The XLTEK EMU40EX EEG 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 XLTEK EMU40EX EEG 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 Description

The Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) EMU40EX System is a powerful and flexible EEG recording system. The EMU40EX System consists of a patient electrode set, EMU40EX EEG Headbox, and the Natus Base Unit.

The EMU40EX System is designed to work with an XLTEK host computer system running the Natus Database and Natus NeuroWorks® data review and analysis software.

The EMU40EX EEG Headbox can be connected to the Natus Base Unit with a cable, or can connect wirelessly through a secure BlueTooth link

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the XLTEK EMU40EX EEG Headbox. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or performance through typical clinical studies with specific acceptance criteria in the way a new drug or high-risk medical device might.

Here's an analysis based on the information provided, keeping in mind the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from testing)	Reported Device Performance
Electromagnetic Compatibility (EMC)	Passed verification in accordance with IEC 60601-1-2: 2007, indicating compliance with applicable standards.
General Performance (Bench Testing)	Passed verification and validation for product requirements including: Signal quality, Functionality, User interface. Also complied with applicable clauses of IEC 60601-1-6: 2010 (Usability), IEC 60601-2-26: 2012 (Electroencephalographs), IEC 62366: 2007 (Usability Engineering), ISO 80601-2-61: 2011 (Pulse Oximeter Equipment).
Software/Firmware Performance	Passed verification and validation according to a robust software development process, internal firmware requirements, and FDA guidance documents (e.g., "The content of premarket submissions for software contained in medical devices," IEC 62304: 2006). Complies with predetermined firmware specifications.
Electrical Safety	Passed verification in accordance with IEC 60601-1: 2005, Am1: 2012, indicating compliance with applicable standards.
Substantial Equivalence (Overall Conclusion)	"The XLTEK EMU40EX EEG Headbox is as safe, as effective, and performs as well as or better than the predicate device."

Explanation of the Study and Device Meeting Acceptance Criteria:

The "study" described here is a set of engineering and performance verification and validation tests, not a clinical trial in the traditional sense. The device, an EEG headbox, is a Class II medical device, and the submission is a 510(k), which seeks to demonstrate "substantial equivalence" to a legally marketed predicate device (XLTEK EMU40 EEG Headbox, K053386).

The acceptance criteria are therefore largely derived from recognized international standards for medical electrical equipment, software development, and specific performance attributes expected of an EEG headbox. The device is deemed to meet these criteria by successfully passing the various verification and validation tests outlined in the document.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of this engineering-focused 510(k) submission. There is no "test set" of patient data or clinical cases described for evaluating algorithm performance. The testing involved hardware, software, and system-level performance against engineering standards.
Data Provenance: Not applicable. The "data" refers to test results from in-house engineering and laboratory testing, rather than patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. Ground truth, in the sense of clinical interpretations or diagnoses for a dataset, is not part of this type of submission for this device. The "ground truth" for the engineering tests would be the established international standards and their specified parameters (e.g., a certain level of electromagnetic compatibility, signal fidelity characteristics, etc.), which are not established by individual experts for each test. Internal engineering and quality assurance personnel would verify adherence to these standards.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable for the reasons outlined in point 3. Testing involves objective measurements against predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size of Human Improvement with AI: Not applicable. This device is an EEG headbox, a signal acquisition and digitization component. It is not an AI-powered diagnostic or interpretive algorithm designed to assist human readers. It acquires physiological signals for interpretation by trained medical professionals using other software (XLTEK NeuroWorks software), but the headbox itself does not have AI capabilities that would directly improve human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done

Standalone Performance Study: No, this device is not an algorithm that performs standalone diagnoses or interpretations. It is hardware that acquires data. Its performance is evaluated based on its ability to accurately and safely acquire and transmit physiological signals, not on diagnostic accuracy.

7. The Type of Ground Truth Used

Type of Ground Truth: For this device, the "ground truth" for its performance is adherence to established engineering standards (e.g., IEC 60601 series, ISO 80601 series) and the manufacturer's internal product specifications for signal quality, functionality, usability, and safety. There is no clinical "ground truth" (like pathology, expert consensus on images, or outcomes data) involved for this hardware component.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device does not use machine learning or AI algorithms that require a "training set" of data for development. Its firmware design and development follow a robust software development process, but this is traditional software engineering, not machine learning.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The image is in black and white.

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

December 14, 2016

Natus Medical Incorporated DBA Excel-tech Ltd. (XLTEK) Mr. Sanjay Mehta Senior Manager, Quality Assurance & Regulatory Affairs 2568 Bristol Circle Oakville, Ontario, L6H 5S1 Canada

Re: K163163

Trade/Device Name: XLTEK EMU40EX EEG Headbox Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: November 3, 2016 Received: November 10, 2016

Dear Mr. Mehta:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163163

Device Name XLTEK EMU40EX EEG Headbox

Indications for Use (Describe)

The XLTEK EMU40EX EEG Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software.

