XLTEK EMU40EX EEG Headbox

K163163 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · GWQ · Dec 14, 2016 · Neurology

Device Facts

• Record ID: K163163
• Device Name: XLTEK EMU40EX EEG Headbox
• Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
• Product Code: GWQ · Neurology
• Decision Date: Dec 14, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

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. 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 judgement in using this information.

Device Story

The XLTEK EMU40EX EEG Headbox is an electroencephalograph system used to acquire, digitize, store, and transmit physiological signals, including EEG, pulse, and oximetry. The system comprises a patient electrode set, the headbox, and a Natus base unit. It connects to a host computer running Natus NeuroWorks software for data review and analysis. The headbox connects to the base unit via cable or secure Bluetooth. It features a touchscreen LCD display for control. The device is operated by trained medical professionals in clinical or research settings. Output is reviewed by clinicians to support diagnostic decision-making for EEG studies.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through bench testing for signal quality, functionality, and user interface, alongside compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-26, IEC 62366, and ISO 80601-2-61 standards.

Technological Characteristics

Electroencephalograph with 40 referential channels and 4 isolated DC channels. Features touch-proof electrode connections, oximeter/photic stimulator ports, and patient event button. Powered by two AAA rechargeable batteries or external battery pack. Connectivity via cable or Bluetooth. Interface includes touchscreen LCD. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-26 (EEG safety), and ISO 80601-2-61 (pulse oximetry).

Indications for Use

Indicated for use in research and clinical environments to acquire, digitize, store, and transmit physiological signals, including EEG, pulse, and oximetry, for EEG studies. Requires operation by trained medical professionals.

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

• XLTEK EMU40 EEG Headbox (K053386)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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.

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)<br>2568 Bristol Circle<br>Oakville, Ontario, L6H 5S1<br>Canada | | |
| Submitter and<br>Application<br>Correspondent | Mr. Sanjay Mehta<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Manufacturing Site: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)<br>2568 Bristol Circle<br>Oakville, Ontario, L6H 5S1<br>Canada | | |
| Trade Name: | XLTEK EMU40EX EEG Headbox | | |
| Common and<br>Classification<br>Name: | Electroencephalograph | | |
| Classification<br>Regulation: | 21 CFR §882.1400 | | |
| Product Code: | GWQ | | |
| Classification<br>Panel: | Neurology | | |
| Substantially<br>Equivalent Devices: | New Model | Predicate 510(k)<br>Number | Predicate<br>Manufacturer / Model |
| | XLTEK EMU40EX EEG<br>Headbox | K053386 | XLTEK / XLTEK<br>EMU40 EEG Headbox |
| Device Description: | The Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)<br>EMU40EX System is a powerful and flexible EEG recording system.<br>The EMU40EX System consists of a patient electrode set, EMU40EX<br>EEG Headbox, and the Natus Base Unit. | | |
| | The EMU40EX System is designed to work with an XLTEK host<br>computer system running the Natus Database and Natus NeuroWorks®<br>data review and analysis software. | | |
| | The EMU40EX EEG Headbox can be connected to the Natus Base Unit<br>with 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.

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 judgement in using this information.

Technology Comparison:

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

| ECG System<br>Characteristic | XLTEK EMU40<br>EEG Headbox<br>(K053386) | XLTEK EMU40EX<br>EEG Headbox<br>(Proposed Device) |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Intended Use | The XLTEK EMU40 EEG<br>Headbox is an<br>electroencephalograph that works<br>in conjunction with XLTEK<br>NeuroWorks software.<br><br>The XLTEK EMU40EX EEG<br>Headbox is used to acquire,<br>digitize, store and transmit<br>physiological signals (such as<br>EEG, pulse and oximetry signals)<br>for EEG studies in research and<br>clinical environments.<br><br>The XLTEK EMU40EX EEG<br>Headbox requires competent user<br>input, and its output must be<br>reviewed and interpreted by<br>trained medical professionals whojudgement in using this<br>information. | Same |
| Referential Channels | 40 | Same |
| DC Channels | Four (4) isolated | Same |
| Electrode Connections<br>(including common<br>input) | Touch-proof | Same |
| Oximeter Connection | Yes | Same |
| Photic Stimulator<br>Connection | Yes | Same |
| Patient Event Button | Yes | Same |

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### Technology Comparison (continued):

| ECG System<br>Characteristic | XLTEK EMU40<br>EEG Headbox<br>(K053386) | XLTEK EMU40EX<br>EEG Headbox<br>(Proposed Device) |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Batteries | Two (2) AAA Rechargeable | Same |
| Compatible with<br>Rechargeable External<br>Battery Pack | Yes | Same |
| Front Panel Base Unit<br>Controls | LCD Display<br>Four (4) buttons | Touchscreen LCD display. |
| Electromagnetic<br>Compatibility | The XLTEK EMU40EX EEG Headbox was verified for performance in<br>accordance with the following standard:<br>IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2:<br>General requirements for basic safety and essential performance –<br>Collateral standard: Electromagnetic compatibility – Requirements<br>and tests. | |
| | Results indicate that the XLTEK EMU40EX EEG Headbox passed<br>verification, and complies with the applicable standards. | |
| Performance<br>Testing – Bench | The XLTEK EMU40EX EEG Headbox was verified and validated for<br>performance in accordance with product requirements including:<br>Signal quality. Functionality. User interface. | |
| | and the applicable clauses of the following standards:<br>IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6:<br>General requirements for basic safety and essential performance –<br>Collateral standard: Usability. IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26:<br>Particular requirements for the basic safety and essential<br>performance of electroencephalographs. IEC 62366: 2007, Medical devices – Application of usability<br>engineering to medical devices. ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61:<br>Particular requirements for basic safety and essential performance of<br>pulse oximeter equipment. | |
| | Results indicate that the XLTEK EMU40EX EEG Headbox passed<br>verification and validation, and complies with the product requirements<br>and the applicable standards. | |
| Conclusion | Verification and validation activities were conducted to establish the<br>performance and safety characteristics of the device modifications made<br>to the XLTEK EMU40EX EEG Headbox. The results of these activities<br>demonstrate that the XLTEK EMU40EX EEG Headbox is as safe, as<br>effective, and performs as well as or better than the predicate device.<br>Therefore, the XLTEK EMU40EX EEG Headbox is considered<br>substantially 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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