XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES

K061269 · Excel Tech. , Ltd. · GXY · Aug 14, 2006 · Neurology

Device Facts

• Record ID: K061269
• Device Name: XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
• Applicant: Excel Tech. , Ltd.
• Product Code: GXY · Neurology
• Decision Date: Aug 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

XLTEK Clear Signal Adhesive Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals. The electrodes are for single patient use only.

Device Story

XLTEK Clear Signal Adhesive Electrodes are cutaneous electrodes designed to interface with recording, monitoring, and stimulation equipment. The device captures biopotential signals—specifically EMG, EEG, and nerve potentials—from the patient's skin surface. These signals are transmitted to external diagnostic or monitoring systems for clinical analysis. Used in clinical settings by healthcare professionals, the electrodes facilitate the acquisition of physiological data necessary for neurological and muscular assessment. The device is intended for single-patient use to prevent cross-contamination.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cutaneous adhesive electrode for biopotential signal acquisition. Single-patient use. Passive sensing component; no energy source or active circuitry. Dimensions and materials not specified in provided text.

Indications for Use

Indicated for patients requiring biopotential signal recording, monitoring, or stimulation, including EMG, EEG, and nerve potential signals. For single patient use only.

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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Excel-Tech. Ltd. % Ms. Nicole Landreville Director of Quality and Regulatory 2568 Bristol Circle Oakville, Ontario Candada L6H 5S1

Re: K061269

AUG 1 4 2006

Trade/Device Name: XLTEK Clear Signal Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: July 14, 2006 Received: July 17, 2006

Dear Ms. Landreville:

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

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Page 2 - Ms. Nicole Landreville

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.

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Mark N Millhause

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## KO6126

Page _ I of _1

## Statement of Indications for Use

510(k) Number (if known):

XLTEK Clear Signal Adhesive Electrodes Device Name:

Indications for Use:

XLTEK Clear Signal Adhesive Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals. The electrodes are for single patient use only.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The Counter Use

Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

) Number.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millhouser

vision Sign-Off) Division of General, Restorative and Neurological Devic