(30 days)
No
The description focuses on the hardware (goggles, cameras, lights, cable) and its function of capturing and displaying eye movements for clinician analysis. There is no mention of automated analysis, algorithms, or any technology that would typically involve AI/ML for interpretation or diagnosis. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is used for viewing and recording eye movements to identify vestibular disorders, which is a diagnostic aid, not a therapeutic intervention.
No
The "Intended Use / Indications for Use" explicitly states, "This device provides no diagnoses nor does it provide diagnostic recommendations."
No
The device description explicitly details hardware components including goggles with cameras, infrared LED lights, visible lights, a plastic shell, a face cushion, and a USB cable. This indicates it is a hardware device with accompanying software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Insight Infrared Video Goggles system works by directly observing and recording eye movements (nystagmus) in a living patient. It does not analyze samples taken from the patient's body.
- Intended Use: The intended use is for "viewing and recording eye movements in support of identifying vestibular disorders in patients." This is a direct observation and recording method, not an in vitro test.
- Device Description: The description details cameras, infrared lights, and goggles worn by the patient to observe eye movements. This aligns with an in vivo (within the living body) observation device, not an in vitro diagnostic.
Therefore, the Insight Infrared Video Goggles fall under the category of a medical device used for observation and recording of physiological responses, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
GWN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared video cameras
Anatomical Site
eyes
Indicated Patient Age Range
12+ years of age.
Intended User / Care Setting
intended for use only by a trained healthcare professional in an appropriate healthcare setting.
trained personnel only, such as audiologists, ENT doctors, physicians, vestibular rehabilitation specialists, or licensed healthcare personnel with a similar level of qualifications.
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 Testing
Sample Size: 5 subjects, evaluated by 2 trained clinicians.
Study Type: Comparative performance test using VisualEyes Video Eye Monitor (K964325) as the reference device.
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Micromedical VisualEyes 515/ 525, K152112
Reference Device(s)
VisualEyes Video Eye Monitor (K964325)
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/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 (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
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
(347) 954-0411
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
Goggles | Primary Predicate Device:
VisualEyes 515/525
(K152112 ) | Secondary Predicate
Device: 2D-VOGfw
System/VN415b (K072254) | Equivalence |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II | Same |
| Product Code | GWN | GWN | GWN | Same |
| Device Description | The Insight Infrared Video
Goggles system displays and
records eye movements
recorded from cameras
mounted to a video goggle.
The videos can be used by a
trained medical professional to
assist in diagnosing vestibular
disorders. | VisualEyes 515/525 is a
software program that
displays, records, and
analyzes eye movements
recorded from a camera
mounted to a video goggle.
This system can utilize the
2D-VOGfw/VN415b system
which is the subject of the
hardware comparison. The
videos can be used by a
trained medical professional
to assist in diagnosing
vestibular disorders. | This system consists of a PC
or laptop, a 2D-VOGfw
Goggle, and a software
platform that by licensing
enables different levels of
functionality recognized as
the VN415m, VN415b,
VO425m, VO425b products.
The "m" indicates
monocular, and the "b"
indicates binocular,
indicating the number of
cameras utilized by the
related system. The
2D-VOGfw Goggles
component comprises
housing and one or two
cameras depending on the
license obtained for this
system. The 2D-VOGfw
Goggle is connected to the
computer via a standard
Firewire connection. | Similar.
The 515/525 software has the
additional feature of eye
tracking and related data
analysis. The
2D-VOGfw/VN415b system can
be used for an additional
assessment known as caloric
testing. These differences do
not raise new questions of
safety or effectiveness. |
| Table 1 - Substantial Equivalence Comparison | |
|---|---|
| ---------------------------------------------- | -- |
6
| 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. | The VisualEyes 515/525
system provides information
to assist in the
nystagmographic evaluation,
diagnosis and
documentation of vestibular
disorders. Nystagmus of the
eye is recorded by the 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 515/525 system
is 5 years of age and up. | VN415m, VN415b, VO425m,
VO425b systems provide
information to assist in the
Oculographic evaluation,
diagnosis and
documentation of vestibular
disorders. Nystagmus of the
eye is recorded by use of
goggle mounted cameras.
These images are
measured, recorded,
displayed and stored in the
associated software. This
information then can be
used by a trained medical
professional to assist in
diagnosing vestibular
disorders. | Similar.
Same intended use, intended
user, and intended use
environment, but different age
population. This difference do
not raise new questions of
safety or effectiveness. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Operator | Insight Infrared Video Goggles
are to be used by trained
personnel only, such as
audiologists, ENT doctors,
physicians, vestibular
rehabilitation specialists, or
licensed healthcare 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. | 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. | Trained medical professional | Same |
| Principle of Operation | Infrared video cameras
mounted inside goggles
display the patient's eye
movements on a connected
computer. The goggles are
light-proof, however a visible
light can be turned on inside
the goggles by the clinician
from an external switch. The
cameras are connected to the
computer via USB cable. The
clinician views and optionally
records the eye movements
using software on the
connected computer. | Software connects to the
cameras which allows it to
display, record, and produce
graphs of the patient's eye
movements. Eye tracking
provides quantitative data to
the clinician which can be
used in conjunction with the
video to diagnose and treat
vestibular dysfunctions. | Infrared video cameras
mounted inside goggles
display the patient's eye
movements on a connected
computer. The goggles are
light-proof, however a visible
light can be turned on inside
the goggles by the clinician
from an external switch. The
cameras are connected to
the computer via a standard
Firewire cable. The clinician
views and optionally records
the eye movements using
software on the connected
computer. | Similar.