The XLTEK EMU40EX EEG 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Submission Date:	03 November 2016
Submitter:	Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1Canada
Submitter andApplicationCorrespondent	Mr. Sanjay MehtaPhone: +1 (905) 287-5055Fax: +1 (905) 829-5304Email: sanjay.mehta@natus.com
Manufacturing Site:	Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1Canada
Trade Name:	XLTEK EMU40EX EEG Headbox
Common andClassificationName:	Electroencephalograph
ClassificationRegulation:	21 CFR §882.1400
Product Code:	GWQ
ClassificationPanel:	Neurology
SubstantiallyEquivalent Devices:	New Model	Predicate 510(k)Number	PredicateManufacturer / Model
	XLTEK EMU40EX EEGHeadbox	K053386	XLTEK / XLTEKEMU40 EEG Headbox
Device Description:	The Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)EMU40EX System is a powerful and flexible EEG recording system.The EMU40EX System consists of a patient electrode set, EMU40EXEEG Headbox, and the Natus Base Unit.
	The EMU40EX System is designed to work with an XLTEK hostcomputer system running the Natus Database and Natus NeuroWorks®data review and analysis software.
	The EMU40EX EEG Headbox can be connected to the Natus Base Unitwith a cable, or can connect wirelessly through a secure BlueTooth link

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Intended Use: The XLTEK EMU40EX EEG Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks® software.

The XLTEK EMU40EX EEG 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.

Technology Comparison:

The XLTEK EMU40EX EEG Headbox employs the same technological characteristics as the predicate device.

ECG SystemCharacteristic	XLTEK EMU40EEG Headbox(K053386)	XLTEK EMU40EXEEG Headbox(Proposed Device)
Intended Use	The XLTEK EMU40 EEGHeadbox is anelectroencephalograph that worksin conjunction with XLTEKNeuroWorks software.The XLTEK EMU40EX EEGHeadbox is used to acquire,digitize, store and transmitphysiological signals (such asEEG, pulse and oximetry signals)for EEG studies in research andclinical environments.The XLTEK EMU40EX EEGHeadbox requires competent userinput, and its output must bereviewed and interpreted bytrained medical professionals whojudgement in using thisinformation.	Same
Referential Channels	40	Same
DC Channels	Four (4) isolated	Same
Electrode Connections(including commoninput)	Touch-proof	Same
Oximeter Connection	Yes	Same
Photic StimulatorConnection	Yes	Same
Patient Event Button	Yes	Same

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Technology Comparison (continued):

ECG SystemCharacteristic	XLTEK EMU40EEG Headbox(K053386)	XLTEK EMU40EXEEG Headbox(Proposed Device)
Batteries	Two (2) AAA Rechargeable	Same
Compatible withRechargeable ExternalBattery Pack	Yes	Same
Front Panel Base UnitControls	LCD DisplayFour (4) buttons	Touchscreen LCD display.
ElectromagneticCompatibility	The XLTEK EMU40EX EEG Headbox was verified for performance inaccordance with the following standard:IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2:General requirements for basic safety and essential performance –Collateral standard: Electromagnetic compatibility – Requirementsand tests.
	Results indicate that the XLTEK EMU40EX EEG Headbox passedverification, and complies with the applicable standards.
PerformanceTesting – Bench	The XLTEK EMU40EX EEG Headbox was verified and validated forperformance in accordance with product requirements including:Signal quality. Functionality. User interface.
	and the applicable clauses of the following standards:IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6:General requirements for basic safety and essential performance –Collateral standard: Usability. IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26:Particular requirements for the basic safety and essentialperformance of electroencephalographs. IEC 62366: 2007, Medical devices – Application of usabilityengineering to medical devices. ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61:Particular requirements for basic safety and essential performance ofpulse oximeter equipment.
	Results indicate that the XLTEK EMU40EX EEG Headbox passedverification and validation, and complies with the product requirementsand the applicable standards.
Conclusion	Verification and validation activities were conducted to establish theperformance and safety characteristics of the device modifications madeto the XLTEK EMU40EX EEG Headbox. The results of these activitiesdemonstrate that the XLTEK EMU40EX EEG Headbox is as safe, aseffective, and performs as well as or better than the predicate device.Therefore, the XLTEK EMU40EX EEG Headbox is consideredsubstantially equivalent to the predicate device

Summary of Performance Testing:

Software

The XLTEK EMU40EX EEG Headbox firmware was designed and developed according to a robust software development process, and was rigorously verified and validated. Firmware information is provided in accordance with internal firmware requirements and the following FDA guidance documents and standards:

The content of premarket submissions for software contained in medical devices, 11 May 05.
Off-the-shelf software use in medical devices, 09 Sep 99.
General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02.
. Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14.
. IEC 62304: 2006, Medical device software – Software life cycle processes

Results indicate that the XLTEK EMU40EX EEG Headbox firmware passed verification and validation, complies with its predetermined firmware specifications, the applicable guidance documents, and the applicable standards.

The XLTEK EMU40EX EEG Headbox was verified for performance in Electrical Safety accordance with the following standard:

IEC 60601-1: 2005, Am1: 2012, Medical electrical equipment Part . 1: General requirements for basic safety and essential performance.
Results indicate that the XLTEK EMU40EX EEG Headbox passed verification, and complies with the applicable standards.

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Regulation Number and Section

§ 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).