The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.

Device Description

The medical system includes the "eVox System" amplifier device, accessories, and a computer (laptop computer or tablet device with internal battery and power cord).

The hardware and ancillary components used in conjunction with the eVox System include an EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, and wall adapter), a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device functioning.

The eVox System consists of two software components:
. Base Station laptop computer software: pre-loaded Evoke software EVO-002-400-BIATS.
. Firmware running on the eVox Amplifier PN SW-MSP430.

The Base Station laptop is running on a Windows Operating System and is paired with the eVox Amplifier with Bluetooth wireless technology. The Evoke software runs on the Base Station computer and has a graphic user interface that allows the clinician to set up a patient and create a new patient record, conduct a study to collect EEG and ERP data, view live EEG and ERP data on the Base Station monitor, and export recorded data to a file.

Firmware for the eVox System resides on the eVox Amplifier. The purpose of the eVox amplifier firmware is to acquire electrophysiology data from the patient and transmit it to the Base Station.

The Amplifier operational mode is controlled wirelessly via the Evoke software. In addition to 19 channels of EEG recording the device includes a mode to measure the cap electrode impedances. This is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location.

The primary software outputs are EEG and ERP data files. These data files are written as floating point numbers in binary format, which represent the electrical potential on each of the 19 EEG channels in microvolts.

The eVox System amplifier device does not come in direct contact with patients. Accessories that contact patients, such as the EEG electrode cap, are the same as used with legally marketed devices or are comprised of the same materials as legally marketed accessories.

The eVox System is intended for prescription use in any healthcare, medical, or athletic or sports clinics, or outside of medical facilities such as in the sports arena under the supervision of a physician. Also, investigations can be performed outside of healthcare facilities, as long as they are led by qualified medical personnel.

The device is not sterile. The device is intended for use by qualified medical personnel only and qualifies for exemption per 21 CFR 801 Subpart D «Prescription devices».

AI/ML Overview

The eVox System is intended for the acquisition, display, and storage of electrical activity of a patient's brain, including electroencephalograph (EEG) and event-related potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (IEC 60601-2-26 Performance Limits)	Reported Device Performance (eVox System)	Met Criteria?
Accuracy of Signal Reproduction	Error < 20%	Pass: Accurately reproduces EEG signals over the specified range	Yes
Input Dynamic Range and Differential Offset Voltage	Amplitude error < 10% (at 300mV offset)	At 300mV Offset: 100% error (Fail); At 187mV Offset: 1.5% error (Pass)	Partially
Input Noise	Max 6 µV peak-to-valley	Maximum noise: 3.4 µV	Yes
Frequency Response	Output amplitude > 71%, < 110%	0.5 Hz: 100% (Pass); 5 Hz: 105% (Pass); 50 Hz: 76% (Pass)	Yes
Common Mode Rejection	Output amplitude < 10mm (= 100µVpp)	With 0 DC Offset: 67.3µVpp (Pass); With 187mV dc Offset: output is saturated (Fail)	Partially

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

The provided summary does not specify a sample size for a test set in terms of patient data or data provenance. The performance data section describes technical validation tests against established standards (IEC 60601-2-26), not clinical studies with patient data. These tests were conducted by accredited laboratories.

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

This information is not applicable as the provided performance data focuses on technical verification against international standards and not on clinical performance evaluated against a ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the performance data details technical compliance tests against pre-defined limits in standards, not clinical evaluations requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not indicated in the provided document. The submission focuses on demonstrating substantial equivalence through technical performance data and comparison to predicate devices, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The provided document describes the standalone performance of the eVox System in terms of its ability to acquire, display, and store EEG/ERP data and its compliance with relevant electrical and safety standards. The performance data presented (e.g., accuracy of signal reproduction, input noise) are measurements of the device's inherent technical capabilities, independent of human interpretation or intervention beyond basic operation. The device itself is an acquisition and display system, not an AI-driven diagnostic algorithm that would require a "human-in-the-loop" performance study in the same way an AI for image interpretation would.

7. Type of Ground Truth Used

The "ground truth" for the performance data presented is based on pre-defined technical specifications and limits set by international standards, specifically IEC 60601-2-26:2012 for electroencephalographs. For electrical safety and EMC, the ground truth is compliance with IEC 60601-1 and IEC 60601-1-2 standards.

