XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248

K040358 · Excel Tech. , Ltd. · GWF · Aug 6, 2004 · Neurology

Device Facts

• Record ID: K040358
• Device Name: XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
• Applicant: Excel Tech. , Ltd.
• Product Code: GWF · Neurology
• Decision Date: Aug 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The Protektor Stimulator is intended to be used for the intraoperative diagnosis of active dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

Device Story

The XLTEK Protektor Stimulator is an evoked response electrical stimulator used in the operating room by clinicians. It delivers electrical stimuli to the nervous system to assess corticospinal axonal conduction. By monitoring responses, the device helps identify potential dysfunction caused by mechanical trauma (traction, shearing, laceration, compression) or vascular insufficiency during surgery. The output allows healthcare providers to assess nerve integrity in real-time, facilitating intraoperative decision-making to prevent permanent neurological damage.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence to existing evoked response electrical stimulators.

Technological Characteristics

Evoked response electrical stimulator; 21 CFR 882.1870; Product Code GWF; Class II device. Operates via electrical stimulation of neural pathways.

Indications for Use

Indicated for intraoperative monitoring of corticospinal axonal conduction in patients undergoing surgical procedures where the spinal cord or corticospinal tracts are at risk of mechanical trauma or vascular insufficiency.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2004

Mr. Cameron Mahon Vice President Customer Satisfaction Excel Tech, Ltd. 2568 Bristol Circle Road Oakville, Ontario Canada L6H 5S1

Re: K040358

Trade/Device Name: XLTEK Protektor Stimulator Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: July 8, 2004 Received: July 12, 2004

Dear Mr. Mahon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars the Medical Device Amendments, or to commerce prior to May 20, 1776, the enaoudance with the provisions of the Federal Food, Drug, devices mat have been rochise in assire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, market the Act include requirements for annual registration, listing of general Controls provisions of the rest 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 If your device is classified (800 a0070) inst Existing major regulations affecting your device can may be subject to sach address, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or ments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri 3155aates over device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of any it cacal statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CT N Fart 6077, moeing (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Cameron Mahon

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manteing of substantial equivalence of your device to a legally premarket notification. The PDA mainly of the Admin volume of this, 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 advice for your act 100 % on one of a more one one one of a cregulation entitled, and Contact the Office of Complanes at (SST) ->>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> "Misbranding by relevelec to promance notified in the Act from the Division of Small other general information on your responsible in the man at its toll-free number [phone] or Manufacturers, International and Octable Scheer http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(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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## Page _ I of __ I

## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K040358

XLTEK Protektor Stimulator Device Name:

Indications for Use:

The Protektor Stimulator is intended to be used for the intraoperative diagnosis The Protection Stimation in corticospinal axonal conduction brought about by of active dystunetion in occuressport.
mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

Prescription Use __X__ (Pcr 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)

Miriam C. Provost

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

(Optional Format 1-2-96)

510(k) Number_________________________________________________________________________________________________________________________________________________________________