MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

K962006 · Menicon Co, Ltd. · HQD · Oct 9, 1996 · Ophthalmic

Device Facts

• Record ID: K962006
• Device Name: MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
• Applicant: Menicon Co, Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: Oct 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The Menicon Z™ Rigid Gas Permeable Contact Lens for Daily Wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes who are myopic or hyperopic and have an astigmatism of up to 3.00 Diopters (D) that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.

Device Story

Menicon Z™ is a lathe-cut, non-polished, rigid gas permeable contact lens. Material is tisilfocon A, a thermoset copolymer of fluoro-methacrylate and siloxanylstyrene. Lens features spherical front/back surfaces and a peripheral curve system for tear exchange. Available in clear or light blue (D&C Green No. 6) with a UV absorber. Used by patients for daily wear to correct refractive errors. Prescribed by eye care professionals. Clinical performance evaluated via randomized controlled trial comparing visual acuity and ocular health against predicate device.

Clinical Evidence

Randomized, controlled 3-month clinical trial (n=118 eyes) comparing Menicon Z™ to Menicon SF-P™. Endpoints included adverse reactions, slit lamp findings, patient symptoms, visual acuity, and keratometry. Results demonstrated visual acuity and clinical findings were comparable to the predicate and within expected limits for daily wear.

Technological Characteristics

Material: tisilfocon A (fluoro-methacrylate and siloxanylstyrene thermoset copolymer). Hydrophobic Material Group III. Water content <0.5%. Lathe-cut, non-polished, spherical geometry. Includes UV absorber 2-(5-Chloro-2H-benzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol. Chemical disinfection only.

Indications for Use

Indicated for daily wear correction of visual acuity in aphakic or non-aphakic persons with nondiseased eyes, including myopia, hyperopia, and astigmatism up to 3.00 D.

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

Submission Summary (Full Text)

{0}

OCT - 9 1996
K962006

510(k) Summary

for the

Menicon Z™ Rigid Gas Permeable Contact Lens

Applicant's Name and Address: Menicon Co., Ltd.
21-19, Aoi 3-Chome
Naka-ku, Nagoya, 460
Japan
Phone [phone]
Fax [phone]

Contact Person: Mr. Taiji Higaki
President
Menicon USA, Inc.
333 West Pontiac Way
Clovis, CA 93612

Summary Prepared: August 14, 1996

Trade Name: Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens
Device Generic Name: tisilfocon A rigid gas permeable contact lens
Classification Name: rigid gas permeable contact lens

Predicate Device: Menicon SF-P™ (melafocon A) Rigid Gas Permeable Contact Lens

Device Description:

The Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens is a lathe-cut nonpolished firm contact lens with spherical front and back surfaces. The posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface

August, 1996
MENICON CO., LTD. -- Z RGP DW

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Premarket Notification (510(k))

allows tear exchange between the lens and the cornea. The lens material, tisilfocon A, is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene, bound by cross-linking agents. The lens colors are light blue or clear. The lens is tinted light blue with color additive D &amp; C Green No. 6. A UV absorber 2-(5-Chloro-2H-benzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol is also added.

## Indications for Use:

The Menicon Z™ Rigid Gas Permeable Contact Lens for Daily Wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes who are myopic or hyperopic and have an astigmatism of up to 3.00 Diopters (D) that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.

## Substantial Equivalence:

The Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is substantially equivalent to the Menicon SF-P™ (melafocon A) Rigid Gas Permeable Contact Lens. Both are Hydrophobic Material Group III (fluoro silicone acrylate) and have less than 0.5% water content.

The applicant performed non-clinical and clinical testing on the device in accordance with the FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses (May 1994). The non-clinical testing supports the safety and effectiveness of the device from microbiological, toxicological, chemistry, and manufacturing perspectives. The applicant sponsored a randomized, controlled clinical trial in which subjects were randomly assigned in a two-to-one ratio to the Menicon Z™ Rigid Gas Permeable Contact Lens and to the predicate device, the Menicon SF-P™ Rigid Gas Permeable Contact Lens. A total of 118 eyes were enrolled in the 3 month study. Based on the analysis of the detailed data presented in the 510(k), it was determined that the clinical findings for the device, i.e., adverse reactions, positive slit lamp findings, patient symptoms, problems, and complaints, visual acuity, lens replacements, discontinued patients, lens wearing time, and keratometry changes were within expected limits for daily wear contact lens wearers. Visual acuity results

August, 1996
MENICON CO., LTD. - Z RGP DW

{2}

Premarket Notification (510(k))

demonstrated that the Menicon Z™ Rigid Gas Permeable Contact Lens was comparable to the predicate lens.

## Conclusion:

Menicon Z™ (tisilfocon A), a Daily Wear Rigid Gas Permeable (nonhydrophobic) contact lens, is a class II medical device. The information submitted in the 510(k) notification established that the device is substantially equivalent to the Menicon SF-P™ Rigid Gas Permeable Contact Lens in that it has the same intended use and comparable technological characteristics as the predicate device and is as safe and effective as that device and does not raise different types of safety and effectiveness questions.

August, 1996
MENICON CO., LTD. - Z RGP DW
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