Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for acquiring, displaying, and storing EEG and ERP data. It mentions software for device functioning, data collection, viewing live data, and exporting data. There is no mention of AI, ML, or any algorithms that would process the data beyond basic signal acquisition and display. The performance studies focus on signal accuracy, noise, frequency response, and safety, not on the performance of any diagnostic or analytical algorithms.

Therapeutic

No.
The device is intended for the acquisition, display, and storage of electrical activity of a patient's brain to aid in diagnosis, not for therapeutic purposes.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the eVox System is "to aid in diagnosis," which categorizes it as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the medical system includes hardware components such as the "eVox System" amplifier device, accessories (EEG cap, charging kit, Subject Response Device), and a computer (laptop or tablet). It also mentions firmware running on the eVox Amplifier. While software is a crucial part of the system, it is not the only component.

IVD (In Vitro Diagnostic)

Based on the provided text, the eVox System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
eVox System Function: The eVox System directly measures electrical activity of the patient's brain (EEG and ERP) by placing electrodes on the head. It does not analyze specimens taken from the body.
Intended Use: The intended use clearly states it's for the acquisition, display, and storage of electrical activity of the brain to aid in diagnosis. This is a direct measurement of physiological activity, not an analysis of a biological sample.

Therefore, the eVox System falls under the category of a medical device that directly interacts with the patient's body to collect physiological data, rather than an IVD device that analyzes samples taken from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

GWO, GWJ, GWQ

Device Description

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.

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».

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Patient's brain / head

Indicated Patient Age Range

All age groups

Intended User / Care Setting

Qualified medical personnel 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.

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

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

Key Results:

Accuracy of signal reproduction: Passed. Test shows that Evoke system accurately reproduces EEG signals over the specified range.
Input dynamic range and differential offset voltage: Passed under relaxed condition (187mV Offset: 1.5% error: Pass), Failed under original condition (300mV Offset: 100% error: Fail). This deviation is acceptable for the intended use of the device.
Input Noise: Passed. Maximum noise: 3.4 uV.
Frequency Response: Passed. 0.5 Hz: 100%; 5 Hz: 105%; 50 Hz: 76%.
Common mode rejection: Failed with 187mV dc Offset (output is saturated), Passed with 0 DC Offset (67.3uVpp).

Key Metrics

Not Found

Predicate Device(s)

K143233, K141316, K112052

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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);

1

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

2

Indications for Use

510(k) Number (if known) K171781

Device Name eVox System

Indications for Use (Describe)

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.

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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3

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 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

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.

5

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».

V. INDICATIONS FOR USE

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.

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.

