathe-cut, Wet shipping)

Regulatory Class: II Product Code: 86 HQD Dated: June 27,1997 Received: June 30,1997

Dear Dr. Schnider:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Cristina M. Schnider, O.D., M.Sc., F.A.A.O.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 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 devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

David M. Whipple
Lorin Dahl Reynolds MD

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K972443

Menicon SF-P™ and Menicon Z™ Rigid Gas Permeable Device Name: Contact Lenses

Indications for Use:

The Menicon SF-P (melafocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eves. The lens may be disinfected using a chemical disinfection system only.

The Menicon Z (tisilfocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

(Please do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kiver F. Warburtor

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K972443

Prescription Use (Per 21 CFR 80.109)

OR _ Over-The-Counter Use

(Optional Format 1-2-96)

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