(46 days)
Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information. The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. · The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. · The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. · aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Entropy trending functionalities included in NeuroWorks are intended to assist the user while monitoring the state of the brain. The automated event marking function of Neuroworks is not applicable to these analysis features. · Neuro Works also includes the display of a quantitative EEG plot, Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to DSA. · This device does not provide any diagnostic conclusion about the patient's condition to the user.
Natus NeuroWorks is electroencephalography (EEG) software that displays physiological signals. The software platform is designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessories let you customize your system to meet your specific clinical EEG monitoring needs.
The provided document describes the Natus NeuroWorks software, an EEG software with functionalities including seizure and spike detection, and various trending capabilities.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance with specific metrics (e.g., sensitivity, specificity, accuracy thresholds for seizure/spike detection). Instead, the demonstration of equivalence for the new trend features relies on qualitative comparison to a predicate device.
The "Comments" column in Table 1: Substantial Equivalence, Trends and other features implicitly states the performance goal for the newly added or enhanced features: to be "Equivalent" or "Same" as the specified predicate device. For example, for Burst Suppression, Envelope Trend, Spectral Entropy, Spectral Edge, Alpha Variability, and R-R interval trend, the comment is "Equivalent: Feature added to Natus NeuroWorks Subject device. With this implementation the Natus NeuroWorks Subject device is now equivalent to NicoletOne and Moberg Predicate devices."
For the DSA / Spectrogram feature, the comment indicates that the feature was already available but improved in terms of common naming, additional color scales for better contrast, and improved spectral resolution (64Hz vs 30Hz), making it "equivalent to NicoletOne predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a separate "test set" for performance evaluation of the trend features as typically understood in a clinical study context. Instead, for the newly added or improved trend features (Burst Suppression, Envelope, Spectral Entropy, Spectral Edge, Alpha Variability, DSA), the performance evaluation involved showing that the "resulting graphs are identical" when using the same study data as examples from the NicoletOne predicate device.
The document does not provide information on the country of origin of this "same study data" or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not specify the number or qualifications of experts used to establish ground truth for the trend feature comparison. The comparison relies on visual identity of trend plots against a predicate device.
For the Seizure Detection and Spike Detection components, the indications for use state they are "intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures/spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces." This implies that the 'ground truth' for these features is ultimately the interpretation by "qualified clinical practitioners," but the document doesn't detail how this was established for the performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any formal adjudication method for the performance evaluation of the trend features. The comparison relies on direct graphical comparisons.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The document states: "There were no clinical studies performed for this submission."
The device functions as "computer-assisted tools" for marking electrographic events to "assist qualified clinical practitioners." However, no study measuring improvement in human reader performance with this assistance is presented.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
While the document doesn't explicitly refer to "standalone performance" metrics for seizure and spike detection (e.g., sensitivity, specificity of the algorithm alone), the performance testing for the trend features was essentially a standalone comparison: the algorithm's output (trend graph) was compared to the predicate's algorithm output using the same input data. The "identical" nature of the graphs suggests successful replication of the predicate's standalone trending functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the trend features (Burst Suppression, Envelope, Spectral Entropy, Spectral Edge, Alpha Variability, DSA), the "ground truth" implicitly used for comparison was the output of the predicate device's algorithms on the same raw EEG data. The goal was to demonstrate that the Natus NeuroWorks algorithms produced graphically identical or equivalent trends.
For the Seizure Detection and Spike Detection, the ground truth is ultimately "electrographic seizures/spikes" as interpreted by "qualified clinical practitioners," but the method of establishing this ground truth for validation is not detailed.
8. The sample size for the training set
The document does not provide information on the sample size for the training set for any of the algorithms. It states that the software was "designed and developed according to a robust software development process" and "rigorously verified and validated," but omits details about machine learning model training.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for the training set was established. Given the lack of details on training data and methods, this information is not available in the provided text.
