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 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". 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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ICS Impulse System Model 1085, which is a nystagmograph used to assess vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.

However, the document is a Summary of Substantial Equivalence, not a full study report of the device's performance against specific acceptance criteria. It primarily focuses on comparing the new device (ICS Impulse Model 1085) to previously cleared predicate devices (K061791 ICS Chartr 200 VNG and K122550 ICS Impulse Type 1085) to demonstrate substantial equivalence, rather than providing detailed performance metrics from a specific study against pre-defined acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not available in the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document declares that "The ICS Impulse adequately meets the design requirements and acceptance criteria" but does not provide a specific table of acceptance criteria with corresponding performance results. The "Description of Testing" section mentions:

UL Electrical Safety testing (passed)
EMC testing (passed)
Software validation (performed)
Risk analysis (performed)
Biocompatibility testing (successfully performed)
Clinical analysis based on published literature (performed)

These are general types of testing, but no quantitative acceptance criteria or performance metrics are detailed.

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

Not explicitly stated for a performance test set. The document mentions "A clinical analysis based on published literature." This suggests that the clinical validation was not based on a new, direct clinical study with a specific test set but rather a review of existing literature, likely supporting the underlying principles of the device's measurements (VOR, nystagmus). Therefore, there is no specific "test set" with a defined sample size or provenance in the context of a prospective study of the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable based on the provided text. Since a direct clinical performance study with a defined test set and ground truth established by experts is not described, this information is not available. The "clinical analysis based on published literature" does not involve fresh ground truth establishment for a specific device test set.

4. Adjudication Method for the Test Set:

Not applicable based on the provided text. No adjudication method is described as there is no specific test set undergoing human expert review for performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No indication of an MRMC study. The document focuses on demonstrating substantial equivalence to predicate devices, not on showing how much human readers improve with AI vs. without AI assistance. This suggests that no MRMC study was performed or reported in this 510(k) summary. The device, a nystagmograph, primarily measures and displays physiological data; it's not described as an AI-powered diagnostic aid that assists human readers in interpreting images or data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document implies that the device "measures, records, displaying, and analyzing eye and head movements." The software processes data: "The OTOsuite Vestibular software processes the head velocity data and velocity data for eye movement (the response)." and "The OTOsuite Vestibular software processes the eye velocity data (the response)." This indicates the algorithm performs analysis alone to generate data. However, specific performance metrics of this standalone algorithmic analysis (e.g., sensitivity, specificity, accuracy against a true measurement) are not reported in this 510(k) summary document. It states the system allows the clinician to "determine if the response is within normal limits or not," implying human interpretation of the algorithm's output.

7. The Type of Ground Truth Used:

Not explicitly detailed for device performance evaluation. Given that the clinical analysis was based on published literature, the "ground truth" would refer to the accepted understanding and measurement of VOR and nystagmus as established in the scientific and medical community. There's no mention of a specific, newly established ground truth (e.g., pathology, outcomes data) for validating the device's measurements in a direct study.

8. The Sample Size for the Training Set:

Not applicable/Not provided. The document describes software validation and risk analysis, but it does not mention a "training set" in the context of a machine learning or AI algorithm that would require one. The device measures physical parameters, and its "analysis" seems to be based on known physiological principles rather than statistical learning from a large dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/Not provided. As there's no mention of a training set, this information is not relevant to the provided text.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed report of a clinical performance study with specific acceptance criteria and results. Therefore, most of the detailed information requested regarding study design, sample sizes, ground truth, and expert involvement is not present.

Summary

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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 (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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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

1. 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.

