(86 days)
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.
The 2D VOG measures horizontal and vertical eye movements and analyzes the eye movements for nystagmus beats and velocity. The results are visually displayed in different diagrams and are stored in a patient manager together with patient data. The device is intended to provide information for use by the health care professional, in conjunction with other clinically relevant information, in the diagnosis of vestibular disorders.
The 2D VOG consists of a video camera mounted in a mask to record eye movements, an image processing board to digitize and analyze eye movement data, a video-overlay board and PC for real time display of eye movements, and software to analyze and display eye movement data. The system has a patient database for storage of patient data and results.
The 2D VOG system software is used for nystagmus analysis during spontaneous nystagmus, caloric. smooth pursuit, optokinetic, rotation, positional, and saccadic examinations.
The provided text describes a 510(k) submission for the SensoMotoric Instruments 2D VOG - Video-Oculography device, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria.
The document is a summary of the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device. It primarily focuses on the regulatory aspects for market clearance rather than detailed performance study results.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or clinical study designs, as this information is not present in the provided text.
The closest information available related to performance is the statement: "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." This indicates that the device's technical specifications and intended use mirror those of the predicate device, but no performance metrics are given.
{0}------------------------------------------------
SEP 1 0 1997
510(k) Summary SensoMotoric Instruments 2D VOG -- Video-Oculography®
| Sponsor: | SensoMotoric Instruments, GmbH (“SMI”)Potsdamer Str. 18a14513 TeltowGERMANY011-49-3328-430-300 (telephone)Contact: Annikki Persson, Product Manager for Medical Applications |
|---|---|
| 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 eyemovements for nystagmus beats and velocity. The results are visually displayed indifferent diagrams and are stored in a patient manager together with patient data.The device is intended to provide information for use by the health careprofessional, in conjunction with other clinically relevant information, in thediagnosis of vestibular disorders.The 2D VOG consists of a video camera mounted in a mask to record eyemovements, an image processing board to digitize and analyze eye movement data,a video-overlay board and PC for real time display of eye movements, and softwareto analyze and display eye movement data. The system has a patient database forstorage of patient data and results.The 2D VOG system software is used for nystagmus analysis during spontaneousnystagmus, caloric. smooth pursuit, optokinetic, rotation, positional, and saccadicexaminations. |
| 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.
{1}------------------------------------------------
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
{2}------------------------------------------------
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "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 at (301) 443-6597.
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
{3}------------------------------------------------
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 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).