COGNISION EEG/EP SYSTEM

K141316 · Neuronetrix Solutions · OLT · Feb 13, 2015 · Neurology

Device Facts

• Record ID: K141316
• Device Name: COGNISION EEG/EP SYSTEM
• Applicant: Neuronetrix Solutions
• Product Code: OLT · Neurology
• Decision Date: Feb 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The COGNISION System is for use by qualified clinical professionals 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.

Device Story

COGNISION EEG/EP System is a combination device for reduced montage recording of EEG and auditory evoked potentials (AEP). System uses elastic bands to position 10 electrode pods on scalp; HydroDot biosensors provide electrical coupling. Electronic circuits in pods perform signal amplification, conditioning, and A/D conversion. Headset connects via cable to handheld control unit (HCU) containing lithium-ion battery; HCU streams data wirelessly to Windows PC. PC software manages test setup, data display, and analysis. Calibrated earphones deliver auditory stimuli for AEP. Used by clinicians in private practice/small clinical settings. Output allows clinicians to view and evaluate brain wave data to support clinical decision-making and patient management.

Clinical Evidence

Device validated in actual use conditions on initial production units or equivalents. Patients with neurological conditions observed in intended use environment; design validation met all acceptance criteria. No specific sensitivity/specificity metrics reported.

Technological Characteristics

Reduced montage headset (<16 electrodes) using elastic bands. Sensing: 10 electrode pods with HydroDot biosensors. Energy: Lithium-ion battery (HCU). Connectivity: Wireless link to Windows PC. Signal processing: Amplification, conditioning, A/D conversion. Software: PC-based for setup, display, and analysis. Complies with biocompatibility and electrical safety standards.

Indications for Use

Indicated for use by qualified clinical professionals in private practice or small clinical settings for acquisition, display, analysis, storage, reporting, and management of EEG and AEP information in adult patients.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• Advanced Brain Monitoring X-10/X-24 family (K131383)
• CareFusion Nicolet EDX 2/ Viking Software (K112052)
• Physiometrix Equinox Digital EEG System (K962447)

Submission Summary (Full Text)

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

February 13, 2015

Neuronetrix Solutions % Cheryl Fisher Senior Consultant OA Emergo Group 816 Congress Ave. Suite 1400 Austin TX 78701

Re: K141316 Trade/Device Name: COGNISION™ EEG/EP SYSTEM Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, GWJ, OMC Dated: January 12, 2015 Received: January 13, 2015.

Dear Ms. Fisher,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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) K141316

Device Name COGNISION™ EEG/EP SYSTEM

Indications for Use (Describe)

The COGNISION System is for use by qualified clinical professionals 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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

## for

# COGNISION™ EEG/ERP SYSTEM

#### 1. Submission Sponsor

Neuronetrix Solutions 1044 E. Chestnut Louisville KY, 40204 United States Phone: [phone] Contact: K.C. Fadem, President

#### 2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: [phone] Office Phone: [phone] Fax: [phone] Contact: Cheryl Fisher, Senior Consultant, QA/RA Email: [e-mail]

#### 3. Date Prepared

1/12/2015

#### 4. Device Identification

| Trade/Proprietary Name: | COGNISION™ EEG/ERP SYSTEM |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | EEG/EP System, EEG Telemetry System |
| Classification Name: | Multiple: Electroencephalograph, Evoked Response Auditory Stimulator |
| Classification Regulation: | Multiple:<br>882.1400<br>882.1900 |
| Product Code: | Multiple:<br>OMC, Reduced Montage Electroencephalograph<br>OLT, Non-Normalizing Quantitative Electroencephalograph Software<br>GWJ, Stimulator, Auditory, Evoked Response |
| Device Class: | All product codes utilized are considered Class II |
| Classification Panel: | Neurology |

#### 5. Legally Marketed Predicate Device(s)

| K131383 | Advanced Brain Monitoring X-10/X-24 family |
|---------|--------------------------------------------|
| K112052 | CareFusion Nicolet EDX 2/ Viking Software |
| K962447 | Physiometrix Equinox Digital EEG System |

#### 6. Device Description

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The COGNISION™ EEG/EP System is a combination device for reduced montage recording and display of electroencephalographic (EEG) and evoked potentials (EP) test data.

