COMPLETE BRAND MULTI-PURPOSE SOLUTION

{0}------------------------------------------------ # ALLERGAN Image /page/0/Picture/1 description: The image shows a stylized representation of a sun or radiating energy. It consists of seven horizontal lines, each thicker in the middle and tapering towards the ends. The lines are arranged in a stacked formation, creating a symmetrical, abstract design that evokes a sense of movement or expansion. 2525 Dupont Drive, P.O. Box 19534, Irvine, Calífornia, USA 92623-9534 Telephone: (714) 246-4500 Website: www.allergan.com ## 510(k) SUMMARY COMPLETE® brand Multi-Purpose Solution FEB 1 1 2002 K013479 This summary uses the format provided in 21 CFR 807.92: Paul J. Nowacki Submitter: (a)(1) Manager Requlatory Affairs Allergan 2525 Dupont Drive Irvine CA 92612 > Phone: (714) 246-6761 (714) 246-4272 Fax: Summary Prepared: October 2001 COMPLETE® brand Multi-Purpose Solution Device Trade Name: (a)(2) Soft (Hydrophilic) Contact Lens Solution Device Common Name: Device Classification Names: Accessories to Contact Lens Solution (86LPN) - Identification of Predicate Device: Whether used with frequent replacement (a)(3) or conventional lenses (those replaced at intervals of 90 days or longer), the or convontional tell brand Multi-Purpose Solution care regimen is substantially equivalent to the approved COMPLETE® brand Multi-Purpose Solution care regimen. - Device Description: There are no formulation or other changes in the device (a)(4) description. - Intended Use (Indications for Use): COMPLETE® brand Multi-Purpose (a)(5) Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to: - Chemically (NOT HEAT) Disinfect . - Clean . - Rinse . - . Store - Remove Protein . - Condition . - Comparison of Technological Characteristics: There are modified cleaning (a)(6) instructions for all soft contact lenses but there are no changes to the product formulation or other technological characteristics. {1}------------------------------------------------ ### 510(k) SUMMARY COMPLETE® brand Multi-Purpose Solution October 16, 2000 Page 2 of 3 #### (b)(1) Discussion of Nonclinical: Microbiological Studies: We evaluated disinfection efficacy using methods outlined in FDA's May 1, 1997, Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products. COMPLETE® brand Multi-Purpose Solution meets FDA requirements for disinfection of contact lenses when used with the modified cleaning regimen. The product also meets USP Modified criteria for Preservative Effectiveness Testing and USP Sterility test requirements as shown by previous testing. Toxicological Studies: Toxicological studies were included in 510(k) K003252 for frequent replacement lenses, on October 16, 2000. #### (b)(2) Discussion of Clinical Data: Nine investigators enrolled 157 subjects who replace hydrogel contact lenses at intervals of three months or longer (conventional wear) in a three-month, parallel group study. Subjects received new lenses and were randomized to use COMPLETE® in either the standard (rub, rinse, soak, optional rinse) regimen or a modified (rinse, soak, mandatory rinse) regimen. One-hundred and fifty-one subjects completed the study with three subjects withdrawing from each regimen. The primary acceptability variable was mean change from baseline in lens comfort score. The modified regimen group was demonstrated to be noninferior to the standard regimen by constructing 95% confidence intervals around the mean changes from baseline in lens comfort at Day 90. Acceptability Results: There was no statistically significant difference between the two regimens in: - Mean lens comfort score at baseline or at any follow-up visit . - Symptoms of discomfort . - . Maximum severity grade of any symptom of discomfort - . Number of subject visits with clinically significant symptoms of discomfort (all causes). - Change from baseline for burning and stinging, blurry vision, unusual eye . secretion, excessive tearing, itchinq, increased lens awareness, redness, or light sensitivity - Overall subjective vision quality . - . Mean lens wearing time - Average daily lens wearing time change from baseline . - Number of Type II or Type IV lenses analyzed at the final study visit . - Subject ratings of the contact lens solution used, comfort rating, and vision . quality. {2}------------------------------------------------ ### 510(k) SUMMARY COMPLETE® brand Multi-Purpose Solution October 16, 2000 Page 3 of 3 #### Discussion of Clinical Data (Continued): (b)(2) Safety Results: No subject in either regimen experienced an unanticipated adverse device effect or a sight-threatening event, iritis, infiltrate, ulcer, ocular infection, or two-grade change in neovascularization. There were no statistically significant differences between the two regimens in: - Worst severity of subject eyes at each visit for the slit lamp examination . findings of edema, corneal neovascularization, bulbar hyperemia, palpebral conjunctival observations, or other complications - Maximum severity grade of any slit lamp examination finding . - Maximum Joseline and the worst change from baseline in any slit lamp . parameter - Number of subjects with clinically significant slit lamp examination findings . - Number of visits with clinically significant slit lamp examination findings . - Change from baseline in study lens-corrected visual acuity . - Number of eyes discontinued from the study, in the average wear time of . lenses, or in the number of missed visits. Cleaning Effectiveness: Lenses from the clinical study were returned to Allergan and examined in the laboratory for surface deposits and general Allergan and Results show that COMPLETE® brand Multi-Purpose Solution used with the modified regimen is equivalent to the standard regimen and is an effective cleaner for soft (hydrophilic) contact lenses. Conclusion: COMPLETE® brand Multi-Purpose Solution used with a modified regimen has an acceptable safety profile and is as effective as COMPLETE® Multi-Purpose Solution used with a standard regimen among hydrogel contact lens wearers who replace their lenses on a conventional replacement schedule of three months or longer. - Conclusions Drawn from Data Supporting Equivalence Determination: (b)(3) We conclude that the safety, efficacy and acceptability of COMPLETE® brand Multi-Purpose Solution, when used with the modified regimen, is substantially equivalent to COMPLETE® brand Multi-Purpose Solution used with the standard regimen and other multipurpose solutions currently on the market. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 1 2002 Allergan, Inc. C/O Paul J. Nowacki Manager, Regulatory Affairs 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 Re: K013479 Trade/Device Name: COMPLETE® brand Multi-Purpose Solution (Modified lens care directions) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: December 19, 2001 Received: December 20, 2001 Dear Mr. Nowacki: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection 910(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars and the Medical Device Americal portor commerce prior to May 26, 1776, the enaomatic with the provisions of the Federal Food, Drug, devices that have been recassince in accessfire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approva and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the devices, basjon to the more general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Fict liefeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) mis existing major regulations affecting your device can may be subject to such additional controls. Existing major may be subject to such additional bontroller "Little 21, Parts 800 to 898. In addition, FDA may be found in the Code of Foucture ing your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuates of a other complies with other requirements of the Act that FDA has made a determination that your device complies with other requiremen that I DA has made a determination administered by other Federal agencies. You must or any rederal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 800), good was and 10 applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ Page 2 - Mr. Paul Nowacki 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph 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 {5}------------------------------------------------ Page _1_ of _1 # K013479 510(K) NUMBER: (IF KNOWN): #### DEVICE NAME: ### COMPLETE® brand Multi-Purpose Solution INDICATIONS FOR USE: COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to: - Chemically (NOT HEAT) Disinfect ● - Clean . - Rinse . - Store . - Remove Protein ● - Condition . (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_ V (Optional Format 1-2-96) Kaiser Walbert C Far / 1.71.76