(243 days)
-
Cadwell Bolt is a software-only device intended for post-hoc analysis of EEG data. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. This device is intended to be used with EEG data from patients of all ages.
-
Cadwell Bolt includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG data. These include the following 10 analyzers:
- -Amplitude Integrated EEG (aEEG),
- -Peak Envelope,
- -Envelope Asymmetry,
- -Spectrogram,
- -Band Power.
- -Power Ratio,
- -Spectral Entropy,
- -Burst Suppression Ratio,
- -Inter-burst Interval, and
- -Bursts-per-Minute.
These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG data. A minimum of one epoch of data is required to perform Bolt analysis.
-
The aEEG functionality included in Cadwell Bolt is intended to monitor the state of the brain.
-
Cadwell Bolt can provide notifications, based on user-defined thresholds, for quantitative EEG measures such as a notification within the application software that can be used when processing a record during acquisition. Delays can occur between the beginning of an event and when the Bolt notification will be shown to a user. Cadwell Bolt notifications cannot be used as a substitute for real-time monitoring of the underlying EEG data by a trained expert.
This device does not provide any diagnostic conclusion about the patient's condition to the user as part of its output. The software does not contain automated detection algorithms.
Cadwell Bolt is a software-only device for use with EEG data. The Cadwell Bolt receives EEG data as an input and uses this input to calculate and display the following quantitative measures of electroencephalographic data:
(1) amplitude integrated EEG (aEEG),
(2) peak envelope,
(3) envelope asymmetry,
(4) spectrogram,
(5) band power,
(6) power ratio.
(7) spectral entropy,
(8) burst suppression ratio.
(9) inter-burst interval, and
(10) bursts-per-minute.
In addition to the 10 analyzers mentioned above, Cadwell Bolt calculates if a value is greater than a user-defined threshold. A horizontal black bar is displayed in the trend window and signifies the current threshold setting. The user may move the bar up/down to adjust the threshold.
Thresholding is available for the following trends:
. peak envelope,
. envelope asymmetry,
spectrogram, .
band power, and ●
power ratio. .
The Cadwell Bolt device performs analysis on a userdefined set of EEG channels within the EEG data and displays graphical results to be interpreted by qualified medical practitioners. Additional user-selectable parameters are available depending on the analyzer selected for display. These parameters include frequency ranges or bands for analysis, number of epochs to average, and minimum burst suppression durations. Using the userdefined thresholds, Cadwell Bolt can provide notifications to the user and can optionally highlight the associated EEG data. Notifications and/ or highlights can be accepted or rejected by a qualified medical practitioner. Additional features and user-selectable parameters include:
Output display color
Output display size ●
Output display name
Epoch length ●
Notch filter ●
Selected inputs (bipolar or referential)
. Output display time scale (y-axis)
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Correlation Coefficient (for graphical and morphological comparison) | Greater than 0.80 | All reported correlation values were $\geq$ 0.900 for Peak Envelope, Envelope Asymmetry, Spectrogram, Band Power, Power Ratio, Spectral Entropy, Burst Suppression (IBI, BSR, BPM). Specific values are provided in the tables below. |
| Percent Difference (for quantitative output amplitude comparison) | Less than 10% | Spectral Entropy: Reported percent differences were 5.3%, 3.4%, 8.7%, 7.2%.Burst Suppression (IBI, BSR, BPM): Reported percent differences were 1.25%, 1.37%, 1.94%. |
Specific Performance Data from the Study:
| Analyzer / Measurement | Time Period | Correlation Coefficient | Percent Difference |
|---|---|---|---|
| Peak Envelope | 15-minute | 0.951 | N/A |
| 1-hour | 0.917 | N/A | |
| 4-hour | 0.913 | N/A | |
| 8-hour | 0.896 | N/A | |
| Envelope Asymmetry | 15-minute | 0.909 | N/A |
| 1-hour | 0.859 | N/A | |
| 4-hour | 0.857 | N/A | |
| 8-hour | 0.819 | N/A | |
| Spectrogram | 15-minute | 0.938 | N/A |
| 1-hour | 0.969 | N/A | |
| 4-hour | 0.825 | N/A | |
| 8-hour | 0.852 | N/A | |
| Band Power | 15-minute | 0.955 (All 10/20 7-12Hz) | N/A |
| 1-hour | 0.898 (All 10/20 7-12Hz) | N/A | |
| 4-hour | 0.874 (All 10/20 7-12Hz) | N/A | |
| 8-hour | 0.891 (All 10/20 7-12Hz) | N/A | |
| Power Ratio | 15-minute | 0.938 | N/A |
| 1-hour | 0.923 | N/A | |
| 4-hour | 0.902 | N/A | |