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May 18, 2020
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta Director, Global Regulatory Affairs 2568 Bristol Circle Oakville, Ontario L6H 5S1 Canada
Re: K200878
Trade/Device Name: Natus NeuroWorks Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OMA, OLT Dated: April 1, 2020 Received: April 2, 2020
Dear Sanjay Mehta:
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 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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,
for 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Natus NeuroWorks
Indications for Use (Describe)
Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information. The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. · The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
· The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
· aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Entropy trending functionalities included in NeuroWorks are intended to assist the user while monitoring the state of the brain. The automated event marking function of Neuroworks is not applicable to these analysis features.
· Neuro Works also includes the display of a quantitative EEG plot, Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to DSA.
· This device does not provide any diagnostic conclusion about the patient's condition to the user.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| Submission Date: | 25 April 2020 |
|---|---|
| Submitter: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1Canada |
| Submitter andApplicationCorrespondent | Mr. Sanjay Mehta |
| Phone: +1 (905) 287-5055 | |
| Fax: +1 (905) 829-5304 | |
| Email: sanjay.mehta@natus.com | |
| Manufacturing Site: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1Canada |
| Trade Name: | Natus NeuroWorks |
| Common andClassificationName: | Electroencephalograph |
| ClassificationRegulation: | 21 CFR §882.1400 |
| Product Code: | OMB (primary), OMA, OLT |
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| SubstantiallyEquivalent Devices: | New Model | Predicate 510(k)Number | PredicateManufacturer / Model |
|---|---|---|---|
| Natus Neuro Works | K180421 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1 Canada | |
| NicoletOne | K173366 | Natus Nurology Inc. | |
| Moberg CNS | K080217 | Moberg. | |
| Device Description: | Natus NeuroWorks is electroencephalography (EEG) software that displays physiological signals. The software platformis designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessorieslet you customize your system to meet your specific clinical EEG monitoring needs. | ||
| Intended Use: | Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is aqualified medical practitioner trained in Electroencephalography who will exercise professional judgment inusing the information. | ||
| The Natus NeuroWorks EEG software allows acquisition, display, archive, review and analysis ofphysiological signals. | |||
| • The Seizure Detection component of Natus NeuroWorks is intended to mark previously acquired sections ofthe adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, inorder to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should beobtained with full scalp montage according to the standard 10/20 system. | |||
| • The Spike Detection component of Natus NeuroWorks is intended to mark previously acquired sections ofthe adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, inorder to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should beobtained with full scalp montage according to the standard 10/20 system. | |||
| • aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Edge and Spectral Entropy trendingfunctionalities included in Natus NeuroWorks are intended to assist the user while monitoring the state of thebrain. The automated event marking function of Natus NeuroWorks is not applicable to these analysis |
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features.
· Natus NeuroWorks also includes the display of a quantitative EEG plot. Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of Natus NeuroWorks is not applicable to DSA.
· This device does not provide any diagnostic conclusion about the patient's condition to the user.
Comparison to Predicate Devices:
The Natus NeuroWorks software application is being compared to the software applications in the predicates NeuroWorks software (K180421) Nicoletone (K173366) and Moberg CNS (K080217). These software applications acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respirations) for Electroencephia and or Polysomnographic recordings. These devices also allow onscreen review, user-controlled annotation and user-controlled marking of data and generating summary reports.
