MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

{0}------------------------------------------------ Image /page/0/Picture/3 description: The image contains a sequence of digits. The digits are '1983780'. The numbers are written in a simple, handwritten style. The image is a close-up of the digits. UEC 18 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: Common Name: Contact Lens Care Multi-Purpose Solution Proprietary Name: Multi-Purpose Disinfecting Solution ID 90746 #### 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. Multi-Purpose Disinfecting Solution ID 90746 can be used to dissolve OPTI-FREE® and OPTI-ZYME® Enzymatic Cleaning Tablets. #### Description: 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) 0.001% and AL-6289 0.0005% as preservatives. {1}------------------------------------------------ ## Substantial Equivalence: Multi-Purpose Disinfecting Solution ID 90746 is substantially equivalent, in terms of its actions and indications for use, to Bausch & Lomb ReNu Multi-Purpose Solution, cleared for marketing under PMA P860023/S12 and 510(k) K974723. 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. ### Safety and Effectiveness: Group I an IV human-worn and laboratory lenses were soaked in Multi-Purpose Disinfecting Solution ID 90746 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 human-worn Group IV lenses by Multi-Puroose Disinfecting Solution ID 90746 than by ReNu MultiPlus™ Multi-Purpose Solution. These studies demonstrate that Multi-Purpose Disinfecting Solution ID 90746 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 & 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head and body. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 18 1998 Mr. Michael E. Pfleger Associate Director, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 Re: K983780 Trade Name: Alcon Multi-Purpose Disinfecting Solution ID 90746 (adding a protein removal claim) Regulatory Class: II Product Code: 86 LPN Dated: October 23, 1998 Received: October 27, 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 (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. Ralph 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): _ Device Name: Multi-Purpose Disinfecting Solution ID 90746 Indications for Use: For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover. 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) | (Division Sign-Off) | | |--------------------------------|----------| | Division of Ophthalmic Devices | | | 510(k) Number | K98 3780 | Prescription Use_ (Per 21 CFR 801.109) OR Over-The-Counter Use_X