S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K040900 · Optical Connection, Inc. · LPL · Jun 15, 2004 · Ophthalmic

Device Facts

• Record ID: K040900
• Device Name: S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
• Applicant: Optical Connection, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens 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 T 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens 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 that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters. The M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia 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 chemical (not heat) or hydrogen peroxide disinfecting systems. 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 (not heat), or hydrogen peroxide disinfecting systems.

Device Story

Hemispherical flexible soft contact lenses; made of hefilcon A (HEMA/NVP copolymer); 42% water content; tinted with Piqment Blue 15; incorporates UV-absorbing compound 2-(benzoyl-3-hydroxyphenoxy)ethyl acrylate. Available in single vision, toric (back surface design), and multifocal (aspheric design) configurations. Prescribed by eyecare practitioners for daily wear or frequent replacement. Patient self-inserts and removes lenses; cleans/disinfects using chemical or hydrogen peroxide systems. Provides refractive correction for ametropia and presbyopia; UV-blocking feature reduces ocular UV exposure.

Clinical Evidence

Bench testing only. Physicochemical testing demonstrated equivalency to predicates. Biocompatibility testing (systemic injection, primary ocular irritation, cytotoxicity) confirmed non-toxic and non-irritating nature. UV-blocking compound extraction testing showed no unsafe levels.

Technological Characteristics

Material: hefilcon A (HEMA/NVP copolymer cross-linked with EGDMA). Water content: 42%. UV-absorbing compound: 2-(benzoyl-3-hydroxyphenoxy)ethyl acrylate. Tint: Piqment Blue 15. Manufacturing: Molded. Refractive index: 1.416. Specific gravity: 1.039. Dk (35°C): 13.375 x 10^-11. Visible light transmittance: 98%. UV transmittance: <10%.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, astigmatism, and presbyopia in aphakic or non-aphakic patients with non-diseased eyes. Astigmatism correction limits: 2.00D for Single Vision/Multifocal, 5.00D for Toric.

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 42 UV (K000376)
• Specialty 42 UV Toric (K011089)
• Saview 55 Multifocal (K030548)

Submission Summary (Full Text)

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K040900

## Optical Connection Inc.

# 510(k) Summary

## Submitter Information:

Optical Connection, Inc. a subsidiary of St. Shine Optical Co., Ltd. 3315 Almaden Expressway, Suite 25 San Jose, CA, 95125

| Contact Person: | Garold L. Edwards, O.D., F.A.A.C<br>Regulatory Consultant |
|-----------------|-----------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |

- Date Prepared: March 23, 2004
## Device Name:

| Common Name: | Soft (Hydrophilic) Contact Lens |
|--------------------------|--------------------------------------------------------------------------------------|
| Trade/Proprietary Names: | S 42 UV Single Vision (hefilcon A) Soft<br>(Hydrophilic) Contact Lens for Daily Wear |
| | T 42 UV Toric (hefilcon A) Soft (Hydrophilic)<br>Contact Lens for Daily Wear |
| | M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic)<br>Contact Lens for Daily Wear |
| Classification Name: | Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II (21 CFR 886.5925) |

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### Predicate Devices:

The molded Specialty 42 UV, Specialty 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lenses and Saview 55 Multifocal (methafilcon A) Soft (Hydrophilic Contact Lens were selected as the predicate devices.

Specialty 42 UV, Specialty 42 UV Toric (hefilcon A) and Saview 55 Multifocal (methafilcon A) devices are manufactured in the same facility, under the same quality system, using the same molding, tinting, packaging and sterilization processes.

### Description of Devices:

S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The 42 UV Contact Lens is available in a single vision lens design, the 42 UV Toric Contact Lens is available in a back surface design, and the 42 UV Multifocal lens is available in an aspheric lens design. The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contains 42% water by weight. 42 UV, 42 UV Toric, and 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are tinted using Piqment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR 5 74.3045 and a UV absorbing compound, 2-(benzoyl-3-hydroxyphenoxy)ethyl acrylate, has been incorporated into the lens polymer.

