ICS Impulse

K151504 · Gn Otometrics · GWN · Nov 16, 2015 · Neurology

Device Facts

• Record ID: K151504
• Device Name: ICS Impulse
• Applicant: Gn Otometrics
• Product Code: GWN · Neurology
• Decision Date: Nov 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2

Intended 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.

Device Story

ICS Impulse System Model 1085 consists of lightweight goggles with integrated high-speed USB video camera, infrared LED for eye illumination, and motion sensor (gyroscope/accelerometer). Used by clinicians to perform vestibular testing, including Video Head Impulse Test (vHIT), Oculomotor, and Positional tests. During testing, clinician rotates patient's head while patient fixates on target; goggles capture eye video and head movement data. OTOsuite Vestibular software processes inputs to calculate slow phase velocities (SPV) and eye position shifts. System provides simultaneous displays of head and eye movement data, allowing clinicians to assess VOR function and nystagmus. Supports both vision and vision-denied testing environments. Output aids clinical decision-making regarding vestibular system health. Device operates via PC connection.

Clinical Evidence

Clinical evidence based on literature review. Bench testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility of patient-contact materials. Software validation and risk analysis were performed. No primary clinical trial data reported.

Technological Characteristics

Lightweight goggles with USB video camera, infrared LED, and motion sensor (gyroscope/accelerometer). Half-silvered mirror for eye imaging. Connectivity via USB to PC. Software-based analysis of eye/head movement. Biocompatible patient-contact materials. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for the assessment of vestibular-ocular reflex (VOR) and nystagmus in patients requiring clinical evaluation of eye and head movements.

Regulatory Classification

Identification

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

Predicate Devices

• Type 1068 ICS Chartr 200 VNG (K061791)
• ICS Type 1085 Impulse (K122550)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div style="display:inline-block;"> <input checked="" type="checkbox" value=""/></div> Residential Use (Rentals of 30+ Consecutive Days) |
|------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block;"> <input type="checkbox" value=""/></div> 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: [phone] (US) Fax: [phone] 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 |

- 3. 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

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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.

- 4. 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.
- 5. 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.
- 6. 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<br>Type 1068 ICS Chartr<br>200 VNG K061791 | GN Otometrics A/S ICS<br>Type 1085 Impulse<br>K122550 | GN Otometrics A/S<br>Type 1085 ICS Impulse |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Focus VNG/ENG<br>is a nystagmograph<br>that is intended to<br>measure, record and<br>display involuntary<br>movements<br>(nystagmus) of the<br>eyeball. | The ICS Impulse System<br>is used in the assessment<br>of the vestibular-ocular<br>reflex (VOR) by<br>measuring, recording,<br>displaying, and analyzing<br>eye and head<br>movements. | The ICS Impulse System is<br>used in the assessment of the<br>vestibular-ocular reflex<br>(VOR) and nystagmus by<br>measuring, recording,<br>displaying, and analyzing<br>eye and head movements. |
| Product Code | GWN | GWN/LXV | GWN |
| Characteristic | GN Otometrics A/S<br>Type 1068 ICS Chartr<br>200 VNG K061791 | GN Otometrics A/S ICS<br>Type 1085 Impulse<br>K122550 | GN Otometrics 1068 A/S<br>Type 1085 ICS Impulse |
| Configuration | ICS Chartr 200 VNG<br>consists of a hardware<br>box and VG-40<br>binocular video<br>goggles. The goggles<br>can record one eye<br>(monocular) or two<br>eye binocular. The<br>ICS Chartr 200 cannot<br>measure head<br>movement | The patient wears a pair<br>of lightweight, tightly-<br>fitting goggles on which<br>is mounted a very small,<br>very light, very fast,<br>firewire video camera<br>and a half silvered<br>mirror. This transparent<br>mirror reflects the image<br>of the patient's eye into<br>the camera. The eye is<br>illuminated by a low-<br>level infra-red light<br>emitting diode which is<br>not visible to the<br>patients. A small sensor<br>on the goggles measures<br>the head movement. The<br>whole goggle system is<br>lightweight but it must be<br>secured tightly to the<br>head to minimize goggle<br>slippage. | The patient wears a pair of<br>lightweight, tightly-fitting<br>goggles on which is mounted<br>a very small, very light, very<br>fast, USB video camera and<br>a half silvered mirror. This<br>transparent mirror reflects<br>the image of the patient's<br>eye into the camera. The eye<br>is illuminated by a low-level<br>infra-red light emitting diode<br>which is not visible to the<br>patients. A small sensor on<br>the goggles measures the<br>head movement. The whole<br>goggle system is lightweight<br>but it must be secured tightly<br>to the head to minimize<br>goggle slippage. |
| Test Battery | The ICS Chartr 200 is<br>a full VNG system<br>which allows for the<br>following types of<br>tests: Oculomotor,<br>Positional, and<br>Calorics. The system<br>allows for recording of<br>the eye with vision and<br>vision denied. The<br>software includes a<br>slow phase velocity<br>algorithm developed in<br>collaboration with Dr<br>Stockwell. | The ICS Impulse system<br>allows for the following<br>types of tests: recording<br>the eye video and room<br>video as known as<br>Monocular Video<br>Frenzel, and Video Head<br>Impulse Test (vHIT).<br>The system allows for<br>recording of the eye with<br><b>vision only</b> . The system<br>also allows for recording<br>of the room through the<br>use of a webcam. A<br>monocular video frenzel<br>(only allows recording of<br>the eye and room with no<br>data analysis). | The ICS Impulse system<br>allows for the following<br>types of tests: Monocular<br>Video Frenzel, Video Head<br>Impulse Test (vHIT)<br>Oculomotor and Positional.<br>The system allows for<br>recording of the eye with<br><b>vision and vision denied</b> .<br>The system also allows for<br>recording of the room<br>through the use of a<br>webcam. A monocular video<br>frenzel (only allows<br>recording of the eye and<br>room with no data analysis).<br>The software includes a slow<br>phase velocity algorithm<br>developed in collaboration<br>with Dr Barin a protégé of<br>Dr Stockwell. |
| Characteristic | GN Otometrics A/S<br>Type 1068 ICS Chartr<br>200 VNG K061791 | GN Otometrics A/S ICS<br>Type 1085 Impulse<br>K122550 | GN Otometrics 1068 A/S<br>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<br>Solution | The VG-40 goggles<br>have a shield that can<br>be opened and closed. | There was no vision<br>denied solution | The ICS Impulse has a<br>solution with a cup and a<br>patch. The cup adheres to<br>the right (test) eye. The cup<br>has a window that allows the<br>IR camera to see through in<br>order to record eye<br>movement but the patient<br>can not see through it. The<br>patch covers the left (non-<br>test) eye and the patient can<br>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<br>Professional - Service Pack<br>2, Vista® Business or<br>Windows 7 Professional 32<br>or 64 bit | Windows XP 32-bit<br>Professional SP3 or Windows<br>7 32-bit Professional or<br>Windows 7 64-bit<br>Professional | 64-bit: Windows 8 Pro, Windows<br>7 Professional<br>32- bit: Windows 8 Pro, Windows<br>7 Professional |
| Operator | Trained personnel required | SAME | SAME |

## 7. Substantial Equivalence Chart

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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.