NEUROLINE, SUBDERMAL NEEDLE ELECTRODES

K020907 · Medicotest A/S · IKT · Jun 14, 2002 · Physical Medicine

Device Facts

• Record ID: K020907
• Device Name: NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
• Applicant: Medicotest A/S
• Product Code: IKT · Physical Medicine
• Decision Date: Jun 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1385
• Device Class: Class 2

Intended Use

The Neuroline Subdermal Needle Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are sterile and for single patient use only.

Device Story

Neuroline Subdermal Needle Electrode; sterile, single-use needle electrode. Used with recording, monitoring, and stimulation equipment to capture biopotential signals (EMG, EEG, nerve potentials). Operated by clinicians in clinical settings. Device functions as a passive interface between patient tissue and diagnostic equipment; no active processing or internal software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Subdermal needle electrode; sterile; single-patient use. Passive sensing component for biopotential signal acquisition. No energy source, software, or complex materials specified.

Indications for Use

Indicated for use with recording, monitoring, and stimulation equipment to record biopotential signals, including EMG, EEG, and nerve potentials. For single patient use.

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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head in profile, with three human faces incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle and faces.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2002

Medicotest A/S c/o Ms. Emalee G. Murphy Kirkpatrick & Lockhart LLP 1800 Massachusetts Avenue, NW Suite 200 Washington, D.C. 20036-1221

Re: K020907

Trade/Device Name: Neuroline Subdermal Needle Electrode Regulation Number: 890.1385 and 882.1330 Regulation Name: Diagnostic electromyography needle electrode Depth electrode Regulatory Class: II Product Code: IKT and GXZ Dated: March 15, 2002 Received: March 20, 2002

Dear Ms. Murphy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Ms. Emalee G. Murphy

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A
Stpt Rhodes
Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510 (k) Number (if known):

Neuroline Subdermal Needle Electrode Device Name:

## Indications For Use:

The Neuroline Subdermal Needle Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are sterile and for single patient use only.

020907

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use **X** OR Over-The-Counter Use **__**
(Per 21 CFR 801.109) and (Optional format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number 15020907