DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570

K021118 · Class A Ent. · GXZ · May 28, 2002 · Neurology

Device Facts

• Record ID: K021118
• Device Name: DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
• Applicant: Class A Ent.
• Product Code: GXZ · Neurology
• Decision Date: May 28, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

Electromyographic (EMG) needle electrodes are monopolar needles intended to be inserted into the muscle or nerve tissue to sense bioelectrical signals. This device is an accessory to the electromyography recording machine, used for assessment of skeletal muscles. EMG electrodes are the property of a licensed physician and intended for single patient use, only.

Device Story

Detachable Monopolar EMG Needle Electrode functions as an accessory to electromyography (EMG) recording systems. Device consists of a needle electrode inserted into muscle or nerve tissue to detect bioelectrical signals. Signals are transmitted to the EMG machine for analysis by a physician. Used in clinical settings for skeletal muscle assessment. Intended for single-patient use to prevent cross-contamination. Provides diagnostic data to assist physicians in evaluating neuromuscular function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Monopolar needle electrode; designed for insertion into muscle/nerve tissue; accessory to EMG recording equipment; single-patient use; non-sterile/sterile (implied by single-use requirement).

Indications for Use

Indicated for use by licensed physicians as an accessory to electromyography recording equipment for sensing bioelectrical signals in skeletal muscle or nerve tissue during EMG studies. Intended for single-patient use.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Samantha L. Draper Quality Assurance Manager Class A Enterprises, Inc. P.O. Box 401964 16039 Walnut Street, Ste. C Hesperia, CA 92340

MAY 2 8 2002

Re: K021118

Trade/Device Name: Detachable Monopolar EMG Needle Electrode Regulation Number: 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: May 8, 2002 Received: May 13, 2002

Dear Ms. Draper:

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, 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 (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.

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Page 2 - Ms. Samantha L. Draper

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). regaration on 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,

Miriam C. Provost

fur 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

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## 510(K) NUMBER: K021118

## DEVICE NAME: Detachable Monopolar EMG Needle Electrode

INDICATIONS FOR USE: Electromyographic (EMG) needle electrodes are INDICATIONS FOR OOL. Elooking ographis (into the muscle or nerve tissue to monopolar necules inconded to be mice is an accessory to the electromygraphy sense bloelectrical agrials: "This dothor with electromyography studies (recording machine, whiler to for ass eries of skeletal muscles). EMG electrodes are the inthinsto oloothour propertion of a licensed physician and intended for single patient use, only.

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)

Miriam C. Provost

Division Sign. Off Division of General, Restorative and Neurological Device

510(k) Number K021118