SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS

K083758 · The Electrode Store, Inc. · GXY · Aug 14, 2009 · Neurology

Device Facts

• Record ID: K083758
• Device Name: SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
• Applicant: The Electrode Store, Inc.
• Product Code: GXY · Neurology
• Decision Date: Aug 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The Electrode Store™ Sterile Cutaneous Electrode is indicated for use as a recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. It is provided packaged and labeled as a sterile device for single patient use.

Device Story

Device consists of sterile cutaneous electrodes, specifically two-finger ring electrodes and facial stimulator probe electrodes. Used by clinicians during electromyography (EMG), nerve conduction studies (NCS), and evoked potential (EP) recordings. Electrodes function as either recording (active/reference) or stimulating interfaces to capture or deliver electrical signals to/from patient nerves/muscles. Single-patient use; sterile packaging. Output is raw electrical signal data for display on compatible EMG/NCS/EP diagnostic equipment. Facilitates clinical assessment of nerve and muscle function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cutaneous electrodes (two-finger rings and facial stimulator probes). Sterile, single-patient use. Conductive interface for electrical signal recording or stimulation. Class II device (21 CFR 882.1320, Product Code GXY).

Indications for Use

Indicated for use as recording or stimulating electrodes during EMG, NCS, and EP procedures. For use on patients undergoing neurophysiological 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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Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993-0002

AUG 1 4 2009

The Electrode Store, Inc. c/o Carl Youngmann, Ph.D., RAC Designated Regulatory and Quality Affairs Representative 1530 Holcomb St. Port Townsend, WA 98368

Re: K083758

Trade/Device Name: Sensory Nerve Electrodes-Two Finger Rings, Stimulator Probe Electrodes-Facial ·

Regulation Number: 21 CFR 882.1320

Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: June 30, 2009 Received: July 2, 2009

Dear Dr. Youngmann:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Carl Youngman, Ph.D., RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Kesia Alexander for

Malvina B. Eydelman, M.D Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

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## Section IV-Indications for Use Statement

K083758 510(k) Number:

The Electrode Store™ Sterile Cutaneous Electrode Device Name:

Indications for Use:

The Electrode Store™ Sterile Cutaneous Electrode is indicated for use as a recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. It is provided packaged and labeled as a sterile device for single patient use.

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

Harry L. Kacen

(Division Sign-Off) Division of Ophthalmic, Neurological and Ea Nose and Throat Devices

510(k) Number K083758

Prescription Use (Per 21 CFR §801 subpart D) OR

Over-The-Counter Use (Per 21 CFR §801 subpart C)

Section IV-Indications for Use Statement

Page IV-1

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