Insight Infrared Video Goggles

K203082 · Vestibular First · GWN · Nov 12, 2020 · Neurology

Device Facts

• Record ID: K203082
• Device Name: Insight Infrared Video Goggles
• Applicant: Vestibular First
• Product Code: GWN · Neurology
• Decision Date: Nov 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Insight Infrared Video Goggles are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.

Device Story

Insight Infrared Video Goggles capture eye movement video for vestibular disorder assessment. Device consists of light-proof goggles with two infrared cameras (940 nm) and internal LEDs; connects to a computer via 4m USB cable. Clinician operates device in clinical setting; goggles block external light to prevent visual fixation, allowing observation of nystagmus. System displays and records video on computer using off-the-shelf software. Clinician views output to identify vestibular disorders; device provides no automated diagnosis or recommendations. Benefits include objective visualization of eye movements during vestibular exams (spontaneous, gaze-evoked, positional).

Clinical Evidence

Bench testing only. Comparative performance study conducted with 5 subjects; two trained clinicians compared Insight Infrared Video Goggles against VisualEyes Video Eye Monitor (K964325). Evaluated spontaneous, gaze-evoked, and positional nystagmus. Insight goggles achieved 100% pass rate for clarity and viewing capability, demonstrating equivalent performance.

Technological Characteristics

Materials: PC+ABS, Silicone. Sensing: Two infrared cameras (940 nm). Energy: USB-powered via computer. Form factor: Goggles with face cushion, 4m USB cable. Connectivity: USB to computer. Software: Off-the-shelf viewing/recording software. Safety standards: ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 62471-1.

Indications for Use

Indicated for viewing and recording eye movements to assist in identifying vestibular disorders in patients aged 12 years and older. For use by trained healthcare professionals in clinical settings.

Regulatory Classification

Identification

A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Predicate Devices

• Micromedical VisualEyes 515/ 525 (K152112)
• 2D-VOGfw/VN415b system (K072254)

Reference Devices

• VisualEyes Video Eye Monitor (K964325)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 12, 2020

Vestibular First % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K203082

Trade/Device Name: Insight Infrared Video Goggles Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: October 10, 2020 Received: October 13, 2020

Dear Dave Yungvirt:

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.

{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 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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

Device Name Insight Infrared Video Goggles

#### Indications for Use (Describe)

The Insight Infrared Video Goggles are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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 [e-mail]

"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}------------------------------------------------

# K203082 510(k) Summary

Date Prepared: 11/4/2020

#### Submitter Information

Vestibular First 9 Mather Ave Broomall, PA 19008 United States VestibularFirst.com

## Contact Information

Connie Qiu

Regulatory Consultant

M-Squared Associates

[phone]

[e-mail]

### Device Identification

Proprietary Name - Insight Infrared Video Goggles

Common Name - Infrared Video Goggles, Video Frenzels, Video Goggles

Classification Name - Nystagmograph (21 CFR § 882.1460)

Product Code: GWN

Device Class: Class 2

Panel: Neurology

### Predicate Devices

Primary Predicate Device: Micromedical VisualEyes 515/ 525, K152112

{4}------------------------------------------------

#### Indications for Use

The Insight Infrared Video Goggles are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.

### Device Description

The Insight Infrared Video Goggles system displays and records eye movements on a computer from cameras mounted to goggles worn by a patient The eye movements called nystagmus are part of the body's balance system and can be analyzed by a trained clinician to provide objective information during a vestibular exam. The goggles are designed to block all external light from the patient's eyes so they are unable to fixate on anything in their visual field. This is an important performance characteristic of the googles since the eyes can suppress abnormal nystagmus when not occluded. The goggles have a durable plastic shell that houses two (2) cameras, infrared LED lights, two (2) switch-driven visible lights, and a face cushion. The goggles connect to the computer with a 4 m USB cable and are designed to be worn by the patient for 10 to 15 minutes on average in various body positions as directed by the clinician.

## Predicate Device Comparison

We have chosen to compare the Insight Infrared Video Goggles with the primary predicate device, VisualEyes 515/525 software (K152112) and the secondary predicate device, 2D-VOGfw/VN415b system for the following reasons:

- The predicate systems have the same classification (Class II) and product code (GWN)
- · The predicate systems, when used together as intended, use software on a computer to display and record eye movements recorded from cameras mounted

{5}------------------------------------------------

to a video goggle in the same manner as the Insight Infrared Video Goggles

- The predicate systems have the same or similar indications for use, intended . operator, and principle of operation, as described in detail in Table 1
- . Multiple predicate devices are necessary and appropriate to support substantial equivalence because the manufacturer Interacoustics A/S have separate hardware and software submissions to support multiple system configurations. Additionally, our primary predicate device specifically references our secondary predicate device as being the compatible hardware system for the software. The Insight Infrared Video Goggles combine both hardware and software components and each will be compared to their respective predicate device as applicable.

