TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR

K013467 · Soflex Contact Lens Industries , Ltd. · LPL · Nov 20, 2001 · Ophthalmic

Device Facts

• Record ID: K013467
• Device Name: TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
• Applicant: Soflex Contact Lens Industries , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Toric Eye-Q (Xylofilcon A) Soft (hydrophilic) Toric Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive an/or corneal astigmatism up to 5.00 diopters. The lens may be disinfected using a chemical disinfection system.

Device Story

Toric Eye-Q is a soft (hydrophilic) contact lens composed of xylofilcon A. Designed for daily wear to correct refractive errors including myopia, hyperopia, astigmatism, and presbyopia. Used by patients with non-diseased eyes; requires chemical disinfection system. Prescribed by eye care professionals to improve visual acuity in aphakic and non-aphakic individuals.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of device characteristics.

Technological Characteristics

Soft (hydrophilic) contact lens material: xylofilcon A. Designed for daily wear. Compatible with chemical disinfection systems. Class II device under 21 CFR 886.5925.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, astigmatism, and presbyopia in aphakic and non-aphakic patients with non-diseased eyes exhibiting up to 5.00 diopters of refractive or 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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 2 0 2001

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

Re: K013467

Trade/Device Name: Toric Eye-Q (xylofilcon A) Soft (hydrophilic) Toric Multifocal 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: October 16, 2001 Received: October 18, 2001

Dear Mr. Walls:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the 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 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. 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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NOV 2 0 2001

510(k) Number (if known): _K013467

Soflex Toric Eye-Q (Xylofilcon A) Soft (hydrophilic) Toric Multifocal Device Name: Contact Lens for Daily Wear

Indications for Use: The Toric Eye-Q (Xylofilcon A) Soft (hydrophilic) Toric Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive an/or corneal astigmatism up to 5.00 diopters. The lens may be disinfected using a chemical disinfection system.

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Concurrence of CDRH, Office of Device Evaluation (ODE) vision of Ophthalmic Devices 510(k) Number K013467 Prescription Use OR Over-The-Counter Use × (Optional Format 1-2-96) (Per 21 CFR 801.109) ivision of Onhthalmic Devices

510(k) Number _ KQ1 3467