(175 days)
Not Found
No
The summary describes image processing and measurement of eye movements but does not mention AI, ML, or any related concepts like deep learning or neural networks. The focus is on recording, displaying, and storing data for a trained professional to interpret.
No.
The device's stated intended use is to "provide information to assist in the Oculographic evaluation, diagnosis and documentation of vestibular disorders" and the information can be used by a "trained medical professional to assist in diagnosing vestibular disorders." It records and measures eye movements for diagnostic purposes, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems "provide information to assist in the Oculographic evaluation, diagnosis and documentation of vestibular disorders."
No
The device description explicitly states that the system consists of a PC or Laptop, 2D-VOG Goggles (comprising housing and cameras), and a software platform. The goggles are a hardware component essential for acquiring the video data.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that this system records and analyzes images of the eye (specifically nystagmus) using goggle-mounted cameras. This is a direct observation and measurement of a physiological process, not the analysis of a biological sample (like blood, urine, tissue, etc.) taken from the body.
- The focus is on Oculographic evaluation. The system is designed to assist in the "Oculographic evaluation, diagnosis and documentation of vestibular disorders" by recording eye movements. This is a form of physiological measurement and analysis, not an in vitro test.
Therefore, while this device is used for diagnostic purposes, it falls under the category of a medical device that performs physiological measurements and analysis, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VN415m, VN415b, VO425m, VO425b systems provide information to assist in the Oculographic evaluation, diagnosis and documentation of vestibular disorders.
Nystagmus of the eye is recorded by use of goggle mounted cameras. These images are measured, recorded, displayed and stored in the software. This information then can be used by a trained medical professional to assist in diagnosing vestibular disorders.
Product codes (comma separated list FDA assigned to the subject device)
GWN
Device Description
This system consists of a PC or Laptop (requirements specified), a 2D-VOG% Goggle and a software platform that by licensing enables different levels of functionality recognized as the VN415m, VN415b, VO425m, VO425b products.
The 2D-VOGry Goggles component comprises housing and one or two cameras depending on the license obtained for this system. Cameras number two can be added to the 2D-VOGm Goggles afterwards with the goades by uparading the product license. The 2D-VOGry Goggles may be added to other products within the 2D-VOGw System in the future.
The 2D-VOG% Goggle is connected to the PC via a standard Firewire connection.
Optionally a rotating chair can be added to the 2D-VOGw System. The chair shall meet our specifications developed for compliance with the 2D-VOGn System.
Functionalities of the products may be controlled by a remote control and/or a foot switch. These controls are connected to the PC via a wireless connection by means of a USB wireless receiver/transmitter.
Test results and reports are formatted and printed by the 2D-VOGw System software. A database containing test results and other patient information can be located and shared on the PC.
Mentions image processing
Nystagmus of the eye is recorded by use of goggle mounted cameras. These images are measured, recorded, displayed and stored in the software.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nystagmus of the eye is recorded by use of goggle mounted cameras.
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professional
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)
The performance data indicated that the 2D-VOGw System meets all specified requirements, and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/1 description: The image shows a logo for Interacoustics. The logo is an oval shape with a globe design. The word "Interacoustics" is written in bold, sans-serif font inside the oval.