The system uses elastic bands to accurately position 10 electrode pods around the head (7 recording channels, 2 linked mastoids, and 1 common).

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). A lithium-ion battery in the HCU is used to power the system. The HCU communicates via a wireless data link to a Windows PC to stream EEG data.

HydroDot® Biosensors (from HydroDot Inc., and not included as part of this submission) are inserted into each electrode pod to electrically couple the electrode pods to the subjects scalp.

Software on the PC is used to setup the tests and view and evaluate the resultant test data using standard EEG/EP display methods.

Calibrated audiometric earphones (from E-A-R Auditory Systems) can be plugged in to the amplifier A/D converter box to deliver various auditory stimuli to produce evoked potential EEG responses.

## 7. Indication for Use Statement

The COGNISION System is for use by qualified clinical professionals 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.

#### 8. Substantial Equivalence Discussion

The following table compares the COGNISION™ EEG/EP System to the predicate device(s) with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

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| anufactur | euronetrix Solution | Advanced Brain Monitoring | areFusio | Physiometrix In | SIGNIFICANT DIFFERENC |
|----------------|----------------------------|---------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| rade Nam | OGNISION™ EEG/ER<br>SYSTEM | | icolet EDX 2/Viki | quinox™ Digital | |
| 0(k) Numbe | (141316 | <131383 | 112052 | 96244 | None |
| egulation Numb | | 882.1400 | | | |
| | 882.1400 882.1900 | | 82.1400 82.1900 | 588 1788 86 57 88 00 17 788 | etween the three predications are I regulations are ommensurate with the DGNISION™ EEG/ERP System |
| | | | | | |
| | | | lditional: 882.18 0.1375, 882.155 2.1890, 882.188 | | |
| gulation Nam | ctroencephalograp | Electroencephalogi | ctroencephalog | | |
| | oked response | 니 | voked respon | ctroencephalogrations taneous Electrod vsiological Amplif | |
| | uditory stimulate | | uditory stimulat | | etween the three predications associations as and |
| | | | | | |
| | | | lditional | | |
| | | | | | |
| | | | voked Response lectrical Stimular lectrical Stimular Nectronicostic Nectromy operalization Jerve Conduction | | he primary regulation for all hree devices is the same whil |
| | | | | | the |
| | | | | | |
| | | | | | |
| | | | elocity | | he Equinox System and the I o System do not perform do not perform of the more the Nicolett EDX 27 Vinner oftware performes EP williams and the provin dditional stimulus try |
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| oduct Cod | 0MC, OLT, GW | OMC | | GXY | |
| | | | | | |
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| | | | dditional: GV WE,GZP,IKN | | Products of this type typically contain multiple product contain multiple products of the product are a complete system |
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| | | | | | |
| | | | | | e X-10 System and GNISION™ EEG/ERP System Syste are the product code: |
| | | | | | ● |
| | | | | | System |

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| The X10 system is a reduced<br>montage EEG device equivalent<br>to the EEG functionality of the<br>COGNISION™EEG/ERP SYSTEM |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| However it does not include<br>GWJ EP Functionality as the<br>COGNISION™EEG/ERP SYSTEM<br>does. |
| The Nicolet EDX 2 and<br>COGNISION™ EEG/ERP System<br>share two main product codes:<br>1. OLT- Non-Normalizing<br>Quantitative<br>Electroencephalograph<br>Software |
| 2. GWJ-Stimulator<br>Auditory Evoked<br>Response |
| The COGNISION™ EEG/ERP<br>System utilizes a reduced<br>montage headset of less than<br>16 electrodes. The Nicolet EDX<br>2 System can utilize either a<br>reduced or full montage array. |
| Additionally the Nicolet EDX 2<br>system has additional<br>modalities associated with<br>other Evoked Potentials such as<br>visual and muscular as well as<br>the auditory evoked potential<br>modality. Wherein the<br>COGNISION™ EEG/ERP System<br>has only Auditory Evoked<br>Potential capability. |

