XLTEK EMU40 EEG HEADBOX, MODEL PK1072

K053386 · Excel Tech. , Ltd. · GWQ · Apr 21, 2006 · Neurology

Device Facts

• Record ID: K053386
• Device Name: XLTEK EMU40 EEG HEADBOX, MODEL PK1072
• Applicant: Excel Tech. , Ltd.
• Product Code: GWQ · Neurology
• Decision Date: Apr 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}. The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments. The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

Device Story

EMU40 Headbox functions as an electroencephalograph component; acquires, digitizes, stores, and transmits physiological signals including EEG, pulse, and oximetry. Operates in conjunction with XLTEK NeuroWorks software. Used in clinical and research environments; requires operation by competent users. Output consists of digitized physiological data for review and interpretation by trained medical professionals. Professional judgment required for clinical decision-making based on interpreted data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electroencephalograph headbox; digitizes physiological signals (EEG, pulse, oximetry). Designed for integration with XLTEK NeuroWorks software. Connectivity via system integration.

Indications for Use

Indicated for acquisition, digitization, storage, and transmission of physiological signals (EEG, pulse, oximetry) for EEG studies in clinical and research environments. Requires trained medical professional interpretation.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Reference Devices

• XLTEK NeuroWorks software (K980214)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized symbol. The symbol consists of three curved lines that resemble human profiles facing to the right. The logo is simple and monochromatic, with a focus on the symbol's abstract representation of people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2006

Excel-Tech. Ltd c/o Ms. Nicole Landreville, Eng. RAC Director, Quality and Regulatory 258 Bristol Circle Oakville, Ontario Canada L6H 5S1

Re: K053386

Trade/Device Name: XLTEK EMU40 EEG Headbox Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWO Dated: March 21, 2006 Received: March 23, 2006

Dear Mr. 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 vour 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

{1}------------------------------------------------

## Page 2 - Ms. 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/dsma/dsmamain.html

Sincerely yours

elmdl

Mark N. Melkerson
Director
Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Statement of Indications for Use

510(k) Number (if known): KoS 3386

Device Name: XLTEK EMU40 EEG Headbox

Indications for Use:

The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}.

The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.

The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

Prescription Use × (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)

QmDQ

(Division Sign Off)

Division of General, Restorative,
and Neurological Devices

510(k) N

(Optional Format 1-2-96)