| 8-hour | 0.867 | N/A | |
| Spectral Entropy | 15-minute | 0.957 | 5.3% |
| 1-hour | 0.961 | 3.4% | |
| 4-hour | 0.998 | 8.7% | |
| 8-hour | 0.972 | 7.2% | |
| Burst Suppression (IBI) | N/A | 0.992 | 1.25% |
| Burst Suppression (BSR) | N/A | 0.999 | 1.37% |
| Burst Suppression (BPM) | N/A | 0.999 | 1.94% |
2. Sample size used for the test set and the data provenance:
The document states that "Arbitrary data of known value was input" and "sample EEG data at various time scales and with various montages and/or frequency bands" were used. However, it does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing involved "analyzing known arbitrary EEG data and confirming that the expected output was obtained" and comparing results with predicate devices, but it does not mention the involvement or qualifications of experts for establishing ground truth on the test data.
4. Adjudication method for the test set:
This information is not provided in the document. The evaluation involved a comparison of calculated metrics (correlation coefficient and percent difference) against predetermined thresholds, not an adjudication process by experts.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document describes a standalone performance evaluation of the software's quantitative output compared to predicate devices, not impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done. The study focused on the Cadwell Bolt Software's ability to calculate and display quantitative EEG measures, and its outputs were compared against those of predicate devices. The device is intended for post-hoc analysis by qualified medical practitioners who exercise professional judgment, implying it functions as a tool rather than a diagnostic algorithm that provides conclusions or replaces real-time monitoring by an expert.
7. The type of ground truth used:
The ground truth for this performance study appears to be established through "known arbitrary EEG data" and by comparing the device's output to the output of legally marketed predicate devices, which serve as a reference for "substantial equivalence." The document states that the software "implements public domain (nonproprietary) quantitative analysis measures that are identical or similar to the predicate devices."
8. The sample size for the training set:
This information is not provided in the document. The document describes verification and validation but does not detail a training set for the Cadwell Bolt Software, implying it uses established algorithms rather than a machine learning model that requires a distinct training phase.
9. How the ground truth for the training set was established:
This information is not provided in the document, as no training set is explicitly mentioned or described.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cadwell Industries, Inc. Emily Whitehead Project Engineer 909 N. Kellogg Street Kennewick, Washington 99336
Re: K190760
Trade/Device Name: Cadwell Bolt Software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, OMA, ORT Dated: October 22, 2019 Received: October 24, 2019
Dear Emily Whitehead:
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 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
{1}------------------------------------------------
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190760
Device Name Cadwell Bolt Software
Indications for Use (Describe)
-
Cadwell Bolt is a software-only device intended for post-hoc analysis of EEG data. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. This device is intended to be used with EEG data from patients of all ages.
-
Cadwell Bolt includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG data. These include the following 10 analyzers:
- -Amplitude Integrated EEG (aEEG),
- -Peak Envelope,
- -Envelope Asymmetry,
- -Spectrogram,
- -Band Power.
- -Power Ratio,
- -Spectral Entropy,
- -Burst Suppression Ratio,
- -Inter-burst Interval, and
- -Bursts-per-Minute.
These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG data. A minimum of one epoch of data is required to perform Bolt analysis.
-
The aEEG functionality included in Cadwell Bolt is intended to monitor the state of the brain.
-
Cadwell Bolt can provide notifications, based on user-defined thresholds, for quantitative EEG measures such as a notification within the application software that can be used when processing a record during acquisition. Delays can occur between the beginning of an event and when the Bolt notification will be shown to a user. Cadwell Bolt notifications cannot be used as a substitute for real-time monitoring of the underlying EEG data by a trained expert.
