EXCEL AMBULATORY EEG

K982479 · Excel Tech. , Ltd. · GWQ · Oct 14, 1998 · Neurology

Device Facts

• Record ID: K982479
• Device Name: EXCEL AMBULATORY EEG
• Applicant: Excel Tech. , Ltd.
• Product Code: GWQ · Neurology
• Decision Date: Oct 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain). When connected, as part of a system, to the NeuroWorks [FDA 510(k) # K980214], the system is also intended to display and archive there signals.

Device Story

Battery-powered electroencephalograph; acquires and stores brain electrical signals. Operates as standalone recorder or integrated with NeuroWorks (K980214) for signal display and archiving. Used in clinical or ambulatory settings; operated by healthcare professionals. Output facilitates neurological assessment and diagnostic decision-making.

Clinical Evidence

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

Technological Characteristics

Battery-powered electroencephalograph; designed for signal acquisition and storage. Integrates with NeuroWorks system for data display and archiving. Class II device, product code GWQ.

Indications for Use

Indicated for patients requiring acquisition and storage of electroencephalographic signals for diagnostic purposes.

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

• NeuroWorks (K980214)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1998

Mr. John R. Mumford President Excel Tech, LTD. 2892 Portland Dr. Oakville, Ontario Canada L6H 5W8

Re: K982479 Trade Name: Excel Ambulatory EEG Regulatory Class: II Product Code: GWQ Dated: July 16, 1998 Received: July 16, 1998

Dear Mr. Mumford:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), 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 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. -------------------------------

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Page 2 - Mr. John R. Mumford

This letter will allow you to begin marketing your device as described in your 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 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"...

Sincerely yours,

Cecelia M. Witten, Ph.D.

ia M. Witten, Ph.D., M.D. Director

Division of General and Restorative 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 : "AMBULATORY EEG"

## ATTACHMENT # 1 STATEMENT OF INDICATIONS FOR USE

| 510(k) Number (if known): | K982479 |
|---------------------------|----------------------|
| Device Name: | Excel Ambulatory EEG |
| Indications For Use: | |

## Intended Use

The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain).

ﺔ ﺍﻟﻤﺘﺤﺪﺓ

When connected, as part of a system, to the NeuroWorks [FDA 510(k) # K980214], the system is also intended to display and archive there signals.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
EEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K982479 |

| Prescription Use<br>er 21 CFR 801.109) | OR | Over-The-Counter Use |
|----------------------------------------|----|----------------------|
|----------------------------------------|----|----------------------|

(Optional Format 1-2-96)