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| Indications for Use | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The COGNISION™<br>EEG/ERP System is for<br>use by qualified clinical<br>professionals in private<br>practice offices or small<br>clinical settings for the<br>acquisition, display,<br>analysis, storage,<br>reporting and<br>management of<br>electroencephalograph<br>(EEG) and auditory<br>evoked potentials (AEP)<br>information. | The X-Series System is<br>intended for<br>prescription use in the<br>home, healthcare<br>facility or clinical<br>research environment<br>to acquire, transmit<br>and display and store<br>physiological signals<br>from patients 6 and<br>older. The X-Series<br>system requires<br>operation by a trained<br>technician. The x-<br>Series System<br>acquires, transmits,<br>displays and stores<br>electroencephalogram<br>(EEG),<br>electrooculogram<br>(EOG),<br>electrocardiogram<br>(ECG) and /or<br>electromyogram<br>(EMG, and<br>accelerometer signals.<br>The X-Series system<br>only acquires and<br>displays physiological<br>signals, no claims are<br>being made for<br>analysis of the<br>acquired signals with<br>respect to the | The Nicolet EDX 2 is<br>intended for the<br>acquisition, display,<br>analysis, storage,<br>reporting, and<br>management of<br>electrophysiological<br>information from the<br>human nervous and<br>muscular systems<br>including Nerve<br>Conduction (NCS),<br>Electromyography<br>(EMG), Evoked<br>Potentials (EP),<br>Autonomic responses<br>and Intra-Operative<br>Monitoring including<br>Electroencephalograp<br>hy (EEG). | The Equinox system is<br>indicated for<br>preserving the full<br>fidelity of the EEG<br>waveform data in the<br>patient population<br>while providing tools<br>for displaying and<br>printing the waveforms<br>for analysis and<br>interpretation by<br>trained healthcare<br>professionals | Intended use is defined<br>as The Equinox Digital<br>EEG System records<br>and digitizes EEG data<br>and automatically<br>stores it on optical disk.<br>Post-processing<br>options include display<br>on paper or computer<br>monitor | The Equinox System performs<br>full montage EEG. The<br>Physiometrix Equinox does not<br>have Evoked Potential<br>capability.<br>All products are intended for<br>use by qualified clinical<br>professionals.<br>All products are used for<br>acquisition and display of EEG<br>data.<br>The Nicolet EDX 2 and the<br>COGNISION systems have the<br>added capability of recording<br>Auditory Evoked Potential.<br>The Nicolet EDX 2 system<br>provides the following<br>capabilities above the<br>COGNISION™ EEG/ERP System<br>Nerve Conduction and<br>Electromyography.<br>The X-10 Systemcontains the<br>following capabilities above the<br>COGNISION™ EEG/ERP<br>SYSTEM, EOG<br>electrooculogram, ECG<br>electrocardiogram, and EMG<br>electromyogram<br>The Equinox System only<br>contains EEG capability and<br>does have auditory evoked<br>potential capability. |