This device does not provide any diagnostic conclusion about the patient's condition to the user as part of its output. The software does not contain automated detection algorithms.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K190760 Traditional 510(k) Summary
This 510(k) summary was prepared to provide an understanding of the basis for the determination of substantial equivalence in accordance with the requirements 21 CFR 807.92.
| Submitter: | Cadwell Industries, Inc.909 N. Kellogg StreetKennewick, Washington 99336509-735-6481 |
|---|---|
| Contact Person: | Emily Whitehead, Project Engineeremilyw@cadwell.com |
| Date Prepared: | November 22, 2019 |
| Trade Name: | Cadwell Bolt Software |
| Regulation Name: | Electroencephalograph |
| Regulation Number: | 21 CFR 882.1400 |
| Regulatory Classification: | Class II |
| Product Codes: | OLT (Primary) non-normalizing quantitativeelectroencephalograph (EEG) softwareORT (secondary) burst suppression detection software forelectroencephalographOMA amplitude-integrated electroencephalograph (aEEG) |
| Review Panel: | Neurological and Physical Medicine Devices (OHT5)Neurosurgical, Neurointerventional and NeurodiagnosticDevices (DHT5A) |
| Predicate Device: | K151929 Persyst 13 EEG Review and Analysis Software;Primary PredicateK173366 NicoletOne; Secondary predicateK161027 Cadwell Ampliscan; Secondary predicate |
| Device Description: | Cadwell Bolt is a software-only device for use with EEGdata. The Cadwell Bolt receives EEG data as an input anduses this input to calculate and display the followingquantitative measures of electroencephalographic data:(1) amplitude integrated EEG (aEEG),Page 1 of 26 |
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- (2) peak envelope,
- (3) envelope asymmetry,
- (4) spectrogram,
- (5) band power,
- (6) power ratio.
- (7) spectral entropy,
- (8) burst suppression ratio.
- (9) inter-burst interval, and
- (10) bursts-per-minute.
In addition to the 10 analyzers mentioned above, Cadwell Bolt calculates if a value is greater than a user-defined threshold. A horizontal black bar is displayed in the trend window and signifies the current threshold setting. The user may move the bar up/down to adjust the threshold.
Thresholding is available for the following trends:
- . peak envelope,
- . envelope asymmetry,
- spectrogram, .
- band power, and ●
- power ratio. .
The Cadwell Bolt device performs analysis on a userdefined set of EEG channels within the EEG data and displays graphical results to be interpreted by qualified medical practitioners. Additional user-selectable parameters are available depending on the analyzer selected for display. These parameters include frequency ranges or bands for analysis, number of epochs to average, and minimum burst suppression durations. Using the userdefined thresholds, Cadwell Bolt can provide notifications to the user and can optionally highlight the associated EEG data. Notifications and/ or highlights can be accepted or rejected by a qualified medical practitioner. Additional features and user-selectable parameters include:
- Output display color
- Output display size ●
- Output display name
- Epoch length ●
- Notch filter ●
- Selected inputs (bipolar or referential)
- . Output display time scale (y-axis)
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| Intended Use: | Cadwell Bolt is intended to be used in conjunction withCadwell Acquisition Software. The Cadwell Bolt device isfor use by qualified medical practitioners and does notprovide any diagnostic conclusions about the patient'scondition to the user. |
|---|---|
| The Cadwell Bolt Software is intended to be used for post-hoc analysis of EEG software to analyzeelectroencephalograph (EEG) data using conventionalmethodology to output and display standard EEGparameters for interpretation by a qualified user.The device uses software algorithms as a tool to analyzeEEG recordings to calculate conventional EEG parameters.(e.g. spectral edge frequency, percent alpha, asymmetry). | |
| This device does not provide any diagnostic conclusionabout the patient's condition to the user as part of its output.The software does not contain automated detectionalgorithms. |
| Primary Predicate K151929 | Subject Device K190760 | Comments |
|---|---|---|
| Persyst 13 Software | Cadwell Bolt | |
