(168 days)
No
The description focuses on standard video nystagmography protocols and algorithms for analyzing eye movements, with no mention of AI or ML techniques. The performance study compares the device's algorithms to a predicate device, not an AI/ML model.
No.
The device is clearly stated to provide information to assist in the "evaluation, diagnosis and documentation of vestibular disorders" and to "assist in diagnosing vestibular disorders," but it does not treat or cure them.
Yes
The "Intended Use / Indications for Use" states that the system provides "information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders," directly indicating its role in diagnosis.
No
The device description explicitly states that the system consists of a head mounted goggle/mask, a camera unit, and a software application, indicating it includes hardware components in addition to the software.
Based on the provided information, the VisualEyes system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The VisualEyes system analyzes eye movements recorded by a camera, which is a physiological measurement, not a specimen taken from the body (like blood, urine, tissue, etc.).
- The intended use is to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. This involves observing and analyzing a physiological response (eye movement) in a living patient.
- The device description focuses on analyzing eye movements recorded from a camera mounted to a video goggle. This reinforces that the input is a video of the eye, not a biological sample.
Therefore, the VisualEyes system falls under the category of a medical device that performs a physiological measurement and analysis, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VisualEyes system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with 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. The target population for VisualEves system is 5 years of age+
Product codes
GWN
Device Description
VisualEyes 505/515/ 525 is a software program that analyzes eye movements recorded from a camera mounted to a video goggle. A standard Video Nystagmography (VNG) protocol is used for the testing. VisualEyes 505/515/ 525 is and update/change, replacing the existing VisualEyes 515/525 release 1 (510(k) cleared under K152112). The software is intended to run on a Microsoft Windows PC platform. The "525" system is a full featured system (all vestibular tests as listed below) while the "515" system has a subset of the "525″ features. "505″ is a simple video recording mode. The VisualEyes 505/ 515/ 525 software is designed to perform the following vestibular tests: ● Spontaneous Nystagmus Test (Included in: VisualEyes 525 and 515) Gaze Test (Included in: VisualEyes 525) ● ● Smooth Pursuit Test (Included in: VisualEyes 525) Saccade Test (Included in: VisualEyes 525) ● ● Optokinetic Test (Included in: VisualEyes 525) ● Dix-Hallpike (Included in: VisualEyes 525 and 515) ● Positional Test (Included in: VisualEyes 525 and 515) ● Caloric Test (Included in: VisualEyes 525 and 515) . SHA (Included in: VisualEyes 525 and 515) ● Step (Included in: VisualEyes 525 and 515) ● Visual VOR (Included in: VisualEyes 525 and 515) ● VOR Suppression (Included in: VisualEyes 525 and 515) ● Visual Eyes 505 (included in VisualEyes 505)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video goggle mounted with cameras
Anatomical Site
Eye
Indicated Patient Age Range
5 years of age+
Intended User / Care Setting
The VisualEyes VNG system is to be used by trained personnel only, such as audiologists, ENT surgeons, doctor's, hearing healthcare professionals or personnel with a similar level of qualifications. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.
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)
Performance Tests: We presented a comparison of the subject device and the predicate devices to demonstrate that the key algorithms for detecting and analysing nystagmus were similar. The demonstration was carried out as a side by side comparison where the same patient was analysed by the subject device and the predicate device simultaneously. All tests were performed on test subjects with conjugate eye movements. This means that an eye movement on one eye will match the movement of the other eye. One camera recorded the left eye and was processed in the predicate device and the other recorded the right eye and was processed in subject device. All results showed equivalence between the predicates and the subject, this means that results processed in predicates are showing equivalence to results from the subject device.
