(165 days)
Not Found
No
The description focuses on standard signal processing and analysis of eye and head movements, without mentioning any AI/ML techniques.
No
This device is used for the "assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements." It is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The device is described as being "used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements" and allows the clinician to "determine if the response is within normal limits or not," which are all diagnostic activities.
No
The device description explicitly states that the device is a "combination of hardware and software" and details several hardware components (goggles, camera, sensor, LED).
Based on the provided information, the ICS Impulse System Model 1085 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The ICS Impulse System directly measures and analyzes physiological responses (eye and head movements) in a living patient. It does not analyze samples taken from the body.
- Intended Use: The intended use is the assessment of the vestibular-ocular reflex and nystagmus by measuring and analyzing eye and head movements. This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the ICS Impulse System Model 1085 falls under the category of a non-IVD medical device used for physiological measurement and assessment.
N/A
Intended Use / Indications for Use
The ICS Impulse System Model 1085 is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.
Product codes
GWN
Device Description
The device is a combination of hardware and software. The patient wears a pair of lightweight, tightly-fitting goggles on which is mounted a very small, very light, very fast, USB video camera and a half silvered mirror. This transparent mirror reflects the image of the patient's eye into the camera. The eye is illuminated by a low-level infra-red light emitting diode which is not visible to the patients. A small sensor on the goggles measures the head movement. The whole goggle system is lightweight but it must be secured tightly to the head to minimize goggle slippage. The software records and displays the information obtained during what is known as a "head impulse test".
Mentions image processing
The high-speed camera captures the image of the eye. The OTOsuite Vestibular software processes the head velocity data and velocity data for eye movement (the response). Simultaneous displays of the data for head movement and for eye movement allow the clinician to determine if the response is within normal limits or not.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Eye and Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained personnel required
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
The device platform (1085) had previously passed UL Electrical Safety testing and EMC testing. Software validation and risk analysis was performed. Biocompatibility testing was successfully performed on the patient contact materials. A clinical analysis based on published literature. The ICS Impulse adequately meets the design requirements and acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2015
GN Otometrics % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114
Re: K151504
Trade/Device Name: ICS Impulse System Model 1085 Regulation Number: 21 CFR 882.1460 Regulation Name: Nystamograph Regulatory Class: Class II Product Code: GWN Dated: May 29, 2015 Received: October 8, 2015
Dear Mr. Kamm:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
William J. Heetderks -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151504
Device Name ICS Impulse System Model 1085
Indications for Use (Describe)
The ICS Impulse System Model 1085 is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Residential Use (Rentals of 30+ Consecutive Days) |
|---|
| Commercial Use (Rentals of 1-29 Consecutive Days) |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary, 510(k) K15 Submitter: GN Otometrics A/S Hoerskaetten 9, Taastrup, DENMARK DK-2630 Registration number: 9612197 C/O GN Otometrics North America 50 Commerce Dr Ste 180 Schaumburg, IL 60173 (US) Phone: 847-534-2150 (US) Fax: 847-534-2153 Contact: Anders Rasmussen, Manager of Research and Development Date Prepared: May 15, 2015
1. Identification of the Device:
Proprietary-Trade Name: ICS Impulse Model 1085 Classification Name: Code GWN, Nystagmograph, Regulation 882.1460 Common/Usual Name: Nystagmograph
2. Equivalent legally marketed devices:
| 510(k) # | Name of Device | Manufacturer |
|---|---|---|
| K061791 | Type 1068 ICS Chartr 200 VNG | GN Otometrics |
| K122550 | ICS Type 1085 Impulse | GN Otometrics |
-
