VIDEO EYE TRAKKER

K964646 · Micromedical Technologies, Inc. · GWN · Jul 15, 1997 · Neurology

Device Facts

• Record ID: K964646
• Device Name: VIDEO EYE TRAKKER
• Applicant: Micromedical Technologies, Inc.
• Product Code: GWN · Neurology
• Decision Date: Jul 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2

Intended Use

The device is used to non-invasively record horizontal and vertical eye movements of patients during routine electronystagmography (ENG) testing of vestibular function using miniature video cameras and pupil tracking hardware. The device is an alternative to skin electrodes and a physiologic signal amplifier for monitoring eye position.

Device Story

Video Eye Trakker records horizontal and vertical eye movements non-invasively; utilizes miniature video cameras and pupil tracking hardware. Serves as alternative to traditional skin electrodes and physiologic signal amplifiers for monitoring eye position during vestibular function testing. Operated by clinicians in clinical settings. Provides eye position data to assist in assessment of vestibular function; aids in diagnosis of vestibular disorders.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison to existing methods for monitoring eye position.

Technological Characteristics

System utilizes miniature video cameras and pupil tracking hardware to monitor eye position. Replaces traditional skin electrodes and physiologic signal amplifiers. Non-invasive recording of horizontal and vertical eye movements.

Indications for Use

Indicated for patients undergoing routine electronystagmography (ENG) testing of vestibular function to record horizontal and vertical eye movements.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Manish Sumant
Biomechanical Engineer
Micromedical Technologies, Inc.
110 West Walnut
Chatham, Illinois 62629

JUL 15 1997

Re: K964646
Trade Name: Video Eye Trakker
Regulatory Class: II
Product Code: 84GWN
Dated: June 4, 1997
Received: June 9, 1997

Dear Mr. Sumant:

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. Manish Sumant

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,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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K964646/A¹

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510(k) Number (if known): K964646

Device Name: Video Eye Trakker

Indications For Use:

The device is used to non-invasively record horizontal and vertical eye movements of patients during routine electronystagmography (ENG) testing of vestibular function using miniature video cameras and pupil tracking hardware. The device is an alternative to skin electrodes and a physiologic signal amplifier for monitoring eye position.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


OR

Over-The-Counter Use

(Optional Format 1-2-96)


(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K964646

R'c vD 12/10/96