2D-VOGFw System 510k Notification
Author Hanne Nielsen
Revision 1
510(K) SUMMAREY OF SAFETY AND EFFECTIVENESS 2D-VOGw System
SUBMITTER INFORMATION
| A | Company Name: | Interacoustics A/S | |
|---|---|---|---|
| B | Company Address: | Drejervaenget 8 | |
| Assens, DK-5610, Denmark | FEB - 5 2008 | ||
| C | Company Phone: | ||
| Company Fax: | +45 6371 3555 | ||
| +45 6371 3522 | |||
| D | Contact Person: | Hanne Nielsen | |
| Quality Manager | |||
| Interacoustics A/S | |||
| E | Date Summary Prepared: | 30/07/2007 | |
| DEVICE IDENTIFICATION | |||
| A | Generic Device Name: | Nystagmograph | |
| B | Trade/proprietary Name: | 2D-VOGfw System | |
| 2D-VOGfw goggle | |||
| VN415m | |||
| VN415b | |||
| VO425m | |||
| VO425b | |||
| C | Classification: | Class II | |
| D | Product Code: | GWN |
SUBSTANTIAL EQUIVALENCE
| Predicate Device | Manufacture | 510(k) No. | Date Cleared |
|---|---|---|---|
| 2D VOG- | |||
| Videooculography | SensoMotoric | ||
| Instruments | K972243 | 09/10/1997 |
1
Image /page/1/Picture/15 description: The image shows a logo for "Interacoustics". The logo is an oval shape with lines running horizontally and vertically to give the appearance of a globe. The word "Interacoustics" is written in a bold, sans-serif font across the center of the globe.
Author Hanne Nielsen
Revision 1
DEVICE DESCRIPTION
This system consists of a PC or Laptop (requirements specified), a 2D-VOG% Goggle and a software platform that by licensing enables different levels of functionality recognized as the VN415m, VN415b, VO425m, VO425b products.
The 2D-VOGry Goggles component comprises housing and one or two cameras depending on the license obtained for this system. Cameras number two can be added to the 2D-VOGm Goggles afterwards with the goades by uparading the product license. The 2D-VOGry Goggles may be added to other products within the 2D-VOGw System in the future.
The 2D-VOG% Goggle is connected to the PC via a standard Firewire connection.
Optionally a rotating chair can be added to the 2D-VOGw System. The chair shall meet our specifications developed for compliance with the 2D-VOGn System.
Functionalities of the products may be controlled by a remote control and/or a foot switch. These controls are connected to the PC via a wireless connection by means of a USB wireless receiver/transmitter.
Test results and reports are formatted and printed by the 2D-VOGw System software. A database containing test results and other patient information can be located and shared on the PC.
INTENDED USE
VN415m, VN415b, VO425m, VO425b systems provide information to assist in the Oculographic evaluation, diagnosis and documentation of vestibular disorders.
Nystagmus of the eye is recorded by use of goggle mounted cameras. These images are measured, recorded, displayed and stored in the software. This information then can be used by a trained medical professional to assist in diagnosing vestibular disorders.
2
Author Hanne Nielsen :
Image /page/2/Picture/2 description: The image shows the Interacoustics logo. The logo is an oval shape with a globe design inside. The word "Interacoustics" is written in a bold, sans-serif font across the center of the globe.
Revision 1
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the 2D-VOG%, System and the predicate device has been performed. The results of this comparison demonstrate that the 2D-VOG% System is equivalent to the marketed predicate device.
PERFORMANCE DATA
The performance data indicated that the 2D-VOGw System meets all specified requirements, and is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of 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 a stylized image of three human profiles facing to the right.
Public Health Service
FEB - 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Interacoustics A/S % Mr. Daniel Eggan Interacoustics USA 7625 Golden Triangle Drive Eden Prairie, MN 55344
Re: K072254
Trade/Device Name: VN415m, VN415b, VO425m, VO425b, 2D-VOGfw Goggles, 2D-VOGfw System Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: January 16, 2008 Received: January 17, 2008
Dear Mr. Eggan:
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.
4
Page 2 – Mr. Daniel Eggan
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Applicant: Interacoustics A/S
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VN415m, VN415b, VO425m, VO425b
Indications For Use:
VN415m, VN415b, VO425m, VO425b systems provide information to assist in the Oculographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of goggle mounted cameras. These images are ryolaghad of the ed and stored in the software. This information then can be modell'oa, rocerated, aleplay of sist in diagnosing vestibular disorders.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nufm Rumm
Division of General, Restorative
(Per 21 CFR 801.109)
and Neurologic
510(k) Number LO72 257
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