| 1. Persyst 13 EEG Review and AnalysisSoftware is intended for the review,monitoring and analysis of EEGrecordings made byelectroencephalogram (EEG) devicesusing scalp electrodes and to aidneurologists in the assessment ofEEG. This device is intended to beused by qualified medicalpractitioners who will exerciseprofessional judgment in using theinformation.2. The Seizure Detection and SeizureProbability component of Persyst 13 isintended to mark previously acquiredsections of the adult (greater than orequal to 18 years old) EEG recordingsthat may correspond toelectrographic seizures, in order toassist qualified clinical practitioners inthe assessment of EEG traces. EEGrecordings should be obtained with a | 1. Cadwell Bolt is a software-only deviceintended for post-hoc analysis of EEGdata. This device is intended to beused by qualified medicalpractitioners who will exerciseprofessional judgment in using theinformation. This device is intendedto be used with EEG data frompatients of all ages.2. Cadwell Bolt includes the calculationand display of a set of quantitativemeasures intended to monitor andanalyze the EEG data. These includethe following 10 analyzers:-Amplitude Integrated EEG (aEEG),-Peak Envelope,-Envelope Asymmetry,-Spectrogram,-Band Power,-Power Ratio,-Spectral Entropy,-Burst Suppression Ratio,-Inter-burst Interval, and | The propose IFU is a subset of thepredicate device. Quantitative measuresare listed in the Cadwell Bolt indicationsfor use (#2); Additional quantitativemeasures not included with K151929 arecovered by the secondary predicatedevices that were cleared in the sameregulation for the same intended use.All newly proposed quantitative measuresare verified against Cadwell internalrequirements and validated to demonstratesubstantial equivalence as compared to thepredicate device implementation; thevalidation testing was submitted as part ofthis 510(k) submission. Both devices areprescription use only, are intended to beused with EEG data for post-hoc analysis,and are intended to be used by medicalprofessionals. Neither Bolt nor the primarypredicate device provide diagnosticconclusions to the user as part of theoutput.Wording differences appear for the sake ofclarification purposes only. Differences in |
| Primary Predicate K151929 | Subject Device K190760 | Comments |
| Persyst 13 Software | Cadwell Bolt | |
| full scalp montage according to thestandard 10/20 system.3. The Spike Detection component ofPersyst 13 is intended to markpreviously acquired sections of thepatient's EEG recordings that maycorrespond to spikes, in order toassist qualified clinical practitioners inthe assessment of EEG traces. TheSpike Detection component isintended to be used in patients atleast one month old. Persyst 13 SpikeDetection performance has not beenassessed for intracranial recordings.4. Persyst 13 includes the calculationand display of a set of quantitativemeasures intended to monitor andanalyze the EEG waveform. Theseinclude FFT, Rhythmicity, PeakEnvelope, Artifact Intensity,Amplitude, Relative Symmetry andSuppression Ratio. Automatic eventmarking is not applicable to thequantitative measures. Thesequantitative EEG measures shouldalways be interpreted in conjunction | -Bursts-per-Minute.These quantitative EEG measuresshould always be interpreted inconjunction with review of theoriginal EEG data. A minimum of oneepoch of data is required to performBolt analysis.3. The aEEG functionality included inCadwell Bolt is intended to monitorthe state of the brain.4. Cadwell Bolt can providenotifications, based on user-definedthresholds, for quantitative EEGmeasures such as a notification withinthe application software that can beused when processing a record duringacquisition. Delays can occur betweenthe beginning of an event and whenthe Bolt notification will be shown toa user. Cadwell Bolt notificationscannot be used as a substitute forreal-time monitoring of theunderlying EEG data by a trainedexpert. | the IFUs between the subject and predicatedevices do not change the intended usebetween the devices. |
| with review of the original EEGwaveforms.5. The aEEG functionality included inPersyst 13 is intended to monitor thestate of the brain. The automatedevent marking function of Persyst 13is not applicable to aEEG. | This device does not provide anydiagnostic conclusion about the patient'scondition to the user as part of its output.The software does not contain automateddetection algorithms. | |
| 6. Persyst 13 provides notifications forseizure detection, quantitative EEGand aEEG that can be used whenprocessing a record duringacquisition. These include an onscreen display and the optionalsending of an email message. Delaysof up to several minutes can occurbetween the beginning of a seizureand when the Persyst 13notifications will be shown to a user.Persyst 13 notifications cannot beused as a substitute for real timemonitoring of the underlying EEG bya trained expert. | ||