| Table 1: Substantial Equivalence, Trends and other features | ||||||
|---|---|---|---|---|---|---|
| Predicate | Predicate | Primary Predicate | Subject Device | |||
| Feature | NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | |
| Device Class | Class II | Class II | Class II | Class II | Identical | |
| Class Name | EEG | EEG | EEG | EEG | Identical | |
| ClassifyingRegulation(Primary) | 882.1400 | 882.1400 | 882.1400 | 882.1400 | Identical | |
| Intended User | MedicalProfessional | Medical Professional | Medical Professional | Medical Professional | Identical | |
| Table 1: Substantial Equivalence, Trends and other features | ||||||
| Predicate | Predicate | Primary Predicate | Subject Device | |||
| Feature | NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | |
| Indications forUse | The NicoletOneEEG/PSGsoftware performsrecording,displaying,analysis, printingand storage ofphysiologicalsignals to assist inthe diagnosis ofvariousneurologicaldisorders, sleepdisorders andsleep relatedrespiratorydisorders. It isintended tomonitor the stateof the brain byrecording anddisplaying EEGsignals and canreceive anddisplay a varietyof third partysignals such asECG, EMG,Oxygen Saturationor Respiration forpatients of allages.NicoletOnesoftware allows: | The ComponentNeuromonitoringSystem is intended tomonitor the state ofthe brain by recordingand displaying EEGsignals, and can alsoreceive and display avariety of vital signsand othermeasurements fromthird-party monitoringdevices (such as ICP,ECG, SpO2, andothers). It also hasthe optional capabilityto record and displaypatient video.The ComponentNeuromonitoringSystem is intended foruse by a physician orother qualifiedmedical personnel. Itis intended for use onpatients of all ageswithin a hospital ormedical environment,including theoperating room,intensive care unit,emergency room, and | The NatusNeuroWorks is EEGsoftware that displaysphysiological signals.The intended User ofthis product is aqualified medicalpractitioner trained inElectroencephalography. This device isintended to be used byqualified medicalpractitioners who willexercise professionaljudgment in using theinformation.The NatusNeuroWorks EEGsoftware allowsacquisition, display,archive, review andanalysis ofphysiological signals.The SeizureDetection componentof NatusNeuroWorks isintended to markpreviously acquiredsections of the adult(greater than or equalto 18 years) EEGrecordings that maycorrespond toelectrographic | The Natus NeuroWorks isEEG software that displaysphysiological signals. Theintended User of thisproduct is a qualifiedmedical practitioner trainedin Electroencephalography.This device is intended tobe used by qualifiedmedical practitioners whowill exercise professionaljudgment in using theinformation.The Natus NeuroWorksEEG software allowsacquisition, display,archive, review andanalysis of physiologicalsignals.The Seizure Detectioncomponent of NatusNeuroWorks is intendedto mark previouslyacquired sections of theadult (greater than orequal to 18 years) EEGrecordings that maycorrespond toelectrographic seizures,in order to assist qualifiedclinical practitioners inthe assessment of EEGtraces. EEG recordingsshould be obtained withfull scalp montage | Equivalent, for the following reasons:- Natus NeuroWorks 9.2 intended use is thesame as Primary predicate and"NicoleOne" predicate devices.- Nicolet One and Moberg CNS and NatusNeuroWorks all permit the recording ofEEG data from corresponding EEGamplifiers.Nicolet One and Moberg CNS and NatusNeuroWorks all permit the receipt of datafrom various third party physiologicalmonitoring devices utilizing the samehardware ports these devices provide tooutput data to external recording systemssuch as Nicolet One, Moberg EEG, andNatus NeuroWorks software. | |
| Table 1: Substantial Equivalence, Trends and other features | ||||||
| Predicate | Predicate | Primary Predicate | Subject Device | |||
| Feature | NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | |
| - Automatedanalysis ofphysiologicalsignals that isintended for useonly in adults.- An optionalAudio/visual alertfor user definedthreshold oncalibrated DCinput. Thesealerts are notintended for useas life supportsuch as vital signsmonitoring orcontinuousmedicalsurveillance inintensive careunits.- Sleep reporttemplates areprovided whichsummarizerecorded andscored sleep datausing simplemeasuresincluding count,average,maximum andminimum values | clinical researchsettings. | - seizures, in order toassist qualifiedclinical practitionersin the assessment ofEEG traces. EEGrecordings should beobtained with fullscalp montageaccording to thestandard 10/20system.- The Spike Detectioncomponent of NatusNeuroWorks isintended to markpreviously acquiredsections of the adult(greater than or equalto 18 years) EEGrecordings that maycorrespond toelectrographic spikes,in order to assistqualified clinicalpractitioners in theassessment of EEGtraces. EEGrecordings should beobtained with fullscalp montageaccording to thestandard 10/20system.- The aEEGfunctionality | according to the standard10/20 system.- The Spike Detectioncomponent of NatusNeuroWorks is intendedto mark previouslyacquired sections of theadult (greater than orequal to 18 years) EEGrecordings that maycorrespond toelectrographic spikes, inorder to assist qualifiedclinical practitioners inthe assessment of EEGtraces. EEG recordingsshould be obtained withfull scalp montageaccording to the standard10/20 system.- aEEG, BurstSuppression, Envelope,Alpha variability,Spectral Edge andSpectral Entropy trendingfunctionalities includedin Natus NeuroWorks areintended to assist the userwhile monitoring thestate of the brain. Theautomated event markingfunction of NatusNeuroWorks is notapplicable to theseanalysis features. | |||
| Table 1: Substantial Equivalence, Trends and other features | ||||||
| Predicate | Predicate | Primary Predicate | Subject Device | |||
| Feature | NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | |
| as well as dataranges fortrended values.This device doesnot provide anydiagnosticconclusion aboutthe patient'scondition and isintended to beused only byqualified andtrained medicalpractitioners, inresearch andclinicalenvironments. | as well as dataranges fortrended values.This device doesnot provide anydiagnosticconclusion aboutthe patient'scondition and isintended to beused only byqualified andtrained medicalpractitioners, inresearch andclinicalenvironments. | included in NatusNeuroWorks isintended to monitorthe state of the brain.The automated eventmarking function ofNatus NeuroWorks isnot applicable toaEEG.- Natus NeuroWorksalso includes thedisplay of aquantitative EEGplot, CompressedSpectrum Array(CSA), which isintended to help theuser to monitor andanalyze the EEGwaveform. Theautomated eventmarking function ofNatus NeuroWorks isnot applicable toCSA.This device does notprovide any diagnosticconclusion about thepatient's condition tothe user. | - Natus NeuroWorks alsoincludes the display of aquantitative EEG plot,Density Spectral Array(DSA), which is intendedto help the user tomonitor and analyze theEEG waveform. Theautomated event markingfunction of NatusNeuroWorks is notapplicable to DSA.- This device does notprovide any diagnosticconclusion about thepatient's condition to theuser. | |||
| User input | Mouse/keyboard | Mouse/keyboard | Mouse/keyboard | Mouse/keyboard | Same | |
| Acquire,display, store | Yes | Yes | Yes | Yes | Same | |
| Table 1: Substantial Equivalence, Trends and other features | ||||||
| Predicate | Predicate | Primary Predicate | Subject Device | |||
| Feature | NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | |
| and archiveEEG/PSG anddata from 3rdpartyphysiologicalmonitoringdevices | ||||||
| Signaldigitized | By separateproprietaryamplifier | Amplifier included aspart of the system | By separateproprietary amplifier | By separate proprietaryamplifier | Equivalent | |
| Third partypass-throughinputs | YesSaO2, heart rate | YesSaO2, heart rate,RsO2 | YesNonin Oximeter pass-through for Oxymetry,HR, and Pulse Wave | YesNonin Oximeter pass-through for Oxymetry, HR,and Pulse Wave | Equivalent | |
| Power | NA | NA | NA | NA | Software operating on a computer. | |
| EEG Software Detectors | ||||||
| SpikeDetection | Yes(Manual &ComputerAssisted) | Yes(Manual) | Yes(Manual & ComputerAssisted) | Yes(Manual & ComputerAssisted) | Same or better:Natus NeuroWorks supports manual andautomatic detection like in NicoletOnepredicate device. The Moberg predicatedevice only allows for Manual detection. | |
| SeizureDetection | Yes(Manual &ComputerAssisted) | Yes(Manual) | Yes(Manual & ComputerAssisted) | Yes(Manual & ComputerAssisted) | ||