| | Insight Infrared Video<br>Goggles | Primary Predicate Device:<br>VisualEyes 515/525<br>(K152112 ) | Secondary Predicate<br>Device: 2D-VOGfw<br>System/VN415b (K072254) | Equivalence |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II | Same |
| Product Code | GWN | GWN | GWN | Same |
| Device Description | The Insight Infrared Video<br>Goggles system displays and<br>records eye movements<br>recorded from cameras<br>mounted to a video goggle.<br>The videos can be used by a<br>trained medical professional to<br>assist in diagnosing vestibular<br>disorders. | VisualEyes 515/525 is a<br>software program that<br>displays, records, and<br>analyzes eye movements<br>recorded from a camera<br>mounted to a video goggle.<br>This system can utilize the<br>2D-VOGfw/VN415b system<br>which is the subject of the<br>hardware comparison. The<br>videos can be used by a<br>trained medical professional<br>to assist in diagnosing<br>vestibular disorders. | This system consists of a PC<br>or laptop, a 2D-VOGfw<br>Goggle, and a software<br>platform that by licensing<br>enables different levels of<br>functionality recognized as<br>the VN415m, VN415b,<br>VO425m, VO425b products.<br>The "m" indicates<br>monocular, and the "b"<br>indicates binocular,<br>indicating the number of<br>cameras utilized by the<br>related system. The<br>2D-VOGfw Goggles<br>component comprises<br>housing and one or two<br>cameras depending on the<br>license obtained for this<br>system. The 2D-VOGfw<br>Goggle is connected to the<br>computer via a standard<br>Firewire connection. | Similar.<br>The 515/525 software has the<br>additional feature of eye<br>tracking and related data<br>analysis. The<br>2D-VOGfw/VN415b system can<br>be used for an additional<br>assessment known as caloric<br>testing. These differences do<br>not raise new questions of<br>safety or effectiveness. |

| Table 1 - Substantial Equivalence Comparison | |
|----------------------------------------------|--|
|----------------------------------------------|--|