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| Anatomical contact sites | Patient's skin (scalp)<br>(auditory stimulators/earphones) | accuracy, precision<br>and reliability<br>Patient's skin (scalp)<br>and chest | Patient's head<br>(auditory stimulators)<br>, skin with electrical<br>stimulator probes | Patient's skin (scalp) | The COGNISION™ EEG/ERP<br>System and the other<br>predicates all use electrodes<br>which contact specific locations<br>on the scalp for EEG<br>recording. The COGNISION™<br>EEG/ERP System and the<br>Nicolet system also use<br>earphones for auditory evoked<br>potentials testing. The X10 and<br>Nicolet also have functionality<br>for recording<br>electrophysiological data from<br>the chest. |
|------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EP Stimulus<br>Modality | Auditory | NA | Auditory | NA | Both the Nicolet EDX 2/Viking<br>and the COGNISION™EEG/ERP<br>SYSTEM contain an auditory<br>evoked potential modality. The<br>X-10 Systemand Equinox<br>System s. do not have an<br>auditory evoked potential<br>modality |
| EP Paradigm<br>(Auditory Stimulus) | P300 Oddball<br>-Single Stimulus<br>-Single Deviant<br>-2 Deviant<br>-Active and Passive | N/A | P300 Oddball<br>-Single Stimulus<br>-Single Deviant<br>-2 Deviant<br>-Active and Passive | N/A | Both the Nicolet EDX 2/Viking<br>and the COGNISION™EEG/ERP<br>SYSTEM utilize the same EP<br>Paradigms. The X-10 and<br>Equinox systems do not have<br>this functionality. |
| EP Task Response | User Buttons | N/A | User Buttons | N/A | Both the Nicolet EDX 2/Viking<br>system and the<br>COGNISION™EEG/ERP SYSTEM<br>utilize user buttons to respond<br>to the auditory evoked<br>Potential. The X-10 and<br>Equinox systems do not have |

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| | | | | | is functionalit |
|----------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------|----------------|------------------------------------------------------------|--------------------------------------------------------------------------------------|
| eneral Displa unctionality | Channel Selectio X/Y Windowing Color Selection Color Selection Grid Display | Selectio<br>Channel Selection X/Y Windowing Color Sellection Grid Display | | Channel Selecti X/Y Windowing Color Selection Grid Display | |
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| P Display unctionalit | average Waves Difference Waves timulus Onset Limulus Onset Lutton Press | N/A | | N/A | |
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| in Couplir | ydroDot® Biosens | Electrod<br>Custom Elect Band and Ge | screte Electro | ydroDot® Bioser | |
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| rget Populati | Adults | Ages 6 and olde | Jnknow | Adults | |
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| Environment | nysician Offic | Home, Healthcar | nysician offi | Jnknow | |
| use | | Facility and Clinica | | | |
| | | Research | | | |
| | | | | | he environment of use is milar for the COGNISION™ IG/ERP SYSTEM, and the leading the |

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| Design | | | | | |
|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The COGNISION™<br>EEG/EP System is a<br>combination device for<br>reduced montage<br>recording and display of<br>electroencephalographic<br>(EEG) and evoked<br>potentials (EP) test data.<br>The system uses elastic<br>bands to accurately<br>position 10 electrode<br>pods around the head.<br>EEG signal amplification,<br>conditioning, and A/D<br>conversion is performed<br>by electronic circuits<br>closely coupled to the<br>electrode pods through<br>short flexible printed<br>wires. The headset is<br>connected by a cable to<br>a handheld control unit<br>and data acquisition box<br>(HCU). A lithium-ion<br>battery in the HCU is<br>used to power the | The X10 System is<br>comprised of a<br>Headset and<br>accessories, Synapse<br>Crème, X-Series Basic<br>Software and BT<br>receiving unit. The<br>system combines<br>hardware, firmware<br>and software to<br>acquire physiological<br>signals. It acquires<br>physiological data<br>through a battery<br>powered headset<br>worn by the patient<br>and provides a flexible<br>platform for applying<br>sensors using synapse<br>cream and acquiring<br>signals from multiple<br>locations on the head<br>or body, transmitting<br>and recording the<br>signals and providing<br>visual indications to | The Nicolet EDX 2<br>System consists of a<br>base unit console<br>containing 2 electrical<br>stimulators, and an<br>auditory and visual<br>stimulator. The base<br>unit also has two<br>trigger inputs and two<br>trigger outputs for<br>connections to<br>external devices. The<br>base unit has up to 12<br>switchable output<br>sites, and is<br>connected through a<br>single USB (2.0)<br>connection to the<br>computer on the<br>control panel. The<br>control panel houses<br>the computer and<br>amplifiers for signal<br>processing through a<br>24-bit A/D converter.<br>Digital Signal | The patient module is a<br>small battery powered<br>unit attached to the<br>patient. It transmits<br>EEG data from the<br>patient to the DSP card<br>via fiber optic cable<br>which also acts as<br>isolation for the patient<br>module. The data are<br>conditioned and<br>digitized at the DSP<br>Card and then<br>transmitted to a host<br>PC (Digital EEG<br>machine) | are both used in a Physician<br>office environment.<br>It is unknown in what<br>environment the Equinox<br>system is utilized. The X-10<br>system is utilized in the Home,<br>Healthcare Facility and Clinical<br>Research Environments and<br>have testing to support these<br>indications whereas the<br>COGNISION™ EEG/ERP System<br>was tested to support its<br>intended environment of use.<br><br>The COGNISION™ EEG/EP<br>System and its predicate<br>devices share a similar<br>configuration including a<br>headset in either reduced or<br>full montage configurations,<br>and a combination of software<br>and hardware that in<br>conjunction with electrodes<br>either cleared with the system<br>or independently appropriately<br>sense brain wave data and<br>transmit the raw data to<br>hardware/software<br>mechanisms that transmit and<br>display the electrical brain<br>wave data. The COGNISION™<br>EEG/EP System, Nicolet EDX<br>2/Viking Software system, and<br>Advanced Brain Monitoring Inc.<br>X-10 system have additional<br>accessories to support<br>additional modalities<br>commensurate with their<br>indications for use. |

