(169 days)
The NeuralScan 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 NeuralScan System is comprised of the NeuralScan Amplifier with embedded firmware for acquisition and transmission of physiological signals, an EEG cap, a Subject Response Device, a laptop computer preloaded with the NeuralScan Evoke software, and a charging kit (that consists of a USB cable, clip kit, and wall adapter).
The NeuralScan Evoke software runs in a Windows Operating System environment and controls the 23 channel (21 EEG and 2 bio channels) NeuralScan EEG amplifier via a USB cable or Wi-Fi connection. The software has a graphical user interface that allows the user to input patient information, create new records, conduct studies to collect EEG and ERP data, view live data streams of the laptop display, record data to a file, analyze resultant test data using standard Frequency EEG analysis and EP display methods and print the results. The software includes a mode to measure the cap electrode impedances which is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. Interpretation of the data is the responsibility of the physician as the software does not provide any diagnosis based on the data.
The patient contacting accessories are commercially sourced and used without modification. The device and the accessories are not sterile and are not intended to be sterilized.
The provided text describes the regulatory clearance for the "NeuralScan System" and includes a summary of non-clinical testing performed to demonstrate its substantial equivalence to predicate devices. However, it explicitly states: "No Clinical testing was necessary to determine substantial equivalence."
Therefore, based on the provided document, the device did not undergo a clinical study involving human subjects to prove its performance against acceptance criteria for diagnostic accuracy or clinical effectiveness. The acceptance criteria and performance data are entirely based on bench testing (non-clinical data) for the device's functional integrity as an electroencephalograph (EEG) and Event-related Potentials (ERP) system.
Given this, I can only provide information derived from the non-clinical testing detailed in the document.
Acceptance Criteria and Reported Device Performance (Non-Clinical Study)
The acceptance criteria and performance measurements for the NeuralScan System are based on bench testing to confirm compliance with recognized medical device standards (primarily IEC 60601-2-26 for electroencephalographs). These tests evaluate the hardware and software's ability to accurately acquire, reproduce, and transmit physiological signals.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Test | Acceptance Criteria (from IEC 60601-2-26) | Reported Device Performance | Result |
|---|---|---|---|
| Accuracy of signal reproduction | Error < 20% (for 2Hz Triangle wave, 50μV to 500μV) | Accurately reproduces EEG signals | Pass |
| Input dynamic range and differential offset voltage | Amplitude error < 10% (for 1mV 6Hz Triangle wave with offset) | 300mV Offset: 1.5% error; 187mV Offset: 1.5% error | Pass |
| Input Noise | Max 6µV peak-to-valley | Maximum noise: 3.4 µV | Pass |
| Frequency Response | Output amplitude > 71%, < 110% (for 0.5 Hz, 5 Hz, 50 Hz) | 0.5 Hz: 100%; 5 Hz: 105%; 50 Hz: 76% | Pass |
| Common mode rejection | Output amplitude < 10mm (= 100µVpp) (for 1Vrms at 60Hz) | With 0 DC Offset: 67.3µVpp; With 187mV dc Offset: 68µVpp | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of clinical patient data. The "test set" here refers to the specific configurations and conditions used for the bench tests. For each test, specific signal parameters and conditions were applied.
- Data Provenance: Not applicable as no clinical patient data was used. The data is generated from controlled laboratory bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for these tests are the precise, known input signals generated by test equipment, and validation against the specified international standards (IEC 60601-2-26). No human experts were involved in establishing the ground truth for these non-clinical tests in the way they would be for diagnostic accuracy studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for clinical studies where human interpretation of medical images or data is being evaluated. For bench testing, the results are objectively measured against established engineering and performance specifications.
5. 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:
- No MRMC clinical study was performed. The document explicitly states, "No Clinical testing was necessary to determine substantial equivalence." This device is intended for the acquisition, display, and storage of EEG/ERP data to aid in diagnosis, with interpretation being the responsibility of a physician. It does not appear to incorporate an AI component for automated diagnostic interpretation or decision support that would necessitate an MRMC study to show AI assistance to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone clinical performance testing was performed. The device's performance was evaluated through non-clinical bench testing for its technical specifications and compliance with safety and performance standards relevant to EEG/ERP systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the non-clinical tests was established by defined input signals and test methods outlined in international standards (IEC 60601-2-26). It is an objective, quantitative ground truth based on engineering principles, rather than clinical consensus or pathological findings.
