The Nystagram™ is a video nystagmograph intended to view, record, and measure eye movements in support of identification of balance disorders. The device is intended for use only by qualified, trained medical personnel to aid in diagnostic recommendations. This device does not provide any medical diagnosis and is intended to be part of a larger balance assessment battery.

Device Description

The Nystagram™ is a device that views, records and measures both vertical and horizontal eye movements for support of identification of balance disorders. The results of the video nystagmograph (VNG) tests are combined with other clinical information to allow qualified medical personnel to determine the health of a patient's vestibular function system. The Nystagram™ system consists of a goggles system with a video camera and accelerometers to record eye movements and head position, computer monitors and other hardware and software to control the operation of the patient stimulus and the test administration functions. The system software is used for nystagmus analysis during oculomotor mobility, positional nystagmus, and caloric examinations. The results are presented in visual diagrams for clinical review.

AI/ML Overview

The provided text describes the Nystagram™ Video Nystagmography System and its substantial equivalence to predicate devices, focusing on the comparative evaluation conducted. Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Oculomotor Tests (Saccades, Gaze, Optokinetic):
- Normal: Symmetrical eye movement without cog-wheeling or clinically significant nystagmus.	Equivalency was demonstrated: interpretations of the data by each audiologist matched for each test ("Normal" or "Abnormal") and subject.
- Abnormal: All other findings.
Positional Tests (Supine, Head Right, Head Left) without visual fixation:
- Positive: Clinically significant nystagmus present.	Equivalency was demonstrated: interpretations of the data by each audiologist matched for each test ("Positive" or "Negative") and subject.
- Negative: No clinically significant nystagmus present.
Positioning Tests (Dix-Hallpike) and Spontaneous Nystagmus Tests:
- Positive: Clinically significant nystagmus present.	Equivalency was demonstrated: interpretations of the data by each audiologist matched for each test ("Positive" or "Negative") and subject. Test results verified that the devices are equivalent in their ability to capture eye motion, administer VNG test protocols, and document Nystagmus for analysis by the clinician.
- Negative: No clinically significant nystagmus present.
Overall Equivalency: Interpretations of data ("Normal/Abnormal" or "Positive/Negative" for each test and subject) between the Nystagram™ and the predicate device must match to demonstrate equivalency.	Test results verified that the devices are equivalent in their ability to capture eye motion, administer VNG test protocols, and document Nystagmus for analysis by the clinician.

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: Five (5) subjects.
- Data Provenance: Prospective. The study involved measuring the response of these subjects to stimuli within a 24-hour period by both the Nystagram™ and a predicate device. The audiologists were in Sugarland, Texas and The Woodlands, Texas, respectively.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Two (2) independent Audiologists.
- Qualifications of Experts: They are described as "independent Audiologist" without further specification of experience (e.g., years of experience).
Adjudication method for the test set:
- The adjudication method was a direct comparison of clinical findings between the two devices as interpreted by two independent audiologists. The equivalency was demonstrated when interpretations of the data by each audiologist matched for each test and subject. This indicates a consensus approach where agreement between the two independent clinical evaluations served as the basis for equivalency.
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:
- This was not a multi-reader, multi-case study in the context of AI assistance. It was a comparative performance study of two medical devices (Nystagram™ vs. a predicate VNG device) where human audiologists served as the evaluators of the device's output. The study aimed to show equivalence between the devices, not how human performance improved with or without AI. Therefore, there is no effect size related to AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The provided text does not describe a standalone algorithm-only performance study. The device "views, records, and measures eye movements," and the "system software is used for nystagmus analysis." However, the "results are presented in visual diagrams for clinical review," and the device is intended for "use only by qualified, trained medical personnel to aid in diagnostic recommendations." The clinical equivalency study explicitly involved human audiologists clinically evaluating the resultant tracings and judging them as "Normal/Abnormal" or "Positive/Negative." This indicates human-in-the-loop performance is integral.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established through expert clinical evaluation/interpretation by the independent Audiologists. They clinically evaluated the tracings and judged the findings as "Normal/Abnormal" or "Positive/Negative." Equivalency was achieved when these expert interpretations from both devices matched.
The sample size for the training set:
- The document does not mention a separate training set or its sample size. The study described is a comparative evaluation for establishing clinical equivalency, involving 5 subjects, which serves as the "test set" for this particular equivalency study.
How the ground truth for the training set was established:
- Since no training set and corresponding ground truth establishment are explicitly described in the provided document, this information is not available. The document focuses on the comparative performance of the device in relation to a predicate device for regulatory clearance.

