← Product Code [OUM](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OUM) · K100954 # ADAPT, MODEL AX-03SN (K100954) _Apeliotus Vision Science, Inc. · OUM · Feb 25, 2011 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OUM/K100954 ## Device Facts - **Applicant:** Apeliotus Vision Science, Inc. - **Product Code:** [OUM](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OUM.md) - **Decision Date:** Feb 25, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.1050 - **Device Class:** Class 1 - **Review Panel:** Ophthalmic ## Indications for Use The AdaptTM is an AC powered, automated adaptometer (biophotometer) intended to measure the time for retinal adaptation after exposure to an adapting light. ## Device Story AdaptTM is an AC-powered, automated adaptometer (biophotometer) used to measure retinal dark adaptation speed. The device utilizes an adapting light to photobleach the retina, followed by a stimulus light to evaluate recovery. It incorporates an infrared camera for monitoring, refractive correction, and a chin rest for patient positioning. Controlled by software, the device automates the testing process, which is performed in a clinical setting. The system measures parameters including rod-cone break and rod intercept to characterize adaptation speed. Healthcare providers use these outputs to assess retinal health, specifically in patients with conditions like age-related macular degeneration (AMD). The device provides objective, repeatable measurements of dark adaptation, aiding in the clinical evaluation of retinal function. ## Clinical Evidence Clinical performance was evaluated through an agreement study and a precision study. The agreement study (n=12) compared AdaptTM to the predicate, showing high correlation in rod-cone break and rod intercept parameters. The precision study (n=14 normal, n=8 AMD patients) assessed repeatability over two weeks; results showed high correlation between visits and precision comparable to the predicate device. ## Technological Characteristics AC-powered automated adaptometer. Features include photobleach light source, stimulus light source, infrared camera, refractive correction mechanism, and chin rest. Software-controlled operation. System components include flash, stimulus, fixation light, patient input, and patient management subsystems. ## Regulatory Identification An adaptometer (biophotometer) is an AC-powered device that provides a stimulating light source which has various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold. ## Predicate Devices - Goldmann-Weekers adaptometer ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # . 510(k): k100954 # 510(k) Summary FEB 2 5 2011 | Submitter: | Apeliotus Vision Science, Inc.
1456 N. Morningside Drive, NE
Atlanta, Georgia 30306 | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | John G. Edwards, CEO
Apeliotus Vision Science, Inc.
1456 N. Morningside Drive, NE
Atlanta, Georgia 30306
Phone: 404-875-9561
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
(biophotometer). | | Intended Use: | The AdaptTM is an AC powered, automated adaptometer (biophotometer)
intended to measure the time for retinal adaptation after exposure to an
adapting light. | | Comparison of
Technological
Characteristics: | The AdaptTM is technologically substantially equivalent to the predicate
in being AC-powered and having a similar design with photobleach light
and stimulus light to evaluate dark adaptation. The AdaptTM differs from
the predicate primarily in that it is controlled by software. | | Verification &
Validation Testing
Testing: | Verification testing was conducted on the following subsystems: Flash,
Stimulus, Fixation Light, Patient Input & Patient Management, Infrared
Camera, Refractive Correction, and Chin Rest. Software
verification/validation was conducted and computer control and
integration was verified. Calibration & Alignment were verified.
Testing demonstrated that the device met product specifications and
performance requirements. Validation testing, including conducting dark
adaptation testing on subjects, was also conducted.
All results met final requirements and demonstrate substantial
equivalence to the predicate device. | | | | | Clinical
Performance
Testing: | An Agreement Study was conducted comparing the AdaptTM against the
predicate with 12 adults having a range of eye health status. Dark
adaptation speed as characterized by both the rod-cone break and the rod
intercept parameters was found to be highly correlated between the two
instruments.
A Precision Study was conducted among 14 adults with normal retinal
health and 8 patients with age-related macular degeneration (AMD).
Each participant was tested twice separated by two weeks. Dark
adaptation speed was characterized using both the rod-cone break and rod
intercept parameters. For comparison, similar measurements were made
on a separate group of 6 normal adults using the predicate. Dark
adaptation speeds for the AdaptTM were highly correlated between the
first and second visits for both parameters, and the precision of the
AdaptTM was comparable to the predicate. | | Conclusion: | By comparison of design features and by testing the AdaptTM, we
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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OUM/K100954](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OUM/K100954) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com