{6}------------------------------------------------

| Indications for use | The Insight Infrared Video<br>Goggles are intended for<br>viewing and recording eye<br>movements in support of<br>identifying vestibular disorders<br>in patients. The device is<br>intended for use only by a<br>trained healthcare<br>professional in an appropriate<br>healthcare setting. This device<br>provides no diagnoses nor<br>does it provide diagnostic<br>recommendations. The target<br>population is 12+ years of<br>age. | The VisualEyes 515/525<br>system provides information<br>to assist in the<br>nystagmographic evaluation,<br>diagnosis and<br>documentation of vestibular<br>disorders. Nystagmus of the<br>eye is recorded by the use of<br>a goggle mounted with<br>cameras. These images are<br>measured, recorded,<br>displayed, and stored in the<br>software. This information<br>then can be used by a<br>trained medical professional<br>to assist in diagnosing<br>vestibular disorders. The<br>target population for<br>VisualEyes 515/525 system<br>is 5 years of age and up. | VN415m, VN415b, VO425m,<br>VO425b systems provide<br>information to assist in the<br>Oculographic evaluation,<br>diagnosis and<br>documentation of vestibular<br>disorders. Nystagmus of the<br>eye is recorded by use of<br>goggle mounted cameras.<br>These images are<br>measured, recorded,<br>displayed and stored in the<br>associated software. This<br>information then can be<br>used by a trained medical<br>professional to assist in<br>diagnosing vestibular<br>disorders. | Similar.<br>Same intended use, intended<br>user, and intended use<br>environment, but different age<br>population. This difference do<br>not raise new questions of<br>safety or effectiveness. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Operator | Insight Infrared Video Goggles<br>are to be used by trained<br>personnel only, such as<br>audiologists, ENT doctors,<br>physicians, vestibular<br>rehabilitation specialists, or<br>licensed healthcare personnel<br>with a similar level of<br>qualifications. The device<br>should not be used without the<br>necessary knowledge and<br>training to understand its use<br>and how results should be<br>interpreted. | The VisualEyes VNG system<br>is to be used by trained<br>personnel only, such as<br>audiologists, ENT surgeons,<br>doctor's, hearing healthcare<br>professionals or personnel<br>with a similar level of<br>qualifications. The device<br>should not be used without<br>the necessary knowledge<br>and training to understand<br>its use and how results<br>should be interpreted. | Trained medical professional | Same |
| Principle of Operation | Infrared video cameras<br>mounted inside goggles<br>display the patient's eye<br>movements on a connected<br>computer. The goggles are<br>light-proof, however a visible<br>light can be turned on inside<br>the goggles by the clinician<br>from an external switch. The<br>cameras are connected to the<br>computer via USB cable. The<br>clinician views and optionally<br>records the eye movements<br>using software on the<br>connected computer. | Software connects to the<br>cameras which allows it to<br>display, record, and produce<br>graphs of the patient's eye<br>movements. Eye tracking<br>provides quantitative data to<br>the clinician which can be<br>used in conjunction with the<br>video to diagnose and treat<br>vestibular dysfunctions. | Infrared video cameras<br>mounted inside goggles<br>display the patient's eye<br>movements on a connected<br>computer. The goggles are<br>light-proof, however a visible<br>light can be turned on inside<br>the goggles by the clinician<br>from an external switch. The<br>cameras are connected to<br>the computer via a standard<br>Firewire cable. The clinician<br>views and optionally records<br>the eye movements using<br>software on the connected<br>computer. | Similar.<br>The Visual Eyes 515/525 has<br>additional capabilities via eye<br>tracking software. The<br>2D-VOGfw/VN415b system<br>utilizes a Firewire instead of<br>USB cable. These differences<br>do not raise new questions of<br>safety or effectiveness. |
| Materials | PC+ABS, Silicone | N/A | Exact materials unknown | Similar.<br>Both housings are made of<br>durable plastic and have a foam<br>or silicone component<br>contacting the face, although |
| | | | | the exact materials are not<br>specified by the<br>2D-VOGfw/VN415b system.<br>These differences do not raise<br>new questions of safety or<br>effectiveness. |
| Infrared (IR) Source | (2) IR LEDs @ 940 nm<br>wavelength | N/A | (2) IR LEDs @ 950 nm<br>wavelength | Similar.<br>There is a 10 nm difference in<br>wavelength, but these<br>differences do not raise new<br>questions of safety or<br>effectiveness. |
| Infrared (IR) Control | On when goggles are plugged<br>in and system is on. | N/A | On when goggles are<br>plugged in and system is on. | Same |
| Light for visual focus<br>point | Yes | N/A | Yes | Same |
| Light blocking opaque<br>goggles | Yes | N/A | Yes | Same |
| Energy Source | External via USB powered by<br>computer | Software powered by<br>connected computer | External via Firewire<br>powered by computer | Similar.<br>2D-VOGfw/VN415b system is<br>powered via Firewire by<br>computer, and the VisualEyes<br>515/525 software is powered by<br>the computer as well. Insight<br>goggles are powered via USB<br>by computer. These differences<br>do not raise new questions of<br>safety or effectiveness. |
| Components | -Binocular video goggles<br>-Face cushion<br>-USB 2.0, 4 m length<br>-Travel Case<br>-Off-the-shelf software with<br>viewing and recording<br>features | -Proprietary software with<br>eye tracking as well as<br>viewing and recording<br>features | -Binocular video goggles<br>-Firewire cable, 4.5 m length | Similar.<br>Off-the-shelf software is used<br>with the Insight Infrared Video<br>Goggles, while the VisualEyes<br>515/525 utilizes its own<br>proprietary software with eye<br>tracking. The cable for the<br>2D-VOGfw/VN415b system has<br>a cable that is 0.5 m longer than<br>the cable for the Insight<br>goggles. The Insight goggles<br>come with a travel case for use<br>to store and transport the<br>goggles. These differences do<br>not raise new questions of<br>safety or effectiveness. |

{7}------------------------------------------------

{8}------------------------------------------------

| Weight | 530 g (face cushion, goggles,<br>and cable) | N/A | 345 g (occluded view)<br>without cables | Similar. The Insight goggles<br>weigh more than the<br>2D-VOGfw/VN415b system's<br>goggles, however these<br>differences do not raise new<br>questions of safety or<br>effectiveness. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interface to Control<br>Device | (1) Visual fixation light is<br>controlled via a switch located<br>on top of goggle body<br>(2) Camera view is controlled<br>by operator interacting with<br>off-the-shelf software | Computer with a standard<br>keyboard and mouse | Two options to control both<br>the visual fixation light and<br>camera view:<br>(1) Via software directly<br>(2) Via remote control that<br>can direct the software | Similar.<br>1. The visual fixation light is<br>controlled by a physical switch<br>in the Insight Infrared Video<br>Goggles while it is controlled by<br>a remote or by the software in<br>the VisualEyes 515/525 plus<br>2D-VOGfw/VN415b system;<br>2. The camera view is<br>controlled by software in the<br>Insight Infrared Video Goggles<br>while it is controlled by a remote<br>or by the software in the<br>VisualEyes 515/525 plus<br>2D-VOGfw/VN415b system.<br>These differences do not raise<br>new questions of safety or<br>effectiveness. |
| Video Recording and<br>Playback Capability | Yes (off-the-shelf software) | Yes | Yes (used in conjunction<br>with the 515/525 software) | Same |
| System Interface | A computer interface that<br>allows for display of both eyes<br>on computer monitor and<br>provides power for the video<br>cameras and the LEDs | A software interface that<br>allows for display of video<br>and charts of eye<br>movements | A computer interface that<br>allows for display of both<br>eyes on computer monitor<br>and provides power for the<br>video cameras and the LEDs | Similar. The Visual Eyes<br>515/525 can provide charts of<br>eye movements via eye<br>tracking software. These<br>differences do not raise new<br>questions of safety or<br>effectiveness. |

