ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

{0}------------------------------------------------ November 25, 1997 K973332 # 510(K) SUMMARY DEC - 2 1997 Submitted by: Michael E. Pfleger Associate 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: Alcon Multi-Purpose Disinfecting Solution ID 90746 Proprietary Name: ### Indications for Use: For the daily cleaning, rinsing, disinfecting and storing of soft (hydrophilic) contact lenses. For use in chemical (not heat) disinfection. Alcon Multi-Purpose Solution ID 90746 can also be used as a diluent for OPTI-ZYME® Enzymatic Cleaner. # Description: Alcon Multi-Purpose Disinfecting Solution ID 90746 is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, tetronic 1304, with edetate disodium 0.05%, Polyquad (polyquaternium-1) 0.0001% and AL-6289 0.0005% as preservatives. #### Substantial Equivalence: Alcon Multi-Purpose Disinfecting Solution ID 90746 is substantially equivalent in terms of its actions and indications to Alcon OPTI-FREE® Multi-Purpose Solution and Alcon OPTI-ONE® Multi-Purpose Solution. These two products were cleared for marketing under P830034/S27 and P830034/S26 respectively. Alcon Multi-Purpose Disinfecting Solution ID 90746 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. {1}------------------------------------------------ ## Safety and Effectiveness: # A. Non-Clinical Data ## Microbiological Studies The product was evaluated for microbiological safety and effectiveness using the FDA Guidelines for contact lens solutions. - The formulation meets the Stand-Alone criteria for disinfection of contact lens against ● bacteria, yeast and mold. - . The finished product is effectively preserved by FDA standards. - Finished product conforms to USP sterility requirements. ● ### Preclinical Preclinical toxicology tests have been conducted to substantiate the safety of the product for use in cleaning, rinsing, chemical disinfection, and overnight storage of all soft (hydrophilic) contact lens (Group I, II, III, and IV). The studies include: (1) acute oral toxicity; (2) cytoxicity (agar overlay); (3) mutagenicity (Ames test); (4) sensitization/allergic potential (guinea pig maximization test); (5) ophthalmic container safety; and (6) ocular safety (irritation) evaluations. Alcon Multi-Purpose Disinfecting Solution ID 90746 should not present an ocular hazard to the consumer when used under the recommended treatment regimens for soft (hydrophilic) contact lenses. # Compatibility/Cleaning Efficacy Studies were conducted to determine product compatibility with soft contact lenses and its ability to clean laboratory deposited lenses. The studies demonstrated the compatibility and cleaning efficacy of Alcon Multi-Purpose Disinfecting Solution ID 90746. #### B. Clinical A study was conducted to clinically evaluate the safety and efficacy of Alcon Multi-Purpose Disinfecting Solution ID 90746 for cleaning, rinsing, disinfection and storage of all soft (hydrophilic) contact lenses (249 patients/498 eyes - 3 months) (121 patients/242 eyes - extending to 6 months). This clinical study demonstrated the safety and efficacy of Alcon Multi-Purpose Disinfecting Solution ID 90746. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. DEC - 2 1997 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Michael E. Pfleger Associate Director, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 Re: K973332 Trade Name: Alcon Multi-Purpose Disinfecting Solution ID 90746 Regulatory Class: II Product Code: 86 LPN Dated: August 29, 1997 Received: September 4, 1997 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 (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. {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):_____________________________________________________________________________________________________________________________________________________ Alcon Multi-Purpose Disinfecting Solution ID 90746 Device Name: Indications for Use: For the daily cleaning, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. For use in chemical (not heat) disinfection. Alcon Multi-Purpose Disinfecting Solution ID 90746 can also be used as a diluent for OPTI-ZYME® Enzymatic Cleaner. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Myra Smith (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number _ K 973332 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_X__