Clinical tests: We have performed clinical comparisons between the three systems. These activities, testing and validation show that VisualEyes 505/515/ 525 perform as specified and is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that create the impression of a head, body, and tail.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2017
Interacoustics A/S Mr. Erik Nielsen Director, Regulatory & Compliance Audiometer Allé 1 Middelfart 5500 Denmark
Re: K163149
Trade/Device Name: VisualEyes Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: March 24, 2017 Received: March 29, 2017
Dear Mr. Nielsen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163149
Device Name
VisualEyes 515 / VisualEyes 525 / VisualEyes 505
Indications for Use (Describe)
The VisualEyes system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with 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. The target population for VisualEves system is 5 years of age+
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 05 - 510(k) Summary
4
510(K) SUMMARY
VisualEyes 505/515/ 525
Submitter Information:
| Company Name |
|---|
| Address |
Phone Fax e-mail Contact Person Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark +45 6371 3555 +45 6371 3522 erni@dgs.com Erik Nielsen, Director, Regulatory & Compliance, November 1, 2016
Date Summary Prepared
Device Identification:
Trade Name
Common Name Classification Name Product Code Class Panel Device Class
Predicate Device 1:
Predicate Device Manufacturer 510(k) No. Date Cleared
Predicate Device 2:
Predicate Device Manufacturer 510(k) No. Date Cleared
VisualEyes 515/ 525 Interacoustics A/S K152112 12/29/2015
Vestibular analysis device
Nystagmograph, apparatus, vestibular analysis
Class II (According to 21 CFR 882.1460)
VisualEyes 505 VisualEyes 515 VisualEyes 525
GWN
Neurology
VIDEO EYE TRAKKER Micromedical Technologies Inc. K964646 07/15/1997
5
characteristics
VisualEyes 505/515/ 525 is a software program that analyzes eye movements Device Description recorded from a camera mounted to a video goggle. A standard Video Nystagmography (VNG) protocol is used for the testing. VisualEyes 505/515/ 525 is and update/change, replacing the existing VisualEyes 515/525 release 1 (510(k) cleared under K152112). The software is intended to run on a Microsoft Windows PC platform. The "525" system is a full featured system (all vestibular tests as listed below) while the "515" system has a subset of the "525″ features. "505″ is a simple video recording mode. The VisualEyes 505/ 515/ 525 software is designed to perform the following vestibular tests: ● Spontaneous Nystagmus Test (Included in: VisualEyes 525 and 515) Gaze Test (Included in: VisualEyes 525) ● ● Smooth Pursuit Test (Included in: VisualEyes 525) Saccade Test (Included in: VisualEyes 525) ● ● Optokinetic Test (Included in: VisualEyes 525) ● Dix-Hallpike (Included in: VisualEyes 525 and 515) ● Positional Test (Included in: VisualEyes 525 and 515) ● Caloric Test (Included in: VisualEyes 525 and 515) . SHA (Included in: VisualEyes 525 and 515) ● Step (Included in: VisualEyes 525 and 515) ● Visual VOR (Included in: VisualEyes 525 and 515) ● VOR Suppression (Included in: VisualEyes 525 and 515) ● Visual Eyes 505 (included in VisualEyes 505) The VisualEyes system provides information to assist in the Indications for Use nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with cameras. These images are measured, displayed and stored in the software. This information then can be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for VisualEyes system is 5 years of age+ Intended operator The VisualEyes VNG system is to be used by trained personnel only, such as audiologists, ENT surgeons, doctor's, hearing healthcare professionals or personnel with a similar level of qualifications. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted. Technological The system consists of a head mounted goggle/mask, a camera unit and a
software application running on a standard PC.
6
We have chosen to compare the VisualEyes 505/ 515/ 525 software with current VisualEyes 515/525 and VIDEO EYE TRAKKER (a.k.a. SPECTRUM) for the following reasons.
- VisualEyes 505/ 515/ 525 (VisualEyes revision 2) is an update/change of the VisualEyes ● 515/ 525 (VisualEyes revision 1)
- . Video Eye Trakker includes the updated functionality in VisualEyes revision 2 and has been used for rotational chair tests.
- . The predicate systems have the same medical purpose so it is easy to compare validation results.
- Both predicate systems have previously obtained FDA 510(k) clearance
Comparison table
VisualEyes 505/515/ 525 (revision 2) Versus VisualEyes 515/ 525 (revision 1)
| NOTE: In the comparisons table the tests present full system ("525" system). | |
|---|---|
| Description | VisualEyes 515/ 525 (rev 1) | VisualEyes 505/515/ 525 (rev 2) | Equivalence |
|---|---|---|---|
| Indications | |||
| for use | The VisualEyes system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with 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. The target population for VisualEyes system is 5 years of age+ | The VisualEyes system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with 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. The target population for VisualEyes system is 5 years of age+ | Same |
| Test options | Spontaneous Nystagmus Test | Spontaneous Nystagmus Test* | Same. |
| This test is as described in | |||
| ANSI S3.45 section 5 | |||
| Gaze Test | Gaze Test | Same | |
| This test is as described in | |||
| ANSI S3.45 section 5 | |||
| Smooth Pursuit | Smooth Pursuit | Same | |
| This test is as described in | |||
| ANSI S3.45 section 7 |
7
| Description | VisualEyes 515/ 525 (rev 1) | VisualEyes 505/515/ 525 (rev 2) Equivalence | |
|---|---|---|---|
| Saccade Test | Saccade Test | Same | |
| This test is as described in | |||
| ANSI S3.45 section 6 | |||