| BurstSuppression | Yes | Yes | No | Yes | Equivalent: | |
| Table 1: Substantial Equivalence, Trends and other features | ||||||
| Predicate | Predicate | Primary Predicate | Subject Device | |||
| Feature | NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | |
| Feature added to Natus NeuroWorks Subjectdevice. With this implementation the NatusNeuroWorks Subject device is nowequivalent to NicoletOne and MobergPredicate devices. | ||||||
| AmplitudeIntegratedEEG (aEEG) | Yes | Yes | Yes | Yes | Same | |
| PowerSpectrum | Yes | Yes | Yes | Yes | Same | |
| EnvelopeTrend | Yes | No | No | Yes | Equivalent:Feature added to Natus NeuroWorks Subjectdevice. With this implementation the NatusNeuroWorks Subject device is nowequivalent to NicoletOne Predicate devices. | |
| Total PowerTrend | Yes | Yes | Yes | Yes | Same | |
| Band PowerTrend | Yes | Yes | Yes | Yes | Same | |
| DSA /Spectrogram | Yes | Yes | Yes | Yes | Equivalent:The feature was already available in NatusNeuroWorks primary predicate device butnamed "CSA". This feature is now calledDSA which is a more commonly used name.In addition to the old color scale from theCSA plot in previous Natus NeuroWorksversions, additional color scales were taken | |
| Table 1: Substantial Equivalence, Trends and other features | ||||||
| Feature | Predicate | Predicate | Primary Predicate | Subject Device | ||
| NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | ||
| Spectral edge/Median freq. Trends | Yes | Yes | No | Yes | provides better contrast improving theperformance of the feature. Spectralresolution of 30Hz in Natus NeuroWorks 9.1is improved in Natus NeuroWorks 9.2 to64Hz (steps of 0.5Hz).To summarize: DSA trend plots in NatusNeuroWorks Subject device do not introducea new trend feature, but in terms ofperformance it is now equivalent toNicoletOne predicate device where is wasnamed "Spectrogram". | |
| Spectral edge/Median freq. Trends | Yes | Yes | No | Yes | Equivalent:Feature added to Natus NeuroWorks Subjectdevice. With this implementation the NatusNeuroWorks Subject device is nowequivalent to NicoletOne and MobergPredicate devices. | |
| Peak Frequency Trend | Yes | Yes | No | No | This feature is not implemented in NatusNeuroWorks subject device because it israrely used. | |
| Spectral Entropy trend | Yes | Yes | No | Yes | Equivalent:Feature added to Natus NeuroWorks Subjectdevice. With this implementation the NatusNeuroWorks Subject device is nowequivalent to NicoletOne and MobergPredicate devices. | |
| Table 1: Substantial Equivalence, Trends and other features | ||||||
| Predicate | Predicate | Primary Predicate | Subject Device | |||
| Feature | NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | |
| FrequencyRatio Trend | Yes | No | Yes | Yes | Equivalent | |
| AlphaVariationTrend | Yes | Yes | No | Yes | Equivalent:Feature added to Natus NeuroWorks Subjectdevice. With this implementation the NatusNeuroWorks Subject device is nowequivalent to NicoletOne and MobergPredicate devices. | |
| Heart Ratedata trend &summary | Yes | Yes | Yes | Yes | Same | |
| R-R intervaltrend | Yes | No | No | Yes | Equivalent:Feature added to Natus NeuroWorks Subjectdevice. With this implementation the NatusNeuroWorks Subject device is nowequivalent to NicoletOne Predicate devices. | |
| Other features | ||||||
| Synchronizedpatient video | Yes | Yes | Yes | Yes | Same | |
| Oximetry datadisplay andreporting | Yes | Yes | Yes | Yes | Same | |
| Table 1: Substantial Equivalence, Trends and other features | ||||||
| Predicate | Predicate | Primary Predicate | Subject Device | |||
| Feature | NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | |
| Data storage | Local or remote,hard disk | Local or remote, harddisk | Local or remote, harddisk | Local or remote, hard disk | Same | |
| Audio/ VisualAlerts OnCalibratedChannels | Yes | Yes | Yes | Yes | Same | |
| Signalsrecorded(output) | Respiratory Effort(abdomen andchest)AirflowPressureSnoreBody PositionPulse RateOximeterECGEEGEMGEOGDCLeg Movementand other signalsrequired for sleepstudies | Respiratory Effort(abdomen and chest)AirflowPressureSnoreBody PositionPulse RateOximeterECGEEGEMGEOGDCLeg Movement andother signals requiredfor sleep studies | Respiratory Effort(abdomen and chest)AirflowPressureSnoreBody PositionPulse RateOximeterECGEEGEMGEOGDCLeg Movement | Respiratory Effort(abdomen and chest)AirflowPressureSnoreBody PositionPulse RateOximeterECGEEGEMGEOGDCLeg Movement | Equivalent | |
