PRECISION UV (VASURFILCON A)

{0}------------------------------------------------ K982988 6 1999 JAN # Attachment C ## Summary of Safety and Effectiveness ### A. General Information - Name and Address of Applicant: 1. Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018 Contact Person: Joseph Foos Vice President Scientific Affairs (847) 294-3306 Phone: (847) 294-3853 Fax - 2. Name of the Device: Proprietarv Name: Precision UVTM (vasurfilcon A) - 3. Identification of Predicate Device: Same as above ## B. Indication for use: Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lenses help protect against transmission of harmful UV radiation to the comea and into the eye. ## C. Description of device: Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are available as clear and locator tinted spherical lenses in the power range from -16.00 to + 10.00 diopters, center thickness from 0.09 - 0.17 mm (minus lenses) and 0.22 - 0.41 mm (plus lenses) with base curves of 8.4 and 8.7mm and a diameter of 14.4mm. The lens material. vasurfilcon A. is a hydrophilic random copolymer of N-vinyl-pyrrolidone (NVP), Methl methacrylate (MMA), Allyl methacrylate (AMA), Ultraviolet absorbing monomer (UVAM) and AIBN (Azo-Iso-butyronitrile) as an initiator. It consists of 74% water and 26% vasurfilicon A. {1}------------------------------------------------ Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are currently marketed domestically and internationally by Wesley Jessen Corporation under PMA P940013. Previously, they were marketed by Pilkington Barnes Hind under Allergan Medical Optic's PMA P790020. #### D. Substantial Equivalence/Safety & Effectiveness: Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are identical to previously marketed Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses of the same material as under 510(k) premarket notification, K961299, and PMA P940013 for all properties (physical, optical, chemical, biocompatible, microbiological, and clinical). There were no changes to the lens material or design; however, the associated labeling and indications were changed. #### E. Summary: Wesley Jessen considers the study, data and referenced literature (epidemiological studies, non-clinical research reports, studies on the nature of UV energy, etc.) submitted under 510(k) premarket notification, K982988, and PMA Supplement, P940013/S6, evidence supporting the additional intended use and associated modified labeling. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 6 1999 Mr. Joseph Foos Vice President, Scientific Affairs Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018-5903 K982988 Re: Trade Name: Precision UV™ (vasurfilcon A) Hydrophilic Contact Lens for Daily Wear (clear and visibility tinted) (Labeling modifications) Regulatory Class: II Product Code: LPL Dated: November 20, 1998 Received: November 23, 1998 Dear Mr. Foos: 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 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). 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 (OS) 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. Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. {3}------------------------------------------------ Page 2 - Mr. Joseph Foos This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, A Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Attachment B ## INDICATIONS STATEMENT 510(k) Number (if known): K982988 Device Name: Precision UVTM clear and tinted (74% water) Daily Wear Soft Contact Lans #### Indication for Use: Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eves that are myopic or hyperopic and may have 2,00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lanses help protect against transmission of harmful UV radiation to the comea and into the eve. #### (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Conterence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The Counter Kaver Warburton (Division Sign-Off) (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K982988 000052