- Description of the Device: The device is a combination of hardware and software. The patient wears a pair of lightweight, tightly-fitting goggles on which is mounted a very small, very light, very fast, USB video camera and a half silvered mirror. This transparent mirror reflects the image of the patient's eye into the camera. The eye is illuminated by a low-level infra-red light emitting diode which is not visible to the patients. A small sensor on the goggles measures the head movement. The whole goggle system is lightweight but it must be secured tightly to the head to minimize goggle slippage. The software records and displays the information obtained during what is known as a "head impulse test" The basic head impulse test starts with the tester standing behind the patient who is wearing the goggles. While the patient is asked to stare at the fixation dot placed on a projection surface in front of them, the tester rotates the patient's head horizontally through a small angle (about 10-20 degrees) in a brief, abrupt and unpredictable manner, varying the direction and the velocity. The goggles collect both head and eye data. The gyroscope measures the velocity of the head movement (the stimulus). The high-speed camera captures the image of the eye. The OTOsuite Vestibular software processes the head velocity data and velocity data for eye movement (the response). Simultaneous displays of the data for head movement and for eye movement allow the clinician to determine if the response is within normal limits or not. The software also records and displays the information obtained during Positional and Oculomotor tests. A Positional test is performed by moving that patient from one position to another position. In the example of Dix-Hallpike, the patient is sitting and the patient's head is turned 45 degrees to one side and then the patient is moved from the sitting position to the supine position. An Oculomotor test is performed by having the patient stare in various directions or under various environments. In the example of Gaze, the patient is sitting and the patient is asked to stare left, right, up, down or center. The Gaze test can be performed with vision or with vision denied. For both Positional and Oculomotor the goggles collect head and eye data. The accelerometer in the small sensor measures where the head is in space. That information is taken and the patient's head position or any movement during testing is displayed in the software. The high speed camera captures the image of the eye. The OTOsuite Vestibular software processes the eye velocity data (the response). The eye movement is
4
analyzed to determine the slow phase velocities (SPV). The head data is only used during collection to display if the patient's head is moving and to guide the tester to position the patient's head appropriately for the test. This is what we refer to as "Head Position Feedback". Tests where slow phase velocity is measured display the eve position trace and slow phase velocity beats in a graph. In Oculomotor there are 2 tests VOR and Skew Deviation that are not SPV tests. VOR (vestibular ocular reflex) which allows for both visual VOR (VVOR) and VOR suppression (VORS). This test is very similar to the head impulse test but the head movement is slow (0.5 Hz) and small (10 degrees). In VVOR the patient is sitting and the examiner moves the head from side to side (like a sinusoid) while the patient stares at a fixed target. In VORS the patient is sitting and the examiner moves the head from side to side (like a sinusoid) while the patient stares at a moving dot projected from the goggle using one of the lasers. The analysis is similar to head impulse, simultaneous displays of the data for head movement and for eye movement allow the clinician to determine if the response is within normal limits or not. In Skew Deviation (also known as cover test or alternate cover test) the patient is sitting and the tester covers and uncovers. The OTOsuite Vestibular software measures the eye position trace during the cover and uncover environments and displays an average eye position shift.
-
- Indications for Use (intended use): The ICS Impulse Model 1085 is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, displaying, and analyzing eye and head movements.
-
- Safety and Effectiveness, comparison to predicate device. This device has the same core hardware and software as our K122550 and adds the ability to record nystagmus as in our other predicate K061791. Video camera interface has been changed from firewire to USB. This is not a meaningful difference. A "vision denied" solution (see table below) has been added which is functionally the same as in K061791.
-
- Description of Testing: The device platform (1085) had previously passed UL Electrical Safety testing and EMC testing. Software validation and risk analysis was performed. Biocompatibility testing was successfully performed on the patient contact materials. A clinical analysis based on published literature. The ICS Impulse adequately meets the design requirements and acceptance criteria.