| Primary Predicate K151929 | Subject Device K190760 | Comments |
| Persyst 13 Software | Cadwell Bolt | |
| 7. Persyst AR (Artifact Reduction) isintended to reduce EMG, eyemovement, and electrode artifactsin a standard 10-20 EEG recording.AR does not remove the entireartifact signal, and is not effectivefor other types of artifacts. AR maymodify portions of waveformsrepresenting cerebral activity.Waveforms must still be read by aqualified medical practitionertrained in recognizing artifact, andany interpretation or diagnosis mustbe made with reference to theoriginal waveforms.This device does not provide anydiagnostic conclusion about the patient'scondition to the user. |
Table 1: Comparison of Indications for Use to Primary Predicate
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Substantial Equivalence
Table 2: Comparison of Subject Device's Technological Characteristics to Predicates
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
|---|---|---|---|---|---|
| Physical State | Software-only | Software-only | Software-only | Software-only | Same |
| Device Class | Class II | Class II | Class II | Class II | Same |
| Class Name | EEG | EEG | EEG | EEG | Same |
| ClassifyingRegulation | 882.1400 | 882.1400 | 882.1400 | 882.1400 | Same |
| Intended User | Medical Professionals | Medical Professionals | Medical Professionals | Medical Professionals | Same |
| User Input | Mouse/Keyboard | Mouse/Keyboard | Mouse/Keyboard | Mouse/Keyboard | Same |
| Power | N/A | N/A | N/A | N/A | All devices aresoftware-only andoperate on a computer. |
| Amplitude-integrated EEG Trend | |||||
| Trend Available | Yes | Yes | Yes | Yes | Same |
| Notification Available | N/A | Yes | No | No | The predicate deviceoffers notifications forthe amplitudeintegrated EEG trend.whereas Bolt does notoffer notifications forthis specific trend.Page 2 of this |
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| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
|---|---|---|---|---|---|
| Summary includes thenotifications that areincluded with otheranalyzers. This featureis a convenience and isbased on user-definedthresholds which arepre-set and lack of thisfeature does not affectthe intended use of thedevice. | |||||
| Amplitude-integrated EEG Trend | |||||
| Analysis Input | EEG data; user-selected channels | EEG data; user-selected channels | EEG data; user-selected channels | EEG data; user-selected channels | Same |
| Analysis Output | Graph | Graph; Over-thresholdnotification | Graph | Graph | Same |
| X-Axis | Linear scale; units oftime; user-adjustable | Linear scale; units oftime; user-adjustable | Linear scale; units oftime; user-adjustable | Linear scale; units oftime; user-adjustable | Same |
| Y-Axis | Semi-log scale; units ofuV; user-adjustable | Semi-log scale; units ofuV; fixed scale | Semi-log scale; units ofuV; fixed scale | Semi-log scale; units ofuV (microvolts); fixedscale | Same |
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| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
|---|---|---|---|---|---|
| User AdjustableFilters | High cut and low-cutfilters | Notch, high-cut, andlow-cut filters | Notch filter | Notch filter | Filtering is performedas a preliminary step,before the trendanalysis. Lack of highand low-cut filters doesnot change theintended use and itdoes not raise differentquestions of safety andeffectiveness asperformance testing(validation of theanalyzers) has beensubmitted todemonstrate substantialequivalence. |
| Power Ratio Trend | |||||
| Trend Available | No | Yes | No | Yes | - |
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| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
|---|---|---|---|---|---|
| Power Ratio Trend | |||||
| Notification Available | NA | Yes | - | Yes | Bolt notificationconsists of a yellowindicator adjacent tothe trend. Optionally,Bolt notificationhighlights the EEGdata for the durationthat the trend is over-threshold. Thepredicate, K151929Persyst 13, marks anddisplays notificationsin the EEG data andcan optionally send anemail to the user if atrend is over-threshold.Although thenotification |
| Device (Right) → | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| Item of Comparison(Below) | methodology is slightlydifferent, both thesubject device andpredicate deviceperform thresholdnotifications in asimilar manner. | ||||
| Power Ratio Trend | |||||
| Analysis Input | - | EEG data; user-selected channels | - | EEG data; user-selected channels | Same |