{9}------------------------------------------------

# Summary of Non-Clinical Performance Data

| Test | Title | Results |
|----------------------------------------------------|--------------------------------------------------------------------------|---------|
| ANSI AAMI ES<br>60601-1:2005 (R)<br>2012+AMD1:2012 | Medical Electrical Equipment. Part 1: General requirements for<br>safety | Pass |
| IEC 60601-1-2:2014 | Medical Electrical Equipment. Part 2: Electrical Safety | Pass |
| IEC 62471-1:2006 | Photobiological safety of lamps and lamp systems | Pass |

#### Table 2 - Electrical and Safety Test Results

#### Table 3 - Biocompatibility Test Results

| Test | Title | Method | Results |
|----------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| ISO<br>10993-5:2009 | Biological evaluation of<br>medical devices - part 5:<br>tests for in vitro Cytotoxicity | V-79 cell lineage<br>Extract: DMEM culture medium +<br>10% Fetal bovine serum and 1%<br>penicillin/Streptomycin kept in a<br>Schott flask at 37C for 24 hours | Non-cytotoxic |
| ISO<br>10993-10:2010 | Biological evaluation of<br>medical devices - part 10:<br>tests for Skin Sensitization | Guinea Pig Maximization Test<br>(GPMT) | Non-sensitizing |
| ISO<br>10993-10:2010 | Biological evaluation of<br>medical devices - part 10:<br>tests for Irritation | Animal Irritation Test - White Rabbit | Non-irritating |

#### Performance Testing

ANSI/ASA S3.45-2009(R)2014 American National Standard Procedures for Testing Basic Vestibular Function is a voluntary standard specific to the GWN product code associated with infrared video goggles for vestibular assessment.

{10}------------------------------------------------

Given the Insight Infrared Video Goggles's function, it was appropriate to perform a performance test which requires a trained clinician to view the eye movements during the relevant Vestibular Function Tests of spontaneous nystagmus, gaze-evoked nystagmus, and positioning and positional nystagmus testing, without the use of eye tracking software. Therefore, the VisualEyes Video Eye Monitor (K964325, Product Code: GWN) was selected as the comparative reference device to the Insight Infrared Video Goggles for this performance test, since unlike the 2D-VOGfw/VN415b system plus VisualEyes 515/525 software, both of the compared devices display eye movements during testing but do not provide caloric testing, and neither utilizes eye tracking software. In addition, both the Insight Infrared Video Goggles and the VisualEyes Video Eye Monitor (K964325) have the same classification (Class II) and product code (GWN) and share common intended use and fundamental technology, and therefore they were used in comparative performance testing to support substantial equivalence.

During the Performance Testing, for each of the subjects, two trained clinicians viewed the eye movements of the same 5 subjects during the relevant Vestibular Function Tests: (1) spontaneous nystagmus, (2) gaze-evoked nystagmus, and (3) positional and positional nystagmus testing. One round of testing was performed with the subject wearing the Insight Infrared Video Goggles (repeated with that device for 2 rounds total to confirm reliability), and the other round of testing was performed with the VisualEyes Video Eye Monitor (K964325) goggles. The Insight Infrared Video Goggles were rated "YES" for all criteria for all subjects tested (Yes/Pass for all 5 subjects for each of the 2 clinicians), including ability to view the eye movements and eye movements displayed clearly enough for assessment. This resulted in 100% PASS (performance present), meeting the acceptance criteria fully. Therefore, the results of this study demonstrate equivalent performance between the Insight Infrared Video Goggles and the VisualEyes Video Eye Monitor (K964325) goggles for the vestibular tests that they share in common.

#### Discussion of Clinical Testing

Clinical testing was not required to demonstrate substantial equivalence.

{11}------------------------------------------------

## Conclusion

The Insight Infrared Video Goggles have a smaller set of testing and software features, all of which are similarly present in the 2D-VOGfw/VN415b system plus VisualEyes 515/525 software. The basis of the substantial equivalence determination is limited to the common intended use and technological characteristics that the two systems share. The two devices share the same intended use, the same fundamental technology, and the same operating principle. Any differences between the two devices are minor and do not raise any new questions about safety and effectiveness. Therefore, the Insight Infrared Video Goggles are substantially equivalent to the 2D-VOGfw/VN415b system plus VisualEyes 515/525 software.