(269 days)
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.
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.
The provided text describes the COGNISION™ EEG/EP System and its equivalence to predicate devices, but it does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner of a clinical or comparative effectiveness study. Instead, it focuses on non-clinical performance data (bench testing) and general statements about design validation.
Here's an breakdown of the information that is available and what is missing based on your request:
Acceptance Criteria and Device Performance
The document presents non-clinical (bench) acceptance criteria and states that the device passed these tests. It does not provide "reported device performance" in terms of clinical outcomes or performance metrics against specific acceptance thresholds in a clinical study.
Table of Acceptance Criteria and Stated Device Performance (Non-Clinical):
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Current Draw | -420 to -525mA | Passed (Implied, as the Conclusion states all tests were passed according to established specifications) |
| Cal Tones | Low Cal Frequency: 13.50 - 14.50 HzLow Cal Power: 31.5 - 33.5 dB μVHigh Cal Frequency: 27.00 - 28.00 HzHigh Cal Power: 31.5 - 33.5 dB μV | Passed |
| Baseline Noise | Noise VRMS: < 1 μV | Passed |
| Crosstalk | Minimum Crosstalk >60 dB @ 10 Hz, 730 mv pk-pk input on driven CH | Passed |
| CMMR | Min Attenuation : < 90 dBCMRR @ 60 HZ : <100 dBCMRR @ 50 HZ : < 100 dB | Passed |
| Gain Linearity | Maximum deviation from linearity : < 0.1 | Passed |
| Frequency Response | Max Deviation: < $0.2x+0.45$ dB @ 0.2-0.4 HzMax Deviation: < $0.45$ dB @ 0.3-32 HzMax Deviation: < $0.15x+0.45$ dB @ 33-50 HzGain @ 33 Hz: -3.418 < x < -2.218 dBGain @ 10 Hz: -0.38 < x < 0.52 dBGain @ 0.4 Hz: -3.90 < x < -2.70 dBGain Pass band Values: Variance 1-20 Hz : < 1 dB | Passed |
| CAL Tone loopback | CAL Tones power spectrum should contain three peaks at 13.9, 28.8 and a third around 45 Hz.CAL Tones Time Domain should have two signals 180 degrees out of phase with each other | Passed |
| Self-Test | ||
| Keypad Test | PASS/FAIL | Passed |
| Button Test | PASS/FAIL | Passed |
| LED Test | PASS/FAIL | Passed |
| Power on | PASS/FAIL | Passed |
| Power off | PASS/FAIL | Passed |
| HCU USB Charge | State is 20-90%: Current 350-460mA | Passed |
| Buzzer Test | PASS/FAIL | Passed |
| Bluetooth Test | PASS/FAIL | Passed |
| Data Flash Test | PASS/FAIL | Passed |
| Audio DAC Test | PASS/FAIL | Passed |
| Audio Flash Test | PASS/FAIL | Passed |
Missing Information from the Request:
The provided text does not contain the following information which is typically found in a clinical study report proving a device meets acceptance criteria:
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "Patients with a neurological condition were observed in an environment consistent with the intended use and the design validation met all acceptance criteria" under "Clinical Performance Data." However, it does not provide details on the number of patients, their demographics, the data provenance, or whether the study was retrospective or prospective. The "test set" in the context of the bench tests is an "automated test set" and does not involve human subjects.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. The "ground truth" for the non-clinical tests would be the known inputs from the biosignal generator and fixtures. For the brief mention of clinical validation, no details about expert adjudication or ground truth establishment are given.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and not mentioned for the non-clinical tests. Not mentioned for the brief clinical validation comment.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not available in the document. The device description does not imply AI assistance, and no MRMC study details are provided.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the device as an "EEG/EP System" for acquisition, display, analysis, storage, reporting, and management of information by "qualified clinical professionals." It doesn't detail an algorithm-only performance assessment in the context of diagnostic or interpretive outcomes. The self-tests and performance tests are essentially standalone evaluations of the hardware/software functionality, but not in the sense of a standalone diagnostic algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the ground truth is derived from the known, precisely controlled signals generated by the "integrated biosignal generator" and other electronic fixtures. For the "clinical performance data" that is mentioned, the method for establishing ground truth for the neurological conditions or observed outcomes is not specified.
-
The sample size for the training set: Not applicable, as this device is not described as an AI/ML device that requires a training set in the conventional sense. Its functionality is based on signal acquisition and processing.
-
How the ground truth for the training set was established: Not applicable, for the same reason as point 7.
