(175 days)
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.
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.
The provided text is a 510(k) summary for the Interacoustics 2D-VOGfw System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device "meets acceptance criteria" in the way a clinical trial for a novel device would. Therefore, the information typically requested in your prompt (e.g., sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not present specific acceptance criteria in a quantitative table format. Instead, it states that "The performance data indicated that the 2D-VOGfw System meets all specified requirements, and is substantially equivalent to the predicate device."
The "performance" in this context refers to the technological characteristics comparing the new device to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | The 2D-VOGfw System meets all specified requirements and is substantially equivalent to the predicate device (2D VOG-Videooculography, K972243). |
| Intended Use Match | Provides information to assist in oculographic evaluation, diagnosis, and documentation of vestibular disorders by recording, measuring, displaying, and storing nystagmus images for trained medical professionals. |
| Technological Characteristics | Comparison of technological characteristics demonstrated equivalence to the marketed predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document refers to "performance data" but does not detail how this data was generated (e.g., retrospective or prospective studies, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a 510(k) summary focused on substantial equivalence, not a clinical study requiring expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The document does not describe a test set or an adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned. This device is a system for recording and displaying eye movements for diagnosis by a trained medical professional; it is not presented as an AI-driven diagnostic aid that would "improve" human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is explicitly stated to "assist in diagnosing vestibular disorders" by a "trained medical professional," indicating a human-in-the-loop system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, not on validating diagnostic accuracy against a specific ground truth.
8. The sample size for the training set:
- Not applicable. The device described does not appear to be an AI/machine learning model where a "training set" would be relevant in this context.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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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 8Assens, DK-5610, Denmark | FEB - 5 2008 |
| C | Company Phone:Company Fax: | +45 6371 3555+45 6371 3522 | |
| D | Contact Person: | Hanne NielsenQuality ManagerInteracoustics A/S | |
| E | Date Summary Prepared: | 30/07/2007 | |
| DEVICE IDENTIFICATION | |||
| A | Generic Device Name: | Nystagmograph | |
| B | Trade/proprietary Name: | 2D-VOGfw System2D-VOGfw goggleVN415mVN415bVO425mVO425b | |
| C | Classification: | Class II | |
| D | Product Code: | GWN |
SUBSTANTIAL EQUIVALENCE
| Predicate Device | Manufacture | 510(k) No. | Date Cleared |
|---|---|---|---|
| 2D VOG-Videooculography | SensoMotoricInstruments | K972243 | 09/10/1997 |
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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.
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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.
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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.
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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
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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
Page __ of ___
§ 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).