| Characteristic | GN Otometrics A/S
Type 1068 ICS Chartr
200 VNG K061791 | GN Otometrics A/S ICS
Type 1085 Impulse
K122550 | GN Otometrics A/S
Type 1085 ICS Impulse |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Focus VNG/ENG
is a nystagmograph
that is intended to
measure, record and
display involuntary
movements
(nystagmus) of the
eyeball. | The ICS Impulse System
is used in the assessment
of the vestibular-ocular
reflex (VOR) by
measuring, recording,
displaying, and analyzing
eye and head
movements. | The ICS Impulse System is
used in the assessment of the
vestibular-ocular reflex
(VOR) and nystagmus by
measuring, recording,
displaying, and analyzing
eye and head movements. |
| Product Code | GWN | GWN/LXV | GWN |
| Characteristic | GN Otometrics A/S
Type 1068 ICS Chartr
200 VNG K061791 | GN Otometrics A/S ICS
Type 1085 Impulse
K122550 | GN Otometrics 1068 A/S
Type 1085 ICS Impulse |
| Configuration | ICS Chartr 200 VNG
consists of a hardware
box and VG-40
binocular video
goggles. The goggles
can record one eye
(monocular) or two
eye binocular. The
ICS Chartr 200 cannot
measure head
movement | The patient wears a pair
of lightweight, tightly-
fitting goggles on which
is mounted a very small,
very light, very fast,
firewire video camera
and a half silvered
mirror. This transparent
mirror reflects the image
of the patient's eye into
the camera. The eye is
illuminated by a low-
level infra-red light
emitting diode which is
not visible to the
patients. A small sensor
on the goggles measures
the head movement. The
whole goggle system is
lightweight but it must be
secured tightly to the
head to minimize goggle
slippage. | The patient wears a pair of
lightweight, tightly-fitting
goggles on which is mounted
a very small, very light, very
fast, USB video camera and
a half silvered mirror. This
transparent mirror reflects
the image of the patient's
eye into the camera. The eye
is illuminated by a low-level
infra-red light emitting diode
which is not visible to the
patients. A small sensor on
the goggles measures the
head movement. The whole
goggle system is lightweight
but it must be secured tightly
to the head to minimize
goggle slippage. |
| Test Battery | The ICS Chartr 200 is
a full VNG system
which allows for the
following types of
tests: Oculomotor,
Positional, and
Calorics. The system
allows for recording of
the eye with vision and
vision denied. The
software includes a
slow phase velocity
algorithm developed in
collaboration with Dr
Stockwell. | The ICS Impulse system
allows for the following
types of tests: recording
the eye video and room
video as known as
Monocular Video
Frenzel, and Video Head
Impulse Test (vHIT).
The system allows for
recording of the eye with
vision only . The system
also allows for recording
of the room through the
use of a webcam. A
monocular video frenzel
(only allows recording of
the eye and room with no
data analysis). | The ICS Impulse system
allows for the following
types of tests: Monocular
Video Frenzel, Video Head
Impulse Test (vHIT)
Oculomotor and Positional.
The system allows for
recording of the eye with
vision and vision denied .
The system also allows for
recording of the room
through the use of a
webcam. A monocular video
frenzel (only allows
recording of the eye and
room with no data analysis).
The software includes a slow
phase velocity algorithm
developed in collaboration
with Dr Barin a protégé of
Dr Stockwell. |
| Characteristic | GN Otometrics A/S
Type 1068 ICS Chartr
200 VNG K061791 | GN Otometrics A/S ICS
Type 1085 Impulse
K122550 | GN Otometrics 1068 A/S
Type 1085 ICS Impulse |
| Photo | Image: GN Otometrics A/S Type 1068 ICS Chartr 200 VNG K061791 | Image: GN Otometrics A/S ICS Type 1085 Impulse K122550 | Image: GN Otometrics 1068 A/S Type 1085 ICS Impulse |
| Vision Denied
Solution | The VG-40 goggles
have a shield that can
be opened and closed. | There was no vision
denied solution | The ICS Impulse has a
solution with a cup and a
patch. The cup adheres to
the right (test) eye. The cup
has a window that allows the
IR camera to see through in
order to record eye
movement but the patient
can not see through it. The
patch covers the left (non-
test) eye and the patient can
not see through it. |
| Electrical safety | IEC 60601-1 | SAME | SAME |
| EMC | IEC 60601-1-2 | SAME | SAME |
| Weight | 15.2 oz (430 g) | 2.1 oz (60g) - goggles | 2.1 oz (60g) - goggles |
| Power Source | USB via PC | SAME | SAME |
| Computer | Microsoft® XP
Professional - Service Pack
2, Vista® Business or
Windows 7 Professional 32
or 64 bit | Windows XP 32-bit
Professional SP3 or Windows
7 32-bit Professional or
Windows 7 64-bit
Professional | 64-bit: Windows 8 Pro, Windows
7 Professional
32- bit: Windows 8 Pro, Windows
7 Professional |
| Operator | Trained personnel required | SAME | SAME |
7. Substantial Equivalence Chart
5
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- Conclusion: After analyzing software validation, risk analysis, bench testing (including 8. biocompatibility), safety, EMC, and clinical validation (literature review) testing we conclude that the ICS Impulse is as safe and effective as the predicate devices, and has essentially the same indications for use and technology, thus rendering it substantially equivalent to the predicate devices.