8. The sample size for the training set:
- Not applicable. The document does not describe the use of machine learning or AI that would require a "training set" in the conventional sense for diagnostic algorithm development. The hardware and software verification and validation were performed on the device itself.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medeia, Inc. % Daniel Lehtonen Regulatory Consultant Compliance and Regulatory Services LLC 3771 Southbrook Dr Dayton, Ohio 45430
Re: K192753
Trade/Device Name: NeuralScan System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, GWJ, GWQ Dated: February 19, 2020 Received: February 20, 2020
Dear Daniel Lehtonen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions 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
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801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192753
Device Name
NeuralScan System
Indications for Use (Describe)
The NeuralScan 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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Image /page/3/Picture/0 description: The image shows the logo for Medeia. The word "Medeia" is written in a combination of colors, with the "M" in green and yellow, the "ede" in black, and the "ia" in blue. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller font size.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the Requirements of Safe Medical Device Systems Act 1990 and 21 CFR Sec. 807.92
510(k) Number:
a1 APPLICANT INFORMATION:
| Date Prepared: | 26 September 2019 |
|---|---|
| Name: | Medeia, Inc. |
| Address: | 7 W. Figueroa StreetSuite 300Santa Barbara, CA, 93101 |
| Contact Person: | Slav Danev |
|---|---|
| Phone Number: | +1 800 433 4609 |
| Fax Number: | +1 800 433 4609 |
| Email: | danev@medeia.com |
a2 NAME OF DEVICE:
| Trade Name: | NeuralScan System |
|---|---|
| Common Name: | EEG/EP System, EEG Amplifier |
| Classification Name: | Non-normalizing quantitative electroencephalograph software21 CFR 882.1400 (OLT);Full-montage standard electroencephalograph21 CFR 882.1400 (GWQ);Stimulator, auditory, evoked response21 CFR 882.1900 (GWJ) |
| Classification Panel: | Neurology |
аЗ PREDICATE DEVICES:
| Predicate Device: | K171781; eVox System |
|---|---|
| Predicate Device: | K141316; CognisionTM |
The FDA database for recalls was searched on 15 Aug 2019 during the preparation of the 510(k) submission and no recalls for the devices noted above were found.
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a4 STATEMENT OF INTENDED USE:
The NeuralScan System is intended for the acquisition, display, analysis, 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.
a5 DESCRIPTION OF THE DEVICE:
The NeuralScan System is comprised of the NeuralScan Amplifier with embedded firmware for acquisition and transmission of physiological signals, an EEG cap, a Subject Response Device, a laptop computer preloaded with the NeuralScan Evoke software, and a charging kit (that consists of a USB cable, clip kit, and wall adapter).
The NeuralScan Evoke software runs in a Windows Operating System environment and controls the 23 channel (21 EEG and 2 bio channels) NeuralScan EEG amplifier via a USB cable or Wi-Fi connection. The software has a graphical user interface that allows the user to input patient information, create new records, conduct studies to collect EEG and ERP data, view live data streams of the laptop display, record data to a file, analyze resultant test data using standard Frequency EEG analysis and EP display methods and print the results. The software includes a mode to measure the cap electrode impedances which is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. Interpretation of the data is the responsibility of the physician as the software does not provide any diagnosis based on the data.
The patient contacting accessories are commercially sourced and used without modification. The device and the accessories are not sterile and are not intended to be sterilized.
The NeuralScan System is intended for prescription use in any healthcare, medical, athletic or sports clinic, or outside of medical facilities provided they are led by qualified medical personnel.
The device is intended for use by qualified medical personnel only and qualifies for exemption per 21 CFR 801 Subpart D Prescription devices.