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| system. The HCU<br>communicates via a<br>wireless data link to a<br>Windows PC to stream<br>EEG data.<br>Software on the PC is<br>used to setup the tests<br>and view and evaluate<br>the resultant test data<br>using standard EEG/EP<br>display methods. | ensure high quality<br>data are obtained. The<br>basic software<br>provides a means to:<br>a. Initiate a<br>study and<br>track patient<br>information<br>b. Acquired and<br>wirelessly<br>transmit<br>signals from<br>the device.<br>c. Visually<br>inspect the<br>signal quality | Processing provides<br>advanced signal<br>processing such as<br>filtering, sound<br>optimization. The<br>base unit firmware<br>and DSP are run from<br>this computer, where<br>data can be acquired<br>and displayed<br>simultaneously | Sterile | Same |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Single Use | Same |
| | | | Shelf Life | Same |
| | | | Power Source | The COGNISIONTM EEG/ERP<br>System and the X-10 system<br>use similar lithium ion batteries<br>while the Nicolet EDX 2/Viking<br>Software system and Equinox<br>system is powered via a<br>standard wall plug. |
| | | | Recording<br>Channels Location<br>and Positioning<br>System | X-10 Systemuses a Li Ion<br>Batteries as does the<br>COGNISIONTM EEG/ERP<br>SYSTEM. |
| | | | | Both the COGNISIONTM<br>EEG/ERP System and the X-10<br>System use the exact same<br>electrode placement<br>configurations of |
| | | | No | No |
| | | | No | No |
| | | | Durable good | Durable good |
| | | | Li Ion Battery | Mains (100-240 VAC) |
| | | | Fz,Cz,Pz,F3,P3,F4,P4<br>Utilizing elastic bands<br>using distance ratios<br>consistent with the 10-20<br>System | Variable<br>Discrete electrode<br>wires |
| | | | Fz,Cz, Pz,F3,P3,F4,P4<br>Utilizing plastic bands<br>using distance ratios<br>consistent with the<br>10-20 System | 10-20 System<br>Utilizing elastic bands<br>using distance ratios<br>consistent with the 10-<br>20 System |

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| | 3. Sampling Rate | 3. | 3. | 3. | 4. A/D Bits | 5. Noise |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------|-----------|------------------------|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| electrophysiological signals (Nerve Conduction and Electromyography) as well as evoked potential information. 3. The COGNISION™ System sampling rate was selected to be ~ 3x greater than the highest pass band frequency to prevent aliasing during signal processing. The sampling rate is closely aligned with both the X-10 system and the Nicolet EDX 22 with Viking Software System | 3. 125/250Hz | 3. 256Hz | 3. 384KHz | 3. Unknown | 4. 16 | 5. ≤ 1µV RMS |
| | | | | 4. Unknown | 4. 16 | 5. ≤ 1.5µV RMS |
|…