I-Portal® 4D Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

Device Description

Not Found

AI/ML Overview

The provided document is limited to a "Substantial Equivalence Determination" from the FDA and does not contain the detailed study information required to answer your request. This type of FDA letter typically confirms that a device is substantially equivalent to a predicate device already on the market, meaning it has a similar intended use and technology, and any differences do not raise new questions of safety or effectiveness. It does not generally include a detailed description of the studies, acceptance criteria, or performance data that would be found in a 510(k) summary or full submission.

Therefore, I cannot provide the requested information, including:

A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
Sample size used for the test set and the data provenance: Not available.
Number of experts used to establish the ground truth for the test set and the qualifications: Not available.
Adjudication method: Not available.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device is a "Video Oculography Eye Tracking System," which is a measurement device for eye movements, not typically an AI diagnostic algorithm that would be assessed with MRMC studies in the context of human reader improvement.
Standalone performance (algorithm only): Not mentioned, and likely not applicable for this type of device which seems to be a hardware/software system for capturing and presenting data.
Type of ground truth used: Not available.
Sample size for the training set: Not available.
How the ground truth for the training set was established: Not available.

The document focuses on the regulatory approval and outlines the device's intended use: "I-Portal® 4D Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations."

To obtain the detailed study information, one would typically need to review the full 510(k) summary or the complete 510(k) submission, which is not provided in this excerpt.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest wings and a tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993-0002

AUG 0 6 2009

c/o Mr. Joe Argyros Vice-President 128 Gamma Drive Pittsburgh, PA 15238-2920

Neuro Kinetics, Inc.

Re: K083603

Trade/Device Name: I-Portal 4D Video Oculography Eye Tracking System (VOG), I-Porta Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN Dated: June 16, 2009 Received: June 17, 2009

Dear Mr. Argyros:

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.

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Kesia Alexander fa

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

Enclosure

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Indications for Use Statements

Indications for Use 510(k) Number: _ k 06 3 6 03 Device Name: I-Portal® Neuro Otologic Test Center (NOTC) Indications for Use:

I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro otologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

Contraindications (if applicable):

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K063603

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4.0 Indications for Use Statements

Indications for Use Statements

Indications for Use Indications for Use Kuss 603 Device Name: 1-Portal® 4D Video Oculography (VOG) System Indications for Use:

Contraindications (if applicable):

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Oththalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K083603

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Indications for Use Statements

Indications for Use Device Name: I-Portal® Video Nystagmography System (VNG) Indications for Use:

I-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

Contraindications (if applicable):

Prescription Use ✗
(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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number k(on) 603

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).