(163 days)
No
The summary describes software that analyzes eye movements based on a standard VNG protocol and compares results to predicate devices, without mentioning AI or ML techniques.
No
The device is used for diagnostic purposes, providing information to assist in the evaluation, diagnosis, and documentation of vestibular disorders, rather than actively treating them.
Yes
The "Intended Use / Indications for Use" states that "The VisualEyes system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders." This explicitly mentions diagnosis as an intended use.
No
The device description explicitly states that the software analyzes eye movements recorded from a camera mounted to a video goggle. While the 510(k) is for the software update, the system as a whole includes hardware (the camera and goggle) which is integral to its function.
Based on the provided information, the VisualEyes system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- VisualEyes Function: The VisualEyes system analyzes eye movements recorded by cameras mounted on goggles. It does not analyze specimens taken from the body. Instead, it directly measures a physiological response (eye movement) in a living patient.
- Intended Use: The intended use is to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders by analyzing eye movements. This is a direct measurement of a physiological function, not an analysis of a biological sample.
Therefore, the VisualEyes system falls under the category of a medical device that performs a physiological measurement, rather than an In Vitro Diagnostic device.
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 VisualEyes system is 5 years of age and above.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Eye
Indicated Patient Age Range
5 years of age and above
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)
Study type: Bench testing and beta testing.
Sample size: Not specified.
Data source: Internal bench testing and external beta testing with various groups in different geographical locations.
Key results: There were no differences found in internal bench testing comparisons or the external beta testing statistical comparisons. VisualEyes 505/515/525 performs substantially equivalent to the predicate devices used for the validation. For the statistical comparison, all data sets showed a negligible statistical difference beneath the specified acceptance criteria.
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.
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).
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August 12, 2020
Interacoustics A/S Erik Nielson Director, Regulatory & Compliance Audiometer Alle 1 Middelfart, 5500 Denmark
Re: K200534
Trade/Device Name: VisualEyes Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: July 10, 2020 Received: July 13, 2020
Dear Erik Nielson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Malvina Eydelman, M.D. Office Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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3
Indications for Use
510(k) Number (if known) K200534
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 VisualEyes system is 5 years of age and above
| 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) |
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510(K) SUMMARY
VisualEyes 505/515/ 525
Submitter Information:
Company Name Address
Phone Fax e-mail Contact Person Date Summary Prepared Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark +45 6371 3555 +45 6371 3522 erni@demant.com Erik Nielsen, Director, Regulatory & Compliance August 07, 2020
Device Identification:
Trade Name
Common Name Classification Name Product Code Class Panel Device Class
Predicate Device: Predicate Device Manufacturer 510(k) No. Date Cleared
Reference devices: Reference Device Manufacturer 510(k) No. Date Cleared
Reference Device Manufacturer 510(k) No. Date Cleared
VisualEyes 505 VisualEyes 515 VisualEyes 525 Vestibular analysis device Nystagmograph, apparatus, vestibular analysis GWN Neurology Class II (According to 21 CFR 882.1460)
VisualEyes 505/515/ 525 Interacoustics A/S K163149 04/26/2017
VIDEO EYE TRAKKER (Aka Spectrum) MicroMedical Technologies Inc K964646 07/15/1997
EyeSeeCam VHIT Interacoustics A/S K131681 09/06/2013
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VisualEyes 505/515/ 525 is a software program that analyzes eye Device movements recorded from a camera mounted to a video goggle. A Description 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:
| Test | Availability |
|---|---|
| Calibration | 515 / 525 |
| Spontaneous nystagmus | 515 / 525 |
| Dix-Hallpike | 515 / 525 |
| Positional | 515 / 525 |
| Caloric | 515 / 525 |
| Gaze | 525 |
| Smooth Pursuit | 525 |
| Random Saccade | 525 |
| Saccadometry | 525 |
| Optokinetic | 525 |
| Sinusoidal Harmonic Acceleration | 515/525 |
| Step Velocity | 515/525 |
| VOR Suppression | 515/525 |
| Visual VOR | 515/525 |
| Subjective Visual Vertical (SVV)- Static | 525 |
| Subjective Visual Vertical (SVV)- | |
| Dynamic | 525 |
| Video Frenzel | 525 |
| Ocular Counter Roll | 525 |
| VORTEQ AHR | 525 |
| vHIT for VORTEQ | 525 |
| Dynamic Visual Acuity (DVA) | 515/ 525/505 |
| Dix-Hallpike Advanced | |
| Lateral Head Roll | |
| vHIT for EyeSeeCam | |
| - Lateral | |
| - LARP | 515/525/505 |
| - RALP |
- SHIMP | |
| Video recording | 505 |
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| 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 and above. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
characteristics | The VisualEyes is a software system is intended to incorporate
various goggle/cameras, rotary chairs, irrigators and other
accessories |
Comparison of technological characteristics with predicate device
We have chosen to compare the VisualEyes 3 software with the VisualEyes 2 as the characteristics of VisualEyes 3 is most similar to VisualEyes 2. The technological principles for VisualEyes 3 is based on refinements from VisualEyes 2 and adoptions of functionality of the two reference devices.
