2D VOG - VIDEO-OCULOGRAPHY

K972243 · Sensomotoric Instruments, GmbH · GWN · Sep 10, 1997 · Neurology

Device Facts

• Record ID: K972243
• Device Name: 2D VOG - VIDEO-OCULOGRAPHY
• Applicant: Sensomotoric Instruments, GmbH
• Product Code: GWN · Neurology
• Decision Date: Sep 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2

Intended Use

The 2D VOG -- Video-Oculography system provides information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye.

Device Story

2D VOG is a nystagmograph system used by healthcare professionals to diagnose vestibular disorders. It consists of a mask-mounted video camera, image processing board, video-overlay board, and PC. The device records eye movements, digitizes and analyzes data for nystagmus beats and velocity, and displays results in various diagrams. It includes a patient database for storage. The system supports analysis during spontaneous, caloric, smooth pursuit, optokinetic, rotation, positional, and saccadic examinations. Clinicians use the output in conjunction with other clinical information to aid diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison to the predicate device.

Technological Characteristics

System includes mask-mounted video camera, image processing board, video-overlay board, and PC. Operates via video-oculography to measure eye movements. Software-based analysis of nystagmus. Connectivity via PC interface. Sterilization not specified.

Indications for Use

Indicated for use by healthcare professionals to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye.

Regulatory Classification

Identification

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

Predicate Devices

• House Infrared/Video Electronystagmograph System (marketed by Eye Dynamics, Inc.)

Submission Summary (Full Text)

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## SEP 1 0 1997

## 510(k) Summary SensoMotoric Instruments 2D VOG -- Video-Oculography®

K972243

| Sponsor: | SensoMotoric Instruments, GmbH (“SMI”)<br>Potsdamer Str. 18a<br>14513 Teltow<br>GERMANY<br>011-49-3328-430-300 (telephone)<br>Contact: Annikki Persson, Product Manager for Medical Applications |
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| Trade Name: | 2D VOG - Video-Oculography® |
| Common Name: | Nystagmograph |
| Classification: | Class II, 21 C.F.R. § 882.1460, Nystagmograph |
| Device Description: | The 2D VOG measures horizontal and vertical eye movements and analyzes the eye<br>movements for nystagmus beats and velocity. The results are visually displayed in<br>different diagrams and are stored in a patient manager together with patient data.<br>The device is intended to provide information for use by the health care<br>professional, in conjunction with other clinically relevant information, in the<br>diagnosis of vestibular disorders.<br><br>The 2D VOG consists of a video camera mounted in a mask to record eye<br>movements, an image processing board to digitize and analyze eye movement data,<br>a video-overlay board and PC for real time display of eye movements, and software<br>to analyze and display eye movement data. The system has a patient database for<br>storage of patient data and results.<br><br>The 2D VOG system software is used for nystagmus analysis during spontaneous<br>nystagmus, caloric. smooth pursuit, optokinetic, rotation, positional, and saccadic<br>examinations. |
| Substantial Equivalence Determination: | The 2D VOG is substantially equivalent the House Infrared/Video |

Electronystagmograph System marketed by Eye Dynamics, Inc. Both devices use similar technology, including PC and computer monitor, masks mounted with video cameras, and software for performing spontaneous, caloric, positional, rotational, optokinctic, saccadic, and smooth pursuit examinations. The devices utilize the same sampling rate and illumination wavelength.

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle's head and neck, formed by three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1997

Ms. Annikki Persson Product Manager Medical Applications SensoMotoric Instruments, GmbH Potsdamer Straße 18a D - 14513 Teltow GERMANY 14513

K972243 Re: 2D VOG - Video-Oculography Trade Name: Requlatory Class: II Product Code: 84GWN Dated: June 11, 1997 Received: June 16, 1997

Dear Ms. Persson:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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

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Page 2 - Ms. Annikki Persson

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "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 [phone] or at [phone].

Sincerely yours,

Thomas J. Callahon

Thomas J. Callaban, 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) Number (if known):

ﻳ

972243

2D VOG -- Video-Oculography Device Name: _

Indications For Use:

The 2D VOG -- Video-Oculography system provides information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye.

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Concurrence of CDRH, Office of Device Evaluation (

Thomas J. Callahan

(Division Sign-Off) Division of Cardiovascular, R and Neurological Devic 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)