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# Comparison to Predicate Devices

| Lens type<br>Predicate<br>device 510(k) | S 42 UV Single<br>Vision, T 42 UV<br>Toric and<br>M 42 UV Multifocal<br>(hefilcon A) Soft<br>(Hydrophilic)<br>Contact Lenses for<br>Daily Wear<br>(molded) | S 42 UV Single<br>Vision, T 42 UV<br>Toric and<br>M 42 UV Multifocal<br>(hefilcon A) Soft<br>(Hydrophilic)<br>Contact Lenses for<br>Daily Wear<br>(lathe-cut) | Specialty 42 and<br>Specialty 42 Toric<br>(hefilcon A) Soft<br>(Hydrophilic)<br>Contact Lenses for<br>Daily Wear | Specialty 42 UV and<br>Specialty 42 UV<br>Toric (hefilcon A)<br>Soft (Hydrophilic)<br>Contact Lenses for<br>Daily Wear | Saview 55<br>Multifocal<br>(methafilcon A) Soft<br>(Hydrophilic)<br>Contact Lens for<br>Daily Wear |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | | | K000376 | K011089 | |
| | | | | | K030548 |
| Material | hefilcon A | hefilcon A | hefilcon A | hefilcon A | methafilcon A |
| Material<br>classification | Hydrophilic Lens<br>Group 1 | Hydrophilic Lens<br>Group 1 | Hydrophilic Lens Group<br>1 | Hydrophilic Lens Group<br>1 | Hydrophilic Lens Group<br>4 |
| Indication for<br>use | myopia, hyperopia,<br>astigmatism, and<br>presbyopia | myopia, hyperopia,<br>astigmatism, and<br>presbyopia | myopia, hyperopia and<br>astigmatism | myopia, hyperopia and<br>astigmatism | myopia, hyperopia and<br>presbyopia |
| Water<br>content | 42% | 42% | 42% | 42% | 55% |
| Visible light<br>transmittance | 98% | 98% | 98% | 98% | 97.6% |
| UV<br>transmittance | < 10% | < 10% | N/A | < 10% | N/A |
| Dk (35°C) | 13.375 x 10 -11 | 13.375 x 10 -11 | 13.250 x 10 -11 | 13.375 x 10 -11 | 19.5 x 10 -11 |
| Powers | +20.00 to -20.00<br>Diopters | +20.00 to -20.00<br>Diopters | +20.00 to -20.00<br>Diopters | +20.00 to -20.00<br>Diopters | +12.00 to -20.00<br>Diopters; continuous<br>add power to +3.25 |
| Color | blue visibility | blue visibility | clear or blue visibility | blue visibility | blue visibility |
| Refractive<br>index | 1.416 | 1.416 | 1.417 | 1.416 | 1.3974 (wet) |
| Specific<br>gravity | 1.039 | 1.039 | 1.031 | 1.039 | N/A |
| Method of<br>manufacture | Molded | Lathe-cut | Moulded | Molded | Molded |

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## Indications for Use:

The S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens 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 T 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens 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 that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.

The M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia 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 chemical (not heat) or hydrogen peroxide disinfecting systems. 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 (not heat), or hydrogen peroxide disinfecting systems.

## Description of Safety and Substantial Equivalence:

A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact 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 lenses to be non-toxic and non-irritating. 42 UV lenses were extracted and evaluated for presence of the UV blocking compound. Results showed no evidence of unsafe amounts of this compound in the extracts. Physicochemical testing of 42 UV lenses demonstrated equivalency to the predicate devices.

## Conclusion:

Information submitted in the 510(k) establishes that S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) contact lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Therefore, the devices are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2004

Optical Connection, Inc. c/o Garold L. Edwards, O.D., F.A.A.O. Regulatory Consultant 3315 Almaden Expressway, Suite 25 San Jose, CA 95118

Re: K040900

Trade/Device Name: rade/Device Name:
S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear (Molded) S 42 UV Single Vision (nemoon A) Soft (Hydrophilic) Contact Lens for Daily Wear (Molded) 1 42 UV Multifocal (hefileon A) Soft (Hydrophilic) Contact Lens for Daily Wear (Molded) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: March 23, 2004 Received: April 6, 2004

Dear Dr. Edwards:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your boother 5. only programially equivalent (for the indications for releved above and have acceminate marketed predicate devices marketed in interstate commerce use stated in the eneround date of the Medical Device Amendments, or to devices that provision in way 20, 1970, the onactions with the provisions of the Federal Food, Drug, and Cosmetic have been receasined in are are a proval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the act include requirements for annual registration, listing of devices, good oonarols provisions or allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is olassinod (600 above) and Existing major regulations affecting your device can be inay oc subject to subli additions, 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 I lease be advisod that i Dr is issual.org ur device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all I cacration and regulations annument limited to: registration and listing (21 CFR Part 807); the Her s requirements, metading, vanufacturing practice requirements as set forth in the quality labeling (21 OF RT art 807), good nort 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/dsma/dsmamain.html

Sincerely yours,

A. Kely C. Rosenthal

A. Ralph Rosenthal, 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: K040900

Device Names:

S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear T 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Indications for Use:

S 42 UV Single Vision (hefilcon 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.

T 42 UV Toric (hefilcon 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 not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.

M 42 UV Multifocal (hefilcon 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 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 chemical (not heat) or hydrogen peroxide, disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR -

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Ophthalmic Evg

510(k) Number K040900