ICS IMPULSE by GN OTOMETRICS | FDA 510(k) Summary

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. (Prescription use).

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, fire-wire 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 eve. 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.

AI/ML Overview

The provided text describes the ICS Impulse device, its intended use, and a comparison to predicate devices, but it does not include detailed information regarding specific acceptance criteria for performance, nor does it present the results of a study designed to explicitly "prove the device meets the acceptance criteria" in a quantitative manner as typically expected for medical device approvals of this nature (e.g., sensitivity, specificity, accuracy against a gold standard in a clinical trial).

The document states that "Clinical testing compared test results to Scleral Search Coils test results. ICS Impulse adequately meets the design requirements and acceptance criteria." However, it does not elaborate on what these "design requirements and acceptance criteria" were in terms of specific performance metrics or thresholds, nor does it provide the detailed results of this clinical testing.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Safety:
Electrical Safety per UL2601 - IEC-60601 (Predicate)	Complies with UL 60601-1, IEC 62471, 1st ed., IEC 60825-1, 2nd ed. UL Listed
EMC (Electromagnetic Compatibility)	IEC 60601-1-2: 2007
Software Validation	Performed
Risk Analysis	Performed
Effectiveness/Performance:
Adequately meets design requirements and acceptance criteria (general statement)	"Clinical testing compared test results to Scleral Search Coils test results. ICS Impulse adequately meets the design requirements and acceptance criteria."
Substantial Equivalence to Predicate Devices (Vorteq, VisualEyes)	Concluded to be "as safe and effective as the predicate device, and has essentially the same indications for use."
Accuracy/Agreement with Scleral Search Coils (Implicit from clinical testing)	Not specifically quantified or detailed in terms of metrics (e.g., correlation coefficient, mean difference, % agreement).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country, retrospective/prospective).
The text only says "Clinical testing compared test results to Scleral Search Coils test results."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
The "Scleral Search Coils" are referred to as the reference standard, which is an objective measurement technique rather than an expert interpretation. If expert interpretation was involved in the "Scleral Search Coils test results," it's not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not specified. The document does not describe the device as an "AI" or "CAD" system in the context of human reader improvement. It's a measurement and display device.

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

The device performs measurements and displays data for a clinician to interpret. The "clinical testing" implicitly refers to the device's measurements being compared to a reference standard, which is a form of standalone performance evaluation of the measurement capability, even if the final interpretation is by a human. However, explicit "standalone" performance metrics (e.g., sensitivity, specificity, accuracy) are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth (reference standard) used for the clinical testing was "Scleral Search Coils test results." Scleral Search Coils are considered a gold standard for precise eye movement measurement.

8. The sample size for the training set

Not specified. The document does not explicitly mention a "training set" in the context of machine learning. The clinical testing described seems to be a validation/comparison study.

9. How the ground truth for the training set was established

Not applicable/Not specified, as a training set is not explicitly mentioned.

Summary

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510(K) Summary, 510(k) K122550 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: Dan Sansonetti, Manager of Research and Development Date Prepared: January 13, 2012

FEB 0 1 2013

Identification of the Device: 1. Proprietary-Trade Name: ICS Impulse Classification Name: Class II, Product Codes: GWN and LXV, Device: Nystagmograph Common/Usual Name: Vestibular testing device

Equivalent legally marketed devices: Micromedical Technologies Inc. Vorteq, K891008 and 2. Micromedical Technologies Inc. VisualEyes K964325.
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, fire-wire 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 eve. 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.
1. Indications for Use (intended use): The ICS Impulse System is used in the assessment of the vestibular-ocular reflex (VOR) by measuring, recording, displaying, and analyzing eve and head movements. (Prescription use).
1. Safety and Effectiveness, comparison to predicate device. This device has the same indications for use as the predicate device but employs different technology to accomplish the same tasks.
1. Description of Testing: The device passed UL Electrical Safety testing and EMC testing. Software validation and risk analysis was performed. Clinical testing compared test results to Scleral Search Coils test results. ICS Impulse adequately meets the design requirements and acceptance criteria.

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7. Substantial Equivalence Chart

Characteristic	Micromedical TechnologiesInc. Vorteq, K891008 andVisualEyes K964325.	ICS Impulse
Intended Use:	VORTEQ® is designed toprovide information about theVestibular Ocular Reflex(VOR) in patients withdizziness or balance problems.	The ICS Impulse System is used in the assessment ofthe vestibular-ocular reflex (VOR) by measuring,recording, displaying, and analyzing eye and headmovements.
Configuration	VORTEQ® utilizes an angularvelocity sensor mounteddirectly to the VisualEyes™FireWire Binocular Goggles.With the VisualEyes™Monocular Goggles, theangular velocity sensor isattached to the back of thegoggles headband forVORTEQ® testing	The patient wears a pair of lightweight, tightly-fittinggoggles on which is mounted a very small, very light,very fast, fire-wire video camera and a half silveredmirror. This transparent mirror reflects the image ofthe patient's eye into the camera. The eye isilluminated by a low-level infra-red light emittingdiode which is not visible to the patients. A smallsensor on the goggles measures the head movement.The whole goggle system is lightweight (only about60g) but it must be secured tightly to the head tominimize goggle slippage
Photo	Image: Person wearing goggles with camera attached	Image: Goggles with camera attached
Interfaces	Firewire for CameraData: Not specified	Firewire for CameraUSB 2 for Data
Electricalsafety	Electrical Safety per UL2601 -IEC-60601.	Complies with UL 60601-1, IEC 62471, 1st.ed., IEC60825-1, 2.ed. UL Listed
EMC	Not specified	IEC 60601-1-2: 2007
Calibration	Performed using a DigitalLightbar, LCD projector orSecondary monitor. Stimulus +/-15 degrees for horizontal and +/-10 degrees for vertical	Performed using 2 Built-In Laser (2) Class II @ +/-7.5degrees.

1. Conclusion: After analyzing bench testing, safety, EMC, software, and clinical validation testing we conclude that the ICS Impulse is as safe and effective as the predicate device, and has essentially the same indications for use, thus rendering it substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 1, 2013

GN Otometrics A/S % Mr. Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Court Naples, FL 34114

Re: K122550

Trade/Device Name: ICS Impulse Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN, LXV Dated: January 21, 2013 Received: January 23, 2013

Dear Mr. Daniel 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.

1f 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 r hat 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

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Page 2 - Mr. Daniel Kamm, P.E.

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Joyce M. Whang

for Victor Krauthamer, Ph.D. Acting 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): K122550

Device Name: ICS Impulse

Indications For Use:

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.

Prescription Use X (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)

Joyce M. Whanq

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K122550

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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).