In summary, the document describes the non-clinical (bench) testing of the COGNISION™ EEG/EP System and declares that it passed these tests, affirming its adherence to engineering specifications. It makes a general statement about clinical validation but lacks specific details typically found in studies proving device performance against acceptance criteria in a clinical setting.
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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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
for
COGNISION™ EEG/ERP SYSTEM
1. Submission Sponsor
Neuronetrix Solutions 1044 E. Chestnut Louisville KY, 40204 United States Phone: (502)561-9040 Contact: K.C. Fadem, President
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (408)410-5920 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Cheryl Fisher, Senior Consultant, QA/RA Email: project.management@emergogroup.com
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:882.1400882.1900 |
| Product Code: | Multiple:OMC, Reduced Montage ElectroencephalographOLT, Non-Normalizing Quantitative Electroencephalograph SoftwareGWJ, 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/ERSYSTEM | 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 | ||||
| oduct Cod | 0MC, OLT, GW | OMC | GXY | ||
| dditional: GV WE,GZP,IKN | Products of this type typically contain multiple product contain multiple products of the product are a complete system | ||||
| e X-10 System and GNISION™ EEG/ERP System Syste are the product code: | |||||
| ● | |||||
| System |
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| The X10 system is a reducedmontage EEG device equivalentto the EEG functionality of theCOGNISION™EEG/ERP SYSTEM |
|---|
| However it does not includeGWJ EP Functionality as theCOGNISION™EEG/ERP SYSTEMdoes. |
| The Nicolet EDX 2 andCOGNISION™ EEG/ERP Systemshare two main product codes:1. OLT- Non-NormalizingQuantitativeElectroencephalographSoftware |
| 2. GWJ-StimulatorAuditory EvokedResponse |
| The COGNISION™ EEG/ERPSystem utilizes a reducedmontage headset of less than16 electrodes. The Nicolet EDX2 System can utilize either areduced or full montage array. |
| Additionally the Nicolet EDX 2system has additionalmodalities associated withother Evoked Potentials such asvisual and muscular as well asthe auditory evoked potentialmodality. Wherein theCOGNISION™ EEG/ERP Systemhas only Auditory EvokedPotential capability. |
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| Indications for Use | |||||
|---|---|---|---|---|---|
| The COGNISION™EEG/ERP System is foruse by qualified clinicalprofessionals in privatepractice offices or smallclinical settings for theacquisition, display,analysis, storage,reporting andmanagement ofelectroencephalograph(EEG) and auditoryevoked potentials (AEP)information. | The X-Series System isintended forprescription use in thehome, healthcarefacility or clinicalresearch environmentto acquire, transmitand display and storephysiological signalsfrom patients 6 andolder. The X-Seriessystem requiresoperation by a trainedtechnician. The x-Series Systemacquires, transmits,displays and storeselectroencephalogram(EEG),electrooculogram(EOG),electrocardiogram(ECG) and /orelectromyogram(EMG, andaccelerometer signals.The X-Series systemonly acquires anddisplays physiologicalsignals, no claims arebeing made foranalysis of theacquired signals withrespect to the | The Nicolet EDX 2 isintended for theacquisition, display,analysis, storage,reporting, andmanagement ofelectrophysiologicalinformation from thehuman nervous andmuscular systemsincluding NerveConduction (NCS),Electromyography(EMG), EvokedPotentials (EP),Autonomic responsesand Intra-OperativeMonitoring includingElectroencephalography (EEG). | The Equinox system isindicated forpreserving the fullfidelity of the EEGwaveform data in thepatient populationwhile providing toolsfor displaying andprinting the waveformsfor analysis andinterpretation bytrained healthcareprofessionals | Intended use is definedas The Equinox DigitalEEG System recordsand digitizes EEG dataand automaticallystores it on optical disk.Post-processingoptions include displayon paper or computermonitor | The Equinox System performsfull montage EEG. ThePhysiometrix Equinox does nothave Evoked Potentialcapability.All products are intended foruse by qualified clinicalprofessionals.All products are used foracquisition and display of EEGdata.The Nicolet EDX 2 and theCOGNISION systems have theadded capability of recordingAuditory Evoked Potential.The Nicolet EDX 2 systemprovides the followingcapabilities above theCOGNISION™ EEG/ERP SystemNerve Conduction andElectromyography.The X-10 Systemcontains thefollowing capabilities above theCOGNISION™ EEG/ERPSYSTEM, EOGelectrooculogram, ECGelectrocardiogram, and EMGelectromyogramThe Equinox System onlycontains EEG capability anddoes have auditory evokedpotential capability. |
