(88 days)
Not Found
No
The description focuses on hardware components (camera, IMU, goggles) and standard signal processing for VOR measurement. There is no mention of AI, ML, or related concepts.
No.
The "Intended Use / Indications for Use" states that the device is "designed to provide information on the performance of the vestibular ocular reflex (VOR) by providing objective measures of eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head." This describes a diagnostic function, not a therapeutic one. The device measures a physiological response to provide information, it does not treat or alleviate a condition.
Yes
The device is intended to provide information on the performance of the vestibular ocular reflex (VOR) by objectively measuring eye-velocity response to head-velocity stimulus, showing the VOR gain. This function of measuring and providing information about a physiological response for evaluation falls under the definition of a diagnostic device.
No
The device description explicitly details hardware components including a head-mounted goggle/mask, a camera unit with a calibration laser, and an inertial measurement unit (IMU) contained within the camera unit. While it includes software, it is not solely software.
Based on the provided information, the EyeSeeCam vHIT is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The EyeSeeCam vHIT directly measures eye movements in response to head movements in a living patient. It does not analyze samples like blood, urine, or tissue.
- The intended use describes measuring the vestibular ocular reflex (VOR) by observing eye responses to head stimuli. This is a physiological measurement performed on a living subject, not an analysis of a biological sample.
- The device description details hardware for capturing eye images and head movement, and software for processing this data. This aligns with a device used for in-vivo measurement, not in-vitro analysis.
Therefore, the EyeSeeCam vHIT falls under the category of a medical device used for physiological measurement, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EyeSeeCam vHIT is designed to provide information on the performance of the vestibular ocular reflex (VOR) by providing objective measures of eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head.
Product codes (comma separated list FDA assigned to the subject device)
GWN, LXV
Device Description
The EyeSeeCam vHIT system consists of a head mounted goggle/mask, a camera unit with calibration laser and a software application running on a standard PC.
The vHIT goggle generally has one camera (monocular) fixed at the top side(s) of the mask. The camera is held in place mechanically with a spherical ball-and-socket joint. The vHIT goggle has support for camera position-for the left and for the right eye. Therefore the camera is interchangeable between the left and right eyes.
The vHIT goggle supports the camera that is used to record the eye images. This constitutes the major component of the vHIT system.
The USB camera uses infrared light (IR), which is not visible to the naked eye. The IR illumination enables sessions to be performed in complete darkness.
The vHIT goggle has dichroic mirrors that allow visible light to pass through and infra red light to be reflected towards the cameras.
A calibration laser is placed in the center of the goggle. This is used for camera / pupil calibration before testing.
The complete system is operated from a standard PC/Laptop via a standard USB connection. The PC application software controls the camera recordings and shows the results of the tests.
EyeSeeCam utilizes an inertial measurement unit (IMU) which is an accelerometer and gyroscope combined. The IMU is contained inside the camera unit. The camera housing is attached to a light weight goggle. The camera records eye movements and the IMU records an electronic waveform that is proportional to head angular velocity (deg/sec).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared light (IR)
Anatomical Site
Eyes, Head
Indicated Patient Age Range
pediatric and adult faces
Intended User / Care Setting
The system is to be used by trained personnel only such as audiologists, ENT surgeons, neurologists, hearing healthcare professionals or personnel with a similar level of education.
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)
Clinical testing compared test results between the EyeSeeCam vHIT and the Predicate Device. The results showed compliance and substantial equivalence between the two instruments.
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.
Not Found
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).
0
EyeSeeCam vHIT
Premarket Notification Submission 510(k
510(K) SUMMARY
EyeSeeCam vHIT
Submitter Information: Company Name
Address
| Phone | |
|---|---|
| Fax | |
| Contact Person | |
Interacoustics A/S Drejervaenget 8 Assens, DK-5610, Denmark +45 6371 3555 +45 6371 3522 info@interacoustics.com Erik Nielsen, Director, Quality and Regulatory Affairs May 22 2013
SEP 06 2013
Date Summary Prepared
Device Identification:
Trade Name Common Name Classification Name Product Code Panel Device Class
Predicate Devices:
Predicate Device Manufacturer 510(k) No. Date Cleared
EyeSeeCam vHIT Vestibular analysis device Nystagmograph, apparatus, vestibular analysis GWN, LXV Neurology / Ear Nose & Throat Class II (According to 21 CFR 882.1460)
VORTEQ/VISUALEYES Micromedical Technologies K891008 / K964325 05/31/1989 / 07/15/1997
Image /page/0/Picture/16 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe above the word "Interacoustics". The globe is made up of several curved lines that form a sphere. The text is in a bold, sans-serif font.
1
Device Description
vHIT is intended to be used as a quick and objective measurement of the vestibular ocular reflex (VOR) in response to head movements in the natural range of daily motions. The results will yield immediate information regarding side-specific vestibular function. EyeSeeCam vHIT allows the healthcare professional to efficiently assess the "dizzy" patient and quickly decide if the dizziness the patient is experiencing is related to a vestibular disorder.
The EyeSeeCam vHIT system consists of a head mounted goggle/mask, a camera unit with calibration laser and a software application running on a standard PC.
