SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY

K022197 · The Electrode Store, Inc. · GXY · Aug 13, 2002 · Neurology

Device Facts

• Record ID: K022197
• Device Name: SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
• Applicant: The Electrode Store, Inc.
• Product Code: GXY · Neurology
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Electrode Store™ Surface Electrodes for Electroencephalography are intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.

Device Story

Surface electrodes for EEG; non-invasive recording of physiological signals. Input: electrical signals from patient skin surface. Output: electrical signal transmission to EEG monitoring equipment. Used in clinical settings (e.g., sleep labs, neurology clinics) by trained healthcare professionals. Device facilitates diagnostic monitoring of brain activity and physiological responses; aids clinical decision-making by providing raw signal data for interpretation by clinicians.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Surface electrode for EEG; non-invasive; cutaneous application. Passive device for signal conduction. No active electronic components or software.

Indications for Use

Indicated for adult and pediatric patients undergoing electroencephalography, biofeedback, sleep studies, and evoked potential recordings for non-invasive physiological signal monitoring.

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)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a flowing design element above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 3 2002

The Electrode Store, Inc. Carl Youngmann, Ph.D. c/o Regulatory Affairs Associates 936 - 11" Avenue East Seattle, Washington 98102

Re: K022197

Trade/Device Name: Surface Electrode for Electroencephalography Regulation Number: 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: July 2, 2002 Received: July 5, 2002

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 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 - Dr. Carl Youngmann

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 vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Hyat Rhodes

a 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}------------------------------------------------

THE ELECTRODE STORE™ Surface Electrode for EEG 510(k)

## Indications for Use Statement

510(k) Number: _ Ko22|97

The Electrode Store™ Surface Electrodes for Electroencephalo-Device Name: graphy

Indications for Use:

The Electrode Store™ Surface Electrodes for Electroencephalography are intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.

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

OR

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801.109) Over-The-Counter Use

Styph Rhodes

(Division Sign-Off) Division of General, Restorative and Neurological Devices

Page 6

Indications for Use Statement

510(k) Number_Ko22197