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| Anatomical contact sites | Patient's skin (scalp)(auditory stimulators/earphones) | accuracy, precisionand reliabilityPatient's skin (scalp)and chest | Patient's head(auditory stimulators), skin with electricalstimulator probes | Patient's skin (scalp) | The COGNISION™ EEG/ERPSystem and the otherpredicates all use electrodeswhich contact specific locationson the scalp for EEGrecording. The COGNISION™EEG/ERP System and theNicolet system also useearphones for auditory evokedpotentials testing. The X10 andNicolet also have functionalityfor recordingelectrophysiological data fromthe chest. |
|---|---|---|---|---|---|
| EP StimulusModality | Auditory | NA | Auditory | NA | Both the Nicolet EDX 2/Vikingand the COGNISION™EEG/ERPSYSTEM contain an auditoryevoked potential modality. TheX-10 Systemand EquinoxSystem s. do not have anauditory evoked potentialmodality |
| EP Paradigm(Auditory Stimulus) | P300 Oddball-Single Stimulus-Single Deviant-2 Deviant-Active and Passive | N/A | P300 Oddball-Single Stimulus-Single Deviant-2 Deviant-Active and Passive | N/A | Both the Nicolet EDX 2/Vikingand the COGNISION™EEG/ERPSYSTEM utilize the same EPParadigms. The X-10 andEquinox systems do not havethis functionality. |
| EP Task Response | User Buttons | N/A | User Buttons | N/A | Both the Nicolet EDX 2/Vikingsystem and theCOGNISION™EEG/ERP SYSTEMutilize user buttons to respondto the auditory evokedPotential. The X-10 andEquinox systems do not have |
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| is functionalit | |||||
|---|---|---|---|---|---|
| eneral Displa unctionality | Channel Selectio X/Y Windowing Color Selection Color Selection Grid Display | SelectioChannel Selection X/Y Windowing Color Sellection Grid Display | Channel Selecti X/Y Windowing Color Selection Grid Display | ||
| P Display unctionalit | average Waves Difference Waves timulus Onset Limulus Onset Lutton Press | N/A | N/A | ||
| in Couplir | ydroDot® Biosens | ElectrodCustom Elect Band and Ge | screte Electro | ydroDot® Bioser | |
| Wires | |||||
| rget Populati | Adults | Ages 6 and olde | Jnknow | Adults | |
| 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™EEG/EP System is acombination device forreduced montagerecording and display ofelectroencephalographic(EEG) and evokedpotentials (EP) test data.The system uses elasticbands to accuratelyposition 10 electrodepods around the head.EEG signal amplification,conditioning, and A/Dconversion is performedby electronic circuitsclosely coupled to theelectrode pods throughshort flexible printedwires. The headset isconnected by a cable toa handheld control unitand data acquisition box(HCU). A lithium-ionbattery in the HCU isused to power the | The X10 System iscomprised of aHeadset andaccessories, SynapseCrème, X-Series BasicSoftware and BTreceiving unit. Thesystem combineshardware, firmwareand software toacquire physiologicalsignals. It acquiresphysiological datathrough a batterypowered headsetworn by the patientand provides a flexibleplatform for applyingsensors using synapsecream and acquiringsignals from multiplelocations on the heador body, transmittingand recording thesignals and providingvisual indications to | The Nicolet EDX 2System consists of abase unit consolecontaining 2 electricalstimulators, and anauditory and visualstimulator. The baseunit also has twotrigger inputs and twotrigger outputs forconnections toexternal devices. Thebase unit has up to 12switchable outputsites, and isconnected through asingle USB (2.0)connection to thecomputer on thecontrol panel. Thecontrol panel housesthe computer andamplifiers for signalprocessing through a24-bit A/D converter.Digital Signal | The patient module is asmall battery poweredunit attached to thepatient. It transmitsEEG data from thepatient to the DSP cardvia fiber optic cablewhich also acts asisolation for the patientmodule. The data areconditioned anddigitized at the DSPCard and thentransmitted to a hostPC (Digital EEGmachine) | are both used in a Physicianoffice environment.It is unknown in whatenvironment the Equinoxsystem is utilized. The X-10system is utilized in the Home,Healthcare Facility and ClinicalResearch Environments andhave testing to support theseindications whereas