TECHNOLOGICAL CHARACTERISTIC COMPARISON: аб
NeuralScan product share similar device characteristics, intended use, performance, specifications, sensors and is the same in design, function, and application to the predicate devices.
The comparison table, beginning on page 5, demonstrates that the NeuralScan device is substantially equivalent to the predicate devices. The nonclinical data support the safety of the device and the hardware and software verification and validation demonstrate that the NeuralScan device should perform as intended in the specified use conditions.
Based on comparisons of device technological characteristics, features, materials, intended use and performance the NeuralScan has been shown to be substantially equivalent to the commercially available predicate devices.
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b1 NON-CLINICAL TESTING:
Bench testing was carried out on the following characteristics:
- . Electroencephalograph (EEG)
- Measurement accuracy
- Communication, data transmission and storage
- Reliability (QoS) Wireless Quality of Service
- Electromagnetic compatibility (EMC)
- Electrical safety testing
- . Wireless Coexistence Wi-Fi testing
- . Software verification and validation testing
- Biocompatibility verification
In addition to the above, usability testing was also conducted.
Referenced Standards and Performance Testing:
The NeuralScan device was tested and meets the requirements of following
- IEC 60601-1- Medical Electrical Equipment Part 1: Basic safety and essential performance ● Ed3.1 2005+A1:2012
- IEC 60601-1-2:2014 - Medical electrical equipment-basic safety and essential performance-EMC
- . IEC 60601-2-26:2012 Medical electrical equipment - Part 2-26: Basic safety and essential performance of electroencephalographs
- ISO 15223-1:2012 Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements
| Test | Test Method Summary | Results / P or F(per IEC 60601-2-26performance limits) |
|---|---|---|
| Accuracy of signalreproductionPurpose: verify signal isaccurately reproduced overa range of amplitudes. | Test circuit and method per IEC 60601-2-26clause 201.12.1.101.1. Amplitude of 2HzTriangle wave varied from 50μV to 500μV.IEC 60601-2-26 Pass-Fail Limit: error < 20% | PassTest shows thatNeuroScan systemaccurately reproduces EEGsignals over the specifiedrange |
| Input dynamic range anddifferential offset voltagePurpose: verify signalaccuracy in presence of dcoffset voltages. | Test circuit and method per IEC 60601-2-26clause 201.12.1.101.2. 1mV 6HzTriangle wave with 300mV offset added.IEC 60601-2-26 Pass-Fail Limit: amplitudeerror < 10% | 300mV Offset:1.5% error: Pass187mV Offset:1.5% error: Pass |
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| Test | Test Method Summary | Results / P or F(per IEC 60601-2-26performance limits) |
|---|---|---|
| Input NoisePurpose: verify that thesignal noise caused byamplifier does not exceedmax 6µV peak-to-valley | Test circuit and method per IEC 60601-2-26clause 201.12.1.101.3. Inputs shortedtogether.IEC 60601-2-26 Pass-Fail Limit: max 6µVpeak-to-valley | Maximum noise: 3.4 µV:Pass |
| Frequency ResponsePurpose: verify signal isaccurately reproduced overa range of frequencies | Test circuit and method per IEC 60601-2-26clause 201.12.1.101.4. Triangle waveAmplitude established at 5Hz, is thenadjusted to 0.5 Hz and 50Hz.IEC 60601-2-26 Pass-Fail Limit: outputamplitude > 71%, < 110% | 0.5 Hz: 100%: Pass5 Hz: 105%: Pass50 Hz: 76%: Pass |
| Common mode rejectionPurpose: verify amplifierrejects common mode noise | Test circuit and method per IEC 60601-2-26clause 201.12.1.101.5. Apply 1Vrms at 60Hzto all inputs tied together.IEC 60601-2-26 Pass-Fail Limit: outputamplitude < 10mm (= 100µVpp) | With 0 DC Offset:67.3µVpp: PassWith 187mV dc Offset:68µVpp: Pass |
Software Verification and Validation Testing
Software verification and validation testing were conducted following the FDA guidance document for software contained in medical devices. The software was considered to be a "moderate" level of concern since a failure or latent flaw could indirectly result in a minor injury to the patient through incorrect or delayed information or through action of the operator.
b2 CLINICAL TESTING:
No Clinical testing was necessary to determine substantial equivalence.
