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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Insight Infrared Video Goggles (K203082):

Device: Insight Infrared Video Goggles
Intended Use: Viewing and recording eye movements in support of identifying vestibular disorders in patients. For use by trained healthcare professionals, target population 12+ years of age. Provides no diagnoses or diagnostic recommendations.

1. Table of Acceptance Criteria and Reported Device Performance

The core performance claims for this device revolve around its ability to clearly view and record eye movements for vestibular assessment, mirroring the capabilities of the predicate device. The study design reflects this by focusing on the subjective assessment of eye movement visibility by trained clinicians.

Acceptance Criteria	Reported Device Performance
Ability to view eye movements clearly enough for assessment during relevant Vestibular Function Tests (spontaneous nystagmus, gaze-evoked nystagmus, positional/positional nystagmus).	"YES" for all criteria for all subjects tested by both clinicians.
Performance present (i.e., eye movements visible and clear for assessment).	100% PASS
Demonstrated equivalent performance to the VisualEyes Video Eye Monitor (K964325) for shared vestibular tests.	Results "demonstrate equivalent performance."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 5 subjects.
Data Provenance: Not explicitly stated regarding country of origin, but implied to be a prospective study conducted specifically for this submission. The testing was comparative against a predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Two trained clinicians.
Qualifications of Experts: Described as "trained clinicians." No specific years of experience or board certifications (e.g., radiologist) are provided in this document, but their role is to assess the visibility and clarity of eye movements, not to make diagnostic calls. The indication for use specifies "trained healthcare professional," and the predicate comparisons mention a similar level of training for the intended operator (audiologists, ENT doctors, physicians, vestibular rehabilitation specialists, or licensed healthcare personnel).

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly described as a formal adjudication process. The document states that "two trained clinicians viewed the eye movements." Since the Insight Infrared Video Goggles were rated "YES" for all criteria by both clinicians for all subjects tested, perfect concordance was achieved, negating the need for a specific adjudication rule like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a formal MRMC comparative effectiveness study in the sense of human readers improving with AI vs. without AI assistance was not performed.
- This device is not an AI-assisted diagnostic tool; it's a hardware device for viewing and recording eye movements.
- The comparative performance testing focused on whether the device itself could provide clear visibility of eye movements, equivalent to a predicate device, as assessed by human clinicians. It does not measure the improvement of human readers' diagnostic accuracy with or without the device, but rather the device's functional equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Standalone Performance: Not applicable in the context of an algorithm's (AI) performance. This device is a hardware component (goggles with cameras) that provides visual data for human interpretation. The "performance" being evaluated is the clarity of the video output as perceived by human clinicians, not an automated algorithm's output. The device "provides no diagnoses nor does it provide diagnostic recommendations."

7. Type of Ground Truth Used

Type of Ground Truth: Expert consensus on the visibility and clarity of eye movements offered by the device. The "ground truth" here is the subjective assessment by the trained clinicians that the eye movements were adequately visible for performing the vestibular function tests. It is not based on pathology, outcomes data, or a definitive clinical diagnosis.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware system for capturing video, not an AI/ML algorithm that requires a training set. The "testing" described is performance validation against basic functionality, not machine learning model training.

9. How Ground Truth for Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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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.

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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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known)

Device Name Insight Infrared Video Goggles

Indications for Use (Describe)

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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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