8. Sample Size for the Training Set

The document does not mention a training set as this device is an EEG/ERP acquisition and display system. It does not appear to involve machine learning or AI algorithms that require a training set in the conventional sense for medical imaging or diagnostic interpretation.

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

Since there is no mention of a training set for machine learning or AI, the establishment of ground truth for a training set is not applicable.

Summary

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December 13, 2017

Evoke Neuroscience, Inc. % Marinela Gombosev Executive VP Operations and Marketing Evoke Neuroscience 200 Valencia Dr. Suite 109 Jacksonville, North Carolina 28546

Re: K171781

Trade/Device Name: eVox System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. GWJ Dated: November 10, 2017 Received: November 13, 2017

Dear Ms. Gombosev:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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) K171781

Device Name eVox System

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	□

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510(k) Summary

l. SUBMITTER
Evoke Neuroscience 200 Valencia Drive, Suite 109 Jacksonville NC 28546 United States David Hagedorn, PhD, CEO, CSO Phone: (917) 261-6096 Fax: (855) 386-5397

CONTACT PERSON

Marinela Gombosev, EVP Operations and Marketing Evoke Neuroscience, Inc. 200 Valencia Drive, Suite 109 Jacksonville NC, 28546 United States Cell Phone: (949) 584-7331 Office Phone: (949) 330-7216 Fax: (855) 386-5397 Email: 510k@evokeneuroscience.com

DATE PREPARED

June 6, 2017

DEVICE II.

Trade/Proprietary Name: eVox System Common/Usual Name: EEG System, EEG Amplifier Classification Name: Electroencephalograph Classification Regulation: 882.1400 Product Code: GWQ, GWJ Device Class: Class 2

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Classification Panel: Neurology

III. PREDICATE DEVICES

Legally Marketed Device(s)	510(k) #	Clearance Date
Mitsar-EEG	K143233	8-13-2015
COGNISION EEG	K141316	2-13-2015
Nicolet EDX System	K112052	3-15-2012

IV. DEVICE DESCRIPTION

The medical system includes the "eVox System" amplifier device, accessories, and a computer (laptop computer or tablet device with internal battery and power cord).

The eVox System consists of two software components:

. Base Station laptop computer software: pre-loaded Evoke software EVO-002-400-BIATS.
. Firmware running on the eVox Amplifier PN SW-MSP430.

Firmware for the eVox System resides on the eVox Amplifier. The purpose of the eVox amplifier firmware is to acquire electrophysiology data from the patient and transmit it to the Base Station.

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The device is not sterile. The device is intended for use by qualified medical personnel only and qualifies for exemption per 21 CFR 801 Subpart D «Prescription devices».

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The following table compares the technological characteristics of the eVox System to those of the predicate devices in order to demonstrate substantial equivalence.

