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

K030548 · St. shine Optical Co., Ltd. · LPL · Apr 4, 2003 · Ophthalmic

Device Facts

• Record ID: K030548
• Device Name: SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
• Applicant: St. shine Optical Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Apr 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Saview 55 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 lenses may be disinfected using chemical 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 or hydrogen peroxide disinfecting systems.

Device Story

Saview 55 Multifocal is a hemispherical, flexible, aspheric soft contact lens made of methafilcon A (55% water content). Designed for daily wear to correct refractive ametropia and presbyopia. Prescribed by eyecare practitioners for daily wear or frequent replacement programs. Patients maintain lenses using chemical or hydrogen peroxide disinfection systems. Lens covers cornea and portion of adjacent sclera; provides refractive correction via aspheric geometry. Benefits include vision correction for presbyopic patients with concurrent astigmatism up to 2.00 diopters.

Clinical Evidence

No clinical data provided. Substantial equivalence based on physicochemical property testing and comparison to legally marketed predicate devices.

Technological Characteristics

Material: methafilcon A (hydrophilic polymer of 2-hydroxyethyl methacrylate, methacrylic acid, diethylene glycol monomethacrylate, crosslinked with ethylene glycol dimethacrylate). Water content: 55%. Tint: Pigment Blue 15. Form: Hemispherical flexible shell, aspheric design. Dk (35°C): 19.5 x 10^-11. Refractive index: 1.3974 (wet). Manufacturing: Moulded. Sterilization: Standard process.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and presbyopia in aphakic or non-aphakic persons with non-diseased eyes; includes patients with 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

• Saview 55 F (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K020917)
• Saview Toric 55 (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K021295)
• PolyVue Unisoft (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear (K980818)

Submission Summary (Full Text)

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K030548

APR 0 4 2003

# 510(k) Summary

#### Submitter Information:

St. Shine Optical Co., Ltd. 4.5F No. 276-2, Sec.1, Ta Tong Rd. Hsi Chih City, 221 Taipei Hsein Taiwan R.O.C.

#### Contact Person:

Garold L. Edwards, O.D., F.A.A.O. Regulatory Consultant 2091 Upper Scenic Drive Felton, California 95018

[phone] Telephone: [phone] Fax:

Date Prepared: February 7, 2003

Device Name:

| Common Name: | Soft (Hydrophilic) Contact Lens |
|--------------------------|-------------------------------------------------------------------------------------|
| Trade/Proprietary Names: | Saview Multifocal (methafilcon A) Soft<br>(Hydrophilic) 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) Contact Lens for Daily Wear, the Saview Toric 55 (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear and the PolyVue Unisoft (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear were selected as the predicate devices.

The Saview 55 Multifocal lenses will be manufactured and sterilized at the same manufacturing site, using identical moulding, sterilization and packaging processes as the Saview 55 F and the Saview Toric 55.

#### Description of Devices:

The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Daily Wear Contact Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Saview 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxvethyl methacrylate. methacrylic acid and diethlene glycol monomethacrylate, crosslinked with ethylene glycol dimethacrylate. The lens contains 55% water by weight. The lens is tinted using Pigment Blue 15.

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# Comparison to Predicate Device

| Device | Saview 55 Multifocal<br>(methafilcon A) Soft<br>(hydrophilic) Contact<br>Lens | Saview 55F and<br>Saview Toric 55<br>(methafilcon A) Soft<br>(hydrophilic) Contact<br>Lenses | PolyVue Silver Chord,<br>Unisoft (methafilcon<br>A) Spherical,<br>Aspherical and Toric<br>Soft (hydrophilic)<br>Contact Lens |
|--------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K020917<br>K021295 | K980818 |
| Material | methafilcon A | methafilcon A | methafilcon A |
| Material classification | Hydrophilic Lens<br>Group 4 | Hydrophilic Lens<br>Group 4 | Hydrophilic Lens<br>Group 4 |
| Indication for use | myopia, hyperopia and<br>presbyopia | myopia, hyperopia and<br>astigmatism | myopia, hyperopia,<br>astigmatism and<br>presbyopia |
| Water content | 55% | 55% | 55% |
| Visible light<br>transmittance | 97.6% | 97.6% | > 95% |
| Dk (35° C) | $19.5 \times 10^{-11}$ | $19.5 \times 10^{-11}$ | $18.83 \times 10^{-11}$ |
| Powers | +12.00 to -20.00<br>Diopters; continuous<br>add power to +3.25 | +12.00 to -20.00<br>Diopters | +20.00 to -20.00<br>Diopters; continuous<br>add power to +3.25 |
| Color | blue visibility | blue visibility | clear or green visibility |
| Refractive index | 1.3974 (wet) | 1.3974 | 1.415 |
| Method of<br>manufacture | Moulded | Moulded | Lathe cut |

# Indications for Use:

The Saview Multifocal (methafilcon 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 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 or hydrogen peroxide disinfecting systems.

# Discussion of Safety and Substantial Equivalence:

Information submitted in the 510(k) establishes that the Saview 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens has physicochemical properties comparable 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.

# Conclusion:

The devices are substantially equivalent to the predicate devices.

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APR o 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

St. Shine Optical Co., Ltd. c/o Garold L. Edwards Regulatory Consultant 2091 Upper Scenic Drive Felton, CA 95018

Re: K030548

Trade/Device Name: Saview 55 Multifocal (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: February 7, 2003 Received: February 20, 2003

Dear Mr. 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 vour 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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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. halyi korenthal

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 STATEMENT

Device Names:

Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

Indications for Use:

The Saview 55 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 lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Evecare 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 disinfecting systems.

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

| Prescription Use | X | OR | Over-the-Counter Use | |
|------------------|---|----|----------------------|--|
|------------------|---|----|----------------------|--|

Daniel W. Brown, PH.D.
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises510(k) Number_K030548