XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382

K052111 · Excel Tech. , Ltd. · GXZ · Aug 17, 2005 · Neurology

Device Facts

• Record ID: K052111
• Device Name: XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
• Applicant: Excel Tech. , Ltd.
• Product Code: GXZ · Neurology
• Decision Date: Aug 17, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

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

Device Story

Sub-dermal needle electrodes designed to interface with external recording, monitoring, and stimulation equipment. Device captures biopotential signals (EMG, EEG, nerve potentials) from patient tissue. Used by clinicians in clinical settings to facilitate diagnostic neurophysiological monitoring. Electrodes are sterile, single-use components. Output is raw electrical signal transmitted to compatible monitoring hardware for clinician interpretation. Benefits include reliable signal acquisition for neurological assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sub-dermal needle electrode; sterile; single-patient use. Designed for compatibility with standard EMG, EEG, and nerve potential monitoring/stimulation equipment. No active electronic components or software.

Indications for Use

Indicated for patients requiring biopotential signal recording, monitoring, or stimulation during EMG, EEG, or nerve potential procedures. For prescription use only; single-patient use.

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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AUG 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nicole Landreville, Eng. RAC Director of Quality and Regulatory Excel Tech LTD 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1

Re: K052111

Trade/Device Name: XLTEK Clear Signal Sub-dermal Needle Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: August 11, 2005 Received: August 12, 2005

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 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- Ms. Nicole Landreville, Eng. RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter witi anow you to oegil mainenes your alence of your device to a legally premaired 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 if you desire specific darrioliance at [phone]. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain Misoranding by reference to your responsibilities under the Act from the Division of Small other general miornituren on Jour Corpumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Buckland
for

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

Enclosure

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## Statement of Indications for Use

K052111 510(k) Number (if known):

XLTEK Clear Signal Sub-dermal Needle Device Name:

Indications for Use:

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

Prescription Use X (Per 21 CFR 801.109) OR

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K052111 barbara bucklus for Mulkerson
(Division Sign-Off)

Division of General. Restorative. and Neurological Devices

**510(k) Number** K052111

(Optional Format 1-2-96)