XLTEK NEUROPATH, MODEL PK1070

K053058 · Excel Tech. , Ltd. · JXE · Feb 7, 2006 · Neurology

Device Facts

• Record ID: K053058
• Device Name: XLTEK NEUROPATH, MODEL PK1070
• Applicant: Excel Tech. , Ltd.
• Product Code: JXE · Neurology
• Decision Date: Feb 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1550
• Device Class: Class 2

Intended Use

The XLTEK NeuroPath is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies. The XLTEK NeuroPath is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements.

Device Story

XLTEK NeuroPath is a nerve conduction velocity measurement device. It functions by delivering electrical stimulation to nerves and recording resulting neuromuscular signals. Used by clinicians as an adjunct to conventional electrodiagnostic measurements to assist in the diagnosis and evaluation of systemic and entrapment neuropathies. The device processes input signals to provide data for clinical assessment of nerve function. It is intended for professional use in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Nerve conduction velocity measurement device (21 CFR 882.1550). Class II. Product code JXE. Utilizes electrical stimulation and signal acquisition for neuromuscular assessment.

Indications for Use

Indicated for use in patients requiring diagnostic evaluation of systemic and entrapment neuropathies via stimulation and measurement of neuromuscular signals. Intended for prescription use only.

Regulatory Classification

Identification

A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 7

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

Re: K053058

Trade/Device Name: XLTEK NeuroPath Regulation Number: 21 CFR 882.1550 Regulation Name: Nerve conduction velocity measurement device Regulatory Class: II Product Code: JXE Dated: January 27, 2006 Received: January 30, 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- Nicole Landreville, Eng.RAC

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.

Sincerely, yours,

Barbara Buchner

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

510(k) Number (if known): K053058

Device Name: XLTEK NeuroPath

Indications for Use:

The XLTEK NeuroPath is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

The XLTEK NeuroPath is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements.

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)

Barbora Buchnerova Mkal

Division of General, Restorative, and Neurological Devices

**510(k) Number** K05 3058

(Optional Format 1-2-96)