(237 days)
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Not Found
No
The summary describes a device that uses video cameras and pupil tracking hardware to record eye movements, which is a standard method for ENG testing. There is no mention of AI, ML, deep learning, or any related concepts in the provided text. The focus is on the hardware and the method of data acquisition, not on algorithmic interpretation or analysis using AI/ML.
No
The device is used for non-invasive recording and monitoring of eye movements during ENG testing, which is a diagnostic procedure, not a therapeutic one.
Yes
The device is used for "electronystagmography (ENG) testing of vestibular function," which is a diagnostic procedure to evaluate balance disorders.
No
The device description explicitly mentions "miniature video cameras and pupil tracking hardware," indicating it includes physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is used to "non-invasively record horizontal and vertical eye movements of patients during routine electronystagmography (ENG) testing." This involves observing and measuring a physiological response directly from the patient's body, not analyzing a sample taken from the body.
- Alternative to Electrodes: The description explicitly mentions it's an "alternative to skin electrodes and a physiologic signal amplifier for monitoring eye position." This further reinforces that it's a device for measuring a physiological signal in vivo, not analyzing a sample in vitro.
Therefore, the device falls under the category of a medical device used for physiological measurement and monitoring, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
84GWN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Miniature video cameras
Anatomical Site
Eye (for eye movements)
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
Re : K964646 Video Eye Trakker 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 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 requlatory 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.
1
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 requlation 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K964246/A'
Paqe
K964646 510(k) Number (if known):_
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 paysiologic 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)
Prescription Lise
(Per 21 CFR 801.109)
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'CVD 12/10/96