CONCLUSIONS DRAWN FROM TESTING: b3
Based on information obtained on the predicate device with reference to the design specification, electrical safety / EMC testing and intended use, the NeuralScan device was subjected to the same type of testing. The results support the conclusion that the NeuralScan device is substantially equivalent to the Predicate devices.
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Substantial Equivalence Comparison Table
| Trade Name | NeuralScan System | eVox System | Cognision™ | Comments | |
|---|---|---|---|---|---|
| 510 (k) Number | K171781 | K141316 | |||
| Product codes | OLT, GWQ, GWJ | GWQ, GWJ | OLT, GWJ, OMC | ||
| Indications for Use | The NeuralScan System isintended for the acquisition,display, analysis, and storage, ofelectrical activity of a patient'sbrain includingelectroencephalograph (EEG)and Event-related Potentials(ERP), obtained by placing twoor more electrodes on the headto aid in diagnosis. | The eVox System is intended forthe acquisition, display, andstorage, of electrical activity of apatient's brain includingelectroencephalograph (EEG)and Event-related Potentials(ERP) obtained by placing two ormore electrodes on the head toaid in diagnosis. | The COGNISION system is foruse by qualified clinicalprofessional in private practiceoffices or small clinical settingsfor the acquisition, display,analysis, storage, reporting andmanagement ofelectroencephalograph (EEG)and auditory evoked potentials(AEP) information. | Product contains multiple productcodes which are generally requiredfor a complete system.The NeuralScan System and theeVox device share the productcodes:GWQ: Full Montage SystemGWJ: Evoked response auditorystimulatorThe NeuralScan System, theCOGNISION system share theproduct code:OLT: Non-normalizing quantitativeelectroencephalograph software andGWJ: Evoked response auditorystimulator | |
| Trade Name | NeuralScan System | eVox System | Cognision™ | Comments | |
| Principle ofOperation | The NeuralScan System deviceis used for acquisition ofphysiological signals using twoor more channels ofElectroencephalography (EEG)from the scalp. It consists of aNeuralScan amplifier, a laptopcomputer (base station), apatient EEG cap, subjectresponse button, ear buds, and acharging cord. The NeuralScanamplifier and software provide ameans to:- Initiate a study, track user EEGand ERP data and enter text orquestionnaire informationacquire and save signals to thememory of the device,transmit signal data from thedevice,visually inspect the acquiredsignal.- manage event- relatedPotentials | The eVox System device is usedfor acquisition of physiologicalsignals using two or morechannels ofelectroencephalography (EEG)from the scalp. It consists of aneVox amplifier, a laptopcomputer (base station), apatient EEG cap, subjectresponse button, ear buds, and acharging cord. The eVoxamplifier and software provide ameans to:- initiate a study, track user EEGand ERP data and enter text orquestionnaire information,acquire and save signals to thememory of the device,transmit signal data from thedevice,visually inspect the acquiredsignal.- manage event- relatedPotentials | The COGNISION EEG/EPSystem is a combination devicefor reduced montage recordingand display ofelectroencephalographic (EEG)and evoked potentials (EP) testdata.The system uses elastic bandsto accurately position 10electrode pods around the head.EEG signal amplification,conditioning, and A/D conversionis performed by electroniccircuits closely coupled to theelectrode pods through shortflexible printed wires.The headset is connected by acable to a handheld control unitand data acquisition box (HCU).The HCU communicates via awireless data link to a WindowsPC to stream EEG data.Software on the PC is used tosetup the tests and view andevaluate the resultant test datausing standard EEG/EP displaymethods. | The NeuralScan System has aprinciple of operation that closelymatches that of its predicates. Alldevices use skin coupling methods,either through electrodes or sensorswhich transmits patient EEG andERP from the surface of the scalp toan amplifier.The connection between the amplifierand electrodes is a wired connectionfor the devices.All devices convert the analog datainto digital data which is thentransmitted to a base station orcomputer.Once transmitted to the base station,the devices display and store thedata on the base station and allowthe user to export the data to a file. | |
