DDAT OMT

K050098 · Ddat(Uk), Ltd. · GWN · May 23, 2005 · Neurology

Device Facts

• Record ID: K050098
• Device Name: DDAT OMT
• Applicant: Ddat(Uk), Ltd.
• Product Code: GWN · Neurology
• Decision Date: May 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

Computer-based nystagmograph; tracks patient eye movements during ocular motor testing. System components: computer, display monitor, lightbar (stimulus provider), and client amplifier. Operated by qualified medical personnel in clinical settings. Device records and displays eye movement data to assist clinicians in diagnostic assessment of ocular motor function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based system; includes display monitor, lightbar stimulus, and client amplifier. Operates as a nystagmograph (21 CFR 882.1460).

Indications for Use

Indicated for patients undergoing ocular motor testing to observe, record, and measure eye movements. Intended for use by qualified medical personnel trained in nystagmography.

Regulatory Classification

Identification

A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Predicate Devices

• CHARTR® ENG/VNG Diagnostic System (K991497)

Submission Summary (Full Text)

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Premarket Notification Submission DDAT OMT

October 28,2004

# KOSOO98

## 510(k) SUMMARY

| Submitted by: | DDAT (UK) Ltd<br>Camden House<br>Warwick Road<br>Kenilworth<br>Warwickshire CV8 1TH |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| 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<br>CHARTR® ENG/VNG Diagnostic System<br>marketed by ICS Medical Corporation (File number<br>K991497).<br>There are no significant differences between the<br>DDAT OMT and the predicate device that would<br>adversely affect the use of the device. The DDAT<br>OMT is substantially equivalent to the predicate<br>device in design, function, materials, and<br>indications for use/intended use. |
| Description of Device: | The DDAT OMT is a computer based medical<br>device comprising of a Computer, a Display<br>Monitor for viewing eye movements, a Lightbar<br>which provides the stimulus for the eye movement<br>and a client amplifier that tracks the patient's eye<br>movement. |
| Indications For Use: | The device is used to observe, record and<br>measure eye movements in patients during ocular<br>motor testing.<br>The DDAT OMT is intended for use by qualified<br>medical personnel trained in the use of<br>nystagmographs. |

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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.

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### 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 [phone] . 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 [phone] or [phone] 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

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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