theCOGNISION™ EEG/ERP Systemwas tested to support itsintended environment of use.The COGNISION™ EEG/EPSystem and its predicatedevices share a similarconfiguration including aheadset in either reduced orfull montage configurations,and a combination of softwareand hardware that inconjunction with electrodeseither cleared with the systemor independently appropriatelysense brain wave data andtransmit the raw data tohardware/softwaremechanisms that transmit anddisplay the electrical brainwave data. The COGNISION™EEG/EP System, Nicolet EDX2/Viking Software system, andAdvanced Brain Monitoring Inc.X-10 system have additionalaccessories to supportadditional modalitiescommensurate with theirindications for use. |
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| system. The HCUcommunicates via awireless data link to aWindows PC to streamEEG data.Software on the PC isused to setup the testsand view and evaluatethe resultant test datausing standard EEG/EPdisplay methods. | ensure high qualitydata are obtained. Thebasic softwareprovides a means to:a. Initiate astudy andtrack patientinformationb. Acquired andwirelesslytransmitsignals fromthe device.c. Visuallyinspect thesignal quality | Processing providesadvanced signalprocessing such asfiltering, soundoptimization. Thebase unit firmwareand DSP are run fromthis computer, wheredata can be acquiredand displayedsimultaneously | Sterile | Same |
|---|---|---|---|---|
| Single Use | Same | |||
| Shelf Life | Same | |||
| Power Source | The COGNISIONTM EEG/ERPSystem and the X-10 systemuse similar lithium ion batterieswhile the Nicolet EDX 2/VikingSoftware system and Equinoxsystem is powered via astandard wall plug. | |||
| RecordingChannels Locationand PositioningSystem | X-10 Systemuses a Li IonBatteries as does theCOGNISIONTM EEG/ERPSYSTEM. | |||
| Both the COGNISIONTMEEG/ERP System and the X-10System use the exact sameelectrode placementconfigurations of | ||||
| No | No | |||
| No | No | |||
| Durable good | Durable good | |||
| Li Ion Battery | Mains (100-240 VAC) | |||
| Fz,Cz,Pz,F3,P3,F4,P4Utilizing elastic bandsusing distance ratiosconsistent with the 10-20System | VariableDiscrete electrodewires | |||
| Fz,Cz, Pz,F3,P3,F4,P4Utilizing plastic bandsusing distance ratiosconsistent with the10-20 System | 10-20 SystemUtilizing elastic bandsusing distance ratiosconsistent with the 10-20 System |
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— Page 5-10 —
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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 | ||||
| 4. Unknown | 4. 24 | 5. <0.6 µV RMS | ||||
| 4. Same as X-10 System | 4. Unknown | 5. Unknown | ||||
| 5. The noise of the COGNISION™ EEG/ERP System is in between the noise range associated with the X-10 Systemand the Nicolet EDX 2 with Viking Software system | ||||||
| 6. The COGNISION™ EEG/ERP System is within the range of the Advanced Brain |
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| Pass Ban | 0.4-40H9 | 0.1-65Hﺔ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | 0.05 to 5KHర్ ర | Unknow6. | SMonitoring Inc. X-10 system and at 0.4Hz the device functionsntended | |
|---|---|---|---|---|---|---|
| > 90dB1 | 105 dBN | >110dB at 50/60 Hz下 | Unknow7. | N | he COGNISION™ EG/ERP System has ppropriately has ppropriately links MRR consisted by the has he predicates | |
| ರ್ 8 | me as the X-10 and colet EDX 2 with king Software syste | |||||
| Yes8. | resರ್ 8 | Yesಂ | Unknowiರ್ ರ | ்ல | ||
| ഗ് | > 60 MC | > 100 GΩ்ல | >1000 ΜΩ்ல | Unknow9. | ||
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10. Non-Clinical Performance Data
The COGNISION™ EEG/EP System is tested using an automated test set to perform all necessary electrical and audio tests.
The test set includes an electronic fixture, integrated biosignal generator, electronic sensors, and an oscilloscope output to produce all required inputs and measure all necessary electronic performance parameters.
The testing protocols are controlled with a LabView application running on a Windowsbased PC.
All testing parameters are automatically recorded in a validation report. The validation report lists the parameters tested and results. The tests which are performed are shown in the Table below. In addition a user can test system functionality by cycling through a self test (parameters for this listed below).
Neuronetrix Solutions utilized the following FDA Guidance documents in the preparation and testing of the COGNISION™ EEG/EP System:
- Electroencephalograph Devices Guidance for 510(k) Content Draft Document Version ● 1.0, November 3, 1997".