The vHIT goggle generally has one camera (monocular) fixed at the top side(s) of the mask. The camera is held in place mechanically with a spherical ball-and-socket joint. The vHIT goggle has support for camera position-for the left and for the right eye. Therefore the camera is interchangeable between the left and right eyes.
The vHIT goggle supports the camera that is used to record the eye images. This constitutes the major component of the vHIT system.
The USB camera uses infrared light (IR), which is not visible to the naked eye. The IR illumination enables sessions to be performed in complete darkness.
The vHIT goggle has dichroic mirrors that allow visible light to pass through and infra red light to be reflected towards the cameras.
A calibration laser is placed in the center of the goggle. This is used for camera / pupil calibration before testing.
The complete system is operated from a standard PC/Laptop via a standard USB connection. The PC application software controls the camera recordings and shows the results of the tests.
EyeSeeCam utilizes an inertial measurement unit (IMU) which is an accelerometer and gyroscope combined. The IMU is contained inside the camera unit. The camera housing is attached to a light weight goggle. The camera records eye movements and the IMU records an electronic waveform that is proportional to head angular velocity (deg/sec).
Image /page/1/Picture/13 description: The image shows the logo for Interacoustics. The logo consists of the word "Interacoustics" in a bold, sans-serif font. Above the word is a symbol that resembles a globe with three horizontal lines running through it. The logo is black and white.
2
EyeSeeCam vHIT
Premarket Notification Submission 510(k)
Indications for Use
The EyeSeeCam vHIT is designed to provide information on the performance of the vestibular ocular reflex (VOR) by providing objective measures of eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head.
Intended operator
Technological Characteristics The system is to be used by trained personnel only such as audiologists, ENT surgeons, neurologists, hearing healthcare professionals or personnel with a similar level of education.
The EyeSeeCam vHIT system consists of a head mounted goggle/mask, a camera unit with calibration laser and a software application running on a standard PC.
Image /page/2/Picture/8 description: The image shows a close-up of a phoropter, an instrument used by eye care professionals to determine an individual's refractive error and prescribe corrective lenses. The phoropter is mounted on a stand and positioned in front of a mannequin head. The device features a complex arrangement of lenses, prisms, and other optical components, allowing the examiner to present different lens combinations to the patient. The phoropter is black and the mannequin head is white.
Nonclinical tests summary
Clinical tests
Conclusion
Design verification and validation were performed according to current standards for medical device safety and EMC. The device was found in compliance with current standards
Clinical testing compared test results between the EyeSeeCam vHIT and the Predicate Device. The results showed compliance and substantial equivalence between the two instruments.
We trust that the verification and validation activities show substantial equivalence with the substantial equivalent device and that the EyeSeeCam vHIT is safe and effective for its claimed purpose.
Image /page/2/Picture/16 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe-like symbol above the word "interacoustics" in a bold, sans-serif font. The globe symbol is made up of three horizontal lines intersecting with three vertical lines, creating a symmetrical design. The text is in all lowercase letters and is closely spaced.
3
Comparison table
| Description | Micromedical Technologies
VORTEQ /VISUALEYES | EyeSeeCam vHIT | Equivalence |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | VORTEQ is designed to
provide information about
the Vestibular Ocular Reflex
(VOR) in patients with
dizziness or balance
problems | The EyeSeeCam vHIT is designed
to provide information on the
performance of the vestibular
ocular reflex (VOR) by providing
objective measures of eye-
velocity response to head-
velocity stimulus, showing the
VOR gain in the plane of rotation
of the head. | Similar
Please refer to Discussion
Similarities in indications
for use
below |
| Technology
General | VORTEQ utilizes an angular
velocity sensor mounted
directly to the VisualEyes™
FireWire Binocular Goggles.