The Visual Eyes 515/525 has
additional capabilities via eye
tracking software. The
2D-VOGfw/VN415b system
utilizes a Firewire instead of
USB cable. These differences
do not raise new questions of
safety or effectiveness. |
| Materials | PC+ABS, Silicone | N/A | Exact materials unknown | Similar.
Both housings are made of
durable plastic and have a foam
or silicone component
contacting the face, although |
| | | | | the exact materials are not
specified by the
2D-VOGfw/VN415b system.
These differences do not raise
new questions of safety or
effectiveness. |
| Infrared (IR) Source | (2) IR LEDs @ 940 nm
wavelength | N/A | (2) IR LEDs @ 950 nm
wavelength | Similar.
There is a 10 nm difference in
wavelength, but these
differences do not raise new
questions of safety or
effectiveness. |
| Infrared (IR) Control | On when goggles are plugged
in and system is on. | N/A | On when goggles are
plugged in and system is on. | Same |
| Light for visual focus
point | Yes | N/A | Yes | Same |
| Light blocking opaque
goggles | Yes | N/A | Yes | Same |
| Energy Source | External via USB powered by
computer | Software powered by
connected computer | External via Firewire
powered by computer | Similar.
2D-VOGfw/VN415b system is
powered via Firewire by
computer, and the VisualEyes
515/525 software is powered by
the computer as well. Insight
goggles are powered via USB
by computer. These differences
do not raise new questions of
safety or effectiveness. |
| Components | -Binocular video goggles
-Face cushion
-USB 2.0, 4 m length
-Travel Case
-Off-the-shelf software with
viewing and recording
features | -Proprietary software with
eye tracking as well as
viewing and recording
features | -Binocular video goggles
-Firewire cable, 4.5 m length | Similar.
Off-the-shelf software is used
with the Insight Infrared Video
Goggles, while the VisualEyes
515/525 utilizes its own
proprietary software with eye
tracking. The cable for the
2D-VOGfw/VN415b system has
a cable that is 0.5 m longer than
the cable for the Insight
goggles. The Insight goggles
come with a travel case for use
to store and transport the
goggles. These differences do
not raise new questions of
safety or effectiveness. |
7
8
| Weight | 530 g (face cushion, goggles,
and cable) | N/A | 345 g (occluded view)
without cables | Similar. The Insight goggles
weigh more than the
2D-VOGfw/VN415b system's
goggles, however these
differences do not raise new
questions of safety or
effectiveness. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interface to Control
Device | (1) Visual fixation light is
controlled via a switch located
on top of goggle body
(2) Camera view is controlled
by operator interacting with
off-the-shelf software | Computer with a standard
keyboard and mouse | Two options to control both
the visual fixation light and
camera view:
(1) Via software directly
(2) Via remote control that
can direct the software | Similar.
- The visual fixation light is
controlled by a physical switch
in the Insight Infrared Video
Goggles while it is controlled by
a remote or by the software in
the VisualEyes 515/525 plus
2D-VOGfw/VN415b system; - The camera view is
controlled by software in the
Insight Infrared Video Goggles
while it is controlled by a remote
or by the software in the
VisualEyes 515/525 plus
2D-VOGfw/VN415b system.
These differences do not raise
new questions of safety or
effectiveness. |
| Video Recording and
Playback Capability | Yes (off-the-shelf software) | Yes | Yes (used in conjunction
with the 515/525 software) | Same |
| System Interface | A computer interface that
allows for display of both eyes
on computer monitor and
provides power for the video
cameras and the LEDs | A software interface that
allows for display of video
and charts of eye
movements | A computer interface that
allows for display of both
eyes on computer monitor
and provides power for the
video cameras and the LEDs | Similar. The Visual Eyes
515/525 can provide charts of
eye movements via eye
tracking software. These
differences do not raise new
questions of safety or
effectiveness. |
9
Summary of Non-Clinical Performance Data
| Test | Title | Results |
|---|---|---|
| ANSI AAMI ES | ||
| 60601-1:2005 (R) | ||
| 2012+AMD1:2012 | Medical Electrical Equipment. Part 1: General requirements for | |
| 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 | |||
| 10993-5:2009 | Biological evaluation of | ||
| medical devices - part 5: | |||
| tests for in vitro Cytotoxicity | V-79 cell lineage | ||
| Extract: DMEM culture medium + | |||
| 10% Fetal bovine serum and 1% | |||
| penicillin/Streptomycin kept in a | |||
| Schott flask at 37C for 24 hours | Non-cytotoxic | ||
| ISO | |||
| 10993-10:2010 | Biological evaluation of | ||
| medical devices - part 10: | |||
| tests for Skin Sensitization | Guinea Pig Maximization Test | ||
| (GPMT) | Non-sensitizing | ||
| ISO | |||
| 10993-10:2010 | Biological evaluation of | ||
| medical 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.
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.