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Technological Comparison

Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
510 (k) Number	K171781	K143233	K141316	K112052
Product codes	GWQ, GWJ,	GWQ	GWJAdditional: OMC, OLT,	GWJAdditional:OLT, GWF, GZP, IKN, JXE, GWE	Product contains multiple productcodes which are generally requiredfor a complete system.The eVox System and the Mitsar –EEG device share the product code:GWQ: Full Montage SystemThe eVox System, the COGNISIONsystem and Nicolet EDX systemshare the product code:GWJ: Evoked response auditorystimulator
Indications for Use	The eVox System isintended for theacquisition, display, andstorage, of electricalactivity of a patient's brainincludingelectroencephalograph(EEG) and Event-relatedPotentials (ERP) obtainedby placing two or moreelectrodes on the head toaid in diagnosis.	The device Mitsar-EEG isintended to acquire,display and store theelectrical activity of apatient's brain obtainedby placing two or moreelectrodes on the headto aid in diagnosis.	The COGNISION system is foruse by qualified clinicalprofessional in private practiceoffices or small clinical settingsfor the acquisition, display,analysis, storage, reporting andmanagement ofelectroencephalograph (EEG)and auditory evoked potentials(AEP) information.	The Nicolet EDX is intended for theacquisition, display, analysis,reporting and management ofelectrophysiological informationfrom the human nervous andmuscular system including NerveConduction (NCS).Electromyography (EMG), EvokedPotentials (VEP), Auditory (AEP)Somatosensory Evoked Potentials(SEP), Electroretinography (ERG)Electrooculography (EOG), P300,Motor Evoked Potential (MEP). The
Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
				Nicolet EDX with Viking Softwaremay be used to determineautomatics responses to physiologicstimuli by measuring the change inelectrical resistance between twoelectrodes (Galvanic Skin Responseand Sympathetic Skin Response).Autonomic testing also includesassessments of RR intervalvariability. The Nicolet EDX withViking Software is used to detectthe physiologic function of thenervous system, for the location ofneural structures during surgeryand to support the diagnosis ofneuromuscular disease orcondition.
				The listed modalities do not includeoverlap in functionality. In general,Nerve Conduction Studies measurethe electrical responses of thenerve; Electromyography measuresthe electrical activity of the muscleand Evoked Potential measureelectrical activity from the CentralNervous System.The Nicolet EDX with VikingSoftware is intended to be used bya qualified healthcare provider.
Principle ofOperation	The eVox System device isused for acquisition ofphysiological signals usingtwo or more channels ofelectroencephalography	The Mitsar EEG consistsof biosignal amplifier,USB cable, USB dongleand software. Themedical system includes	The COGNISION EEG/EP Systemis a combination device forreduced montage recordingand display ofelectroencephalographic (EEG)	The Nicolet EDX system with VikingSoftware (Viking EDX) is designedfor the acquisition, display, analysis,reporting and management ofelectrophysiological information	The eVox System has a principle ofoperation that closely matches thatof its predicates. All devices useskin coupling methods, eitherthrough electrodes or sensors
Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
	(EEG) from the scalp. Itconsists of an eVoxamplifier, a laptopcomputer (base station),a patient EEG cap, subjectresponse button, earbuds, and a charging cord.The eVox amplifier andsoftware provide a meansto:a) initiate a study, trackuser EEG and ERP dataand enter text orquestionnaireinformation,b) acquire and savesignals to the memoryof the device,c) transmit signal datafrom the device,d) Visually inspect theacquired signal.e)Manage Event-related Potentials	"Mitsar EEG" device andcomputer (stationary PCwith uninterruptiblepower supply (UPS) orlaptop with internalbattery). The Mitsar EEGdevice is an amplifierwhich receives patientEEG data from a patientEEG cap or EEGelectrodes.	and evoked potentials (EP) testdata.The system uses elastic bandsto accurately position 10electrode pods around thehead.EEG signal amplification,conditioning, and A/Dconversion is performed byelectronic circuits closelycoupled to the electrode podsthrough short flexible printedwires.The headset is connected by acable to a handheld control unitand data acquisition box (HCU).The HCU communicates via awireless data link to a WindowsPC to stream EEG data.Software on the PC is used tosetup the tests and view andevaluate the resultant test datausing standard EEG/EP displaymethods.	