SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR

K020642 · Soflex Contact Lens Industries , Ltd. · LPL · May 24, 2002 · Ophthalmic

Device Facts

• Record ID: K020642
• Device Name: SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
• Applicant: Soflex Contact Lens Industries , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: May 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Soft K. (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system. The Soft K. Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and 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 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system.

Device Story

Soft K. and Soft K. Toric are hydrophilic contact lenses composed of xylofilcon A; designed for daily wear to manage keratoconus and correct refractive ametropia (myopia, hyperopia, and astigmatism). Lenses are prescribed by eye care professionals for patients with non-diseased eyes. Lenses are compatible with standard chemical or heat disinfection systems. Device provides vision correction through physical lens geometry; no electronic or software components involved.

Technological Characteristics

Hydrophilic contact lens material: xylofilcon A. Daily wear modality. Compatible with chemical or heat disinfection systems.

Indications for Use

Indicated for daily wear in patients requiring keratoconus management and correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 4 2002

Soflex-Isralens Contact Lens Ltd. c/o Kevin Walls, RAC Regulatory Insight Inc. 13 Red Fox Lane Littleton, CO 80127

Re: K020642

Trade/Device Name: Soft K. and Soft K. Toric (xyloficon A) Soft (hydrophilic) Keratoconus Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Daily Wear Contact Lens Regulatory Class: Class II Product Code: LPL Dated: February 26, 2002 Received: February 27, 2002

Dear Mr. Walls:

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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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to FDA finding of substantial equivalence of your device to a legally promaticate 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 8613. Additionally, for questions on the promotion and advertising of Compliance at (301) 591 - 1010 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general 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. Ralph 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

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510(k) Number (if known): K020642

Soflex Soft K. (xylofilcon A) Soft (hydrophilic) Keratoconus Device Name: Contact Lens for Daily Wear and the Soflex Soft K. Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear

Indications for Use: The Soft K. (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system.

> The Soft K. Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and 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 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thith Zec Cohen, M.D.

ivision of Ophthalmic Devi

510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

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Over-The-Counter Use (Optional Format 1-2-96)