NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES

K983597 · Medicotest, Inc. · GXZ · Jan 11, 1999 · Neurology

Device Facts

• Record ID: K983597
• Device Name: NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
• Applicant: Medicotest, Inc.
• Product Code: GXZ · Neurology
• Decision Date: Jan 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

Device Story

Neuroline Disposable Monopolar Needle Electrode is a sterile, single-use device designed for recording muscle electrical activity during electromyography (EMG) procedures. The needle electrode is inserted into the patient's muscle tissue by a clinician to detect electrical signals generated by muscle fibers. These signals are transmitted to an external EMG recording system for analysis. The device facilitates diagnostic assessment of neuromuscular function. Being disposable, it eliminates the need for cleaning and sterilization between patients, reducing the risk of cross-contamination.

Clinical Evidence

Bench testing only.

Technological Characteristics

Monopolar needle electrode; disposable; sterile; designed for single-patient use; interfaces with standard EMG recording equipment.

Indications for Use

Indicated for recording muscle activity during Electromyography (EMG) procedures. For single patient use only.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 1999

Ms. Emalee G. Murphy C/O McKenna & Cuneo, L.L.P. 1900 K Street, Northwest Washington, D.C. 20006

Re: K983597

Trade Name: Neuroline Disposable Monopolar Needle Electrode Regulatory Class: II Product Code: GXZ Dated: October 9, 1998 Received: October 13, 1998

Dear Ms.Murphy:

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.

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

## Page 2 – Ms. Emalee G. Murphy

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 vour 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.

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}------------------------------------------------

意味和几几次儿的儿儿儿儿儿 1177. 0

Page 1 of l

510 (k) Number (if known):

Neuroline Disposable Monopolar Needle Electrode Device Name:

人983597

## Indications For Use:

Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional format 1-2-96)

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