| Patient population | All age groups | All age groups | Adult Population | ||
| Use environment | Intended for use in anyhealthcare facility, medicalfacility, athletic or sports clinics,or outside of medical facilitiesprovided they are led by qualifiedmedical personnel. | Intended for use in anyhealthcare, medical, or athleticor sports clinics, or outside ofmedical facilities such as in thesports arena under thesupervision of a physician.Also, investigations can beperformed outside of healthcarefacilities, as long as they are ledby qualified medical personnel. | Physicians' Offices | ||
| FDA Device Class | Class II | Class II | Class II | ||
| Trade Name | NeuralScan System | eVox System | Cognision™ | Comments | |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 | ||
| SystemComponents | NeuralScan System consists of:- a NeuralScan amplifier,- a laptop computer (basestation),- a patient EEG cap,- subject response button, earbuds,- and a charging cord. | eVox System consists of:- an eVox amplifier,- a laptop computer (basestation),- a patient EEG cap,- subject response button, earbuds,- and a charging cord. | COGNISIONTM consists of:- Head Set- Auditory stimulator- Handheld Control Unit(HCU) including InterfaceSoftware- Connecting Headset cablebetween the headset andthe handheld control unit | ||
| Sterile | No | No | No | ||
| Single Use | No | No | No | ||
| Shelf life | Durable good | Durable good | Durable good | ||
| Interface withAmplifier | USB or WiFi to PC | Class 2 Bluetooth version 2.0 toPC | Bluetooth 2.0/4.0 | ||
| Power Supply | Li-Ion Battery, with USB cablefor charging the battery. | Li-Ion Battery, with USB cablefor charging the battery. | Li-Ion Battery | ||
| Typical BiopotentialSignals Recorded | Electroencephalography (EEG),EP/ERP | Electroencephalography (EEG),EP/ERP | Electroencephalography (EEG),EP/ERP | ||
| Electroencephalography (EEG), ERP | |||||
| ERP StimulusModality | Auditory; Visual | Auditory; Visual | Auditory | ||
| ERP Paradigm(Auditory andVisual Stimuli) | P300 Oddball- Single Stimulus- Single Deviant- 2 Deviant- Active and Passive | P300 Oddball- Single Stimulus- Single Deviant- 2 Deviant- Active and Passive | P300 Oddball- Single Stimulus- Single Deviant- 2 Deviant- Active and Passive | ||
| ERP TaskResponse | User Buttons | User Buttons | User Buttons | ||
| Skin Coupling | Custom Electrode Band and Gel | Custom Electrode Band and Gel | Discrete Electrode Wires | The NeuralScan, and eVox use thesame method of utilizing a conductivegel between electrode and the skin.The COGNISION system usesHydroDot Biosensor | |
| Trade Name | NeuralScan System | eVox System | Cognision™ | Comments | |
| Number of SignalRecordingChannels | Up to 23 | Up to 21 | Up to 10 | Both the NeuralScan and Evoxsystems have 2 bio-channels | |
| EEG inputterminals | up to 21 channels | up to 19 channels | Up to 7 channels | Full montage for 10-20 system has21 channels | |
| EEG RecordingChannels Locationand PositioningSystems | Any of the 21 EEG Channelsincluding: Fz, Cz, Pz, F3, P3, F4,P4 Utilizing elastic bands usingdistance ratios consistent withthe 10-20 System | Any of the 19 EEG Channelsincluding: Fz, Cz, Pz, F3, P3, F4,P4 Utilizing elastic bands usingdistance ratios consistent withthe 10-20 System | Fz, Cz, Pz, F3, P3, F4, P4Utilizing elastic bands usingdistance ratios consistent withthe 10-20 System | Same - full and reduced montagerecording capabilities | |
