MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS

K970019 · Menicon U.S.A., Inc. · LPL · Mar 25, 1997 · Ophthalmic

Device Facts

• Record ID: K970019
• Device Name: MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
• Applicant: Menicon U.S.A., Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Mar 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The alternate designs of the Menicon Z (tisilfocon A) contact lens are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.00 Diopters (D) or less that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.

Device Story

Rigid gas permeable contact lenses in bifocal and trifocal designs; intended for daily wear correction of presbyopia, myopia, hyperopia, and astigmatism. Material is tisilfocon A (fluoro-silicone acrylate), a thermoset copolymer of fluoromethacrylate and siloxanyldyrene. Lenses are tinted with D&C Green No. 6 and contain a UV absorber. Operated by patient for vision correction. Clinical benefit includes improved visual acuity in presbyopic patients. Substantial equivalence established via comparison to spherical Menicon Z design.

Clinical Evidence

Randomized, controlled clinical trial compared spherical Menicon Z to Menicon SF-P. Evaluated adverse reactions, slit lamp findings, patient symptoms, visual acuity, lens replacements, discontinuation rates, wearing time, and keratometry changes. Findings were within expected limits for daily wear contact lenses.

Technological Characteristics

Material: tisilfocon A (fluoro-silicone acrylate, Group III). Composition: thermoset copolymer of fluoromethacrylate and siloxanyldyrene. Additives: D&C Green No. 6 (21 CFR 74.3206) and UV absorber (2-(5-Chloro-2H-benzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol). Design: Bifocal and trifocal rigid gas permeable. Disinfection: Chemical only.

Indications for Use

Indicated for daily wear in non-aphakic, non-diseased presbyopic patients with myopia or hyperopia and astigmatism ≤ 3.00 D.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

Predicate Devices

• spherical design lens of the Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens

Reference Devices

• Menicon SF-P™ Rigid Gas Permeable Contact Lens

Submission Summary (Full Text)

{0}

K970019

MAR 25 1997

VI 510(k) Summary for the
Alternate Designs of Menicon Z™ (tisilfocon A)
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 U.S.A. Inc.
333 West Pontiac Way
Clovis, CA 93612

Summary Prepared December 27, 1996

Trade Name:
Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens
Bifocal design contact lens
Trifocal design contact lens

Device Generic Name:
tisilfocon A (rigid gas permeable contact lens)

Classification Name:
Rigid gas permeable contact lens

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## Predicate Device:

The spherical design lens of the Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens

## Device Description:

The alternate designs of the Menicon Z (tisilfocon A) contact lens are bifocal and trifocal design contact lenses. Conventional bifocal / trifocal designs are employed in the alternate designs of Menicon Z (tisilfocon A) rigid gas permeable contact lenses.

The lens material, tisilfocon A, is a thermoset copolymer derived from fluoromethacrylate and siloxanyldyrene, bound by crosslinking agents. The lens is classified fluoro-silicone acrylate, group III, page 16, FDA's premarket notification (510(k)) guidance document for daily wear contact lenses, May 12, 1994. The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (2-(5-Chloro-2H-benzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol)) is added.

## Indications for Use:

The alternate designs of the Menicon Z (tisilfocon A) contact lens are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.00 Diopters (D) or less that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.

## Substantial Equivalence:

The alternate designs of the Menicon Z (tisilfocon A) contact lens are substantially equivalent to the spherical design of the Menicon Z (tisilfocon A) contact lens, which is a lens with an existing USAN

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The applicant performed non-clinical and clinical testing on the spherical design of the Menicon Z (tisilfocon A) contact lens 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 spherical design of the Menicon Z™ Rigid Gas Permeable Contact Lens and to that of the Menicon SF-P™ Rigid Gas Permeable Contact Lens.

It was determined that the clinical findings 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 the expected limits for daily wear lens wearers.

Conclusion:

The alternate designs of the Menicon Z (tisilfocon A) contact lens are a class II medical device. The information submitted in the 510(k) notification established the device is substantially equivalent to the spherical design of the Menicon Z (tisilfocon A) contact lens in that the device has the comparable characteristics as the predicate device and is as safe and effective as the predicate device and does not raise different types of safety and effective questions.

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