TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES

K973444 · Medelec, Inc. D.B.A. Teca Corp. · IKT · Nov 20, 1997 · Physical Medicine

Device Facts

• Record ID: K973444
• Device Name: TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
• Applicant: Medelec, Inc. D.B.A. Teca Corp.
• Product Code: IKT · Physical Medicine
• Decision Date: Nov 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1385
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that musche. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug, delivery. Once the physician is satisfied with the location, he/she injects a very. therein via the lumen of the needle.

Device Story

Disposable hypodermic monopolar needle electrode; features open lumen for dual-functionality. Input: electrical signals from muscle tissue during EMG; output: motor unit action potential recordings. Device enables physician to locate specific muscle via stimulation/recording, then deliver medication directly through needle lumen. Used in clinical settings by physicians. Benefits: combines diagnostic EMG localization with therapeutic drug delivery in single procedure; single-use design eliminates cross-contamination risk.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Monopolar needle electrode with open lumen for drug delivery. Single-use, sterile. Designed for EMG, muscle stimulation, and recording. No software or electronic processing components.

Indications for Use

Indicated for patients requiring electromyography (EMG) procedures, muscle stimulation, motor unit action potential recording, and targeted intramuscular drug delivery. For use by physicians.

Regulatory Classification

Identification

A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

Submission Summary (Full Text)

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

Image /page/0/Picture/2 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 curved lines representing its wings or feathers. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James P. Hurlman Manager, Regulatory Affairs TECA Corporation 3 Campus Drive Pleasantville, New York 10570

NOV 20 1997

K973442 Re : TECA Disposable Monopolar Needle Electrodes K973444 K97544
TECA MyoJect Disposable Needle Electrodes Regulatory Class: II Product Code: IKE Dated: September 11, 1997 Received: September 11, 1997

Dear Mr. Hurlman:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976, the markment 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ 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 devices in the Federal Register. Please note: this response to your premarket notification submission does

.

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

Page 2 - Mr. James P. Hurlman

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.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Additionally, for questions on Compliance at [phone]. the promotion and advertising of your devices, please contact Also, please note the Office of Compliance at [phone]. the regulation entitled, "Misbranding by reference to Other general premarket notification" (21 CFR 807.97). 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,
Jolly Da

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

Enclosures

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

510(k) Number (if known):

Device Name: Disposable Hypodermic Needle Electrode

Indications For Use:

The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that musche. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug, delivery. Once the physician is satisfied with the location, he/she injects a very. therein via the lumen of the needle.

Note: TECA Corp. does not supply any drugs with needle electrodes nor does TECA Corp. offer for sale any form of drugs.

(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 Sign-Off)
Division of General Restorative Devices
510(k) Number K973442

Prescription Use (Per 21 CFR 801.009)

OR

Over-The-Counter Use___

(Optional Format 1-2-96)

3