FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550

K982950 · Chalgren Enterprises, Inc. · IKT · Jun 22, 1999 · Physical Medicine

Device Facts

• Record ID: K982950
• Device Name: FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
• Applicant: Chalgren Enterprises, Inc.
• Product Code: IKT · Physical Medicine
• Decision Date: Jun 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1385
• Device Class: Class 2

Intended Use

Fine wire electrodes are supplied preloaded into a needle assembly. The needle is inserted into human muscle tissue and then removed, leaving the fine wires implanted for a short term. An adaptor cable is attached to the fine wires and then connected to an EMG instrument for electromyographic (EMG) diagnostic tests. This device is intended for use by licensed physicians. Physicians using this device are well trained in the use of EMG electrodes, their placement, and proper use of related EMG instruments. The fine wire electrodes are designed to record electrical activity in muscle tissue. As recording electrodes, there is no risk of damage to the tissue from electrical current. Fine wire electrodes allow for multiple tests without additional needle sticks.

Device Story

Device consists of fine wire electrodes preloaded into needle assembly; needle facilitates insertion into human muscle tissue; needle removed leaving wires implanted short-term. Adaptor cable connects implanted wires to external EMG instrument. Used by licensed physicians in clinical settings for diagnostic electromyographic testing. Device functions as passive recording electrode; no electrical current delivered to tissue. Benefit includes ability to perform multiple tests without repeated needle sticks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive fine wire electrodes; needle-based insertion mechanism; adaptor cable interface for EMG instrumentation. No active energy source or software components.

Indications for Use

Indicated for use by licensed physicians trained in EMG procedures to record electrical activity in human muscle tissue for diagnostic electromyographic (EMG) testing.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 22 1999

Mr. Richard Kaiser Chief Executive Officer Chalgren Enterprises, Inc. 8021 Carmel Street Gilroy, California 95020

Re: K982950 Regulatory Class: II Product Code: IKT Dated: March 24, 1999 Received: March 26, 1999

Dear Mr. Kaiser:

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 (OS) 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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## Page 2 - Mr. Richard Kaiser

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

Enclosure

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K982950 510(k) Number (if known):

Device Name: FINE WIRE ELECTRODE

Indications For Use:

Fine wire electrodes are supplied preloaded into a needle The needle is inserted into human muscle tissue and then assembly. removed, leaving the fine wires implanted for a short term. An adaptor cable is attached to the fine wires and then connected to an EMG instrument for electromyographic (EMG) diagnostic tests.

This device is intended for use by licensed physicians. Physicians using this device are well trained in the use of EMG electrodes, their placement, and proper use of related EMG instruments.

The fine wire electrodes are designed to record electrical activity in muscle tissue. As recording electrodes, there is no risk of damage to the tissue from electrical current.

Fine wire electrodes allow for multiple tests without additional needle sticks.

K. Harris

Richard Kaiser, CEO 3-24-99

:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Pcolle

(Diviside Sign Off)
Divi... (eral Restorative Devices
510(k) Number K982950

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)