With the VisualEyes™
Monocular Goggles, the
angular velocity sensor is
attached to the back of the
goggle headband for
VORTEQ testing. This solid
state sensor produces an
electronic waveform that is
proportional to head angular
velocity (deg/sec). | EyeSeeCam utilizes an inertial
measurement unit (IMU) which
is an accelerometer and
gyroscope combined. The IMU is
contained inside the camera
housing. The camera housing is
attached to a light weight
goggle. The camera records eye
movements and the IMU records
an electronic waveform that is
proportional to head angular
velocity (deg/sec). | Similar
See following technical
comparison and photo
below |
| Technology
Photo | Image: Micromedical Technologies VORTEQ/VISUALEYES | Image: EyeSeeCam vHIT | Similar
See following
technological comparison |
| Technology
(Interface) | Firewire® (IEEE-1394a) | USB | Similar
Two similar
communication
protocols/technologies |
| Technology
(Mono/Dual
Cameras) | Monocular or binocular | Monocular camera,
interchangeable between left
and right eyes | Similar
One or two cameras for
VORTEQ while only one |
| Description | Micromedical Technologies
VORTEQ /VISUALEYES | EyeSeeCam vHIT | Equivalence |
| | | | for EyeSeeCam |
| Technology
(Goggle) | Comfortable fit, Molded
vinyl, fits adult faces only
(aprx 400 grams) | Snug fit, Molded cleanable
silicone, Fits pediatric and
adult faces
(aprx 60 grams) | Similar
Based on description |
| (Technology)
Calibration | Non head-mounted LED
(E.g. a Digital Lightbar) | Head mount laser with 5 point
calibration | Similar
We ascertain that that the
calibration systems are
substantially equivalent
with the same purpose to
adjust the camera
recordings to the eye
positions. Both
technologies measure eye
movements to projected
dot patterns, (MMT uses a
light bar and ESC uses a
laser on the goggle). |
| Technology
(Sample rate) | 250Hz | 220Hz | Similar
The sample rate deviation
is appraised not to
influence the
measurements. |
| Technology
(Head tracking
sensor) | Gyroscopes with 6 degrees
of freedom | Inertial Measurement Unit (IMU)
gyroscope with 6 degrees of
freedom | Same |
| Technology
(Gain ) | Instantaneous gain
measured at 45 ms with
selectable slide bar to
change to any value, e.g. 40,
60, 80 ms | Instantaneous gain at 40, 60,
and 80 ms like a scleral coil
search method | Similar
EyeSeeCam has tree fixed
values like scleral coil
while VORTEQ has a range
also covering the same
values. |
| Technology
(Data Analysis) | V-Plot, Gain Plot | Velocity Regression Plot, Gain
Plot | Same |
| Compliance
Standards | Safety: IEC 60601-1, UL
60601, CAN/CSA-C22.2 No.
601.1-M90, Class II, Type B,
IPXO,
EMC: IEC 60601-1-2
Laser: IEC 62471-1, IEC
60825-1 | Safety: IEC60601-1, ANSI/AAMI
ES60601-1, CAN/CSA-C22.2 No.
60601.1:08, Class II, Type B,
IPXO,
EMC: IEC 60601-1-2
Laser: IEC 62471-1, IEC 60825-1 | Same |
Image /page/3/Picture/4 description: The image shows the logo for Interacoustics. The logo consists of the word "Interacoustics" in a bold, sans-serif font. Above the word is a symbol that resembles a globe with three horizontal lines running through it. The logo is black and white.
4
510(k) Summary p. 5
Interacous
C
5
EyeSeeCam vHIT
Discussion, Similarities in indications for use
The vestibulo-ocular reflex (VOR) is a reflex eve movement that stabilizes images on the retina during head movement by producing an eye movement in the direction opposite to head movement, thus preserving the image on the center of the visual field. For example, when the head moves to the right, the eyes move to the left and when the head moves up the eyes move down. The indication for use for EyeSeeCam includes a slightly more detailed description of the same head impulse test procedure used to measure the VOR - including the canal tested is in the direction of the head movement - this includes both vertical and horizontal VOR test described by VORTEQ is certainly capable of testing both horizontal and vertical canals, it just doesn't specify which canals are tested in the intended use statement.
Summary of similarities
We appraise that slightly different technologies have been used in the two products (e.g. USB or Firewire / one or two cameras) but the functionality is ascertained to have the same purpose.
Discussion of differences
We did not find any essential or major differences between the two devices.
Verification and validation summary
We have verified EMC, safety and software performance. We have performed clinical comparisons between the EyeSeeCam and VORTEQ. We have reviewed the literature for articles about vestibular testing with vHT. All these activities, testing and validation show that EyeSeeCam vHIT performs as specified and is safe and effective.
Conclusion
We have compared key issues for the EyeSeeCam vHIT and the predicate device VORTEQ. We have performed a comparison validation between EyeSeeCam and VORTEQ. All similarities and differences have been discussed. We trust that the results of these comparisons demonstrate that the EyeSeeCam vHIT is substantially equivalent to the marketed predicate device.
Any deviations between EyeSeeCam vHIT and predicate devices are appraised to have no adverse affect on the safety and effectiveness of the device.
Image /page/5/Picture/14 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe-like symbol above the word "interacoustics" in a bold, sans-serif font. The globe symbol is made up of curved lines that form a spherical shape with horizontal lines running through it. The overall design is simple and modern.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus-like design with three wavy lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2013
Interacoustics A/S c/o Mr. Erik Nielsen Director. Quality and Regulatory Affairs Drejervaenget 8 Assens, Denmark DK-5610
Re: K131681
Trade/Device Name: EyeSeeCam vHIT Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: June 10, 2013 Received: June 10, 2013
Dear Mr. Nielsen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
7
Page 2 - Mr. Erik Nielsen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
for: Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
Applicant: Interacoustics A/S
510(k) Number (if known): K131681
Device Name: EyeSeeCam - vHIT
Indications for Use:
The EyeSeeCam vHIT is designed to provide information on the performance of the vestibular ocular reflex (VOR) by providing objective measures of eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eric A. Mann -S
Page 1 of 1
Image /page/8/Picture/13 description: The image shows the logo for Interacoustics. The logo consists of the word "Interacoustics" in a bold, sans-serif font, with a stylized globe-like symbol above it. The symbol is made up of several curved lines that intersect to form a spherical shape. The logo is black and white.