55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K051095 · Optical Connection, Inc. · LPL · Aug 16, 2005 · Ophthalmic

Device Facts

• Record ID: K051095
• Device Name: 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
• Applicant: Optical Connection, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The 55 UV (methafilcon A) Soft (Hydrophilic) 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 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and 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 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes. The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement.

Device Story

Hemispherical flexible shells covering cornea and adjacent sclera; made of methafilcon A (hydrophilic polymer of HEMA and methacrylic acid cross-linked with ethyleneglycol dimethacrylate and water). Available in single vision, double slab-off back surface (Toric), and aspheric (Multifocal) designs. Incorporates UV-absorbing monomer 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyphenyl] ethyl methacrylate and Pigment Blue 15 tint. Used by patients for daily wear; prescribed by eye care practitioners. Lenses are disinfected via chemical or hydrogen peroxide systems. Benefits include vision correction and UV protection.

Clinical Evidence

Bench testing only. Testing included systemic injection, primary ocular irritation, and cytotoxicity studies. Results confirmed lenses are non-toxic and non-irritating. Physicochemical properties were compared to predicates to establish equivalence.

Technological Characteristics

Material: methafilcon A (HEMA/methacrylic acid polymer, 55% water). UV-absorbing monomer: 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyphenyl] ethyl methacrylate. Tint: Pigment Blue 15. Design: Molded hemispherical shells (single vision, double slab-off toric, aspheric multifocal). Dk (35°C): 18.9 x 10^-11. Refractive index: 1.410.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, presbyopia, and astigmatism (up to 2.00D) in aphakic or non-aphakic persons with non-diseased eyes.

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

• Saview 55 F (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens (K020197)
• Saview 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens (K030548)
• Saview 55 Toric Contact Lens (K021295)
• Frequency 55UV (methafilcon A) Soft (Hydrophilic) lenses (K982997)

Submission Summary (Full Text)

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AUG 1 6 2005

K 0 51095

#### Optical Connection : C.

## 510(k) Summary

## Submitter Information:

Optical Connection, Inc. a subsidiary of St. Shine Optical Co., Ltd. 3315 Almaden Expressway, Suite 25 San Jose, CA 951 18 Registration No. 3004182654

| Contact Person: | Garold L. Edwards, O.D., F.A.A.O.<br>Regulatory Consultant |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone]. |
| Date Prepared: | April 19, 2005 |
| Device Name: | |
| Common Name: | Soft (Hydrophilic) Contact Lens |
| Trade/Proprietary Names: | 55 UV (methafilcon A) Soft<br>(Hydrophilic) Contact Lens for Daily Wear<br><br>55 UV Multifocal (methafilcon A) Soft (Hydrophilic)<br>Contact Lens for Daily Wear<br><br>55 UV Toric (methafilcon A) Soft (Hydrophilic)<br>Contact Lens for Daily Wear |
| Classification Name: | Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II (21 CFR 886.5925) |

## Predicate Devices:

The Saview 55 F (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens, the Saview 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens and the Saview 55 Toric Contact Lens were selected as the predicate devices manufactured in the same facility, under the same quality system, using the same molding, tinting,

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packaging and sterilization processes. The Frequency 55UV (methafilcon A) Soft (Hydrophilic) lenses manufactured by Aspect Vision Care Ltd. have been chosen as the predicate lens using the same UV absorbing monomer.

## Description of Devices:

The 55 UV, 55 UV Multifocal, and the 55 UV Toric (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells, which cover the cornea and a portion of the adjacent sclera. The 55 UV Contact Lens is available in a single vision lens design, the 55 UV Toric Contact Lens is available in a double slab-off back surface design and the 55 UV Multifocal Contact Lens is available in an aspheric lens design. 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%). A UV absorbing compound, 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxypheny]] ethyl methacrylate, has been incorporated into the lens polymer. Lenses are tinted using the color additive Pigment Blue 15, ([Phthalocyaninato(2-)] copper).

