XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16

K992313 · Excel Tech. , Ltd. · GWF · Aug 19, 1999 · Neurology

Device Facts

• Record ID: K992313
• Device Name: XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
• Applicant: Excel Tech. , Ltd.
• Product Code: GWF · Neurology
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The EP-16 is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument assess a patient's neurological status during surgery of long term monitoring in the ICU.

Device Story

The XLTEK EP-16 Evoked Potential Headbox is a medical device used in operating rooms and critical care settings for neurological monitoring. It functions as an interface for capturing and assessing a patient's neurological status during surgical procedures or long-term ICU monitoring. The device processes electrical signals related to evoked potentials, allowing clinicians to monitor neurological integrity in real-time. It is operated by trained healthcare professionals, such as neurologists or technicians, to assist in clinical decision-making during critical care or surgery. By providing continuous neurological data, the device helps clinicians detect changes in patient status, potentially improving surgical outcomes and patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is an evoked potential headbox designed for neurological signal acquisition. It operates as an electrical stimulator/monitor under 21 CFR 882.1870. Technical details regarding specific materials, connectivity, or software architecture are not provided in the source document.

Indications for Use

Indicated for neurological monitoring and assessment of patients in operating rooms and critical care units (ICU) during surgery or long-term monitoring.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. John R. Mumford President Excel Tech, Ltd. 2568 Bristol Circle Oakville, Ontario Canada L61-51S I

APR - 9 2012

Re: K992313

Trade/Device Name: XLTEK EP-16 Evoked Potential Headbox Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF, GWQ, GWJ, GWE Dated (Date on orig SE ltr): June 30, 1999 Received (Date on orig SE ltr): July 9, 1999

Dear Mr. Mumford:

This letter corrects our substantially equivalent letter of August 19, 1999.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D.
Director
Division of Ophthalmic, Neurological,
and Ear, Nose and Throat Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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## EXCEL TECH, LTD. 510(K) NOTIFICATION OF A NEW DEVICE : 2015) "XLTEK EP-16 Evoked Potential Device"

## ATTACHMENT # 1

## STATEMENT OF INDICATIONS FOR USE

Page 1 of 1

510(k) Number ( if known ) :

Device Name : XLTek EP-16 Evoked Potential Headbox Indications for Use :

The EP-16 is intended for use in the operating room and critical care areas for neurological monitoring The LF-10 is thended for use in the operating room and EMG techniques to provide the and assessment. The instrument assess a patient's neurological status during surgery of long term monitoring in the ICU.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Russell S. Vaysor Sr., J20

sion of General 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The Counter Use _

(Optional Format 1-2-96)