ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM by ICS MEDICAL CORP.

The CHARTR® ENG/VNG Diagnostic System is a computer based medical device consisting of a Computer utilizing the Pentium III processor, Windows 98 Operating System. Computer Monitor, two Display Monitors for viewing eve movements and utilizes the following accessories: Light Bar, Video Goggles, External Isolation Transformer. Video Distribution Amplifier. Caloric Stimulator. Color Printer, Patient Electrodes, and Interconnection Cables.

AI/ML Overview

The provided text is a 510(k) summary for the ICS Medical CHARTR® ENG/VNG Diagnostic System, and a letter from the FDA determining substantial equivalence to predicate devices. This type of document is generally focused on regulatory approval based on equivalence to existing devices, rather than detailed studies proving performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding specific study details (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) is not present in the provided text.

Based on the information available:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the CHARTR® ENG/VNG Diagnostic System itself. Instead, the basis for approval is "substantial equivalence" to predicate devices. The "performance" reported implicitly is that the device "observes, records, and measures eye movements in patients during testing of vestibular function," which aligns with the intended use statement.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices for observing, recording, and measuring eye movements during vestibular function testing.	The CHARTR® ENG/VNG Diagnostic System is substantially equivalent to the 2D VOG-VIDEO-OCULOGRAPHY device marketed by SensoMotric Instruments, GmbH ("SMI") and the CHARTR®ENG SYSTEM marketed by ICS Medical Corporation. It observes, records, and measures eye movements in patients during testing of vestibular function.

Study Details (Based on available information)

1. Sample sizes used for the test set and the data provenance:

Not provided. The document describes a regulatory submission based on substantial equivalence to predicate devices, not a de novo study with a specific test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided. Ground truth establishment, if any, is not detailed.

3. Adjudication method for the test set:

Not provided.

4. 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:

No, an MRMC study was not described. The device is for recording and measuring eye movements, not an AI-assisted diagnostic tool for human readers in the context typically associated with MRMC studies in imaging.

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

Not explicitly described as a standalone performance study. The device is a "computer based medical device" that utilizes accessories to "observe, record, and measure eye movements." Its performance is inherent in its function as a diagnostic system for vestibular function, rather than an "algorithm only" in the sense of an AI model being evaluated. The approval is based on its functional equivalence to existing devices.

6. The type of ground truth used:

Not explicitly stated as a separate ground truth study. The basis for approval is substantial equivalence to established devices, implying that the "ground truth" is effectively the established performance and clinical utility of those predicate devices for their intended use.

7. The sample size for the training set:

Not applicable/Not provided. This document does not describe the development or training of an AI model with a training set. It refers to a computer-based system, but not an AI/ML system in the modern sense.

8. How the ground truth for the training set was established:

Not applicable/Not provided. As there is no mention of a training set, the establishment of its ground truth is not discussed.

Summary

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JUL 28 1999

K 991497

510(k) SUMMARY

ICS MEDICAL CORPORATION Submitted by: 2227 Hammond Drive Schaumburg, IL 60173-3860 (847)-397-2150 Telephone: (847)-397-0666 Fax: Delmar F. Bloem. President Contact Person: July 23, 1999 Date Summary Prepared: Trade Name of Device: ICS Medical CHARTR® ENG/VNG Diagnostic System Common Name: Nystagmograph Nystagmograph, Class II, 21 CFR 882.146 Classification Name:

Substantial Equivalence: The CHARTR® ENG/VNG Diagnostic System is substantially equivalent to the 2D VOG-VIDEO- OCULOGRAPHY device marketed by SensoMotric Instruments, GmbH ("SMI") and the CHARTR®ENG SYSTEM marketed by ICS Medical Corporation.

Description of Device:

Intended Use: This Device is used to observe, record, and measure eve movements in patients during testing of vestibular function.

Y2K Compliance: This system is Y2K compliant.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 1999

Mr. Delmar F. Bloem President ICS Medical Corporation 2227 Hammond Drive Schaumburg, Illinois 60173-3860

K991497 Re:

Trade Name: ICS Medical CHARTR® ENG/VNG Diagnostic System Regulatory Class: II Product Code: GWN Dated: April 27, 1999 Received: April 29, 1999

Dear Mr. Bloem:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Delmar F. Bloom

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Rastanoting Daviga

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):_

Device Name: ICS Medical CHARTR ENG/VNG Diagnostic System

Indications For Use:

This device is used to observe, record and measure eye movements in patients during testing of vestibular function.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

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).