(125 days)
No
The summary does not mention AI, ML, or any related concepts, and the device description is purely hardware-focused.
No
The device is described as an observational and measurement tool for eye movements, not one that treats or provides therapy. Its intended use is to observe, record, and measure, which are diagnostic/assessment functions.
Yes
The device is described as "observ(ing), record(ing) and measur(ing) eye movements" and the predicate device is a "Diagnostic System." These terms strongly suggest a diagnostic function.
No
The device description explicitly lists hardware components (Computer, Display Monitor, Lightbar, client amplifier) in addition to software.
Based on the provided information, the DDAT OMT 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.
- DDAT OMT Function: The DDAT OMT observes, records, and measures eye movements. This is a direct measurement of a physiological function of the patient's body, not an analysis of a sample taken from the body.
- Intended Use: The intended use clearly states it's for observing, recording, and measuring eye movements in patients during ocular motor testing. This is a clinical assessment performed directly on the patient.
Therefore, the DDAT OMT falls under the category of a medical device used for physiological measurement and assessment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DDAT OMT is intended to be used to observe, record and measure eye movements in patients during ocular motor testing.
The DDAT OMT is intended for use by qualified medical personnel trained in the use of nystagmographs.
Product codes
GWN
Device Description
The DDAT OMT is a computer based medical device comprising of a Computer, a Display Monitor for viewing eye movements, a Lightbar which provides the stimulus for the eye movement and a client amplifier that tracks the patient's eye movement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of nystagmographs
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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)
Not Found
§ 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
Premarket Notification Submission DDAT OMT
October 28,2004
KOSOO98
510(k) SUMMARY
| Submitted by: | DDAT (UK) Ltd
Camden House
Warwick Road
Kenilworth
Warwickshire CV8 1TH |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | +44 (0) 1926 514060 |
| Fax: | +44 (0) 1926 514060 |
| Contact Person: | Kevin Eyres, CEO |
| Date summary prepared: | October 28, 2004 |
| Registration Number: | 3004059926 |
| Trade Name of Device: | DDAT OMT |
| Common Name: | Nystagmograph |
| Classification Name: | Nystagmograph |
| Product Code: | GWN |
| Regulation number: | 21 CFR 882.1460 |
| Device Class | Class II |
| Substantial equivalence: | The DDAT OMT is substantially equivalent to the
CHARTR® ENG/VNG Diagnostic System
marketed by ICS Medical Corporation (File number
K991497).
There are no significant differences between the
DDAT OMT and the predicate device that would
adversely affect the use of the device. The DDAT
OMT is substantially equivalent to the predicate
device in design, function, materials, and
indications for use/intended use. |
| Description of Device: | The DDAT OMT is a computer based medical
device comprising of a Computer, a Display
Monitor for viewing eye movements, a Lightbar
which provides the stimulus for the eye movement
and a client amplifier that tracks the patient's eye
movement. |
| Indications For Use: | The device is used to observe, record and
measure eye movements in patients during ocular
motor testing.
The DDAT OMT is intended for use by qualified
medical personnel trained in the use of
nystagmographs. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2005
DDAT (UK), Ltd. C/o Ms. Chantel Carson Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K050098
Trade/Device Name: DDAT OMT Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN Dated: May 16, 2005 Received: May 16, 2005
Dear Ms. Carson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your your be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conimered pror to may 20, 2017) in accordance with the provisions of the Federal Food, Drug, uc vices that have been recuire approval of a premarket approval application (PMA). and Costicule 710-1710-11-18, subject to the general controls provisions of the Act. The Tou may, morerere, mains of the Act include requirements for annual registration, listing of general controls proving practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elaboritional controls. Existing major regulations affecting your device it may be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the over ents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease of advised that I Drivisian that your device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must or any I catal statutes and states requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant) 850ccions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Chantel Carson
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Les A. T.
Miriam C. Provost, Ph.D. from Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Premarket Notification Submission DDAT OMT
October 28,2004
Indications for Use
KO50098
510(k) Number (if known):
Device Name:
DDAT OMT
Indications for Use:
The DDAT OMT is intended to be used to observe, record and measure eye movements in patients during ocular motor testing.
The DDAT OMT is intended for use by qualified medical personnel trained in the use of nystagmographs.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
virlon Sign-Oif) Viston of General, Restorative nd Neurological Devices
50098