| Analysis Output | - | Graph; over-thresholdnotification | - | Graph; over-thresholdnotification | Same |
| X-Axis | - | Linear scale; units oftime; user-adjustable | - | Linear scale; units oftime; user-adjustable | Same |
| Y-Axis | - | Linear scale; numericalvalues; user-adjustable | - | Linear scale; numericalvalues; user-adjustable | Same |
| User AdjustableFilters | - | Notch, high cut, andlow-cut filters | - | Notch filter only | Filtering is performedas a preliminary step,before the trendanalysis. Lack of highand low-cut filters doesnot change theintended use and itdoes not raise differentquestions of safety andeffectiveness asperformance testing |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| (validation of theanalyzers) has beensubmitted todemonstrate substantialequivalence. | |||||
| Band Power Trend | |||||
| Trend Available | Yes | Yes | No | Yes | - |
| Notification Available | NA | Yes | - | Yes | Bolt notificationconsists of a yellowindicator adjacent tothe trend. Optionally,Bolt notificationhighlights the EEGdata for the durationthat the trend is over-threshold. Thepredicate, K151929Persyst 13, marks anddisplays notificationsin the EEG data andcan optionally send on |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| email to the user if atrend is over-threshold.Although thenotificationmethodology is slightlydifferent, both thesubject device andpredicate deviceperform thresholdnotifications in asimilar manner. | |||||
| Band Power Trend | |||||
| Analysis Input | EEG data; user-selected channels | EEG data; user-selected channels | - | EEG data; user-selected channels | Same |
| Analysis Output | Graph | Graph; over-thresholdnotification | - | Graph; over-thresholdnotification | Same |
| X-Axis | Linear scale; units oftime; user-adjustable | Linear scale; units oftime; user-adjustable | - | Linear scale; units oftime; user-adjustable | Same |
| Y-Axis | Linear or Log scale;units of percent; user-adjustable | Linear scale: numericalvalues; user-adjustable | - | Linear scale; units ofpercent; user-adjustable | Same |
| User AdjustableFilters | High cut and low-cutfilters | Notch, high cut, andlow-cut filters | - | Notch filter | Filtering is performedas a preliminary step,before the trendanalysis. Lack of highand low-cut filters doesnot change the |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| intended use and itdoes not raise differentquestions of safety andeffectiveness asperformance testing(validation of theanalyzers) has beensubmitted todemonstrate substantialequivalence. | |||||
| Spectrogram Trend | |||||
| Trend Available | Yes | Yes | No | Yes | - |
| Notification Available | NA | No | - | Yes | The predicate deviceoffers notifications forthe amplitudeintegrated EEG trend,whereas Bolt does notoffer notifications forthis specific trend.Page 2 of thisSummary includes thenotifications that areincluded with otheranalyzers. This featureis a convenience and isbased on user-definedthresholds which are |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| pre-set and lack of thisfeature does not affectthe intended use of thedevice. | |||||
| Analysis Input | EEG data; user-selected channels | EEG data; user-selected channels | - | EEG data; user-selected channels | Same |
| Analysis Output | Graph | Graph | - | Graph; over-thresholdnotification | Additional notificationoutput is available inBolt. This option ismade available forusers' preference anddoes not affect theprimary analysis outputwhich is similarbetween the subjectand predicate devices. |
| X-Axis | Linear scale; units oftime; user-adjustable | Linear scale; units oftime; user-adjustable | - | Linear scale; units oftime; user-adjustable | Same |
| Spectrogram Trend | |||||
| Y-Axis | Linear or Log scale;user-adjustable | Linear scale; units ofHz; user-adjustable | - | Linear scale; units ofHz; user-adjustable | Same |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| User AdjustableFilters | High cut and low-cutfilters | Notch, high cut, andlow-cut filters | - | Notch filter | Filtering is performedas a preliminary step,before the trendanalysis. Lack of highand low-cut filters doesnot change theintended use and itdoes not raise differentquestions of safety andeffectiveness asperformance testing(validation of theanalyzers) has beensubmitted todemonstrate substantialequivalence. |
| Spectral Entropy Trend | |||||
| Trend Available | Yes | No | No | Yes | - |
| Notification Available | NA | - | - | No | Same |
| Analysis Input | EEG data; user-selected channels | - | - | EEG data; user-selected channels | Same |
