ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments.

The Enobio is intended to acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes, amplifies them, and uses WiFi connectivity to transmit the EEG data to a dedicated host computer with the software.

This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

Device Description

The Neuroelectrics device, Enobio Wireless EEG, performs electroencephalographic measurements with non-invasive technology.

Enobio is a wireless, battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designed for use in a clinical environment or hospital.. Enobio use must be controlled by specialized medical personnel able to guarantee the correct recording.

ENOBIO WIRELESS EEG, consists of three models designated as the 8, 20 and 32 channels. ENOBIO WIRELESS EEG has a sampling rate of 500 SPS, it works in a bandwidth from 0 to 125Hz (DC coupled) and it provides a resolution of 24 bits - 0.05μV. Enobio is capable of acquiring a variety of electrophysiological signals. These signals include EEG, EOG, ECG and EMG.

The Enobio system is primarily made up of the following three items:

Necbox (amplifier, transmitter and control box),
the neoprene cap with the electrodes and
the NIC software.

The Necbox, which has a data amplifier, connects directly via Wi-Fi to the Neuroelectrics Instrument Controller (NIC) software running on a computer. The EEG data is streamed through the standard Wi-Fi band, and the standard Wi-Fi operating distance range is 10 meters. In all situations the amplifiers store a copy of the data locally to allow for data back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.

AI/ML Overview

The provided document is a 510(k) summary for the Enobio Wireless EEG device. It does not present a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance study with detailed metrics against defined acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a comparison of characteristics.

Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth, expert adjudication, and comparative effectiveness studies are not applicable directly from this document, as the submission strategy relies on non-clinical data and equivalence.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a table of acceptance criteria with quantitative performance metrics against them. Instead, it states that the device "passed all the testing in accordance with internal requirements, national standards, and international standards" and lists the types of tests conducted. These tests implicitly serve as the performance evaluation.

Test Category	Reported Device Performance/Compliance
Biocompatibility	Passed testing in accordance with: - ISO 10993-1: 2009 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) - ISO 10993-5: 2009 (Test for In Vitro Cytotoxicity) - ISO 10993-10: 2010 (Tests for Irritation and Delayed-Type Hypersensitivity)
Electrical Performance	Passed testing in accordance with: - IEC 60601-1: 2005 + CORR. 1 (2006) + CORR 2 (2007) (General Requirements for Basic Safety and Essential Performance) - IEC 60601-1-2:2007 (Third Edition) (EMC Requirements and Tests) - IEC 60601-2-26:2012 (Particular requirements for electroencephalographs) - IEC 60601-1-11: 2010 (Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility) - IEC 61000-4-3 (Radiated, radio-frequency, electromagnetic field immunity test)
Software V&V	Testing conducted in accordance with IEC 62304 and FDA Guidance
Disinfection	Testing completed
Electrode Compatibility	Testing completed
Product Specification Compliance Tests	Passed for: - Bandwidth - Sampling Rate (Fixed 500 Hz, within predicate's range) - Input Referred Noise - Dynamic Range - Operating Hours - Resolution (24 bits - 0.05μV) - Input Impedance

2. Sample sized used for the test set and the data provenance

Not applicable for non-clinical performance testing of a hardware device. The tests were in a lab setting, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for non-clinical hardware performance testing is established by engineering specifications and national/international standards, not by expert medical interpretation.

4. Adjudication method

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is an EEG acquisition system, not an AI algorithm. Its performance is evaluated based on its ability to accurately acquire and transmit electrophysiological signals, which were tested via non-clinical performance tests.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" is defined by the technical specifications and accepted international standards for medical electrical equipment and electroencephalographs (e.g., IEC 60601 series, ISO 10993 series). Performance is measured against these established technical benchmarks.

8. The sample size for the training set

Not applicable. This is a hardware device; no "training set" in the context of machine learning is involved.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

June 2, 2017

Neuroelectrics Barcelona S.L.U. % Deirdre Barrow Senior Consultant, Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin. Texas 78746

Re: K162681

Trade/Device Name: Enobio Wireless EEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GWL Dated: April 21, 2017 Received: April 27, 2017

Dear Deirdre Barrow:

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 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

for

Carlos L. Peña, PhD, MS 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) K162681

Device Name Enobio Wireless EEG

Indications for Use (Describe)

ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments.

