(28 days)
The EMU128S is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals.
The EMU128S is a digital electroencephalograph.
This document describes a Special 510(k) Notification for the EMU128S device. A Special 510(k) is submitted when there are minor modifications to a legally marketed device that do not affect its fundamental intended use or alter its fundamental scientific technology. Therefore, the submission focuses on demonstrating substantial equivalence to the predicate device, rather than requiring extensive new clinical studies or detailed performance criteria beyond what was established for the predicate.
Given this context, the document outlines the substantial equivalence claim.
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate) | Reported Device Performance (EMU128S) |
|---|---|---|
| Intended Use | Acquire, store, and archive electroencephalographic signals. | Acquire, store, and archive electroencephalographic signals. |
| Technological Characteristics | Digital electroencephalograph with 128 channels. | Digital electroencephalograph with 128 channels, with the addition of a switch matrix. |
| Safety and Effectiveness | Demonstrated safe and effective through prior 510(k) clearance. | Substantially equivalent in safety and effectiveness to the predicate device due to no change in acquisition, display, storage, or archiving of EEG data. The change is the addition of a switch matrix, which facilitates external device attachments without affecting EEG data. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. For a Special 510(k) based on substantial equivalence to a predicate device for minor modifications, a new test set and clinical study proving safety and effectiveness are typically not required if the fundamental technology and intended use remain unchanged. The comparison is primarily based on engineering and design control documentation, and potentially bench testing to confirm the new component (the switch matrix) does not negatively impact performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth establishment for a test set is not typically part of a Special 510(k) for this type of modification. The assessment relies on the established safety and effectiveness of the existing predicate device.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or required. The modification (addition of a switch matrix) is an engineering change to facilitate external device attachments and does not directly involve diagnostic interpretation by human readers that would necessitate such a study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study of an algorithm was conducted or required. The EMU128S is a hardware device for acquiring EEG signals, not an AI or algorithmic diagnostic tool.
7. Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate device (XLTEK 128 Channel EEG Headbox) which was previously cleared by the FDA. The current submission argues that the EMU128S, despite its modification, performs equivalently to this predicate.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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 MahonVice-President of Customer Satisfaction |
|---|---|
| Address: | Excel Tech, Ltd.2568 Bristol CircleOakville, OntarioCanada, L6H 5S1 |
| Telephone: | (905) 829-5300 |
| Fax: | (905) 829-5304 |
| E-mail: | cmahon@xltek.com |
| Common Names: | EMU128S,EMU128 Switch Matrix,128 Channel EEG Headbox |
| Classification Name: | Electroencephalograph |
| Predicate Devices: | Excel Tech Ltd. - 128 Channel EEG Headbox |
| Description: | The EMU128S is a digitalelectroencephalograph. |
| Substantial Equivalence: | The EMU128S is substantially equivalent insafety and effectiveness to the XLTEK 128Channel EEG Headbox. There is no change tothe acquisition, display, storage, or archiving ofthe EEG data. The change is the addition of aswitch matrix. This switch matrix is an array ofrelays used to facilitate external devicesattachments to the wires that contact the patient. |
| Indications for Use: | The EMU128S is intended to be used as anelectroencephalograph: to acquire, store, andarchive electroencephalographic signals. |
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ここに
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 (800) 638-2041 or (301) 796-7100 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_
§ 882.1400 Electroencephalograph.
(a)
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.(b)
Classification. Class II (performance standards).