| Analysis Output | Graph; numerical value | - | - | Graph; numericalentropy value | Same |
| X-Axis | Linear scale; units oftime; user-adjustable | - | - | Linear scale; units oftime; user-adjustable | Same |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| Spectral Entropy Trend | |||||
| Y-Axis | Linear or Log scale;units of entropy; user-adjustable | - | - | Linear scale; units ofentropy (1-100); fixedscale | Same |
| User AdjustableFilters | High cut and low-cutfilters | - | - | Notch filter | Filtering is performedas a preliminary step,before the trendanalysis. Lack of notchfilter with respect tothe secondarypredicate, NicoletOneK173366, predicatedoes not change theintended use and itdoes not raise differentquestions of safety andeffectiveness asperformance testing(validation of theanalyzers) has beensubmitted to |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| demonstrate substantialequivalence. | |||||
| Peak Envelope Trend | |||||
| Trend Available | Yes | Yes | No | Yes | |
| Notification Available | NA | Yes | - | Yes | Bolt notificationconsists of a yellowindicator adjacent tothe trend. Optionally,Bolt notificationhighlights the EEGdata for the durationthat the trend is over-threshold. Thepredicate, K151929Persyst 13, marks anddisplays notificationsin the EEG data andcan optionally send anemail to the user if atrend is over-threshold.Although thenotificationmethodology is slightlydifferent, both thesubject device andpredicate deviceperform threshold |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| notifications in asimilar manner. | |||||
| Peak Envelope Trend | |||||
| Analysis Input | EEG data; user-selected channels | EEG data; user-selected channels | - | EEG data; user-selected channels | Same |
| Analysis Output | Graph | Graph; over-thresholdnotification | - | Graph; over-thresholdnotification | Same |
| X-Axis | Linear scale; units oftime; user-adjustable | Linear scale; units oftime; user-adjustable | - | Linear scale; units oftime; user-adjustable | Same |
| Y -Axis | Linear or Log scale;units of uV; user-adjustable | Linear scale; units ofuV; user-adjustable | - | Linear scale; units ofuV; user-adjustable | Same |
| User AdjustableFilters | High cut and low cutfilters | Notch, high cut, andlow cut filters | - | Notch filter | Filtering is performedas a preliminary step,before the trendanalysis. Lack of highand low-cut filters doesnot change theintended use and itdoes not raise differentquestions of safety andeffectiveness asperformance testing(validation of theanalyzers) has been |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| submitted todemonstrate substantialequivalence. | |||||
| Asymmetry Trend | |||||
| Trend Available | No | Yes | No | Yes | |
| Asymmetry Trend | |||||
| Notification Available | - | Yes | - | Yes | Same |
| Analysis Input | - | EEG data; user-selected channelsrestricted tohomologous inputs | - | EEG data; user-selected channelsrestricted tohomologous inputs | Same |
| Analysis Output | - | Graph; over-thresholdnotification | - | Graph; over-thresholdnotification | Same |
| X-Axis | - | Linear scale; units oftime; user-adjustable | - | Linear scale; units oftime; user-adjustable | Same |
| Y-Axis | - | Linear scale; units ofpercent; user-adjustable | - | Linear scale; units ofpercent; user-adjustable | Same |
| User AdjustableFilters | - | Notch, high cut, andlow cut filters | - | Notch filter | Filtering is performedas a preliminary step,before the trendanalysis. Lack of highand low-cut filters does |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| not change theintended use and itdoes not raise differentquestions of safety andeffectiveness asperformance testing(validation of theanalyzers) has beensubmitted todemonstrate substantialequivalence. | |||||
| Burst Suppression Ratio | |||||
| Trend Available | Yes | No | No | Yes | - |
| Notification Available | No | - | - | No | Same |
| Analysis Input | EEG data; user-selected channels | - | - | EEG data; user-selected channels | Same |
| Analysis Output | Graph and numericalvalue | - | - | Graph and numericalvalue | Same |
| X-Axis | Linear scale; units oftime; user-adjustable | - | - | Linear scale; units oftime; user-adjustable | Same |
| Y-Axis | Linear scale; units ofpercent; user-adjustable | - | - | Linear scale; units ofpercent; fixed scale | Same |
| User AdjustableFilters | High-cut and low-cutfilters | - | - | Notch filter | Filtering is performedas a preliminary step,before the trend |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| analysis. Lack of highand low-cut filters doesnot change theintended use and itdoes not raise differentquestions of safety andeffectiveness asperformance testing(validation of theanalyzers) has beensubmitted todemonstrate substantialequivalence. | |||||
