SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

K993580 · Specialty Ultravision, Inc. · LPL · Feb 2, 2000 · Ophthalmic

Device Facts

• Record ID: K993580
• Device Name: SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
• Applicant: Specialty Ultravision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Feb 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Device Story

Specialty 55 is a hemispherical, flexible, hydrophilic contact lens covering the cornea and adjacent sclera. Designed for daily wear or frequent replacement to correct refractive ametropia (myopia/hyperopia). Prescribed by eyecare practitioners. Lens material is methafilcon A (HEMA and methacrylic acid cross-linked with ethyleneglycol dimethacrylate, 55% water content). Tinted with D&C Green #6 via in-monomer entrapment. Disinfection via chemical or hydrogen peroxide systems. Provides vision correction for patients with non-diseased eyes and astigmatism up to 2.00 diopters.

Clinical Evidence

Bench testing only. Testing conducted per FDA 1994 Class II Contact Lens Guidance. Results demonstrated non-cytotoxicity, comparable physicochemical properties to the predicate, and no detectable tint leaching in extracts.

Technological Characteristics

Hydrophilic lens (Group 4); material: methafilcon A (HEMA, methacrylic acid, ethyleneglycol dimethacrylate); water content: 55%; refractive index: 1.42; specific gravity: 1.06; Dk (35°C): 18.8 x 10^-11; light transmittance: ~98%; manufacturing: molded; tint: D&C Green #6.

Indications for Use

Indicated for daily wear correction of myopia and hyperopia in aphakic or non-aphakic persons with non-diseased eyes; may correct refractive or corneal astigmatism up to 2.00 diopters.

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

• Specialty 55 (methafilcon A) Soft Single Vision Contact Lens for Daily Wear (K984090)

Submission Summary (Full Text)

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2 2000 FEB

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K 993580

# 510(k) Summary

## Submitter Information:

Specialty UltraVision, Inc. 307 Orchard City Drive, Suite 100 Campbell, CA 95008 Garold Edwards, O.D., F.A.A.O. Contact Person: Vice President, Technical Affairs [phone] Telephone: Fax: [phone]

Date Prepared: October 19, 1999

### Device Name:

| Common Name: | Soft (Hydrophilic) Contact Lens |
|--------------------------|----------------------------------------------------------------------------------------------|
| Trade/Proprietary Names: | Specialty 55 (methafilcon A) Soft (Hydrophilic) Single<br>Vision Contact Lens for Daily Wear |
| Classification Name: | Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II (21 CFR 886.5925) |

### Predicate Devices:

The Specialty 55 (methafilcon A) Soft Single Vision Contact Lens for Daily Wear was selected as the predicate device. This device, which was cleared under 510(k) K984090, is manufactured from the same polymer and the same lens design.

#### Description of Devices:

The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is available as a single vision lens. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is tinted using D & C Green #6 in an in-monomer tinting process.

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Comparison to Predicate Device

| PARAMETER | Specialty 55 (methafilcon A)<br>Soft (Hydrophilic) Single<br>Vision Contact Lens for Daily<br>Wear | Specialty 55 (methafilcon A)<br>Soft (Hydrophilic) Single<br>Vision Contact Lens for Daily<br>Wear |
|-------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| material | methafilcon A | methafilcon A |
| material classification | Hydrophilic Lens Group 4 | Hydrophilic Lens Group 4 |
| indication for use | myopia, hyperopia | myopia, hyperopia |
| water content | 55% | 55% |
| light transmittance | Approximately 98% | Approximately 98% |
| Dk (35° C) | 18.8 x 10 -11 | 18.8 x 10 -11 |
| powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters |
| color | blue visibility | blue visibility |
| refractive index | 1.42 | 1.42 |
| specific gravity | 1.06 | 1.06 |
| Method of manufacture | Molded | Molded |
| Tint | D&C Green #6 | Vat Blue #6 |
| Tint process | Entrapment process during<br>polymerization | Entrapment process during<br>polymerization |

## Indications for Use:

The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eves that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

## Description of Safety and Substantial Equivalence:

Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device, and to establish the safety and effectiveness of the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear. All testing was conducted in accordance to the Premarket Notification 510(k) Guidance Document for Class II Contact Lenses issued by FDA in May, 1994. Results of cytotoxicity testing show the lens material to be non-cytotoxic. the physicochemical properties of the lens to be comparable to the predicate device, and the leachability testing demonstrates no detectable level of tint in the test extracts.

## Conclusion:

Information submitted in the 510(k) establishes that the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear has comparable physicochemical properties to the predicate device and does not raise questions of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 2 2000 FEB

Garold L. Edwards, O.D. Vice President, Technical Affairs Specialty Ultravision, Inc. 307 Orchard City Drive Suite 100 Campbell, CA 95008

Re: K993580

Trade Name: Specialty 55 (methafilcon A) Soft (hydrophilic) Single Vision Lens For Daily Wear (cast-molded, visitint with D & C Green #6)

Regulatory Class: II Product Code: 86 LPL Dated: January 14, 2000 Received: January 18, 2000

Dear Dr. Edwards:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 (Premarket Approval), 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 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 device 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 - Garold L. Edwards, O.D.

This letter will allow you to begin marketing your device as described in your 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 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 device, 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,

A. Ralph Rosenthal

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 STATEMENT

#### Device Name:

Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear

#### Indications for Use:

The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use__ Over-the-Counter Use OR

E.S. Co. Ph.D.
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K 993580

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