6

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	GWJ
Additional: OMC, OLT,	GWJ
Additional:
OLT, GWF, GZP, IKN, JXE, GWE	Product contains multiple product
codes which are generally required
for a complete system.
The eVox System and the Mitsar –
EEG device share the product code:
GWQ: Full Montage System
The eVox System, the COGNISION
system and Nicolet EDX system
share the product code:
GWJ: Evoked response auditory
stimulator
Indications for Use	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.	The device Mitsar-EEG is
intended to acquire,
display and store the
electrical activity of a
patient's brain obtained
by placing two or more
electrodes on the head
to aid in diagnosis.	The COGNISION system is for
use by qualified clinical
professional in private practice
offices or small clinical settings
for the acquisition, display,
analysis, storage, reporting and
management of
electroencephalograph (EEG)
and auditory evoked potentials
(AEP) information.	The Nicolet EDX is intended for the
acquisition, display, analysis,
reporting and management of
electrophysiological information
from the human nervous and
muscular system including Nerve
Conduction (NCS).
Electromyography (EMG), Evoked
Potentials (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 Software
may be used to determine
automatics responses to physiologic
stimuli by measuring the change in
electrical resistance between two
electrodes (Galvanic Skin Response
and Sympathetic Skin Response).
Autonomic testing also includes
assessments of RR interval
variability. The Nicolet EDX with
Viking Software is used to detect
the physiologic function of the
nervous system, for the location of
neural structures during surgery
and to support the diagnosis of
neuromuscular disease or
condition.
				The listed modalities do not include
overlap in functionality. In general,
Nerve Conduction Studies measure
the electrical responses of the
nerve; Electromyography measures
the electrical activity of the muscle
and Evoked Potential measure
electrical activity from the Central
Nervous System.
The Nicolet EDX with Viking
Software is intended to be used by
a qualified healthcare provider.
Principle of
Operation	The eVox System device is
used for acquisition of
physiological signals using
two or more channels of
electroencephalography	The Mitsar EEG consists
of biosignal amplifier,
USB cable, USB dongle
and software. The
medical system includes	The COGNISION EEG/EP System
is a combination device for
reduced montage recording
and display of
electroencephalographic (EEG)	The Nicolet EDX system with Viking
Software (Viking EDX) is designed
for the acquisition, display, analysis,
reporting and management of
electrophysiological information	The eVox System has a principle of
operation that closely matches that
of its predicates. All devices use
skin coupling methods, either
through electrodes or sensors
Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
	(EEG) from the scalp. It
consists of an eVox
amplifier, a laptop
computer (base station),
a patient EEG cap, subject
response button, ear
buds, and a charging cord.
The eVox amplifier and
software provide a means
to:
a) initiate a study, track
user EEG and ERP data
and enter text or
questionnaire
information,
b) acquire and save
signals to the memory
of the device,
c) transmit signal data
from the device,
d) Visually inspect the
acquired signal.
e)Manage Event-
related Potentials	"Mitsar EEG" device and
computer (stationary PC
with uninterruptible
power supply (UPS) or
laptop with internal
battery). The Mitsar EEG
device is an amplifier
which receives patient
EEG data from a patient
EEG cap or EEG
electrodes.	and evoked potentials (EP) test
data.
The system uses elastic bands
to accurately position 10
electrode pods around the
head.
EEG signal amplification,
conditioning, and A/D
conversion is performed by
electronic circuits closely
coupled to the electrode pods
through short flexible printed
wires.
The headset is connected by a
cable to a handheld control unit
and data acquisition box (HCU).
The HCU communicates via a
wireless data link to a Windows
PC to stream EEG data.
Software on the PC is used to
setup the tests and view and
evaluate the resultant test data
using standard EEG/EP display
methods.	from the human nervous and
muscular systems.
The system is designed to perform
nerve conduction studies (NCS),
needle electromyography (EMG)
testing, evoked potential (EP)
testing, and intra-operative
monitoring (IOM). The system can
also perform multi-modality
recording through Multi-mode
programs (MMP). Viking EDX
provides a variety of tests spanning
the various modalities.	which transmits patient EEG and
ERP from the surface of the scalp to
an amplifier.
The connection between the
amplifier and electrodes is a wired
connection for the devices.
All devices convert the analog data
into digital data which is then
transmitted to a base station or
computer.
Once transmitted to the base
station, the devices display and
store the data on the base station
and allow the user to export the
data to a file.
Patient population	All age groups	All age groups	Adults	Unknown
Use environment	Intended for 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	Intended for use in