| Impedance Test | Yes | Yes | Yes | ||
| Amplifier InputImpedance | > 200 ΜΩ | > 10 ΜΩ | > 60 ΜΩ | Performance testing per IEC 60601-2-26:2012 confirmed 10 ΜΩ issufficient to eliminate distortion in themeasured signal. | |
| Analog to DigitalConversion | 24 Bit | 24 Bit | 16 Bit | ||
| Sampling Rate | 200, 500, 1000 Hz | 250 Hz | 125/250 Hz | Clinically relevant humanelectrophysiology does not exceed100 Hz and therefore there is notechnical need to sample above 250Hz. | |
| Common moderejection | >110 dB | >110 dB | >90dB | ||
| Analysis Software | Embedded, commerciallyavailable, and user defined. | Embedded, commerciallyavailable, and user defined. | Embedded, commerciallyavailable, and user defined. | ||
| Resolution | 24 bits | 24 bits | 16 bits | ||
| Band Pass | 0.1 to 50 Hz | 0.1 to 50 Hz | 0.4 to 40 Hz | ||
| Noise | 2-3 μVp-p | 2-3 μVp-p | ≤1μV RMS | ||
| Audio Type | Burst (White Noise) | Burst (White Noise) | Unknown | The NeuroScan system uses a bursttype noise stimulus to evoke andERP | |
| Audio Duration | 100ms | 100ms | 50ms | ||
| Audio Side | Both | Both | Unknown | ||
| Trade Name | NeuralScan System | eVox System | Cognision™ | Comments | |
| Audio FrequencyRange | 440Hz-16kHz | 440 Hz-16kHz | Unknown | The NeuralScan system generates asound with a frequency range of440Hz-16kHz which is a sufficientlywide enough band for humanhearing. | |
| Intensity | 0 to 85dB | 0 to 85dB | Unknown | The sound emitted by theNeuralScan system is a flat whitenoise burst, therefore the peak andaverage are the same. Maximumdecibel level is 85dB, well below125dB (no risk to user). | |
| Audio NoisePatterns | 12.5% occurrence randomlydistributed over 10 minutes | 12.5% occurrence randomlydistributed over 10 minutes | 10% occurrence within 10-60minutes | The balance of this pattern is best toelicit the desired ERPs. | |
| Input VoltageRange | ± 400 mV | ± 150 mV | Not Stated | Due to the 24x gain that is applied tothe A/D channels by the NeuralScanthe dynamic range is ± 400 mV forthe NeuralScan System which issufficient for its use environment. | |
| General Specifications | |||||
| Safety StandardsCompliance | IEC 60601-1: 2005 +CORR. 1:2006 + CORR.2:2007 + AM1:2012 (or IEC60601-1: 2012 reprint)EN 60601-1-2:2014IEC 60601-2-26:2012 | IEC 60601-1: 2005 +CORR. 1:2006 + CORR.2:2007 + AM1:2012 (or IEC60601-1: 2012 reprint)EN 60601-1-2:2012IEC 60601-2-26:2012 | UL 60601-1:2003EN60601-1-2/A1:2007EN60601-1-2/A1:2007EN 60601-2-26IEC 60601-2-40 | ||
| OperatingEnvironment | 10 to +45 °C, Relative humidity,30% to 70% non- condensing | 0 to +45 °C, Relative humidity,5% to 95% non- condensing | 60-90 °F | ||
| StorageEnvironment | -40° to 70° C, Relative humidity,5% to 95% non- condensing | -20° to 45° C, Relative humidity,5% to 95% non- condensing | Not Published |
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| Conclusion | The comparison tabulated above demonstrates that the NeuralScan device issubstantially equivalent to the predicate devices. The nonclinical data support thesafety of the device and the hardware and software verification and validationdemonstrate that the NeuralScan device should perform as intended in thespecified use conditions. |
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| Declarations | • This summary includes only information that is also covered in the body of the510(k).• This summary does not contain any puffery or unsubstantiated labeling claims.• This summary does not contain any raw data, i.e., contains only summarydata.• This summary does not contain any trade secret or confidential commercialinformation.• This summary does not contain any patient identification information. |
§ 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).