(82 days)
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Not Found
No
The summary describes a device that uses infra-red sensors and a processing unit to measure and present eye movement data. There is no mention of AI, ML, or any related technologies in the intended use, device description, or specific sections for AI/ML information.
No.
The device is used to measure and aid in the detection and diagnosis of vestibular disorders, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is used, then, to aide in the detection and diagnosis of vestibular disorders." This indicates its role in the diagnostic process.
No
The device description explicitly states it uses infra-red sensors and an IR oculography method, indicating the presence of hardware components beyond just software.
Based on the provided information, the EveTrak™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the living body ("in vitro").
- EveTrak™ Function: The EveTrak™ measures eye movements directly on the patient's body using infra-red sensors. It does not analyze specimens taken from the patient.
- Intended Use: The intended use describes measuring eye movements during tests performed on the patient to aid in the detection and diagnosis of vestibular disorders. This is a form of in vivo (within the living body) diagnostic testing.
Therefore, the EveTrak™ falls under the category of a medical device used for in vivo diagnostic testing, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EveTrak™ is used to non-invasively measure the vertical and horizontal eve movements during a variety of tests performed during electronystagmography (ENG) testing. This testing includes, but is not limited to: saccadic test, smooth pursuit, optokinetic nystagmus, and kinetic vestibular tests. It provides a trained clinician with data and graphs representing a patient's ability to perform certain eve movements voluntarily, as well as the patient's involuntary eye movements due to head movement, eye movement and/or body movement as is normally performed in vestibular diagnostic testing such as in Hallpike positional tests. It is used, then, to aide in the detection and diagnosis of vestibular disorders.
Product codes
GWN
Device Description
The EyeTrak™ does not incorporate a camera for vertical and horizontal eye movement measurement, therefore it is not as cumbersome as other similar devices, and does not have focal length and resolution limitations based on the camera and camera lens used. The EyeTrak™ instead measures horizontal and vertical eye movement non-invasively using infra-red sensors and an IR oculography method with background light suppression. This allows for direct transmission of sensor signals to a processing unit, which in turn provides the signals to the software for processing, saving, and presentation. A camera and monitor can be used to monitor torsional eye movements, and a sensor can be added to measure head movement.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Infra-red sensors (IR oculography method)
Anatomical Site
Eye (eye movements)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained clinician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines above it, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 1999
Mr. Douglas R. Morr Chief Engineer Bertec Corp. 6185 Huntley Road, Suite B Worthington, Ohio 43229
K991642 Re: Trade Name: EyeTrak™: ENG System Regulatory Class: II Product Code: GWN Dated: May 12, 1999 Received: May 13, 1999
Dear Mr. Morr:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Douglas R. Morr
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image is a black and white line drawing of a cube with cutouts in the shape of the letters B and C. The letter B is on the left side of the cube, and the letter C is on the right side of the cube. The cube is drawn in a simple, geometric style. There is a circled R symbol on the bottom right of the image.
BERTEC CORPORATION
1483 Delashmut Avenue, Columbus, OH 43212, U.S.A. Phone: 614-421-2803 Fax: 614-421-2811 sales@bertec.com www.bertec.com
Statement of Indications for Use: XIV.
Statement of Indications for Use
Page 1 of 1
510(k) Number (if known): K991642
Device Name:
EyeTrak™ : ENG System
Indications for Use:
The EveTrak™ is used to non-invasively measure the vertical and horizontal eve movements during a variety of tests performed during electronystagmography (ENG) testing. This testing includes, but is not limited to: saccadic test, smooth pursuit, optokinetic nystagmus, and kinetic vestibular tests. It provides a trained clinician with data and graphs representing a patient's ability to perform certain eve movements voluntarily, as well as the patient's involuntary eye movements due to head movement, eye movement and/or body movement as is normally performed in vestibular diagnostic testing such as in Hallpike positional tests. It is used, then, to aide in the detection and diagnosis of vestibular disorders.
The EyeTrak' does not incorporate a camera for vertical and horizontal eye movement measurement, therefore it is not as cumbersome as other similar devices, and does not have focal length and resolution limitations based on the camera and camera lens used. The EyeTrak™ instead measures horizontal and vertical eye movement non-invasively using infra-red sensors and an IR oculography method with background light suppression. This allows for direct transmission of sensor signals to a processing unit, which in turn provides the signals to the software for processing, saving, and presentation. A camera and monitor can be used to monitor torsional eye movements, and a sensor can be added to measure head movement.
The results are used to provide documentation of a patient's performance on specific tests.
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
PREMARKET NOTIFICATION
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K9916542 |
|---|---|
| --------------- | ---------- |
Acolly