NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES

K973529 · Medicotest A/S · IKT · Nov 20, 1997 · Physical Medicine

Device Facts

• Record ID: K973529
• Device Name: NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
• Applicant: Medicotest A/S
• Product Code: IKT · Physical Medicine
• Decision Date: Nov 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1385
• Device Class: Class 2

Intended Use

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

Device Story

Neuroline Disposable Concentric Needle Electrode is a single-use device designed for recording muscle electrical activity during electromyography (EMG). The device functions as a sensor to detect bioelectric signals from muscle tissue. It is intended for use by clinicians in a clinical setting to assist in diagnostic assessments. The output is an electrical signal transmitted to an EMG machine for analysis by a healthcare provider to evaluate muscle function and diagnose neuromuscular conditions. The disposable nature of the device eliminates the need for sterilization between patients, reducing cross-contamination risks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable concentric needle electrode for EMG signal acquisition. Single-patient use design. Technical specifications and materials are not detailed in the provided documentation.

Indications for Use

Indicated for recording muscle activity during Electromyography (EMG) procedures in patients requiring diagnostic muscle assessment. For single patient use only.

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)

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Image /page/0/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized design of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Emalee G. Murphy McKenna & Cuneo, L.L.P. Representing Medicotest A/S 1900 K Street, N.W. Washington, D.C. 20006-1108

NOV 20 1997

Re: K973529 Neuroline, Disposable Concentric Needle Electrode Requlatory Class: II Product Code: IKT September 18, 1997 Dated: September 18, 1997 Received:

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 requlations 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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Paqe 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 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,

Acollepto

2 Cellia 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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## ENCLOSURE NO.

l of Page 1

510 (k) Number (if known):

Neuroline Disposable Concentric Needle Electrode Device Name:

Indications For Use:

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

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## 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)

Scall

(Divisio Sion-l Sign-Off Restorative Devices Division 13529 , બ 510(k) Number