SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR

K033655 · Soflex Contact Lens Industries , Ltd. · LPL · Jul 30, 2004 · Ophthalmic

Device Facts

• Record ID: K033655
• Device Name: SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
• Applicant: Soflex Contact Lens Industries , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Jul 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring management and for the correction of myopia and hyperopia in aphakic and nonaphakic persons that may exhibit refractive and/or corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with visual acuity. 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 management and for the correction of myopia, hyperopia and astigmatism in aphakic and non-aphakic persons that exhibit refractive and/or post-refractive surgery corneal irregularity and corneal astigmatism. The lens may be disinfected with a chemical or heat disinfection system.

Device Story

Soft (hydrophilic) contact lenses made of xylofilcon A; designed for daily wear to correct refractive errors and manage corneal irregularities/keratoconus. Lenses are worn by patients; prescribed by eye care professionals. Lenses provide vision correction through physical refraction; compatible with standard chemical or heat disinfection systems. Benefits include improved visual acuity for patients with irregular corneas or post-surgical astigmatism.

Clinical Evidence

No clinical data provided; substantial equivalence based on material characteristics and intended use.

Technological Characteristics

Material: xylofilcon A (hydrophilic polymer). Type: Soft contact lens. Form factor: Keratoconus-specific geometry. Disinfection: Compatible with chemical or heat systems. Connectivity: None. Software: None.

Indications for Use

Indicated for daily wear in aphakic and non-aphakic persons requiring correction of myopia, hyperopia, and astigmatism, including those with corneal irregularities or post-refractive surgery corneal astigmatism.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

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

Re: K033655

Trade/Device Name: Softex Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear and Soflex Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus 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: May 14, 2004 Received: May 18, 2004

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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Page 2 - Kevin Walls, RAC

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,

Akalyi 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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510(k) Number (if known): K033655

Soflex Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Device Name: Sollex Ooft N (Nylor and the Softex 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 Ecris for Bully Woulds management and for the correction of requiring Koratoooia (myopia and hyperopia) in aphakic and nonaphakic persons that may exhibit refractive and/or corneal aptiatio persons that may corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with irregular asigmation a may be disinfected with a chemical or heat disinfection system.

> The Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus The Bort it Tono (Xaily Wear is indicated for daily wear for persons Contact Lens for Daily management and for the correction of requiring koratoopia (myopia, hyperopia and astigmatism) in refractive and non-aphakic persons that exhibit refractive and/or aphake and non aphan opst-refractive surgery corneal irregularity correal astigmatism. 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)

Tricia Rae Cohen M.D.

Division of Ophthalmic

510(k) Number K033655

Prescription Use
X
(Per 21 CFR 801.109)

OR

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