TOENNIES NEUROSCREEN SYSTEM

K972419 · Erich Jaeger, Inc. · IKN · Apr 30, 1998 · Physical Medicine

Device Facts

• Record ID: K972419
• Device Name: TOENNIES NEUROSCREEN SYSTEM
• Applicant: Erich Jaeger, Inc.
• Product Code: IKN · Physical Medicine
• Decision Date: Apr 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Intended Use

Diagnostic electromyography, nerve conduction velocity measurement, evoked response electrical stimulator, evoked response photic stimulator, and evoked response auditory stimulator.

Device Story

Toennies Neuroscreen System performs diagnostic neurophysiological testing; includes electromyography (EMG), nerve conduction velocity (NCV) measurement, and evoked response testing. Device utilizes electrical, photic, and auditory stimulators to elicit responses. Operated by clinicians in diagnostic settings to assess nerve and muscle function. System processes physiological signals to provide diagnostic data for clinical decision-making regarding neurological conditions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

System includes electrical, photic, and auditory stimulators for neurophysiological diagnostics. Operates as a diagnostic workstation for EMG and NCV measurements. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for diagnostic electromyography, nerve conduction velocity measurement, and evoked response testing using electrical, photic, or auditory stimulation.

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1998

Mr. D. Grotheer Manager Quality and Regulatory Affairs Erich Jaeger Gmbh Leibnizstrabe 7 D-97204 Hochberg, Germany

Re: K972419 Toennies Neuroscreen System Trade Name: Requlatory Class: II Product Code: IKN Dated: January 26, 1998 Received: January 30, 1998

## Dear Mr. Grotheer:

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, Druq, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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. Grotheer

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,

Colin M. Witten, Ph.D. M

Ph.D., M.D. Celna M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

## K972419

Device Name:

## TOENNIES NEUROSCREEN SYSTEM

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Indications For Use:

Diagnostic electromyography, nerve conduction velocity measurement, evoked response electrical stimulator, evoked response photic stimulator, and evoked response auditory stimulator.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Dioeele

neral Restorative Dev

Use

✓

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

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