| Optokinetic Test | Optokinetic Test | Same | |
| This test is as described in | |||
| ANSI S3.45 section 8 | |||
| Dix-Hallpike | Dix-Hallpike* | Same | |
| This test is as described in | |||
| ANSI S3.45 section 8 | |||
| Positional Test | Positional Test* | Same | |
| This test is as described in | |||
| ANSI S3.45 section 8 | |||
| Caloric Test | Caloric Test* | Same | |
| This test is as described in | |||
| ANSI S3.45 section 9 | |||
| Video recording mode | Video recording mode (VE505) | Same. | |
| Reporting tools | Reporting tools | Same | |
| Algorithms | IA Curver tracker | IA Curve tracker | Same – An algorithm |
| comparison evaluation | |||
| has been performed. This | |||
| evaluation shows high | |||
| correlation between the | |||
| algorithm used in the | |||
| predicate device and the | |||
| new as the algorithms are | |||
| the same | |||
| Hardware | |||
| Platform | 2D-VOG GOGGLES, 2D-VOG | ||
| SYSTEM | 2D-VOG GOGGLES, 2D-VOG | ||
| SYSTEM | Same |
All tests are included in the VisualEyes 525. Tests marked with * is the only tests present in the VisualEyes ਵਰਤ
8
Comparison table
VIDEO EYE TRAKKER (K964646) Versus VisualEyes 515/ 525
Note. The VIDEO EYE TRAKKER (K964646) is currently marketed under the name SPECTRUM software for the Micromedical VisualEyes
| Description | VIDEO EYE TRAKKER | VisualEyes 515/ 525 | Equivalence |
|---|---|---|---|
| Indications | |||
| for use | The device is used to non-invasively | ||
| record horizontal and vertical eye | |||
| movements of patients during | |||
| routine electronystagmography | |||
| (ENG) testing of vestibular function | |||
| using miniature video cameras and | |||
| pupil tracking hardware. | |||
| The device is an alternative to skin | |||
| electrodes and a physiologic signal | |||
| amplifier for monitoring eye | |||
| position. | The VisualEyes system provides | ||
| information to assist in the | |||
| nystagmographic evaluation, | |||
| diagnosis and documentation of | |||
| vestibular disorders. Nystagmus | |||
| of the eye is recorded by use of | |||
| a goggle mounted with 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. | |||
| The target population for | |||
| VisualEyes system is 5 years of | |||
| age+ | Similar | ||
| See discussion of | |||
| indications for use | |||
| below. | |||
| SHA (Sinusoidal Harmonic Test) | SHA (Sinusoidal Harmonic Test) | Same | |
| See discussion below | |||
| this table | |||
| Step Test | Step Test | Same | |
| See discussion below | |||
| this table | |||
| Visual VOR | Visual VOR | Same | |
| See discussion below | |||
| this table | |||
| Visual Suppression | Visual Suppression | Same | |
| See discussion below | |||
| this table |
9
Discussion, Similarities in indications for use
Note. This is identical with the discussion in the 510(k) submission for revision 1 of VisualEyes system
| VIDEO EYE TRAKKER | VisualEyes | Discussion |
|---|---|---|
| Routine | ||
| electronystagmography | Assists in the | |
| nystagmographic | ||
| evaluation, diagnosis and | ||
| documentation of | ||
| vestibular disorders | The term | |
| "electronystagmography" | ||
| is not relevant in this | ||
| application as video is | ||
| used but "Routine | ||
| nystagmography" and | ||
| "nystagmographic | ||
| evaluation" have | ||
| equivalence indications | ||
| Using miniature video | ||
| cameras and pupil tracking | ||
| hardware | Recorded by use of a | |
| goggle mounted with | ||
| cameras | Camera method is | |
| identical | ||
| No population age limits | Population limit is age | |
| above 5 years | The age limitation (5 | |
| years of age +) has been | ||
| added as the system is | ||
| not designed for children | ||
| under 5 as the goggle | ||
| does not fit very small | ||
| faces well. We appraise | ||
| it as similar indications | ||
| as it is a practical | ||
| restriction. |
VIDEO EYE TRAKKER vs. VisualEyes
Summary of IFU similarities
We appraise that the slightly different phrasing in the indications for use are the only deviation in the comparisons. The deviations are discussed above and appraised to be substantially equivalent and hence do not raise any issues regarding safety and efficiency
Performance Tests
We presented a comparison of the subject device and the predicate devices to demonstrate that the key algorithms for detecting and analysing nystagmus were similar. The demonstration was carried out as a side by side comparison where the same patient was analysed by the subject device and the predicate device simultaneously. All tests were performed on test subjects with conjugate eye movements. This means that an eye movement on one eye will match the movement of the other eye. One camera recorded the left eye and was processed in the predicate device and the other recorded the right eye and was processed in subject device. All results showed equivalence between the predicates and the subject, this means that results processed in predicates are showing equivalence to results from the subject device.
10
Clinical tests
We have performed clinical comparisons between the three systems. These activities, testing and validation show that VisualEyes 505/515/ 525 perform as specified and is safe and effective.
Discussion of differences
We did not find any essential or major differences between the devices.
Conclusion
We have compared key issues for the VisualEyes 505/515/ 525 and the predicate devices. We have performed a comparison validation between VisualEyes 505/515/ 525 and the predicate devices. All similarities and differences have been discussed. We trust that the results of these comparisons demonstrate that the VisualEyes 505/515/ 525 is substantially equivalent to the marketed predicate devices.
Any deviations between VisualEyes 505/515/ 525 and predicate devices are appraised to have no adverse effect on the safety and effectiveness of the device.