EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX

K991642 · Bertec Corp. · GWN · Aug 3, 1999 · Neurology

Device Facts

• Record ID: K991642
• Device Name: EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
• Applicant: Bertec Corp.
• Product Code: GWN · Neurology
• Decision Date: Aug 3, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1460
• Device Class: Class 2

Intended 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.

Device Story

EyeTrak™ ENG System measures vertical/horizontal eye movements non-invasively for vestibular diagnostics. Input: infrared (IR) sensor signals via IR oculography with background light suppression; optional head movement sensor; optional camera/monitor for torsional eye movement monitoring. Processing: signals transmitted to processing unit for software-based analysis, storage, and presentation. Output: data and graphs documenting patient performance on tests (saccadic, smooth pursuit, optokinetic nystagmus, kinetic vestibular, Hallpike positional). Usage: clinical setting; operated by trained clinicians. Benefit: aids detection/diagnosis of vestibular disorders; avoids limitations of camera-based systems (focal length/resolution).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared (IR) sensors; IR oculography method; background light suppression; processing unit for signal acquisition and software presentation; optional head movement sensor and camera/monitor for torsional eye movement.

Indications for Use

Indicated for patients undergoing electronystagmography (ENG) testing to measure vertical and horizontal eye movements for the detection and diagnosis of vestibular disorders. Used by trained clinicians to assess voluntary eye movements and involuntary movements related to head or body motion.

Regulatory Classification

Identification

A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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## BERTEC CORPORATION

1483 Delashmut Avenue, Columbus, OH 43212, U.S.A. Phone: [phone] Fax: [phone] [e-mail] 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