(258 days)
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 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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Video Eye Monitor" (also referred to as "VISUALEYES: VIDEO EYE MONITOR"). This document does not contain information about acceptance criteria, device performance, a study to prove meeting acceptance criteria, sample sizes, expert qualifications, or types of ground truth.
The letter states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, which means it has met the regulatory requirements for clearance based on this equivalence. It describes the intended use of the device: "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... 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."
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or similar technical documentation that would detail the device's performance against specific acceptance criteria.
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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 1 5 1997
K964325 Re : Video Eye Monitor Trade Name: Requlatory 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 Requlations, 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 requlations.
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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 (301) 594-4648. 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,
Thomas J. Callahon
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)
Thomas J. Callahon
(Division Sign-Division of Ca and Neurological De 510(k) Num
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use ... .
§ 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).