(33 days)
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.
Toric Eye-Q (xylofilcon A) Soft (hydrophilic) Toric Multifocal Contact Lens for Daily Wear
This document is an FDA 510(k) clearance letter for a contact lens. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the substantial equivalence determination. Therefore, I cannot provide the requested information based on the given text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design of three overlapping shapes that resemble an abstract human figure.
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.
{1}------------------------------------------------
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
Page 1 of 1
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.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
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
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
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.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.