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| Comparison to Predicate Device | | | | |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| PARAMETER | | | | |
| | 55 UV, 55 UV Multifocal,<br>and 55 UV Toric Soft<br>(hydrophilic) Contact<br>Lenses for Daily Wear | Saview 55 F and Saview<br>Toric 55 (methafilcon A) Soft<br>(hydrophilic) Contact Lenses<br>for Daily Wear<br>K020197/ K021295 | Saview 55 Multifocal<br>(methafilcon A) Soft<br>(hydrophilic) Contact<br>Lenses for Daily Wear<br>K030548 | Frequency 55 UV<br>(methafilcon A) Soft<br>(hydrophilic) Contact<br>Lenses for Daily Wear<br>K982997 |
| Submission number | N/A | | | |
| Material | methafilcon A | methafilcon A | methafilcon A | methafilcon A |
| Material classification | Hydrophilic Lens Group 4 | Hydrophilic Lens Group 4 | Hydrophilic Lens Group 4 | Hydrophilic Lens<br>Group 4 |
| Indication for use | myopia, hyperopia,<br>presbyopia and<br>astigmatism | myopia and hyperopia | myopia, hyperopia, and<br>presbyopia | myopia, hyperopia and<br>astigmatism |
| Water content | 55% | 55% | 55% | 55% |
| Visible light<br>transmittance | 90.3% (93.3% @590 nm) | 97.6% | 97.6% | 93.6% @590 nm |
| UV transmittance<br>@280-315 nm:<br>@316 - 380 nm: | 9.1%<br>(2.435%)<br>15.816% | N/A | N/A | 5.0%<br>(6.00%<br>4.09%) |
| Dk (35° C) | $18.9 x 10^{-11}$ | $19.5 x 10^{-11}$ | $19.5 x 10^{-11}$ | $14.0 x 10^{-11}$ |
| Powers | +4.00 D to -20.00 D;<br>Continuous add power<br>to +3.25 (55 UV<br>Multifocal only);<br>Cylinder powers<br>0.50 D to -2.50 D (55<br>Toric only) | +4.00D to -6.00 D (in 0.25 D<br>steps)<br>+ 4.50D to +12.00D (in 0.50 D<br>steps)<br>6.50D to -20.00D (in 0.50D<br>steps);<br>Cylinder powers<br>-0.50 D<br>to -2.50 D (Saview Toric 55<br>only) | +12.00 to -20.00 D:<br>Continuous add power to<br>+3.25 | +12.00 to -20.00 D |
| Color | blue visibility,<br>Pigment Blue #15 | blue visibility,<br>Pigment Blue #15 | blue visibility,<br>Pigment Blue #15 | aqua visibility,<br>Reactive Blue #4 and<br>Reactive Yellow #86 |
| Refractive index | 1.410 | 1.3974 | 1.3974 | 1.4027 |
| Method of<br>manufacture | Molded | Molded | Molded | Molded |

mparison to Predicate Device

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## Indications for Use:

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aphakic persons with non-diseased eyes that may exhibith risual gouity aphakic persons will hon aboused of see with visual acuity.
astigmatism up to 2.00 diopters that does not interfere with visual acuity.

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The 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily The 55 UV Tone (Memailieon A) John (Tryaltiplian) - Station of Shigmatism) in weal for the Corroet aphakic persons with non- diseased eyes.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting the lenses may be disiniseled baing enomise the lenses for daily wear and/or frequent systems. Eye care practilioners may prosense in Program, the lenses may replacement. Then prosember or hydrogen peroxide disinfecting systems.

## Description of Safety and Substantial Equivalence:

A series of pre-clinical tests were performed to demonstrate the safety and A senes of pre-cimean of the 55 UV Multifocal, and the 55 UV Toric (methafilcon A) effectiveness of the object Lenses for Daily Wear, and to establish substantial equivalence to the predicate devices.

Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lesses to be non-toxic and non-irritating. The 55 UV lenses were extracted and lenses to be non loxic and normination in evidence of unsafe amounts of evaluated for presence of restauranical testing of the 55 UV lenses demonstrated equivalency to the predicate devices.

## Conclusion:

Information submitted in the 510(k) establishes that the 55 UV, the 55 UV Multifocal and information Jobmitt But I Leis (methafilcon A) have comparable physicochemical me to o v to the predicate devices and do not raise questions of safely and properies to the proutes the mas shown the lenses remain sterile and that lens erroperties do not change before the expiration date. Therefore, the devices are substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is an abstract image of an eagle.

AUG 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Optical Connection, Inc. A subsidiary of St. Shine Optical Co. Ltd. c/o Garold L. Edwards, O.D., F.A.A.O. Regulatory Consultant 2091 Upper Scenic Drive Felton, CA 95018

Re: K051095

Trade/Device Name: 55 UV (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: July 22, 2005 Received: July 25, 2005

Dear Dr. Edwards:

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 - Garold L. Edwards, O.D., F.A.A.O.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

David M. Whipple

David M. Whipple Acting 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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# Optical Connection

## INDICATIONS STATEMENT

## Device Names:

55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear 55 UV (methallicon A) Soft (Hydrophilic) Contact Lens for Doily Wear 55 UV Mullilocal (methallicon A) Soft (Hydrophilic) Contact Lens for Daily Wear

#### Indications for Use:

The 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated
The 55 UV (methafilcon A) Soft (Hydrophilic and hyseropial in The 55 UV (memallicon A) 301 (hydrophility) Contropia (myopia and hyperopid) in
for daily wear for the correction of refractive ametropia (myopia and hibitrefrastive for adily wear for the concellon of for actives that may exhibit refractive with visual aphakic of hot-aprialism up to 2.00 diopters that does not interfere with visual acuity.

The 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is The 55 to V Montrocal (memail.com) of refractive ametropia (myopia and inalcated for addity wear for the Generalians in the phakic persons with non-diseased
hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased hypelopla) and presoyopia in aphakis and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is me 99 of for daily wear for the correction of refractive ametropia (myopia, indicated for Gally Woulfrom) in aphakic and/or not aphakic persons with nondiseased eyes.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting me lemses may be analy prescribe the lenses for daily wear and/or systems. Eye Card practibed for a Frequent Replacement Program, the llenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. ...

Over-the-Counter Use_ OR Prescription Use______________________________________________________________________________________________________________________________________________________________ X (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) CA 95118 . phone 4.JS.265.5644 . 13x 408.265 11.09 . 3315 Almade d Member of the Shine Optical Group on't Have to Settle for 20/20