| Signalsrecorded(output) from3rd partyphysiological | SpO2 - PeripheralCapillary OxygenSaturationT - Temperature | Oxygen Saturation,Pulse Rate,Temperature,Respiratory Rate, | Same | Same | Equivalent | |
| Table 1: Substantial Equivalence, Trends and other features | ||||||
| Predicate | Predicate | Primary Predicate | Subject Device | |||
| Feature | NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | |
| monitoringdevices | HR - Heart RateNIBPS - Non-Invasive BloodPressure SystolicNIPBD - Non-Invasive BloodPressure Dystolic | Heart Rate,Non-InvasiveBlood PressureSystolic,Non-InvasiveBlood PressureDystolic,Non-InvasiveBlood PressureMean, InvasiveBlood PressureSystolic,Invasive BloodPressure Dystolic,Invasive BloodPressure Mean,Blood FlowPerfusion,Brain & TissueOxygenation,IntracranialPressure | ||||
| Reportgenerationincludingcounts indexes,max / min/average/duration, rangebased data | Yes, customizabletemplates | Yes, customizabletemplates | Yes, customizabletemplates | Yes,customizable templates | Same | |
| Table 1: Substantial Equivalence, Trends and other features | ||||||
| Feature | Predicate | Predicate | Primary Predicate | Subject Device | ||
| NicoletOneK173366 | Moberg CNSK080217 | Natus NeuroWorksK180421 | Natus NeuroWorks | Comments | ||
| Numeric &graphicalrepresentations |
The following table provides a substantial equivalson of the Natus NeuroWorks software application under review to three predicate devices.
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Detailed description of new Trend features:
| NicoletOne K173366 (Predicate device) | Natus NeuroWorks (subject device) | Comments | |
|---|---|---|---|
| Description ofBurstSuppressiontrend | The Burst Suppression Trend is an analyzerthat has been developed to identify BurstSuppression Pattern in the EEG. It isrecognized by a periodic pattern of low voltage(less than 10 μν) and relatively shorter patternsof higher amplitude complexes.Three types of burst channels are available inthe Calculated Channels editor:- Burst rate: average n° of segments withhigher-amplitude and mixed-frequencyactivity over the analysis window length- % Suppression, "Burst Suppressionratio", or "BSR": % of (sum of durationof suppression during analysis window /analysis window length). The defaultanalysis window is 10 min- IBI, "Inter-burst interval": Duration of thelast complete suppression period (willbe detected 1 – 2 seconds after arrivalof burst ending the suppression...)In addition to the trends, these BS values canbe displayed in the Heads-Up toolbar fromNatus NeuroWorks. | The Burst Suppression Trend is an analyzerthat has been developed to identify BurstSuppression Pattern in the EEG. It isrecognized by a periodic pattern of low voltage(less than 10 µv) and relatively shorter patternsof higher amplitude complexes.Three types of burst channels are available inthe Calculated Channels editor:- Burst rate: average n° of segmentswith higher-amplitude and mixed-frequency activity over the analysiswindow length- % Suppression, "Burst Suppressionratio", or "BSR": % of (sum of durationof suppression during analysis window/ analysis window length). The defaultanalysis window is 10 min- IBI, "Inter-burst interval": Duration ofthe last complete suppression period(will be detected 1 - 2 seconds afterarrival of burst ending thesuppression...)In addition to the trends, these BS values canbe displayed in the Heads-Up toolbar fromNatus NeuroWorks. | Same |
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Image /page/17/Figure/0 description: The image shows examples of Burst Suppression trends in NicoletOne and Natus NeuroWorks. The text explains that the Burst Suppression features eliminate the need to manually count bursts and also show trend plots and values for Bursts, % Suppression, and Inter-Burst Interval (IBI). The programming code and drawing algorithm for Burst Suppression was taken over from NicoletOne software, a product owned by Natus. The trend plots for Burst Suppression in Natus NeuroWorks are shown on the same study data, and the resulting graphs are identical.
