OPTI-ONE MULTI-PURPOSE SOLUTION

{0}------------------------------------------------ DEC 1 8 1998 # DRAFT 510(K) SUMMARY Submitted by: Michael Pfleger Director, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 551-4877 (Phone) (817) 551-4630 (Fax) ### Device Name: Contact Lens Care Multi-Purpose Solution Common Name: OPTI-ONE® Multi-Purpose Solution Proprietary Name: ### Indications for Use: For use in the daily cleaning, removing protein deposits, chemical (not heat) disinfection and storage of chemical (not heat) disinfection soft (hydrophilic) contact lenses as recommended by your eye practitioner. For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover. OPTI-ONE® Multi-Purpose Solution can be used to dissolve OPTI-FREE® and OPTI-ZYME® Enzymatic Cleaning Tablets. #### Description: OPTI-ONE® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution containing borates, citrates, mannitol, and sodium chloride with PATONIC® and TETRONIC® surfactants, and edetate disodium 0.05% and POLYQUAD® (polyquaternium-1) 0.001% preservatives. #### Substantial Equivalence: OPTI-ONE® Multi-Purpose Solution is substantially equivalent, in terms of its actions and indications for use, to Bausch & Lomb ReNu MultiPlus™ Multi-Purpose Solution, cleared for marketing under PMA P860023/S12 and 510(k) K974723. OPTI-ONE Multi- {1}------------------------------------------------ Purpose Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products. #### Safety and Effectiveness: Group I and IV human-worn and laboratory deposited lenses were soaked in OPTI-ONE Multi-Purpose Solution or ReNu MultiPlus™ Multi-Purpose Solution and were compared for protein removal. Statistical analysis of the data showed that significantly more protein was removed from both human-worn and laboratory deposited Group IV lenses by OPTI-ONE Multi-Purpose Solution than by ReNu MultiPlus Multi-Purpose Solution. These studies demonstrate that OPTI-ONE Multi-Purpose Solution continues to remove protein while lenses are stored. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its head, representing the department's mission to promote health and well-being. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 8 1998 Mr. Michael E. Pfleger Director, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 Re: K983973 Trade Name: OPTI- ONE ® Multi-Purpose Solution (adding a protein removal claim) Regulatory Class: II Product Code: 86 LPN Dated: November 6, 1998 Received: November 9, 1998 Dear Mr. Pfleger: 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 (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 . {3}------------------------------------------------ Page 2 - Mr. Michael E. Pfleger 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 Roerl Rosenthal A. Ralph Rosenthal, M.D Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known):_K983973 Device Name: OPTI-ONE® Multi-Purpose Solution Indications for Use: For use in the daily cleaning, removing protein deposits, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye practitioner. For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover. OPTI-ONE® Multi-Purpose Solution can be used to dissolve OPTI-ZYME® Enzymatic Cleaning Tablets. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use X Eis G --- (Division Sign-Off) on of Ophthalmic Devices K983973 5100k) Number