COMPLETE BLINK-N-CLEAN LENS DROPS

{0}------------------------------------------------ # 510(k) SUMMARY COMPLETE® BLINK-N-CLEAN® Lens Drops This summary uses the format provided in 21 CFR 807.92: | (a)(1) | Submitter: | Paul J. Nowacki<br>Manager<br>Regulatory Affairs<br>Advanced Medical Optics<br>1700 E. St. Andrew Place<br>Santa Ana, CA 92799-5162 | |--------|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | | | Phone: (714) 247-8601<br>Fax: (714) 247-8677<br>EMail: paul.nowacki@amo-inc.com | | | Summary Prepared: | September 30, 2004 | | (a)(2) | Device Trade Name:<br>Drops | COMPLETE® BLINK-N-CLEAN® Lens | | | Device Common Name: | Soft (Hydrophilic) and Rigid Gas<br>Permeable Contact Lens Solution | | | Device Classification/Panel: | Class II (Special Controls)/Ophthalmic<br>Device | | | Device Classification Names: | Accessories, Soft Lens Products (LPN)<br>Products, Contact Lens Care, Rigid Gas<br>Permeable (MRC) | - Identification of Predicate Device: COMPLETE® BLINK-N-CLEAN® (a)(3) Lens Drops is the same as the currently-marketed lens drops and substantially equivalent to other lubricating and rewetting drop products. - Device Description: COMPLETE® BLINK-N-CLEAN® Lens Drops is a (a)(4) sterile, isotonic, buffered, solution containing lubricants, preservatives, buffers, surfactants, ancillary ingredients, and purified water. The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips. - Intended Use (Indications for Use): COMPLETE® BLINK-N-CLEAN® (a)(5) Lens Drops is indicated to lubricate and rewet soft (hydrophilic) contact lenses, disposable lenses and extended wear lenses, as well as rigid gas permeable lenses before application and during wear. - Comparison of Technological Characteristics: The technological (a)(6) characteristics of the product remain the same. {1}------------------------------------------------ ### 510(k) SUMMARY COMPLETE® BLINK-N-CLEAN® Lens Drops March 2004 ### Discussion of Nonclinical Studies: (b)(1) COMPLETE®BLINK-N-CLEAN® Lens Drops was evaluated for compatibility with silicone acrylate lenses and fluorosilicone acrylate rigid gas permeable (RGP) lenses during thirty (30) regimen cycles. Average changes in diameter, power and base curve for the test lenses were within established acceptance criteria, with test lenses showing a trend comparable to that of the controls. In addition, visual observations did not show evidence of surface deposits, discoloration and/or deformities. Based on these results, COMPLETE® BLINK-N-CLEAN® Lens Drops is compatible with all RGP contact lenses. In addition, a study for quantifying surface protein accumulation on human-worn contact lenses and subsequent protein removal in simulated in-eye use of lens rewetter products has been conducted. The results show that COMPLETE® BLINK-N-CLEAN® Lens Drops removal significant amount of protein than the predicate devices. - Other preclinical safety and efficacy criteria were established in P910075/S7. - (b)(2) Clinical: Clinical safety and acceptability of COMPLETE® BLINK-N-CLEAN® Lens Drops was established in 910075/S7. - Data Supporting Equivalence (b)(3) Conclusions Drawn from Determination: The safety, efficacy and performance of COMPLETE® BLINK-N-CLEAN® Lens Drops is substantially equivalent to other contact lens care lubricating and rewetting drops currently on the market. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES 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 its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### OCT 1 9 2004 Advanced Medical Optics c/o Mr. Paul Nowacki C/O WITH T and Novelatory Affairs and Medical Compliance 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92799-5162 Re: K040839 Trade/Device Name: Complete® Blink-N-Clean® Lens Drops Regulation Number: 21 CFR 886.5918; 21 CFR 886.5928 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: MRC; LPN Dated: August 13, 2004 Received: August 17, 2004 Dear Mr. Nowacki: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector o re(s) perceise is substantially equivalent (for the indications felerenced above and nave use ally marketed predicate devices marketed in interstate for use stated in the encreated to togens and ment date of the Medical Device Amendments, or to commerce provide to May 20, 1978, are emorance with the provisions of the Federal Food, Drug, devices mat have been recation in acceranted in accerantes approval application (PMA). and Cosment Act (Act) that do not require approvial controls provisions of the Act. The r ou may, merciole, market the act include requirements for annual registration, listing of general controls provisions of use tice, 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 II your device is classified (300 a0010) and Existing major regulations affecting your device can may be subject to such additional controls. Existing major regulation of th Inty be subject to such additional controlions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I DA 3 loodated or a cevice complies with other requirements of the Act that IDA has made a doloriminations administered by other Federal agencies. You must of any I cuclar statutes and reguirements, including, but not limited to: registration and listing Compry with an the recess requirements, modeling practice requirements as set (21 CFR Part 807), labornig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ### Page 2 - Mr. Paul Nowacki This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin mailing of substantial equivalence of your device to a legally premaince noticated. The 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 If you t 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 other general micronal 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 helyi korentbol 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}------------------------------------------------ ## Indications for Use 510(K) NUMBER: (IF KNOWN): DEVICE NAME: COMPLETE® BLINK-N-CLEAN® Lens Drops INDICATIONS FOR USE: - COMPLETE® BLINK-N-CLEAN® Lens Drops is indicated to lubricate and rewet soft # (hydrophilic) contact lenses, disposable lenses and extended wear lenses, as well as rigid gas permeable lenses before application and during wear. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) Use t C) (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 Ear, Nose and Throat Devises | | | 510(k) Number | K040839 | Page 1 of ____________________________________________________________________________________________________________________________________________________________________