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Image /page/18/Figure/0 description: The image shows a description of the envelope trend, which is a line graph representing variations in the amplitude of EEG activity. The algorithm slices the EEG into blocks of a specific length, ideally 20-30 seconds, for better elimination of movement artifacts. For each block, all waves in the EEG are detected, and the peak-to-peak amplitude is calculated in each wave. The waves are then lined up by size, and the median peak-to-peak amplitude in the block is found, which is the numerical value of the envelope.
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Image /page/19/Figure/0 description: The image shows two examples of envelope trends in NicoletOne and Natus NeuroWorks. The text states that the programming code and drawing algorithm for Envelope was taken over from NicoletOne software, a product owned by Natus. The following examples show trend plots for Envelope trend in Natus NeuroWorks on the same study data as the example for Nicoletone, and consequently the resulting graphs are identical. The graphs show the envelope trend over time, with the x-axis representing time and the y-axis representing the envelope trend.
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| Description of Spectral Entropy (SEN) trend | Spectral Entropy shows a line graph representing the "complexity" or "regularity" of a signal.SEN can take values from 0 (if the signal is completely regular, e.g. a sine wave) to 100 (if the spectrum is that of uncorrelated white noise).Example of a spectral Entropy trend in Nicoletone: |
|---|---|
| Spectral Entropy shows a line graph representing the "complexity" or "regularity" of a signal.SEN can take values from 0 (if the signal is completely regular, e.g. a sine wave) to 100 (if the spectrum is that of uncorrelated white noise).The programming code and the drawing algorithm for Spectral Entropy was taken over from NicoletOne software, a product owned byNatus.The following example show the trend plot for Spectral Entropy_in Natus NeuroWorks on the same study data as the example for Nicoletone. Consequently the resulting graphs are identical: | |
| Same |
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Image /page/21/Figure/0 description: The image shows two identical graphs that describe the spectral edge trend. The 95% spectral edge is the frequency below which one finds 95% of the total power. The spectral edge and median frequencies are derived from the power spectrum from a block of EEG. The algorithm for spectral edge was taken over from NicoletOne software, a product owned by Natus.
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| The following example show the trend plot forSpectral Edge trend in Natus NeuroWorks on thesame study data as the example for Nicoletone.Consequently the resulting graphs are identical: | |||
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| Description ofAlpha Variability | Alpha variability is the analysis of the changein power in the 6Hz to 14Hz band (includingalpha) compared to the wide band powerbetween 1Hz and 20Hz.The Alpha Variability Trend/Relative Alpha,takes a moving average of the spectrum. Themoving average contains 60 blocks of datawhere one block is typically 2 seconds.$Alpha variability = \frac{BandPower(6Hz, 14Hz)}{BandPower(1Hz, 20Hz)}$ | Alpha variability is the analysis of the changein power in the 6Hz to 14Hz band (includingalpha) compared to the wide band powerbetween 1Hz and 20Hz.The Alpha Variability Trend/Relative Alpha,takes a moving average of the spectrum. Themoving average contains 60 blocks of datawhere one block is typically 2 seconds.$Alpha variability = \frac{BandPower(6Hz, 14Hz)}{BandPower(1Hz, 20Hz)}$ | Same |
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Image /page/23/Figure/0 description: The image shows examples of Alpha Variability trends in NicoletOne. The algorithm for Alpha Variability was taken over from NicoletOne software, a product owned by Natus. The following examples show trend plots for Alpha Variability trend in NicoletOne and in Natus NeuroWorks on the same study data as the example for NicoletOne, and consequently the resulting graphs are identical. There are three trend plots shown in the image.