functional diagnostics
wards and departments
at out-patient clinics,
hospitals, health
research institutes,
health centers and other
medical institutions.	Physicians' Offices	Physicians' Offices
Trade Name	eVox System	MITSAR-EEG	COGNISION™	Nicolet EDX 2 Viking Software	Comments
	performed outside of
healthcare facilities, as
long as they are led by
qualified medical
personnel.	Also, investigations can
be performed outside of
healthcare facilities, as
long as they are led by
qualified medical
personnel.
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 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.	The Mitsar-EEG is
intended to acquire,
display and store the
electrical activity of a
patient's brain by placing
two or more electrodes
on the head to aid in
diagnosis.	The COGNISION system is a
combination device for reduced
montage recording and display
of electroencephalograph (EEG)
and evoked potentials (EP) test
data.	The Nicolet EDX with Viking
Software (Viking EDX) is intended
for the acquisition, display, analysis,
reporting and management of
electrophysiological information
from the human nervous and
muscular systems. The system is
designed to perform nerve
conduction studies (NCS), needle
electromyography (EMG) testing,
evoked potential (EP) testing, and
intra-operative monitoring (IOM).
The system can also perform multi-
modality recording through Multi-
mode programs (MMP).Viking EDX
provides a variety of tests spanning
the various modalities.
ERP Stimulus
Modality	Auditory; Visual	None	Auditory	Auditory; Visual
System
Components	eVox System consists of :	"Mitsar EEG" consists of	COGNISION™ consists of:
• Head Set	CareFusion Nicolet EDX 2 Viking
Software 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 response
button, ear buds,
• and a charging cord.	• biosignal amplifier,
• computer
(stationary PC with
uninterruptible
power supply (UPS)
• or laptop with
internal battery)
• USB cable,
• USB dongle
• and software.	• Auditory stimulator
• Handheld Control Unit
(HCU) including Interface
Software
Connecting Headset cable
between the headset and
the handheld control unit	• EDX Console
• Electrical stimulators
• Auditory Stimulator
• Trigger input/output
• LED google interface Control
Panel
• Amplifier
• Computer Monitor
• Keyboard,
Mouse
• Printer
ERP Paradigm
(Auditory and
Visual 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 Task
Response | User Buttons | User Buttons | User Buttons | User Buttons | |
| Skin Coupling | Custom Electrode Band
and Gel | Custom Electrode Band
and Gel | HydroDot Biosensor | Discrete Electrode Wires | The eVox system, Mitsar EEG, and
Nicolet EDX use the same method
of utilizing a conductive gel
between electrode and the skin
The COGNISION system uses
HydroDot 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 | |
| Typical
Biopotential
Signals Recorded | Electroencephalography
(EEG), EP/ERP | Electroencephalography
(EEG) | Electroencephalography (EEG),
EP/ERP | Electroencephalography (EEG),
EP/ERP | The eVox System, the COGNISION
system and the Nicolet EDX record
EEG and EP/ERP.
TheMitsar-EEG device does |
| Number of Signal
Recording
Channels | Up to 21 | Up to 21 | Up to 10 | 7 | nothave EP/ERP modality. |
| Recording
Channels Location
and Positioning
Systems | Fz,Cz,Pz,F3,P3,F4,P4
Utilizing elastic bands
using distance ratios
consistent with the 10-20
System | Fz,Cz,Pz,F3,P3,F4,P4
Utilizing elastic bands
using distance ratios
consistent with the 10-
20 System | Fz,Cz,Pz,F3,P3,F4,P4
Utilizing elastic bands using
distance ratios consistent with
the 10-20 System | Variable Discrete electrode wires | The eVox system, the Mitsar system
and the COGNISION system use the
same exact electrode placement
configuration and a similar method
position of electrodes.
The Nicolet EDX system has a
variable electrode configuration
that may be configured in similar
manner. |
| Impedance Test | Yes | Yes | Yes | Yes | |
| Amplifier Input
Impedance | > 10 MΩ | > 200 MΩ | > 60 MΩ | > 1000 MΩ | Performance testing per IEC 60601-
2-26:2012 confirmed 10 MΩ is
sufficient to eliminate distortion in
the measured signal. |
| Trade Name | eVox System | MITSAR-EEG | COGNISION™ | Nicolet EDX 2 Viking Software | Comments |
| Analog to Digital
Conversion | 24 Bit | 16 Bit | 16 Bit | 24 Bit | |
| Sampling Rate | 250 Hz | 500 Hz | 125/250 Hz | 384 KHz | Clinically relevant human
electrophysiology does not exceed
100 Hz and therefore there is no
technical need to sample above
250 Hz. |
| Common mode
rejection | >110 dB | >100 dB | >90dB | >110dB | |
| Analysis Software | Embedded, commercially
available, and user
defined. | Embedded, commercially
available and user
defined. | Embedded, commercially
available, and user defined. | Embedded, commercially available
and user defined. | |
| Interface with
Amplifier | Class 2 Bluetooth® version
2.0 to PC | USB cable to PC | Bluetooth 2.0/4.0 | USB cable to PC | |
| Power Supply | Li-Ion Battery, with USB
cable for charging the
battery. | USB cable | Li Ion Battery | Mains (100-240 VAC) | |
| EEG input
terminals | 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 the
Cognition System.
The eVox system meets the
frequency requirements of IEC
60601-2-26 (0.5Hz-50 Hz) |
| Noise | 2-3 uVp-p | 71%,