(347) 954-0411

cqiu@msquaredassociates.com

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

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Indications for Use

Device Description

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

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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 VideoGoggles	Primary Predicate Device:VisualEyes 515/525(K152112 )	Secondary PredicateDevice: 2D-VOGfwSystem/VN415b (K072254)	Equivalence
Classification	Class II	Class II	Class II	Same
Product Code	GWN	GWN	GWN	Same
Device Description	The Insight Infrared VideoGoggles system displays andrecords eye movementsrecorded from camerasmounted to a video goggle.The videos can be used by atrained medical professional toassist in diagnosing vestibulardisorders.	VisualEyes 515/525 is asoftware program thatdisplays, records, andanalyzes eye movementsrecorded from a cameramounted to a video goggle.This system can utilize the2D-VOGfw/VN415b systemwhich is the subject of thehardware comparison. Thevideos can be used by atrained medical professionalto assist in diagnosingvestibular disorders.	This system consists of a PCor laptop, a 2D-VOGfwGoggle, and a softwareplatform that by licensingenables different levels offunctionality recognized asthe VN415m, VN415b,VO425m, VO425b products.The "m" indicatesmonocular, and the "b"indicates binocular,indicating the number ofcameras utilized by therelated system. The2D-VOGfw Gogglescomponent compriseshousing and one or twocameras depending on thelicense obtained for thissystem. The 2D-VOGfwGoggle is connected to thecomputer via a standardFirewire connection.	Similar.The 515/525 software has theadditional feature of eyetracking and related dataanalysis. The2D-VOGfw/VN415b system canbe used for an additionalassessment known as calorictesting. These differences donot raise new questions ofsafety or effectiveness.

Table 1 - Substantial Equivalence Comparison
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Indications for use	The Insight Infrared VideoGoggles are intended forviewing and recording eyemovements in support ofidentifying vestibular disordersin patients. The device isintended for use only by atrained healthcareprofessional in an appropriatehealthcare setting. This deviceprovides no diagnoses nordoes it provide diagnosticrecommendations. The targetpopulation is 12+ years ofage.	The VisualEyes 515/525system provides informationto assist in thenystagmographic evaluation,diagnosis anddocumentation of vestibulardisorders. Nystagmus of theeye is recorded by the use ofa goggle mounted withcameras. These images aremeasured, recorded,displayed, and stored in thesoftware. This informationthen can be used by atrained medical professionalto assist in diagnosingvestibular disorders. Thetarget population forVisualEyes 515/525 systemis 5 years of age and up.	VN415m, VN415b, VO425m,VO425b systems provideinformation to assist in theOculographic evaluation,diagnosis anddocumentation of vestibulardisorders. Nystagmus of theeye is recorded by use ofgoggle mounted cameras.These images aremeasured, recorded,displayed and stored in theassociated software. Thisinformation then can beused by a trained medicalprofessional to assist indiagnosing vestibulardisorders.	Similar.Same intended use, intendeduser, and intended useenvironment, but different agepopulation. This difference donot raise new questions ofsafety or effectiveness.
Intended Operator	Insight Infrared Video Gogglesare to be used by trainedpersonnel only, such asaudiologists, ENT doctors,physicians, vestibularrehabilitation specialists, orlicensed healthcare personnelwith a similar level ofqualifications. The deviceshould not be used without thenecessary knowledge andtraining to understand its useand how results should beinterpreted.	The VisualEyes VNG systemis to be used by trainedpersonnel only, such asaudiologists, ENT surgeons,doctor's, hearing healthcareprofessionals or personnelwith a similar level ofqualifications. The deviceshould not be used withoutthe necessary knowledgeand training to understandits use and how resultsshould be interpreted.	Trained medical professional	Same
Principle of Operation	Infrared video camerasmounted inside gogglesdisplay the patient's eyemovements on a connectedcomputer. The goggles arelight-proof, however a visiblelight can be turned on insidethe goggles by the clinicianfrom an external switch. Thecameras are connected to thecomputer via USB cable. Theclinician views and optionallyrecords the eye movementsusing software on theconnected computer.	Software connects to thecameras which allows it todisplay, record, and producegraphs of the patient's eyemovements. Eye trackingprovides quantitative data tothe clinician which can beused in conjunction with thevideo to diagnose and treatvestibular dysfunctions.	Infrared video camerasmounted inside gogglesdisplay the patient's eyemovements on a connectedcomputer. The goggles arelight-proof, however a visiblelight can be turned on insidethe goggles by the clinicianfrom an external switch. Thecameras are connected tothe computer via a standardFirewire cable. The clinicianviews and optionally recordsthe eye movements usingsoftware on the connectedcomputer.	Similar.The Visual Eyes 515/525 hasadditional capabilities via eyetracking software. The2D-VOGfw/VN415b systemutilizes a Firewire instead ofUSB cable. These differencesdo not raise new questions ofsafety or effectiveness.
Materials	PC+ABS, Silicone	N/A	Exact materials unknown	Similar.Both housings are made ofdurable plastic and have a foamor silicone componentcontacting the face, although
				the exact materials are notspecified by the2D-VOGfw/VN415b system.These differences do not raisenew questions of safety oreffectiveness.
Infrared (IR) Source	(2) IR LEDs @ 940 nmwavelength	N/A	(2) IR LEDs @ 950 nmwavelength	Similar.There is a 10 nm difference inwavelength, but thesedifferences do not raise newquestions of safety oreffectiveness.
Infrared (IR) Control	On when goggles are pluggedin and system is on.	N/A	On when goggles areplugged in and system is on.	Same
Light for visual focuspoint	Yes	N/A	Yes	Same
Light blocking opaquegoggles	Yes	N/A	Yes	Same
Energy Source	External via USB powered bycomputer	Software powered byconnected computer	External via Firewirepowered by computer	Similar.2D-VOGfw/VN415b system ispowered via Firewire bycomputer, and the VisualEyes515/525 software is powered bythe computer as well. Insightgoggles are powered via USBby computer. These differencesdo not raise new questions ofsafety or effectiveness.
Components	-Binocular video goggles-Face cushion-USB 2.0, 4 m length-Travel Case-Off-the-shelf software withviewing and recordingfeatures	-Proprietary software witheye tracking as well asviewing and recordingfeatures	-Binocular video goggles-Firewire cable, 4.5 m length	Similar.Off-the-shelf software is usedwith the Insight Infrared VideoGoggles, while the VisualEyes515/525 utilizes its ownproprietary software with eyetracking. The cable for the2D-VOGfw/VN415b system hasa cable that is 0.5 m longer thanthe cable for the Insightgoggles. The Insight gogglescome with a travel case for useto store and transport thegoggles. These differences donot raise new questions ofsafety or effectiveness.

