SYNERGY LT

K981405 · Oxford Instruments, Plc. · GWF · Jul 16, 1998 · Neurology

Device Facts

• Record ID: K981405
• Device Name: SYNERGY LT
• Applicant: Oxford Instruments, Plc.
• Product Code: GWF · Neurology
• Decision Date: Jul 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The SYNERGY LT is a 2 channel electromyograph which provides facilities for EMG and Evoked Potentials testing for a range of clinical applications. SYNERGY LT is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment. Caution: Federal law restricts this device to sale by or on the order of a physician, or other licensed practitioner.

Device Story

Synergy LT is a 2-channel electromyograph; records, displays, and documents electrophysiological signals from human nervous and muscular systems. Used in clinical environments by physicians or licensed practitioners for EMG and evoked potentials testing. Device captures electrical activity; processes signals for clinical review; assists in diagnostic assessment of neuromuscular conditions. Output provides visual data for clinician interpretation to support clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

2-channel electromyograph; designed for EMG and evoked potentials testing; clinical environment use; standard electrophysiological recording and display capabilities.

Indications for Use

Indicated for patients requiring electromyography (EMG) and evoked potentials testing to record, display, and document electrophysiological information from the nervous and muscular systems.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 6 1998

Mr. Jeff Hall Quality Assurance Manager Oxford Instruments Medical Systems Division Manor Way, Old Woking Surrey, GU22 9JU, England

Re: K981405 Trade Name: Synergy Lt Regulatory Class: II Product Code: GWF Dated: April 15, 1998 Received: April 20, 1998

Dear Mr. Hall:

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.

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.

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Page 2 - Jeff Hall

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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510(k) NUMBER (IF KNOWN) : K981405 DEVICE NAME : SYNERGY LT____________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

INDICATIONS FOR USE:

The SYNERGY LT is a 2 channel electromyograph which provides facilities for EMG and Evoked Potentials testing for a range of clinical applications.

SYNERGY LT is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment.

Caution: Federal law restricts this device to sale by or on the order of a physician, or other licensed practitioner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division ) mr. Or

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