K Number
K100954
Device Name
ADAPT, MODEL AX-03SN
Date Cleared
2011-02-25

(324 days)

Product Code
Regulation Number
886.1050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Adapt™ is an AC powered, automated adaptometer (biophotometer), intended to measure the time for retinal adaptation after exposure to an adapting light.
Device Description
The AdaptTM is an AC-powered, automated, adaptometer (biophotometer).
More Information

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Not Found

No
The summary describes a device that measures retinal adaptation time and compares its performance to a predicate device using standard statistical methods. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.

No
The device is an adaptometer, intended to measure the time for retinal adaptation after exposure to an adapting light. This is a diagnostic function, not a therapeutic one.

Yes

The device measures retinal adaptation time to assess eye health, which is a diagnostic function. The performance studies also compare its measurements to a predicate device in patients with both normal and diseased retinas (age-related macular degeneration), implying its use in identifying or characterizing a condition.

No

The device description explicitly states it is an "AC powered, automated adaptometer (biophotometer)" and "AC-powered, automated, adaptometer (biophotometer)", indicating it is a hardware device with software control, not a software-only device.

Based on the provided information, the Adapt™ device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is an adaptometer intended to measure the time for retinal adaptation. This is a measurement of a physiological function within the body (in vivo), not an analysis of a sample taken from the body (in vitro).
  • Device Description: The description reinforces that it's an adaptometer, which is a type of ophthalmic device used for in-vivo testing.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components of an IVD.

Therefore, the Adapt™ is an in-vivo diagnostic device, specifically an ophthalmic device used to assess retinal function.

N/A

Intended Use / 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.

Product codes

HJW,OUM

Device Description

The AdaptTM is an AC-powered, automated, adaptometer (biophotometer).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

retinal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

Goldmann-Weekers adaptometer

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 886.1050 Adaptometer (biophotometer).

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

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