from the human nervous andmuscular systems.The system is designed to performnerve conduction studies (NCS),needle electromyography (EMG)testing, evoked potential (EP)testing, and intra-operativemonitoring (IOM). The system canalso perform multi-modalityrecording through Multi-modeprograms (MMP). Viking EDXprovides a variety of tests spanningthe various modalities.	which transmits patient EEG andERP from the surface of the scalp toan amplifier.The connection between theamplifier and electrodes is a wiredconnection for the devices.All devices convert the analog datainto digital data which is thentransmitted to a base station orcomputer.Once transmitted to the basestation, the devices display andstore the data on the base stationand allow the user to export thedata to a file.
Patient population	All age groups	All age groups	Adults	Unknown
Use environment	Intended for use in anyhealthcare, medical, orathletic or sports clinics,or outside of medicalfacilities such as in thesports arena under thesupervision of a physician.Also, investigations can be	Intended for use infunctional diagnosticswards and departmentsat out-patient clinics,hospitals, healthresearch institutes,health centers and othermedical institutions.	Physicians' Offices	Physicians' Offices
Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
	performed outside ofhealthcare facilities, aslong as they are led byqualified medicalpersonnel.	Also, investigations canbe performed outside ofhealthcare facilities, aslong as they are led byqualified medicalpersonnel.
Safety class	Class II	Class II	Class II	Class II
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1	Per ISO 10993-1	Per ISO 10993-1
Intended Use	The eVox System isintended for theacquisition, display, andstorage, of electricalactivity of a patient's brainincludingelectroencephalograph(EEG) and Event-relatedPotentials (ERP) obtainedby placing two or moreelectrodes on the head toaid in diagnosis.	The Mitsar-EEG isintended to acquire,display and store theelectrical activity of apatient's brain by placingtwo or more electrodeson the head to aid indiagnosis.	The COGNISION system is acombination device for reducedmontage recording and displayof electroencephalograph (EEG)and evoked potentials (EP) testdata.	The Nicolet EDX with VikingSoftware (Viking EDX) is intendedfor the acquisition, display, analysis,reporting and management ofelectrophysiological informationfrom the human nervous andmuscular systems. The system isdesigned to perform nerveconduction studies (NCS), needleelectromyography (EMG) testing,evoked potential (EP) testing, andintra-operative monitoring (IOM).The system can also perform multi-modality recording through Multi-mode programs (MMP).Viking EDXprovides a variety of tests spanningthe various modalities.
ERP StimulusModality	Auditory; Visual	None	Auditory	Auditory; Visual
SystemComponents	eVox System consists of :	"Mitsar EEG" consists of	COGNISION™ consists of:• Head Set	CareFusion Nicolet EDX 2 VikingSoftware consists of:
Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
	• an eVox amplifier,• a laptop computer(base station),• a patient EEG cap,• subject responsebutton, ear buds,• and a charging cord.	• biosignal amplifier,• computer(stationary PC withuninterruptiblepower supply (UPS)• or laptop withinternal battery)• USB cable,• USB dongle• and software.	• Auditory stimulator• Handheld Control Unit(HCU) including InterfaceSoftwareConnecting Headset cablebetween the headset andthe handheld control unit	• EDX Console• Electrical stimulators• Auditory Stimulator• Trigger input/output• LED google interface ControlPanel• Amplifier• Computer Monitor• Keyboard,Mouse• Printer
ERP Paradigm(Auditory andVisual Stimuli)	P300 Oddball- Single Stimulus- Single Deviant- 2 Deviant- Active and Passive	None	P300 Oddball- Single Stimulus- Single Deviant- 2 Deviant- Active and Passive	P300 Oddball- Single Stimulus- Single Deviant- 2 Deviant- Active and Passive
ERP TaskResponse	User Buttons	User Buttons	User Buttons	User Buttons
Skin Coupling	Custom Electrode Bandand Gel	Custom Electrode Bandand Gel	HydroDot Biosensor	Discrete Electrode Wires	The eVox system, Mitsar EEG, andNicolet EDX use the same methodof utilizing a conductive gelbetween electrode and the skinThe COGNISION system usesHydroDot Biosensor.
Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
Sterile	No	No	No	No
Single Use	No	No	No	No
Shelf life	Durable good	Durable good	Durable good	Durable good
TypicalBiopotentialSignals Recorded	Electroencephalography(EEG), EP/ERP	Electroencephalography(EEG)	Electroencephalography (EEG),EP/ERP	Electroencephalography (EEG),EP/ERP	The eVox System, the COGNISIONsystem and the Nicolet EDX recordEEG and EP/ERP.TheMitsar-EEG device does
Number of SignalRecordingChannels	Up to 21	Up to 21	Up to 10	7	nothave EP/ERP modality.
RecordingChannels Locationand PositioningSystems	Fz,Cz,Pz,F3,P3,F4,P4Utilizing elastic bandsusing distance ratiosconsistent with the 10-20System	Fz,Cz,Pz,F3,P3,F4,P4Utilizing elastic bandsusing distance ratiosconsistent with the 10-20 System	Fz,Cz,Pz,F3,P3,F4,P4Utilizing elastic bands usingdistance ratios consistent withthe 10-20 System	Variable Discrete electrode wires	The eVox system, the Mitsar systemand the COGNISION system use thesame exact electrode placementconfiguration and a similar methodposition of electrodes.The Nicolet EDX system has avariable electrode configurationthat may be configured in similarmanner.
Impedance Test	Yes	Yes	Yes	Yes
Amplifier InputImpedance	> 10 MΩ	> 200 MΩ	> 60 MΩ	> 1000 MΩ	Performance testing per IEC 60601-2-26:2012 confirmed 10 MΩ issufficient to eliminate distortion inthe measured signal.
Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
Analog to DigitalConversion	24 Bit	16 Bit	16 Bit	24 Bit
Sampling Rate	250 Hz	500 Hz	125/250 Hz	384 KHz	Clinically relevant humanelectrophysiology does not exceed100 Hz and therefore there is notechnical need to sample above250 Hz.
Common moderejection	>110 dB	>100 dB	>90dB	>110dB
Analysis Software	Embedded, commerciallyavailable, and userdefined.	Embedded, commerciallyavailable and userdefined.	Embedded, commerciallyavailable, and user defined.	Embedded, commercially availableand user defined.
Interface withAmplifier	Class 2 Bluetooth® version2.0 to PC	USB cable to PC	Bluetooth 2.0/4.0	USB cable to PC
Power Supply	Li-Ion Battery, with USBcable for charging thebattery.	USB cable	Li Ion Battery	Mains (100-240 VAC)
EEG inputterminals	up to 19 channels	up to 21 channels	Up to 7 channels	2-8 channels
Resolution	24 bits	16 bits	16 bits	24 bits
Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
Band Pass	0.1 to 50 Hz	0.162-70 Hz	0.4 to 40 Hz	Unknown	The Band pass is the subset of theCognition System.The eVox system meets thefrequency requirements of IEC60601-2-26 (0.5Hz-50 Hz)
Noise	2-3 uVp-p	< 1.5μVp-p	≤1µV RMS	<0.6µV RMS	The measured noise of 2-3uVp-pfor the eVox System is well withinthe IEC 60601-2-26:2012requirement of 6 uVp-p.
Type	Burst (White Noise)	None	Unknown	Click, Pip, Burst	The eVox system uses a burst typenoise stimulus to evoke an ERP.
Duration	100ms	None	50ms	0.05 to 1 ms	100ms is a typical length forevoking an ERP.
Side	Both	None	Unknown	Left, Right, Both
Frequency Range	440 Hz-16kHz	None	Unknown	250Hz-8kHz	The eVox system generates a soundwith a frequency range of 440Hz-16kHz which is a sufficiently wideenough band for human hearing.
Intensity	0 to 85dB	None	Unknown	0 to 139dB pSBL	The sound emitted by the eVoxsystem is a flat white noise burst,therefore the peak and average isthe same.Maximum decibel level is 85dB,well below 125dB (no risk to user).
Noise Patterns	12.5% occurrencerandomly distributed over	None	10 % occurrence within 10-60minutes	Unknown	The balance of this pattern is bestto elicit the desired ERPs.
Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
	10 minutes		Not Stated	Not Stated
Input VoltageRange	+/-150 mV	5 mV	Not Stated	Not Stated	Due to the 24x gain that is appliedto the A/D channels by the eVoxfirmware the dynamic range is +/-150 mV for the eVox System whichis sufficient for its use environment
Safety StandardsCompliance	IEC 60601-1: 2005 +CORR. 1:2006 + CORR.2:2007 + AM1:2012 (orIEC 60601-1: 2012 reprint)EN 60601-1-2:2012IEC 60601-2-26:2012	EN 60601-1:2005EN 60601-1-2:2005EN 60601-2-26	UL 60601-1:2003EN60601-1-2/A1:2007EN60601-1-2/A1:2007EN 60601-2-26IEC 60601-2-40	EN / IEC 60601-1:1998+A1:1991+A2:1995IEC 60601-1-1:2000EN/IEC 60601-1-2: Ed 2.0+A1:2004IEC 60601-2-40: 1998, Ed 1,UL60601-1:2003-04-25 Ed1, Rev2003/06/30
OperatingEnvironment	0 to +45 °C, Relativehumidity, 5% to 95% non-condensing	Not Published	60-90 °F	Not Published
StorageEnvironment	-20° to 45° C , Relativehumidity, 5% to 95% non-condensing	Not Published	Not Published	Not Published

