MENICON Z RIGID GAS PERMEABLE CONTACT LENS

K081443 · Menicon Co, Ltd. · HQD · Sep 23, 2008 · Ophthalmic

Device Facts

• Record ID: K081443
• Device Name: MENICON Z RIGID GAS PERMEABLE CONTACT LENS
• Applicant: Menicon Co, Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: Sep 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with non-diseased eyes. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

Device Story

Menicon Z (tisilfocon A) is a rigid gas permeable contact lens; material is a thermoset copolymer of fluoromethacrylate and siloxanylstyrene. Lens features include UV absorber (benzotriazol) and light blue tint. Designs include progressively flattening peripheral curves, reverse curves, or decentered optic zones to manage irregular corneas. Prescribed by eye care professionals for patients requiring rigid lenses for refractive correction or irregular corneal management. Lens provides oxygen permeability and physical correction of corneal surface irregularities; improves visual acuity in patients with keratoconus, post-surgical corneas, or other corneal ectasias. Chemical disinfection required.

Clinical Evidence

No new clinical study required. Evidence relies on retrospective case study data demonstrating maintenance of corneal physiology and visual acuity for keratoconus and irregular corneal conditions, supported by prior clearances (K962006, K970019, P990018) for the tisilfocon A material.

Technological Characteristics

Material: Tisilfocon A (fluoromethacrylate and siloxanylstyrene thermoset copolymer). Additives: D&C Green No. 6 (21 CFR 74.3206) and benzotriazol UV absorber. Design: Rigid gas permeable, custom geometry (reverse curves, decentered optics). Sterilization: Chemical disinfection system.

Indications for Use

Indicated for correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic or non-aphakic persons with non-diseased eyes. Also indicated for management of irregular corneal conditions including keratoconus, pellucid marginal degeneration, or post-penetrating keratoplasty or refractive surgery (e.g., LASIK).

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

• Rose K Post Graft Rigid Gas Permeable Contact Lenses (K013646)
• Dyna Intra-Limbal lens (enflufocon A & hexafocon A) (K020006)
• Boston XO (hexafocon A) (K013762)
• Boston EO (enflufocon B) (K053124)
• Boston ES (enflufocon A) (K071043)

Submission Summary (Full Text)

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# 510(k) summary MENICON Z (tisilfocon A) RIGID GAS PERMEABLE CONTACT LENSES May 2008

## 1. Applicant Information

| Menicon Co., Ltd. | |
|---------------------------------|--------------------------|
| 21-19, Aoi 3-chome, | |
| Naka-ku, Nagoya, Aichi 460-0006 | |
| JAPAN | |
| Contact Person: | Takahiro Ochi |
| Telephone No.: | [phone] |
| Fax No.: | [phone] |
| E-mail: | [e-mail] |

#### 2. Device Information

Classification name: Lenses, Rigid Gas Permeable, Daily Wear Contact Lenses Device classification: Class II Regulation number: 21 CFR 886.5916 Product code: HQD Proprietary name: Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses

#### 3. Predicate Devices

Menicon claims substantial equivalence of the Menicon Z (tisilfocon A) to the following predicate devices.

- Rose K Post Graft Rigid Gas Permeable Contact Lenses: K013646 .
- . Dyna Intra-Limbal lens (enflufocon A & hexafocon A): K020006
- . Boston XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses: K013762, K053124, K071043.

#### 4. Description of device

The Menicon Z lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents. The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (benzotriazol) is added.

Lens designs for the management of irregular corneas include: 1) progressively flattening peripheral curves, 2) a reverse curve or series of reverse curves in the peripheral design, or 3) decentered optic zone and resulting peripheral curves, or 4) a combination of the first three systems.

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K081443

#### 5. Indications for use

The Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with non-diseased eyes.

The lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

The lenses may be disinfected using a chemical disinfection system only.

#### 6. Description of safety and substantial equivalence

The safety and efficacy of the Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lens material was demonstrated in 510(k) Premarket Notifications and Premarket Approvals (PMA) as follows.

- . K962006 cleared on October 9, 1996
- . K970019 cleared on March 25, 1997 (multifocal designs)
- P990018 approved on July 11, 2000 (up to 7 days extended wear) �
- P990018/S002 approved on July 12, 2002 (up to 30 days continuous wear)

Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to Rose K Post Graft Rigid Gas Permeable Contact Lenses, cleared in 510(k) Premarket Notification K013646 and Dyna Intra-Limbal lens Rigid Gas Permeable Contact Lenses, cleared in 510(k) Premarket Notification K020006, including an indication for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

#### 7. Clinical data:

Clinical study for the Menicon Z (tisilfocon A) material has been deemed as not necessary in support of this clearance, as no new or additional questions of safety or effectiveness have been raised.

Results of a retrospective case study using the Menicon Z lenses for the management of keratoconus and other irregular corneal conditions demonstrated that the lenses effectively maintained corneal physiology and visual acuity.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle.

SEP 2 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Menicon Co. Ltd. c/o Beverley D. Venuti, Ph.D., R.A.C. Staff Consultant Foresight Regulatory Strategies, Inc. 269A Ballardvale Street Wilmington MA 01887

Re: K081443

Trade/Device Name: Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Codc: HQD Dated: August 21, 2008 Received: August 25, 2008

Dear Dr. Venuti:

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 - Beverley D. Venuti, Ph.D., R.A.C.

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Malvina B. Estrada, M.D.

Malvina B. Eydelman. M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known):

# KO81443

Device Name: Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lenses

Indications for Use:

The Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with non-diseased eyes.

The lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

The lenses may be disinfected using a chemical disinfection system only.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------|---------|
| Division of Ophthalmic Ear,<br>Nose and Throat Devices | |
| 510(k) Number | K081443 |

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