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices May 29, 1998
- Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators
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| Test | Test Description | Acceptance Criteria |
|---|---|---|
| Current Draw | Measures current draw for nominal values,tests for shorts and abnormal functionality | -420 to -525mA |
| Cal Tones | Determines internal continuity andfunctioning CAL Tones | Low Cal Frequency: 13.50 - 14.50 HzLow Cal Power: 31.5 - 33.5 dB μVHigh Cal Frequency: 27.00 - 28.00 HzHigh Cal Power: 31.5 - 33.5 dB μV |
| BaselineNoise | Measures internal "baseline" noise fromUberyoke and Electrode Strings by shortingamplifiers to ground | Noise VRMS: < 1 μV |
| Crosstalk | Measures channel to channel crosstalk byinjecting a large known signal into a channeland monitoring its effects on other channelsoutputs | Minimum Crosstalk >60 dB@ 10 Hz, 730 mv pk-pk input on drivenCH |
| CMMR | Inject a known signal into all electrodes thenevaluate the EEG signal to establish theCMRR | Min Attenuation : < 90 dBCMRR @ 60 HZ : <100 dBCMRR @ 50 HZ : < 100 dB |
| Gain Linearity | To validate gain and gain linearity byinjecting a spectrum of EEG voltages at agiven frequency and record the outputvoltage. Enter gain offset into COGNISION™ | Maximum deviation from linearity : $<$ 0.1 |
| FrequencyResponse | To validate gain across a spectrum offrequencies by injecting a spectrum of EEGfrequencies at a given voltage and recordingthe voltage attenuation | Max Deviation: < $0.2x+0.45$ dB @ 0.2-0.4 HzMax Deviation: < $0.45$ dB @ 0.3-32 HzMax Deviation: < $0.15x+0.45$ dB @ 33-50 HzGain @ 33 Hz: -3.418 < x < -2.218 dBGain @ 10 Hz: -0.38 < x < 0.52 dBGain @ 0.4 Hz: -3.90 < x < -2.70 dBGain Pass band Values:Variance 1-20 Hz : < 1 dB |
| CAL Toneloopback | Determines Uberyoke internal continuityand basic functionality using CAL Tones | CAL Tones power spectrum shouldcontain three peaks at 13.9, 28.8 and athird around 45 Hz.CAL Tones Time Domain should havetwo signals 180 degrees out of phasewith each other |
Self-Test
In the field, the user can perform a self-test by pressing the key combination O-*. This will cycle the system through the following tests to ensure that the system is operating properly (see HCU SELF TEST LOGIC SCHEMA, IN-1706, for detailed description of the self-test)
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| Test | Test Description | Acceptance Criteria |
|---|---|---|
| Keypad Test | To ensure all buttons on the keypad work | PASS/FAIL |
| Button Test | To validate user button functionality. | PASS/FAIL |
| LED Test | To ensure the LEDX visibly turn on and off. | PASS/FAIL |
| Power on | To ensure that the unit will power ON. | PASS/FAIL |
| Power off | To ensure that the unit will power OFF. | PASS/FAIL |
| HCU USB Charge | To ensure the HCU can charge via USB | State is 20-90%: Current 350-460mA |
| Buzzer Test | To ensure that the buzzer is workingproperly | PASS/FAIL |
| Bluetooth Test | To ensure that Bluetooth is workingproperly | PASS/FAIL |
| Data Flash Test | To ensure that data is written to Flashproperly | PASS/FAIL |
| Audio DAC Test | To ensure that the Audio DAC is workingproperly | PASS/FAIL |
| Audio Flash Test | To ensure that data is written to AudioFlash properly | PASS/FAIL |
Conclusions: The COGNISION™ EEG/EP System passed the testing according to the established specifications and the COGNISION™ EEG/EP System is consistent with that of the predicate devices in terms of EEG/EP recording performance. The
As part of demonstrating safety and effectiveness of COGNISION™ EEG/ERP System and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, NeuroNetrix Solutions completed a number of tests. The COGNISION™ EEG/ERP System meets all the requirements for overall design, biocompatibility, and electrical safety confirms that the design output meets the design inputs and specifications. The COGNISION™ EEG/ERP System passed all testing stated above as shown by the acceptable results obtained.
The COGNISION™ EEG/ERP 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.
11. Clinical Performance Data
The COGNISION™ System was validated in actual use conditions on initial production units or their equivalents. Patients with a neurological condition were observed in an environment consistent with the intended use and the design validation met all acceptance criteria.
12. Statement of Substantial Equivalence
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By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the difference between the COGNISION™ EEG/EP System and the predicate devices do not raise any questions regarding its safety and effectiveness. The COGNISION™ EEG/EP System, as designed and manufactured, is det ermined to be substantially equivalent to the referenced predicate devices.
§ 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).