Comparison tables
VisualEyes 3 to Predicate Device VisualEyes 2
| Functionality Description | 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 and above | Same |
| Spontaneous Nystagmus Test | Same |
| Gaze Test | Same |
| Smooth Pursuit Test | Same |
| Saccade Test | Same |
| Optokinetic Test | Same |
| Dix-Hallpike Test | Same |
| Positional Test | Same |
| Caloric Test | Same |
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| SHA Test | Same |
|---|---|
| Step Test | Same |
| VOR Suppression Test | Same |
| Saccadometry | This is the same. |
| Saccadometry is a broad term that means saccadic | |
| eye movements being measured. The VisualEyes | |
| saccade test involves a single stimulus (dot) moving | |
| from one position to the other. The patient either | |
| looks to or away from the dot. There is no | |
| difference in the stimulus presentation between the | |
| predicate and new software. The only difference is | |
| that for the antisaccade the patient looks away from | |
| the target instead of towards the target. The exact | |
| same measures of latency, accuracy and velocity | |
| are recorded and plotted. | |
| Since the stimulus presented and the algorithms | |
| have not changed for the saccade tests there are | |
| no device safety or effectiveness differences | |
| between the two devices. | |
| Advanced Dix Hallpike Test | This is the same. |
| For the Advanced Dix Hallpike there are no | |
| changes in how the test is performed. The only | |
| change was the inclusion of the new torsional eye | |
| tracker from Johns Hopkins. This has been verified | |
| and demonstrates that there are no device safety or | |
| effectiveness differences between the two devices. |
VisualEyes 3 software also adopts functions from the Micromedical Technologies Spectrum software as the Spectrum supports many of the protocols that are being ported into VisualEyes 3.
The VHIT function is adopted into VisualEyes 3 software from EyeSeeCam VHIT
Functionality adopted from reference device VIDEO EYE TRAKKER
| Functionality Description | Equivalence |
|---|---|
| ENG | Same |
| Ocular Counter roll | Uses the Johns Hopkins torsional algorithm not the |
| Spectrum tracking algorithm | |
| VORTEQ Active Head Rotation (AHR) | Same |
| VORTEQ Dynamic Visual Acuity (DVA) | Same |
| VORTEQ Video Head Impulse Test (vHIT) | Same |
| Dynamic Subjective Visual Vertical (SVV) in | |
| Orion AT chair | Same |
| Static Subjective Visual Vertical in the Orion | |
| Comprehensive Chair | Same |
| Torsional Tracking Algorithm | This is the same. |
| Improved in release VisualEyes 3 with the addition | |
| of libraries from Johns Hopkins. This has been | |
| verified and demonstrates that there are no device | |
| safety or effectiveness differences between the two | |
| devices. |
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| Functionality adopted from reference device EyeSeeCam | |
|---|---|
| Functionality Description | Equivalence |
| vHIT | Same |
Verification and validation summary
In order to validate the new software, bench testing was conducted internally, and beta testing was conducted with various groups in different geographical locations externally. The purpose of the testing is to confirm that the results collected on the updated VisualEyes software generated the same clinical findings as the existing predicate devices.
The beta testing was conducted in external sites that had either MMT or IA existing predicate devices. All data was exported from the external beta sites and transferred to licensed internal clinical audiologists who compared the test results for substantial equivalency. The data was collected sequentially, which involved having the same subject tested on VisualEyes and then tested again on either IA or MMT predicate devices. The data sets were compared to determine if there were any statistically significant differences in the data collected from predicate and current devices.
Summary
There were no differences found in internal bench testing comparisons or the external beta testing statistical comparisons. VisualEyes 505/515/525 performs substantially equivalent to the predicate devices used for the validation.
For the statistical comparison, all data sets showed a negligible statistical difference beneath the specified acceptance criteria.
It is the professional opinion of both clinical reviewers of the validation that all the data between the new VisualEyes software and the data collected and analyzed with both predicate devices are substantially equivalent. There are no differences between any of the products tested.
Conclusion
We have compared key issues for the VisualEyes 505/515/ 525 and the predicate devices. We have performed a comparison validation between VisualEves 505/515/ 525 and the 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.
We trust that the results of these comparisons demonstrate that the VisualEyes 505/515/ 525 is substantially equivalent to the marketed predicate devices (K163149).