TECA NCS ELECTRODE SYSTEM 2000

K971914 · Medelec, Inc. D.B.A. Teca Corp. · GXY · Mar 26, 1998 · Neurology

Device Facts

• Record ID: K971914
• Device Name: TECA NCS ELECTRODE SYSTEM 2000
• Applicant: Medelec, Inc. D.B.A. Teca Corp.
• Product Code: GXY · Neurology
• Decision Date: Mar 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The NCS Electrode System 2000 is for electromyographic recording, stimulating, and referencing in motor, sensory nerve conduction, and volitional electromyography.

Device Story

NCS Electrode System 2000 consists of electrodes used for electromyographic (EMG) recording, nerve stimulation, and referencing. Device facilitates motor and sensory nerve conduction studies and volitional EMG. Used in clinical settings by healthcare professionals to acquire electrophysiological signals. Electrodes interface with EMG instrumentation to capture electrical activity from nerves and muscles; output assists clinicians in diagnosing neuromuscular conditions. System provides necessary electrical contact for signal acquisition and stimulation delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrode system for electrophysiological signal acquisition and stimulation. Specific materials and ASTM standards not disclosed in provided text. Device functions as a passive interface for EMG instrumentation.

Indications for Use

Indicated for use in electromyographic recording, stimulating, and referencing during motor nerve conduction, sensory nerve conduction, and volitional electromyography procedures.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James P. Hurlman Manager, Quality Assurance and Regulatory Affairs Medelec, Inc. d.b.a TECA Corporation Three Campus Drive 10570 Pleasantville, New York

MAR 2 6 1998

Re: K971914 TECA NCS Electrode System 2000 Requlatory Class: II Product Code: GXY December 22, 1997 Dated: Received: December 29, 1997

Dear Mr. Hurlman:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਸ 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 In addition, FDA may publish further announcements action. 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 requlations.

{1}------------------------------------------------

## Page 2 - Mr. James P. Hurlman

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 requlation (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.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

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

{2}------------------------------------------------

Page_1_of_1

510(k) Number (if known):

Device Name: TECA NCS Electrode System 2000

Indications For Use:

The NCS Electrode System 2000 is for electromyographic recording, stimulating, and referencing in motor, sensory nerve conduction, and volitional electromyography.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices

Division of General Restorative Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

OVER-the-Counter dose

(Optional Format 1-2-96)