VISUALEYES: VIDEO EYE MONITOR

K964325 · Micromedical Technologies, Inc. · GWN · Jul 15, 1997 · Neurology

Device Facts

• Record ID: K964325
• Device Name: VISUALEYES: VIDEO EYE MONITOR
• 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 Eye Monitor is used to observe eye movements from various stimuli used in vestibular diagnostic testing. It allows observation of horizontal, vertical and torsional eye movements. The Eye Monitor is mainly used to visually detect nystagmus positional maneuvers (e.g. Hallpike (e.g. Hallpike positional tests) or caloric tests. The device is especially useful in situations where the operator needs to observe the patient’s eyes to distinguish nystagmus from artifacts. These observations are currently done using Fresnel lenses. The eye movements could also be recorded on suitable media (e.g. video tape) to provide documentation for any diagnosis based on observation of the Eye Monitor.

Device Story

Video Eye Monitor captures patient eye movements during vestibular diagnostic testing; provides real-time visual feedback to clinician; replaces traditional Fresnel lenses for observing nystagmus; allows differentiation between nystagmus and artifacts; supports recording to external media (e.g., video tape) for diagnostic documentation; used in clinical settings by trained operators; aids in clinical decision-making by providing clear visualization of ocular responses to stimuli.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Video-based eye monitoring system; utilizes camera/imaging hardware for real-time visualization of ocular movements; supports external video recording; intended for clinical vestibular diagnostic environments.

Indications for Use

Indicated for patients undergoing vestibular diagnostic testing requiring observation of horizontal, vertical, and torsional eye movements, including nystagmus during positional maneuvers (e.g., Hallpike) or caloric tests.

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: K964325
Trade Name: Video Eye Monitor
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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510(k) Document number: K964325
Device Name: VISUALEYES: VIDEO EYE MONITOR

## Indications For Use:

The Eye Monitor is used to observe eye movements from various stimuli used in vestibular diagnostic testing. It allows observation of horizontal, vertical and torsional eye movements.

The Eye Monitor is mainly used to visually detect nystagmus positional maneuvers (e.g. Hallpike (e.g. Hallpike positional tests) or caloric tests. The device is especially useful in situations where the operator needs to observe the patient’s eyes to distinguish nystagmus from artifacts. These observations are currently done using Fresnel lenses.

The eye movements could also be recorded on suitable media (e.g. video tape) to provide documentation for any diagnosis based on observation of the Eye Monitor.

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over the Counter Use ____