SYNERGY IOM SYSTEM

K984052 · Oxford Instruments Medical Systems · IKN · May 17, 1999 · Physical Medicine

Device Facts

• Record ID: K984052
• Device Name: SYNERGY IOM SYSTEM
• Applicant: Oxford Instruments Medical Systems
• Product Code: IKN · Physical Medicine
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Intended Use

The Synergy IOM System is a 2, 5, or 10 channel electromyograph which provides facilities for EMG, EEG, Evoked Potentials, ECG and NCV testing to be used for Intra-Operative Monitoring.

Device Story

Synergy IOM System is a multi-channel (2, 5, or 10) electromyograph designed for intra-operative monitoring (IOM). Device acquires physiological signals including EMG, EEG, Evoked Potentials, ECG, and NCV. System processes these signals to provide real-time neurophysiological data to clinicians during surgery. Used in operating room environments by trained medical professionals. Output allows surgeons and neurophysiologists to monitor patient neurological status, facilitating clinical decision-making regarding surgical maneuvers and potential nerve or spinal cord injury prevention.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Multi-channel (2, 5, or 10) electromyograph system. Supports EMG, EEG, Evoked Potentials, ECG, and NCV modalities. Designed for intra-operative monitoring. System architecture supports signal acquisition and processing for clinical neurophysiological assessment.

Indications for Use

Indicated for intra-operative monitoring (IOM) using EMG, EEG, Evoked Potentials, ECG, and NCV testing in patients requiring neurophysiological assessment during surgical procedures.

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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Public Health Service

MAY 17 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oxford Instruments Medical Systems c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton. Maryland 21114

Re: K984052

> Trade Name: Oxford Instruments Synergy IOM System Regulatory Class: II Product Code: IKN and CAB Dated: February 15, 1999 Received: February 16, 1999

Dear Mr. Smith:

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 (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 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. E.J. Smith

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

Enclosure

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K984052

## 510(k) Number (if Known):

Device Name: Oxford Instruments Synergy IOM System

Classification Panel:

Indications for Use: ・ 球

The Synergy IOM System is a 2, 5, or 10 channel electromyograph which provides facilities for EMG, EEG, Evoked Potentials, ECG and NCV testing to be used for Intra-Operative Monitoring.

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

| Concurrence of CDHR, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-----------------------------|
| Perscription Use | ✓ |
| or | Over-the-Counter Use ______ |

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K984052 |
|---------------|---------|
|---------------|---------|

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