This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

K162681

1. Submission Sponsor

Neuroelectrics Barcelona SLU

Avenida Tibidabo 47 bis

08035 Barcelona

SPAIN

Phone number: + 34 932540370

Contact: Ana Maiques

Title: CEO

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Cell Phone: +353 86 8733815

Office Phone: (512) 327.9997

Contact: Deirdre Barrow, Senior Consultant, RA

Email: project.management@emergogroup.com

3. Date Prepared

September 21, 2016

4. Device Identification

Trade/Proprietary Name:	ENOBIO WIRELESS EEG
Common/Usual Name:	Electroencephalograph
Classification Name:	Full-Montage Standard Electroencephalograph
Regulation Number:	882.1400 & 882.1835

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Product Code:	GWQ, Full-Montage Standard Electroencephalograph &GWL, Amplifier, Physiological Signal
Device Class:	Class II
Classification Panel:	Neurology

5. Legally Marketed Predicate Device

DeviceName	510(k)No.	Product Code	ClassificationRegulation	Sponsor
NicoletWirelessEEG	K103140	GWL & GWQ	21 CFR 882.1835 &21 CFR 882.1400	Carefusion 209, Inc.

6. Indication for Use Statement

ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments.

This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

7. Device Description

The Neuroelectrics device, Enobio Wireless EEG, performs electroencephalographic measurements with non-invasive technology.

The Enobio system is primarily made up of the following three items:

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Necbox (amplifier, transmitter and control box),
the neoprene cap with the electrodes and
the NIC software.

8. Substantial Equivalence Discussion

The following table compares the ENOBIO WIRELESS EEG to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	Neuroelectrics	Carefusion	Significant Differences
Trade Name	ENOBIO WIRELESS EEG	Nicolet Wireless EEG
510(k) Number	K162681	K103140 (predicate)	n/a
Product Code	GWL & GWQ	GWL & GWQ	Same
RegulationNumber	882.1835 & 882.1400	882.1835 & 882.1400	Same
Regulation Name	Amplifier, PhysiologicalSignal & Full-MontageStandardElectroencephalograph	Amplifier, PhysiologicalSignal & Full-MontageStandardElectroencephalograph	Same
Indications for Use	ENOBIO is an EEGportable monitoringdevice of 8, 20, 32channels intended forthe use in clinical patientmonitoring for use inhospitals and othermedical environments.The Enobio is intended toacquire, store, transmit	The Nicolet WirelessEEG Amplifier isintended to be used as afront end amplifier toacquire, store, andtransmitelectrophysiologicalsignals in a wired orwireless mode for theNicolet Neurodiagnostic	No significant difference aseach device acquires,stores, amplifies andtransmits EEG signals tohost software forneurological applications.
Manufacturer	Neuroelectrics	Carefusion	Significant Differences
Trade Name	ENOBIO WIRELESS EEGand displayelectrophysiologicalsignals in wireless modeas an aid in diagnostics.The system digitizesanalogue EEG signalscollected by a cap withelectrodes, amplifiesthem, and uses WiFiconnectivity to transmitthe EEG data to adedicated host computerwith the software.This device is intended tobe used by trainedhealth-care personnel. Itis restricted to sale by oron order of a physician	Nicolet Wireless EEGsystem.
Mechanism of Action	The Enobio Wireless EEGis a wireless andwearableelectrophysiology sensorsystem for the recordingof electroencephalogram(EEG) measurements	The device is intendedto be used as a front endNicoletEEGwireless32/64amplifier with theNicolet Neurodiagnosticsystem to record,measure, store, analyzeand display cerebral andextra cerebralphysiologic data for EEGand Sleep studies withor without synchronousdigital video. The deviceis wearable on the torsoor head	No Significant Difference; the differences between them are:● The Enobio Wireless EEG is only available in a wireless assembly whilst the Nicolet Wireless EEG is available in a wired and wireless assembly.● The associated software systems are obviously proprietary and are therefore different but the fundamental technology of acquiring, storing, amplifying and transmitting EEG signals to host software is very similar between the two
Manufacturer	Neuroelectrics	Carefusion	Significant Differences
Trade Name	ENOBIO WIRELESS EEG	Nicolet Wireless EEG
TechnologyOverview	System components:• cap with electrodes• control box(amplifier,transmitter)• software for PC	System components:• patient cable• amplifier, CPU anddisplay monitor,telemetry unit• access pointInterface to amplifier:Wired Ethernet(10/100baseT)orWirelessEthernet (802.11b/g)	devices• The Enobio Wireless EEGis only available in abattery operatedconfiguration whereasthe predicate device,Nicolet Wireless EEG,can be battery or ACpowered.No significant difference aseach device consists of amethod of capturing thesignal, storing, amplifyingand transmitting the signalNo significant difference asthe predicate device,Nicolet Wireless EEG offerswired or wireless signaltransmission to the hostcomputer used to displayand manage acquired data.The proposed device,Enobio Wireless EEG, offerswireless signal transmissiononly.
	A/D conversion:24 bits	A/D conversion:24 bits	Same
	Sampling rate:500 Hz	Sampling rate:125, 250, 500, ... 48000Hz	No significant difference asthe predicate device,Nicolet Wireless EEG offersthe user a choice ofsampling rates that the usermay select. The proposeddevice, Enobio Wireless
Manufacturer	Neuroelectrics	Carefusion	Significant Differences
Trade Name	ENOBIO WIRELESS EEG	Nicolet Wireless EEG	EEG, provides a fixedsampling rate of 500 Hzincluded within the rangeoffered by the predicatedevice.
AnatomicalLocation	Worn on the head via aheadcap or headband	Worn on the torsoand/or via a headcap	No significant difference asthe only option available forthe proposed device, EnobioWireless EEG, is a headcapor headband which isincluded with the optionsavailable with the NicoletWireless EEG
Material	ABS 40%c, ABS, gel ,neoprene	Not specified	No significant difference aswhile a potential differenceexists between the devicesin terms of patientcontacting materials,appropriatebiocompatibility testing hasbeen conducted on theproposed device.
Number ofChannels	8, 20, 32 channels	32 or 64 channel	No significant difference asthe number of channelsreflects the simpler natureof the Enobio device.Testing has been conductedto ensure each modelperforms in accordancewith the intended use.
TemperatureControl Range	Use Temperature Range:+5 to 45 °CStorage in BoxTemperature Range: -25to +70 °C	Not defined but as theuse has been confinedto research institutions,clinic, hospital,operating room andepilepsy evaluation	No significant difference asthe operating environmentis very similar to that of theproposed device thereforethe operating range in
Manufacturer	Neuroelectrics	Carefusion	Significant Differences
Trade Name	ENOBIO WIRELESS EEG	Nicolet Wireless EEG
Pressure Range	Atmospheric Pressure:700 - 1.000 hPa	environments it wouldbe expected to be withinthe same range as thatof the proposed device	terms of temperature,pressure and humiditywould be expected to havesimilar parameters.
Humidity Range	15 - 93 %
Sterile	no	no	Same
Single-Use	no	no	Same
Shelf Life	5 years	Unknown	Unknown; predicate deviceshelf life is not available
SoftwareMicroprocessor	ATSAM4SD32CGWL	Unknown	N/A
Battery Operated	yes	yes	Same
AC Powered	no	yes	No significant difference:The Enobio Wireless EEG isonly available in a batteryoperated configurationwhereas the predicatedevice, Nicolet WirelessEEG, can be battery or ACpowered
Complies with ISO10993-1	yes	yes	Same
Electrical SafetyTesting Passed	yes	yes	Same