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These predicate devices support features and technology equivalence of the Natus NeuroWorks software under review. As indicated, the Natus NeuroWorks software and the predicate devices are equivalent in features and technical characteristics.
The Natus NeuroWorks software and predicate devices are not life sustaining devices. The Natus NeuroWorks software is intended for use only by qualified and trained mactitioners in clinical and research environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.
Similarly to the predicate devices, Natus North as the qualified users with computer assisted scoring of events which will mark sections of the recorded signals for subsequent review by the user. These functions are provided as computer-aded tools. Users are instructed to review, accept or reject the results of the assisted scoring tools in accordance with their professional judgment.
Natus NeuroWorks software and all predicates inclusition of synchronized video recording/review, audio/visual threshold based alerts for calibrated external devices (pulse oximeter) as well as trending of any collected data for summary review and reporting.
The differences between Natus NeuroWorks and the predicate devices are mainly related to user workflow. There are no major differences that significantly alter the intended use or raise of safety or effectiveness. The predicates devices NeuroWorks software (K18042), and NicoletOne (K173366), as well as the device under review, Natus NeuroWorks software, have equivalent intended use: to record and process EEGPSG and other physiological signals to assist in the diagnoss of various neurological disorders and sleep related respiratory disorders affecting patients in all age groups.
Brief Summary of Performance Tests:
| BioCompatibility | Natus NeuroWorks is a software-only device. Biocompatibility testing is not applicable. |
|---|---|
| Electrical Safety andEMC | Natus NeuroWorks is a software-only device. Electrical safety evaluation and EMC evaluation is not applicable. |
| Animal Study | There were no animal studies performed for this submission. |
| Clinical Study | There were no clinical studies performed for this submission. |
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Software
The Natus NeuroWorks software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following FDA guidance documents and standards:
- The content of premarket submissions for software contained in medical devices, 11 May 05. .
- Off-the-shelf software use in medical devices, 09 Sep 99. .
- General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. .
- Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14. .
- . Cybersecurity for networked medical devices containing off-the-shelf (OTS) software, 14 Jan 05
- IEC 62304: 2006, Medical device software Software life cycle processes
Results indicate that the Natus NeuroWorks software complies with its predetermined specifications, the applicable guidance documents, and the applicable standards.
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Performance Testing – Bench The Natus NeuroWorks software was verified for performance in accordance with internal requirements and the applicable clauses of the following standards:
- · IEC 62304: 2006, Medical device software Software life cycle processes
- IEC 62366: 2007, Am1: 2014, Medical devices Application of usability engineering to medical devices .
- IEC 60601-1-6 Medical electrical equioment-part 1-6 General requirements for basic safety and essential . performance -Collateral standard :Usability
- ISO 14971: 2012, Medical devices Application of risk management to medical devices .
Results indicate that the Natus NeuroWorks software complies with its predetermined specifications and the applicable standards.
In addition , Bench and performance testing was performed to confirm
- · Functional testing of the supported Amplifiers with NeuroWorks software
- Functional testing of the supported Neuroworks Workflows within the software .
- Functional testing of the supported Peripheral Components within the software .
- Interoperability between the NeuroWorks amplifiers and Physiological Monitoring units. .
- Functional and bench testing of the Trend data with Neuroworks software. .
- Comparison testing of the Trend data between Neuroworks and Predicate device (NicoletOne . software)
Results indicate that the Natus NeuroWorks software complies with its predetermined specifications and the applicable standards.
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The substantial equivalence of the Natus Neuroworks software with the predicate devices was Conclusion demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Natus Neuroworks software is similar to that of the predicate device(s). Verification and Validation were performed to ensure no new questions of safety or effectiveness are raised. The results of these activities demonstrate that the Natus Neuroworks software is as safe, as effective, and performs as well as or better than the 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).