SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF

K020910 · The Electrode Store, Inc. · GXZ · Jul 19, 2002 · Neurology

Device Facts

• Record ID: K020910
• Device Name: SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
• Applicant: The Electrode Store, Inc.
• Product Code: GXZ · Neurology
• Decision Date: Jul 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Electrode Store™ Subdermal Needle Electrode for Electroencephalography (EEG) is intended for single-use, subdermal application to record physiological signals or to apply electrical stimulation. It is indicated for use with adult or pediatric patients as a recording or stimulating electrode during electroencephalography.

Device Story

Subdermal needle electrode designed for single-use EEG applications; functions as interface for recording physiological signals or delivering electrical stimulation. Used in clinical settings by healthcare professionals; device inserted subdermally to capture or transmit electrical activity. Output consists of raw electrical signals processed by external EEG monitoring equipment; aids clinicians in diagnostic assessment of neurological function. Benefits include reliable signal acquisition for EEG monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Subdermal needle electrode; single-use; intended for EEG recording and electrical stimulation. No specific materials or software algorithms described.

Indications for Use

Indicated for adult and pediatric patients requiring subdermal electrodes for recording physiological signals or applying electrical stimulation during electroencephalography (EEG).

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Electric Store Carl Youngmann, PhD, RAC c/o R.A. Associates 936-11th Avenue East Seattle, Washington 98102

(JUL 1 9 2002

Re: K020910

Trade/Device Name: Subdermal Needle Electrode for Electroencephalograpy Regulation Number: 882.1350 Regulation Name: Needle Electrode Regulatory Class: II Product Code: GXZ Dated: June 6, 2002 Received: June 11, 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. Iisting 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 - 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 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). 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,

Hipt Rhode

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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THE ELECTRODE STORE™ Subdermal Needle Electrode for EEG 510(k)

Indications for Use Statement

510(k) Number: KO20910

The Electrode Store™ Subdermal Needle Electrode for Electro-Device Name: encephalography (EEG)

Indications for Use:

The Electrode Store™ Subdermal Needle Electrode for Electroencephalography (EEG) is intended for single-use, subdermal application to record physiological signals or to apply electrical stimulation. It is indicated for use with adult or pediatric patients as a recording or stimulating electrode during electroencephalography.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Hyt Quorln

of General, Restorative and Neurological Devices

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801.109)

Over-The-Counter Use

510(k) Number.

Indications for Use Statement