SOLO-CARE PLUS MULTIPURPOSE SOLUTION

{0}------------------------------------------------ K03/522 ### 510(k) SUMMARY PART IX. In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based. # 510(k) SUMMARY FOR SOLOCare Plus Multipurpose Solution #### 1. Submitter Information CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Steven Dowdley Contact Person: 678-415-3897 Telephone No. ### 2. Device Name Classification Name: Proprietary Name: Soft (hydrophilic) Contact Lens Solution SOLO-Care Plus Multipurpose Solution ### 3. Predicate Device(s) SOLO-Care Plus Multipurpose Solution #### Description of the Device 4. SOLO-Care Plus Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, bis-tris propane, pluronic F127. cremephor and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%. #### ട. Indications for Use SOLO-CARE PLUS Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat)disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. #### 6. Description of Safety and Substantial Equivalence SOLO-Care Plus Multipurpose solution is substantially equivalent in terms of its actions and indications for use, to SOLO-Care Plus Multipurpose Solution, cleared for marketing under 510(k) K012731. SOLO-Care Plus 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. ### Silicone Hydrogel Lens Compatibility Data: A study was conducted to verify that Lotrafilcon A (silicone hydrogel) lenses are compatible with SOLO-Care Plus. The study showed there was no significant difference between SOLO-Care™ Plus Multi-Purpose Solution and the saline control solution, with respect to optical and physical changes in the measured properties of the lenses. SOLO-Care Plus meets the guidelines set forth in FDA's May 1, 1997 Guidance for {1}------------------------------------------------ Industry, Premarket Notification 510(k) Guidance Document for Contact Lens Care products. ### In Vitro Cleaning Efficacy This study was conducted to compare the protein cleaning efficacy of SOLO-Care™ Plus Multi-Purpose Solution to currently marketed SOLO-Care Multipurpose Solution. Results of the study showed that SOLO-Care Plus is substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal. This data was previously submitted and reviewed in original 510(k) submission - K012731. ### Cytotoxicity A series of cytotoxicity studies were conducted to demonstrate the safety of SOLO-Care Multipurpose Solution. Results of the testing demonstrated that SOLO-Care Multipurpose Solution is non-cytotoxic and is a non-irritant. This data was previously submitted and reviewed in original 510(k) submission - K012731. ### Microbiological A two series of microbiological studies were conducted to demonstrate the microbial efficacy SOLO-Care Multipurpose Solution. The first series evaluated the product under a rub/rinse regimen, while the second regimen evaluated the performance of the product under a pre-rinse/ no rub regimen. In the studies, both regimen demonstrated that SOLO-Care Multipurpose Solution met the stand-alone criteria with organic load for disinfection. Additionally, the regimen test criteria was also meet for both regimen for SOLO-Care Plus. This data was previously submitted and reviewed in original 510(k) submission - K012731. # Clinical Testing A series of clinical studies have been conducted, submitted and reviewed in original 510(k) submission - K012731 to support the substantial equivalency of SOLO-Care Plus. # 7. Substantial Equivalence The data provided in this 510(k) submission concludes that SOLO-Care Plus Multipurpose Solution is substantially equivalent to SOLO-CARE PLUS Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat)disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure or a bird in flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 7 2003 CIBA Vision Corporation c/o Steven Dowdley, RAC CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, GA 30097 Re: K031522 Trade/Device Name: SOLO-Care Plus Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: May 12, 2003 Received: May 28, 2003 Dear Mr. Dowdley: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be acivised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Steven Dowdley, 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Keipi 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 Enclosure {4}------------------------------------------------ # PART III. INDICATIONS FOR USE STATEMENT 510(k) Number: (Number to be assigned) SOLO-Care™ Plus Multi-Purpose Solution Device Name: ### Indications for Use: SOLO-CARE PLUS Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat)disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: or over-the-counter: (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises 510(k) Number. K031522