1. 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.
1. 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.
1. 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/SType 1068 ICS Chartr200 VNG K061791	GN Otometrics A/S ICSType 1085 ImpulseK122550	GN Otometrics A/SType 1085 ICS Impulse
Intended Use	The Focus VNG/ENGis a nystagmographthat is intended tomeasure, record anddisplay involuntarymovements(nystagmus) of theeyeball.	The ICS Impulse Systemis used in the assessmentof the vestibular-ocularreflex (VOR) bymeasuring, recording,displaying, and analyzingeye and headmovements.	The ICS Impulse System isused in the assessment of thevestibular-ocular reflex(VOR) and nystagmus bymeasuring, recording,displaying, and analyzingeye and head movements.
Product Code	GWN	GWN/LXV	GWN
Characteristic	GN Otometrics A/SType 1068 ICS Chartr200 VNG K061791	GN Otometrics A/S ICSType 1085 ImpulseK122550	GN Otometrics 1068 A/SType 1085 ICS Impulse
Configuration	ICS Chartr 200 VNGconsists of a hardwarebox and VG-40binocular videogoggles. The gogglescan record one eye(monocular) or twoeye binocular. TheICS Chartr 200 cannotmeasure headmovement	The patient wears a pairof lightweight, tightly-fitting goggles on whichis mounted a very small,very light, very fast,firewire video cameraand a half silveredmirror. This transparentmirror reflects the imageof the patient's eye intothe camera. The eye isilluminated by a low-level infra-red lightemitting diode which isnot visible to thepatients. A small sensoron the goggles measuresthe head movement. Thewhole goggle system islightweight but it must besecured tightly to thehead to minimize goggleslippage.	The patient wears a pair oflightweight, tightly-fittinggoggles on which is mounteda very small, very light, veryfast, USB video camera anda half silvered mirror. Thistransparent mirror reflectsthe image of the patient'seye into the camera. The eyeis illuminated by a low-levelinfra-red light emitting diodewhich is not visible to thepatients. A small sensor onthe goggles measures thehead movement. The wholegoggle system is lightweightbut it must be secured tightlyto the head to minimizegoggle slippage.
Test Battery	The ICS Chartr 200 isa full VNG systemwhich allows for thefollowing types oftests: Oculomotor,Positional, andCalorics. The systemallows for recording ofthe eye with vision andvision denied. Thesoftware includes aslow phase velocityalgorithm developed incollaboration with DrStockwell.	The ICS Impulse systemallows for the followingtypes of tests: recordingthe eye video and roomvideo as known asMonocular VideoFrenzel, and Video HeadImpulse Test (vHIT).The system allows forrecording of the eye withvision only . The systemalso allows for recordingof the room through theuse of a webcam. Amonocular video frenzel(only allows recording ofthe eye and room with nodata analysis).	The ICS Impulse systemallows for the followingtypes of tests: MonocularVideo Frenzel, Video HeadImpulse Test (vHIT)Oculomotor and Positional.The system allows forrecording of the eye withvision and vision denied .The system also allows forrecording of the roomthrough the use of awebcam. A monocular videofrenzel (only allowsrecording of the eye androom with no data analysis).The software includes a slowphase velocity algorithmdeveloped in collaborationwith Dr Barin a protégé ofDr Stockwell.
Characteristic	GN Otometrics A/SType 1068 ICS Chartr200 VNG K061791	GN Otometrics A/S ICSType 1085 ImpulseK122550	GN Otometrics 1068 A/SType 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 DeniedSolution	The VG-40 goggleshave a shield that canbe opened and closed.	There was no visiondenied solution	The ICS Impulse has asolution with a cup and apatch. The cup adheres tothe right (test) eye. The cuphas a window that allows theIR camera to see through inorder to record eyemovement but the patientcan not see through it. Thepatch covers the left (non-test) eye and the patient cannot 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® XPProfessional - Service Pack2, Vista® Business orWindows 7 Professional 32or 64 bit	Windows XP 32-bitProfessional SP3 or Windows7 32-bit Professional orWindows 7 64-bitProfessional	64-bit: Windows 8 Pro, Windows7 Professional32- bit: Windows 8 Pro, Windows7 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.

Regulation Number and Section

§ 882.1460 Nystagmograph.

(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).