CUTANEOUS (BAR) ELECTRODE

K991769 · Neuro Supplies, Inc. · GXY · Aug 18, 1999 · Neurology

Device Facts

• Record ID: K991769
• Device Name: CUTANEOUS (BAR) ELECTRODE
• Applicant: Neuro Supplies, Inc.
• Product Code: GXY · Neurology
• Decision Date: Aug 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

Cutaneous (Bar) Electrode is intended for non-invasive use as a recording (active/reference) or stimulating electrode during electromyographic (EMG), Nerve Conduction Studies(NCS), and Evoked Potentials (EP) recordings.

Device Story

Cutaneous (Bar) Electrode functions as a non-invasive interface for electrophysiological monitoring; device captures electrical signals from skin surface or delivers electrical stimulation to underlying nerves/muscles; used by clinicians during EMG, NCS, and EP procedures; output consists of raw electrical data for diagnostic interpretation by healthcare providers; facilitates assessment of nerve and muscle function; intended for clinical use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-invasive cutaneous electrode; bar-style form factor; designed for electrical signal recording and stimulation; passive component; no software or active electronic circuitry.

Indications for Use

Indicated for use as a non-invasive recording or stimulating electrode during electromyographic (EMG), Nerve Conduction Studies (NCS), and Evoked Potentials (EP) procedures in patients requiring such diagnostic testing.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1999

Mr. Ronald Luich, PE President Neuro Supplies, Inc. 86 Boston Post Road Waterford, Connecticut 06385

Re: K991769 Trade Name: Cutaneous (Bar) Electrode K991770 Trade Name: Cutaneous Ground Electrode K991771 Trade Name: Digital Ring Electrode K991772 Trade Name: Cutaneous (Disc) Electrode Regulatory Class: II Product Code: GXY Dated: May 21, 1999 Received: May 24, 1999

Dear Mr. Luich:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (OS) 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 devices 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. Ronald Luich, PE

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

Thurell S. Hagen

Jer 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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Nouro Supplies, Inc. 510(k) Submisslon Cutaneous (bar) Electrode, K991769

## Section 12 - Intended Use Statement

510(k) Number (If known): K991769

Device Name: Cutaneous (Bar) Electrode

Indications For Use:

Cutaneous (Bar) Electrode is intended for non-invasive use as a recording (active/reference) or stimulating electrode during electromyographic (EMG), Nerve Conduction Studies(NCS), and Evoked Potentials (EP) recordings.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Thunole Layon sirJ.P

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of General Restorat 510(k) Number

K 99/769