CHRONOS VISION EYE TRACKING DEVICE (C-ETD)

K062015 · Chronos Vision · GWN · Oct 31, 2006 · Neurology

Device Facts

• Record ID: K062015
• Device Name: CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
• Applicant: Chronos Vision
• Product Code: GWN · Neurology
• Decision Date: Oct 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2

Intended Use

The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

Device Story

C-ETD measures 3D eye movements and head rotation/translation; used in vestibular/visual research. Device integrates with external stimulus generators (rotating/translating devices, visual displays). Operated by qualified medical personnel in clinical settings. System records, stores, displays, and analyzes nystagmus data to assist clinicians in diagnosing vestibular disorders. Device provides raw data and analysis but no automated diagnostic recommendations. Benefits include objective quantification of oculomotor function to support clinical decision-making.

Clinical Evidence

Bench testing only. System performance verified using an artificial eye model.

Technological Characteristics

Nystagmograph system for 3D eye and head movement tracking. Integrates with external stimulus generators. Software-based analysis of oculomotor signals. Class II device (21 CFR 882.1460).

Indications for Use

Indicated for patients with suspected vestibular disorders requiring measurement, recording, and analysis of nystagmus. Intended for use by trained medical personnel. No specific age or gender restrictions noted.

Regulatory Classification

Identification

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

Predicate Devices

• Micromedical Technologies Video Eye Monitor (K964325)
• SensoMotoric Instruments 2D VOG-Video-Oculography (K972243)
• Fall Prevention Technologies BalanceBack VNG (K042529)
• DDAT (UK) DDAT OMT (K050098)
• Eye Dynamics House IR/VNG (K925111)

Submission Summary (Full Text)

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K06 2015

Page ① of 2

## 510(k) Summary for the Chronos Vision Eye Tracking Device (C-ETD)

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

### 1. General Information

| Submitter: | Chronos Vision<br>Wiesenweg 9<br>12247 Berlin<br>Germany |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OCT 31 2006 |
| Contact Person: | Maureen O'Connell<br>O'Connell Regulatory Consultants, Inc.<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | October 12, 2006 |
| Names | |

Device Name:

2.

Chronos Vision Eye Tracking Device (C-ETD)

Classification Name:

Nystagmograph Product Code: GWN

## 3. Predicate Devices

The Chronos Vision Eye Tracking Device (C-ETD) is substantially equivalent to a combination of the following devices: Micromedical Technologies Video Eye Monitor (K964325), SensoMotoric Instruments 2D VOG-Video-Oculography (K972243), Fall Prevention Technologies BalanceBack VNG (K042529), DDAT (UK) DDAT OMT (K050098) and Eye Dynamics House IR/VNG (K925111).

## 4. Device Description

The Chronos Vision Eye Tracking Device (C-ETD) facilitates measurement of three-dimensional eye movements and head movement (rotation and translation). It is a basic instrument for many types of vestibulo-oculomotor and visual research functions.

The Eye Tracking Device will be used in combination with appropriate stimulus generators (rotating or translating devices, visual displays).

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#### 5. Indications for Use

The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

#### 6. Performance Data

..

Testing was provided which verified system performance using an artificial eye model.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

O'Connell Regulatory Consultants, Inc % Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

OCT 3 1 2006

Re: K062015

Trade/Device Name: Chronos Vision Eye Tracking Device (C-ETD) Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: October 12, 2006 Received: October 13, 2006

Dear Ms. O'Connell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Maureen O'Connell

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.

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ___K062015

Device Name: ___Chronos Vision Eye Tracking Device (C-ETD) ___________________________________________________________________________________________________________________

Indications for Use:

The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, storing, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

| Prescription Use | <b>X</b> |
|-----------------------------|----------|
| (Part 21 CFR 801 Subpart D) | |
| | AND/OR |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General,

and Neurological Devices

| 510(k) Number | K062015 | Page 1 of 1 |
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