Comparison of Characteristics

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Enobio Wireless EEG and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Neuroelectrics completed a number of non-clinical performance tests. The Enobio Wireless EEG meets all the requirements for overall design, biocompatibility, and electrical safety, confirming that the design output meets the design inputs and specifications for the device.

The Enobio Wireless EEG passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

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Biocompatibility; ●
- ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing o
- O ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Test for In Vitro Cytotoxicity
- ISO 10993-10: 2010, Biological Evaluation of Medical Devices Part 10: Tests for Irritation O and Delayed-Type Hypersensitivity
- . Electrical Performance;
  - o IEC 60601-1: 2005 + CORR. 1 (2006) + CORR 2 (2007), Medical Electrical Equipment -Part 1 General Requirements for Basic Safety and Essential Performance
  - o IEC 60601-1-2:2007 (Third Edition), Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. (General II (ES/EMC))
  - IEC 60601-2-26:2012, Medical electrical equipment Part 2-26: Particular requirements o for the basic safety and essential performance of electroencephalographs
  - o IEC 60601-1-11: 2010, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests; all applicable requirements were met
  - o IEC 61000-4-3, Radiated, radio-frequency, electromagnetic field immunity test
- . Software verification and validation testing per IEC 62304 and FDA Guidance
- . Disinfection testing
- Compatibility of electrodes with Enobio Wireless EEG ●
- . Product specification compliance tests:
  - Bandwidth O
  - O Sampling Rate
  - Input Referred Noise O
  - O Dynamic Range
  - O Operating Hours
  - o Resolution
  - Input Impedance o

10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be

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demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.

The Enobio Wireless EEG, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device, Nicolet Wireless EEG.

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).