(34 days)
Not Found
No
The summary describes a device for acquiring and transmitting physiological signals (EEG, pulse, oximetry) and mentions software for data review and analysis, but there is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on signal acquisition, transmission, and basic software functionality for review.
No
The device is described as an electroencephalograph used to acquire, digitize, store, and transmit physiological signals for EEG studies, which is for diagnostic or monitoring purposes, not for treating a condition.
Yes
Explanation: The device is an electroencephalograph (EEG headbox) used to acquire, digitize, store, and transmit physiological signals (like EEG signals) for EEG studies in research and clinical environments. Its output must be reviewed and interpreted by "trained medical professionals" who exercise "professional judgment in using this information," indicating its role in providing data for diagnosis.
No
The device description explicitly states the system consists of hardware components including a patient electrode set, EMU40EX EEG Headbox, and the Natus Base Unit, and the performance studies include verification and validation of these hardware components.
Based on the provided information, the XLTEK EMU40EX EEG Headbox is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies". This describes a device that measures electrical activity in the brain and other physiological parameters directly from the patient.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description reinforces that the device is connected to a patient via electrodes.
The device is an electroencephalograph, which is a medical device used for in vivo (within the living body) measurement of electrical activity.
N/A
Intended Use / Indications for 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 judgment in using this information.
Product codes (comma separated list FDA assigned to the subject device)
GWQ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment" in "research and clinical environments."
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing – Bench: The XLTEK EMU40EX EEG Headbox was verified and validated for performance 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 essential performance of electroencephalographs. IEC 62366: 2007, Medical devices – Application of usability engineering to medical devices. ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. Results indicate that the XLTEK EMU40EX EEG Headbox passed verification and validation, and complies with the product requirements and the applicable standards.
Electromagnetic Compatibility: The XLTEK EMU40EX EEG Headbox was verified for performance in accordance 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 – Requirements and tests. Results indicate that the XLTEK EMU40EX EEG Headbox passed verification, and complies with the applicable standards.
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.
Electrical Safety: The XLTEK EMU40EX EEG Headbox was verified for performance in 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.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the XLTEK EMU40EX EEG Headbox. The results of these activities demonstrate that the XLTEK EMU40EX EEG Headbox is as safe, as effective, and performs as well as or better than the predicate device. Therefore, the XLTEK EMU40EX EEG Headbox is considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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.
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) | ||
2568 Bristol Circle | |||
Oakville, Ontario, L6H 5S1 | |||
Canada | |||
Submitter and | |||
Application | |||
Correspondent | Mr. Sanjay Mehta | ||
Phone: +1 (905) 287-5055 | |||
Fax: +1 (905) 829-5304 | |||
Email: sanjay.mehta@natus.com | |||
Manufacturing Site: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | ||
2568 Bristol Circle | |||
Oakville, Ontario, L6H 5S1 | |||
Canada | |||
Trade Name: | XLTEK EMU40EX EEG Headbox | ||
Common and | |||
Classification | |||
Name: | Electroencephalograph | ||
Classification | |||
Regulation: | 21 CFR §882.1400 | ||
Product Code: | GWQ | ||
Classification | |||
Panel: | Neurology | ||
Substantially | |||
Equivalent Devices: | New Model | Predicate 510(k) | |
Number | Predicate | ||
Manufacturer / Model | |||
XLTEK EMU40EX EEG | |||
Headbox | K053386 | XLTEK / XLTEK | |
EMU40 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, 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 |
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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
Characteristic | XLTEK EMU40
EEG Headbox
(K053386) | XLTEK EMU40EX
EEG Headbox
(Proposed Device) |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Intended Use | The XLTEK EMU40 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 whojudgement in using this
information. | Same |
| Referential Channels | 40 | Same |
| DC Channels | Four (4) isolated | Same |
| Electrode Connections
(including common
input) | Touch-proof | Same |
| Oximeter Connection | Yes | Same |
| Photic Stimulator
Connection | Yes | Same |
| Patient Event Button | Yes | Same |
5
Technology Comparison (continued):
| ECG System
Characteristic | XLTEK EMU40
EEG Headbox
(K053386) | XLTEK EMU40EX
EEG Headbox
(Proposed Device) |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Batteries | Two (2) AAA Rechargeable | Same |
| Compatible with
Rechargeable External
Battery Pack | Yes | Same |
| Front Panel Base Unit
Controls | LCD Display
Four (4) buttons | Touchscreen LCD display. |
| Electromagnetic
Compatibility | The XLTEK EMU40EX EEG Headbox was verified for performance in
accordance 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 – Requirements
and tests. | |
| | Results indicate that the XLTEK EMU40EX EEG Headbox passed
verification, and complies with the applicable standards. | |
| Performance
Testing – Bench | The XLTEK EMU40EX EEG Headbox was verified and validated for
performance 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 essential
performance of electroencephalographs. IEC 62366: 2007, Medical devices – Application of usability
engineering to medical devices. ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61:
Particular requirements for basic safety and essential performance of
pulse oximeter equipment. | |
| | Results indicate that the XLTEK EMU40EX EEG Headbox passed
verification and validation, and complies with the product requirements
and the applicable standards. | |
| Conclusion | Verification and validation activities were conducted to establish the
performance and safety characteristics of the device modifications made
to the XLTEK EMU40EX EEG Headbox. The results of these activities
demonstrate that the XLTEK EMU40EX EEG Headbox is as safe, as
effective, and performs as well as or better than the predicate device.
Therefore, the XLTEK EMU40EX EEG Headbox is considered
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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