84 CHANNEL EEG

K014146 · Xltek · GWQ · Jan 14, 2002 · Neurology

Device Facts

• Record ID: K014146
• Device Name: 84 CHANNEL EEG
• Applicant: Xltek
• Product Code: GWQ · Neurology
• Decision Date: Jan 14, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The 84 Channel EEG is intended to be used as an electroencephalograph: to acquire, display, store, and archive electroencephalographic signals.

Device Story

The 84 Channel EEG is a digital electroencephalograph designed to acquire, display, store, and archive electroencephalographic signals. It functions as a modification of existing ambulatory EEG technology, expanding channel capacity to 84 channels. The device is intended for clinical use by healthcare professionals to monitor and record brain electrical activity. It processes input signals from electrodes placed on the patient, transforming these into digital data for visualization and archival. The output allows clinicians to review neurological data to assist in clinical decision-making regarding patient brain function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital electroencephalograph; 84-channel capacity; software-based signal acquisition and processing; intended for clinical environment.

Indications for Use

Indicated for use as an electroencephalograph to acquire, display, store, and archive electroencephalographic signals. Patient population not specified.

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.

Predicate Devices

• 24 Channel Ambulatory EEG (K982479)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: This image shows a document header with the XLTEK logo on the left. To the right of the logo is the text "SPECIAL 510(K) 84 CHANNEL EEG". Below the logo, it says "SPECIAL 510(K) DEVICE MODIFICATION", and to the right, it says "DECEMBER 14, 2001 PAGE 49 of 51". At the top of the image, the number "1014146" is written in handwriting.

## Section F -- 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR § 807.92.

| Name: | Cameron Mahon<br>Vice President, Customer Satisfaction | JAN 1 4 2002 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Address: | XLTEK<br>2568 Bristol Circle<br>Oakville, Ontario<br>Canada, L6H 5S1 | |
| Telephone: | [phone] | |
| Fax: | [phone] | |
| E-mail: | [e-mail] | |
| Common Names: | 84 Channel EEG | |
| Classification Name: | Electroencephalograph | |
| Predicate Devices: | 24 Channel Ambulatory EEG [FDA 510(k) K982479] | |
| Description: | The 84 Channel EEG is a digital electroencephalograph | |
| Substantial Equivalence: | The 84 Channel EEG is substantially equivalent to the 24 Channel<br>Ambulatory EEG [FDA 510(k) K982479] | |
| Indications for Use: | The 84 Channel EEG is intended to be used as an<br>electroencephalograph: to acquire, display, store, and archive<br>electroencephalographic signals | |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three birds in flight, representing health, hope, and well-being. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JAN 1 4 2002

XLTEK Sonja Markez Regulatory Affairs 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1

Re: K014146

Trade Name: 84 Channel EEG Regulation Number: 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: December 14, 2001 Received: December 18, 2001

Dear Ms. Markez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Sonja Markez

This letter will allow you to begin marketing your device as described in your Section 510(k) remarket 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Mark N Millerson

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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Image /page/3/Picture/0 description: The image shows the logo for "XLTEK" along with the text "SPECIAL 510(k)" and "84 CHANNEL EEG". Below the logo, the text "SPECIAL 510(k) DEVICE MODIFICATION" is present. On the right side of the image, the date "DECEMBER 14, 2001" and the page number "PAGE 50 of 51" are displayed.

# Section G -- INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

84 Channel EEG

Indications for Use:

The 84 Channel EEG is intended to be used as an electroencephalograph: to acquire, display, store, and archive electroencephalographic signals.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21\$ CFR 801.109)

Over-The Counter Use OR

Mark N. Millerson

neral, Restorative and Neuros cal Devices Kol4146

510(k) Number -

(Optional Format 1-2-96)