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Weight	530 g (face cushion, goggles,and cable)	N/A	345 g (occluded view)without cables	Similar. The Insight gogglesweigh more than the2D-VOGfw/VN415b system'sgoggles, however thesedifferences do not raise newquestions of safety oreffectiveness.
Interface to ControlDevice	(1) Visual fixation light iscontrolled via a switch locatedon top of goggle body(2) Camera view is controlledby operator interacting withoff-the-shelf software	Computer with a standardkeyboard and mouse	Two options to control boththe visual fixation light andcamera view:(1) Via software directly(2) Via remote control thatcan direct the software	Similar.1. The visual fixation light iscontrolled by a physical switchin the Insight Infrared VideoGoggles while it is controlled bya remote or by the software inthe VisualEyes 515/525 plus2D-VOGfw/VN415b system;2. The camera view iscontrolled by software in theInsight Infrared Video Goggleswhile it is controlled by a remoteor by the software in theVisualEyes 515/525 plus2D-VOGfw/VN415b system.These differences do not raisenew questions of safety oreffectiveness.
Video Recording andPlayback Capability	Yes (off-the-shelf software)	Yes	Yes (used in conjunctionwith the 515/525 software)	Same
System Interface	A computer interface thatallows for display of both eyeson computer monitor andprovides power for the videocameras and the LEDs	A software interface thatallows for display of videoand charts of eyemovements	A computer interface thatallows for display of botheyes on computer monitorand provides power for thevideo cameras and the LEDs	Similar. The Visual Eyes515/525 can provide charts ofeye movements via eyetracking software. Thesedifferences do not raise newquestions of safety oreffectiveness.

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Summary of Non-Clinical Performance Data

Test	Title	Results
ANSI AAMI ES60601-1:2005 (R)2012+AMD1:2012	Medical Electrical Equipment. Part 1: General requirements forsafety	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
ISO10993-5:2009	Biological evaluation ofmedical devices - part 5:tests for in vitro Cytotoxicity	V-79 cell lineageExtract: DMEM culture medium +10% Fetal bovine serum and 1%penicillin/Streptomycin kept in aSchott flask at 37C for 24 hours	Non-cytotoxic
ISO10993-10:2010	Biological evaluation ofmedical devices - part 10:tests for Skin Sensitization	Guinea Pig Maximization Test(GPMT)	Non-sensitizing
ISO10993-10:2010	Biological evaluation ofmedical devices - part 10: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.

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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.

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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.

Regulation Number and Section

§ 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).