ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM

K991497 · Ics Medical Corp. · GWN · Jul 28, 1999 · Neurology

Device Facts

• Record ID: K991497
• Device Name: ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
• Applicant: Ics Medical Corp.
• Product Code: GWN · Neurology
• Decision Date: Jul 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2

Intended Use

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

Device Story

Computer-based diagnostic system for vestibular function testing; utilizes Pentium III processor and Windows 98 OS. Inputs include eye movement data captured via video goggles and patient electrodes. System components include light bar, caloric stimulator, video distribution amplifier, and isolation transformer. Operates in clinical settings by healthcare professionals. Device records and measures eye movements, displaying results on monitors for clinician review. Output assists clinicians in assessing vestibular function and diagnosing related disorders.

Technological Characteristics

Computer-based system; Pentium III processor; Windows 98 OS. Components: video goggles, patient electrodes, light bar, caloric stimulator, isolation transformer, video distribution amplifier. Connectivity: interconnection cables. Class II nystagmograph (21 CFR 882.146).

Indications for Use

Indicated for patients undergoing vestibular function testing to observe, record, and measure eye movements.

Regulatory Classification

Identification

A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Predicate Devices

• 2D VOG-VIDEO-OCULOGRAPHY (SensoMotric Instruments, GmbH)
• CHARTR®ENG SYSTEM (ICS Medical Corporation)

Submission Summary (Full Text)

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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: [phone] 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:

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.

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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three parallel lines forming its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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510(k) Number (if known):_

Device Name: ICS Medical CHARTR ENG/VNG Diagnostic System

Indications For Use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Optional Format 3-10-98)

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