EMU128S, MODEL EX-NW-128S

K040360 · Excel Tech. , Ltd. · GWQ · Mar 12, 2004 · Neurology

Device Facts

• Record ID: K040360
• Device Name: EMU128S, MODEL EX-NW-128S
• Applicant: Excel Tech. , Ltd.
• Product Code: GWQ · Neurology
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The EMU128S is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals.

Device Story

The EMU128S is a digital electroencephalograph used to acquire, store, and archive EEG signals. It functions as a 128-channel EEG headbox. The device incorporates a switch matrix, which is an array of relays designed to facilitate the attachment of external devices to the wires contacting the patient. It operates similarly to existing EEG headboxes, maintaining the same methods for data acquisition, display, storage, and archiving. The device is intended for clinical use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Digital electroencephalograph; 128-channel headbox; includes a switch matrix consisting of an array of relays for external device connectivity.

Indications for Use

Indicated for use as an electroencephalograph to acquire, store, and archive electroencephalographic signals. No specific patient population, age, or disease state contraindications are provided.

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

• Excel Tech Ltd. - 128 Channel EEG Headbox

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: This image shows the date March 12, 2004, along with the company name XLLTEK. Below the company name, the text "SPECIAL 510(K) NOTIFICATION OF A NEW DEVICE" is written. The image also contains some text on the right side, but it is not fully legible.

K040360 Special 510(k) EMU128S March 8 2004 PAGE _________________________________________________________________________________________________________________________________________________________________________

## Appendix C - 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 of Customer Satisfaction |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Excel Tech, Ltd.<br>2568 Bristol Circle<br>Oakville, Ontario<br>Canada, L6H 5S1 |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Common Names: | EMU128S,<br>EMU128 Switch Matrix,<br>128 Channel EEG Headbox |
| Classification Name: | Electroencephalograph |
| Predicate Devices: | Excel Tech Ltd. - 128 Channel EEG Headbox |
| Description: | The EMU128S is a digital<br>electroencephalograph. |
| Substantial Equivalence: | The EMU128S is substantially equivalent in<br>safety and effectiveness to the XLTEK 128<br>Channel EEG Headbox. There is no change to<br>the acquisition, display, storage, or archiving of<br>the EEG data. The change is the addition of a<br>switch matrix. This switch matrix is an array of<br>relays used to facilitate external devices<br>attachments to the wires that contact the patient. |
| Indications for Use: | The EMU128S is intended to be used as an<br>electroencephalograph: to acquire, store, and<br>archive electroencephalographic signals. |

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

Excel-Tech Ltd. c/o Mr. Cameron Mahon 2568 Bristol Circle Oakville, L6H5S1 Canada

Re: K040360

Trade/Device Name: EMU128S Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ, GYC Dated (Date on orig SE 1tr): January 30, 2004 Received (Date on orig SE ltr): February 13, 2004 APR

Dear Mr. Mahon:

This letter corrects our substantially equivalent letter of March 12, 2004.

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.

Image /page/1/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

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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 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); 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/ResourcesforYou/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

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Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: EMU128S

Indications For Use:

The EMU128S is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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

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K040360 510(k) Number_