ADAPT, MODEL AX-03SN

{0}------------------------------------------------ # . 510(k): k100954 # 510(k) Summary FEB 2 5 2011 | Submitter: | Apeliotus Vision Science, Inc.<br>1456 N. Morningside Drive, NE<br>Atlanta, Georgia 30306 | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | John G. Edwards, CEO<br>Apeliotus Vision Science, Inc.<br>1456 N. Morningside Drive, NE<br>Atlanta, Georgia 30306<br>Phone: 404-875-9561<br>Email: jedwards@apeliotus.com | | Date Prepared: | February 18, 2011 | | Trade Name: | AdaptTM | | Classification: | 886.1050 | | Product Codes: | HJW | | Predicate Device: | Goldmann-Weekers adaptometer | | Device Description: | The AdaptTM is an AC-powered, automated, adaptometer<br>(biophotometer). | | Intended Use: | The AdaptTM is an AC powered, automated adaptometer (biophotometer)<br>intended to measure the time for retinal adaptation after exposure to an<br>adapting light. | | Comparison of<br>Technological<br>Characteristics: | The AdaptTM is technologically substantially equivalent to the predicate<br>in being AC-powered and having a similar design with photobleach light<br>and stimulus light to evaluate dark adaptation. The AdaptTM differs from<br>the predicate primarily in that it is controlled by software. | | Verification &<br>Validation Testing<br>Testing: | Verification testing was conducted on the following subsystems: Flash,<br>Stimulus, Fixation Light, Patient Input & Patient Management, Infrared<br>Camera, Refractive Correction, and Chin Rest. Software<br>verification/validation was conducted and computer control and<br>integration was verified. Calibration & Alignment were verified.<br>Testing demonstrated that the device met product specifications and<br>performance requirements. Validation testing, including conducting dark<br>adaptation testing on subjects, was also conducted.<br>All results met final requirements and demonstrate substantial<br>equivalence to the predicate device. | | | | | Clinical<br>Performance<br>Testing: | An Agreement Study was conducted comparing the AdaptTM against the<br>predicate with 12 adults having a range of eye health status. Dark<br>adaptation speed as characterized by both the rod-cone break and the rod<br>intercept parameters was found to be highly correlated between the two<br>instruments.<br>A Precision Study was conducted among 14 adults with normal retinal<br>health and 8 patients with age-related macular degeneration (AMD).<br>Each participant was tested twice separated by two weeks. Dark<br>adaptation speed was characterized using both the rod-cone break and rod<br>intercept parameters. For comparison, similar measurements were made<br>on a separate group of 6 normal adults using the predicate. Dark<br>adaptation speeds for the AdaptTM were highly correlated between the<br>first and second visits for both parameters, and the precision of the<br>AdaptTM was comparable to the predicate. | | Conclusion: | By comparison of design features and by testing the AdaptTM, we<br>conclude it is substantially equivalent to the predicate device. | {1}------------------------------------------------ ### 510(k) Summary (Continued) {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Apeliotus Vision Science, Inc. c/o Mr. John G. Edwards Chief Executive Officer 1456 N. Morningside Drive, NE Atlanta, GA 30306 FEB 2 5 20:1 . Re: K100954 Trade/Device Name: Adapt™ Regulation Number: 21 CFR 886.1050 Regulation Name: Adaptometer (biophotometer) Regulatory Class: I Exempt Product Code: OUM Dated: February 18, 2011 Received: February 22, 2011 Dear Mr. Edwards: We have reviewed your premarket notification submission and have found this device to be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification. The final classification regulation for your device appears in Title 21 of the Code of Federal Regulations (CFR) 21 CFR 886.1050. We suggest that you review this regulation since it may grant other exemptions from certain general controls of the Act. Your device classification regulation name, regulatory class, and product code are shown above. When listing your device with the Food and Drug Administration, please use this product code. In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review 21 CFR Section 886.9 to determine whether or not your new device (s) meets the limitations of exemption from Section 510(k) of the Act. {3}------------------------------------------------ Page 2 - Mr. John G. Edwards If you have any questions regarding this letter, please contact Daryl Kaufman at (301) 796-6620 or the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 796-7100, or at its Internet address ''http://www.fda.gov/cdrh/dsmamain.html.'' Sincerely yours, Kesia Alexander Malviña B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # Indications for Use Statement 510(k) Number: k100954 Device Name: AdaptTM Indications For Use: The Adapt™ is an AC powered, automated adaptometer (biophotometer), intended to measure the time for retinal adaptation after exposure to an adapting light. Prescription Use X - AND/OR: (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) *(Division Sign-Off)* Division of Ophthalmic, Neurological and Ear Nose and Throat Devices 510(k) Number K10954