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VII. PERFORMANCE DATA

a. Verification and Validation Testing

Verification and validation testing was performed for the eVox System and the required documentation was provided with the 510k application per the FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and General Principles of Software Validation.

b. Performance Testing

Extensive functional device testing and user testing has been performed with satisfactory results.

Additionally, tests have been performed by the accredited laboratories and show full compliance with standards below with the exception of DC offset, which passed under a relaxed condition. This deviation is acceptable for the intended use of the device.

IEC 60601 - 2 - 26:2012 Medical electrical equipment - Part 2: Particular requirements for the safety of electroencephalographs.

Test	Test Method Summary	Results / P or F(per IEC 60601-2-26performance limits)
Accuracy of signalreproductionPurpose: verify signal isaccurately reproduced overa range of amplitudes.	Test circuit and method per IEC 60601-2-26 clause 201.12.1.101.1. Amplitude of2Hz Triangle wave varied from 50uV to500uV.IEC 60601-2-26 Pass-Fail Limit: error < 20%	PassTest shows that Evokesystem accuratelyreproduces EEG signalsover the specified range
Input dynamic range anddifferential offset voltagePurpose: verify signalaccuracy in presence of dcoffset voltages.	Test circuit and method per IEC 60601-2-26 clause 201.12.1.101.2. 1mV 6HzTriangle wave with 300mV offset added.IEC 60601-2-26 Pass-Fail Limit: amplitudeerror < 10%	300mV Offset: 100%error: Fail
		187mV Offset: 1.5% error:Pass

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Test	Test Method Summary	Results / P or F(per IEC 60601-2-26 performance limits)
Input NoisePurpose: verify that thesignal noise caused byamplifier does not exceedmax 6 μ V peak-to-valley	Test circuit and method per IEC 60601-2-26 clause 201.12.1.101.3. Inputs shortedtogether.IEC 60601-2-26 Pass-Fail Limit: max 6 μ Vpeak-to-valley	Maximum noise: 3.4 uV:Pass
Frequency ResponsePurpose: verify signal isaccurately reproduced overa range of frequencies	Test circuit and method per IEC 60601-2-26 clause 201.12.1.101.4. Triangle waveAmplitude established at 5Hz, is thenadjusted to 0.5 Hz and 50Hz.IEC 60601-2-26 Pass-Fail Limit: outputamplitude > 71%, < 110%	0.5 Hz: 100%: Pass5 Hz: 105%: Pass50 Hz: 76%: Pass
Common mode rejectionPurpose: verify amplifierrejects common mode noise	Test circuit and method per IEC 60601-2-26 clause 201.12.1.101.5. Apply 1Vrms at60Hz to all inputs tied together.IEC 60601-2-26 Pass-Fail Limit: outputamplitude < 10mm (= 100uVpp)	With 0 DC Offset:67.3uVpp: PassWith 187mV dc Offset:output is saturated: Fail

c. Safety Testing

The tests have been performed by the accredited laboratories and show full compliance with standards below:

IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 plus US Differences to: US National standard ANSI/AAMI ES60601-1: 2005 / A2:2010 (FDA recognition # 19-4).

d. Electrical Safety and Electromagnetic Compatibility (EMC)

The tests have been performed by the accredited laboratories and show full compliance with standards below. The device under consideration has passed the tests according to IEC 60601-1-2:2007.

IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility

{17}------------------------------------------------

(FDA recognition # 19-1)

VIII. CONCLUSIONS

The eVox System passed the testing according to the established specifications and the eVox System is consistent with that of the predicate devices in terms of EEG and ERP recording performance.

As part of showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Evoke Neuroscience completed a number of tests. The eVox System meets all the requirements for overall design, biocompatibility, and electrical safety confirms that the design output meets the design inputs and specifications.

The eVox System passed all testing stated above as shown by the acceptable results obtained.

The eVox System complies with the applicable voluntary standards for biocompatibility and electrical safety. The device passed all the testing in accordance with national and international standards.

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).