Summary

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K130201

510(k) Summary NystagramTM Video Nystagmography System

APR 2 6 2013

Date Prepared: January 24, 2013

Submitter: Ototronix LLC 26620 Interstate 45 North Houston, TX 77386 Telephone: 281-203-0253 Fax: 832-550-2116
Mr. Bernard Horwath Contact: Regulatory Affairs Consultant 4486 Timberline Ct Vadnais Heights, MN 55127 Telephone: 651- 231-1761

Proprietary Name: Nystagram™ Video Nystagmography System

Common/Usual Name: Video Nystagmograph, VNG

Classification Name: Nystagmograph, 21 CFR 882.1460, Class II, Product Code GWN

Establishment Registration Number: 3008612563

Description:

Indications for Use:

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Substantial Equivalence:

The Nystagram™ Video Nystagmograph System is substantially equivalent to most commercially available VNG systems in the market. Specifically the Nystagram™ is substantially equivalent to the following predicate devices:

· BalanceBack VNG device (K042529)
· GN Otometrics ICS Chartr ENG/VNG System (K991497)
· Interacoustics 2D-VOG System (K072254)

All four devices have the same intended use and use similar technology and components. All patient preparation and test protocols are standard for all four devices.

Technological Characteristics:

Technically from a design and mechanism of action standpoint, the Nystagram™ is substantially equivalent to the predicate devices. They are all designed to record, view, and measure nystagmus in support of identification of balance disorders. The Nystagram and the predicate devices use similar technologies and components. Video cameras mounted to goggles record nystagmus. Infrared (IR) illumination of the eye area aids the cameras. Computer hardware and software detect and measure nystagmus during oculomotor mobility, positional nystagmus, and caloric examinations.

All patient preparation and test protocols are standard for the Nystagram™ and the predicate devices. The Nystagram™ and the predicate devices are designed for safety of the patient as well as the test administrator. All systems used IEC 60601 or variants to analyze safety.

Performance Bench Testing:

Tests of hardware and software have been performed to verify system specifications. Test plans were developed to ensure the product met all the specified requirements. The device conforms to the following standards:

IEC 60601-1-1 (2000)
· IEC 60601-1 (2005)
· IEC 60601-1-2 (2007)
· ANSI S3.45(2009)

In addition, a comparative evaluation was conducted between the Nystagram™ and the GN Otometrics ICS Chartr VNG/ENG (Predicate Device) for the purpose of establishing clinical equivalency. Five (5) subjects' response to stimuli was measured and the resulting nystagmus or lack of nystagmus was recorded using the Predicate Device by an independent Audiologist located in Sugarland, Texas and the Nystagram™ by an independent Audiologist located in The Woodlands, Texas. The two testing sessions were within a 24 hour time period. The test battery included evaluation of Oculomotor function, Positional, Positioning and Spontaneous Nystagmus.

For the Oculomotor tests (Saccades, gaze and optikenetic), data were analyzed regarding symmetry and smoothness of eye movements and presence of nystagmus. Resultant tracings were clinically evaluated and judged to be:

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"Normal" for symmetrical eye movement without cog-wheeling or clinically significant nystagmus, OR
· "Abnormal" for all other findings

For the Positional tests without visual fixation (Supine, Head Right and Head Left), data were analyzed regarding the presence of clinically significant nystagmus. If so, the direction of the nystagmus was noted. Resultant tracings were clinically evaluated and judged to be:

· "Positive" if clinically significant nystagmus was present, OR
· "Negative" if no clinically significant nystagmus was present

For the Positioning Tests (Dix-Hallpike) and Spontaneous Nystagmus Tests, data were analyzed regarding the presence of clinically significant nystagmus. If so, the direction of the nystagmus was noted. Resultant tracings were clinically evaluated and judged to be:

· "Positive" if clinically significant nystagmus was present, OR
· "Negative" if no clinically significant nystagmus was present

The data collected from the Nystagram™ and Predicate Device were compared regarding the clinical findings of "Normal/Abnormal" or "Positive/Negative" for each test and subject. Equivalency between devices was demonstrated when interpretations of the data by each audiologist matched for each test and subject.

Test results verified that the devices are equivalent in their ability to capture eye motion, administer VNG test protocols and document Nystagmus for analysis by the clinician.

Conclusion:

Based upon the extensive testing conducted and the comparison to the predicate devices, it is the conclusion of Ototronix that the Nystagram™ is substantially equivalent to the predicate devices already on the market cleared by the 510(k) review process and presents no new concerns about safety or effectiveness.

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Public Health Service

April 26, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Ototronix, LLC c/o Bernard Horwath 4486 Timberline Ct St. Paul, MN 55127

Re: K130201

Trade/Device Name: Nystagram Video Nystagmography System Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: January 24, 2013 Received: January 28, 2013

Dear Mr. Horwath:

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 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.

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eric A.FMann -S

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K130201

Nystagram™ Video Nystagmography System :

Indications for Use:

Prescription Use ਨ (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 Office of Device Evaluation (ODE)

Cherish RaGiusto 2013.04.19 4:40:36 -04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number K130201

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).