| Inter-burst Interval | |||||
| Trend Available | Yes | No | No | Yes | - |
| Inter-burst Interval | |||||
| Notification Available | No | - | - | No | Same |
| Analysis Input | EEG data; user-selected channels | - | - | EEG data; user-selected channels | Same |
| Analysis Output | Graph and numericalvalue | - | - | Graph and numericalvalue | Same |
| X-Axis | Linear scale; units oftime; user-adjustable | - | - | Linear scale; units oftime; user-adjustable | Same |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| Y-Axis | Linear scale; units oftime; user-adjustable | - | - | Linear scale; units oftime; user-adjustable | Same |
| User AdjustableFilters | High-cut and low-cutfilters | - | - | Notch filter | Filtering is performedas a preliminary step,before the trendanalysis. Lack of highand low-cut filters doesnot change theintended use and itdoes not raise differentquestions of safety andeffectiveness asperformance testing(validation of theanalyzers) has beensubmitted todemonstrate substantialequivalence. |
| Bursts-per-Minute | |||||
| Trend Available | Yes | No | No | Yes | Same |
| Notification Available | No | - | - | No | Same |
| Analysis Input | EEG data; user-selected channels | - | - | EEG data; user-selected channels | Same |
| Device (Right) →Item of Comparison(Below) | NicoletOneK173366 | Persyst 13 EEG Reviewand Analysis SoftwarePrimary PredicateK151929 | Cadwell AmpliscanK161027 | Cadwell BoltSubject DeviceK190760 | Comments |
| Analysis Output | Graph and numericalvalue | - | - | Graph and numericalvalue | Same |
| X-Axis | Linear scale; units oftime; user-adjustable | - | - | Linear scale; units oftime; user-adjustable | Same |
| Y-Axis | Linear scale; units of #of bursts; user-adjustable | - | - | Linear scale; units of #of bursts; user-adjustable | Same |
| User AdjustableFilters | High-cut and low-cutfilters | - | - | Notch filter | Filtering is performedas a preliminary step,before the trendanalysis. Lack of highand low-cut filters doesnot change theintended use and itdoes not raise differentquestions of safety andeffectiveness asperformance testing(validation of theanalyzers) has beensubmitted todemonstrate substantialequivalence. |
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Electrical Safety and Electromagnetic Compatibility Testing:
Non-Clinical Performance Testing:
Not Applicable: Software-only
The Cadwell Bolt Software was tested for performance in accordance with internal requirements. Additionally, software verification and validation were performed to test the implementation of the Bolt analyzers and the overall function of Bolt software. Overall implementation of Bolt measures was tested by analyzing known arbitrary EEG data and confirming that the expected output was obtained. By these results, the Cadwell Bolt Software meets predetermined requirements for the 10 analyzers proposed in this 510(k).
Cadwell Bolt Software implements public domain (nonproprietary) quantitative analysis measures that are identical or similar to the predicate devices identified in this submission. Arbitrary data of known value was input, and results were compared for each Cadwell Bolt Software analyzer proposed in this 510(k) and each predicate which has been identified as containing the analyzer to demonstrate substantial equivalence. The results were similar in morphology and magnitude for each measure, the pre-specified criteria necessary to demonstrate adequate performance. Minor differences were observed in the trend outputs, but these subtle differences were due to smoothing and graphical display; they do not affect overall morphology of the output. Therefore, given the identical inputs and adequately similar outputs, the performance data are adequate to demonstrate that the proposed Cadwell Bolt Software is substantially equivalent to the identified predicate analyzers.
Additional analysis of the results included the following: the graphical outputs from Bolt and the predicate devices were quantified and a correlation coefficient was calculated between the two device outputs. For trends with a quantitative output displayed to the user. percent difference was also calculated. The percent difference calculation provides comparisons of amplitudes while the correlation coefficient provides comparison of morphology.
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Correlation values greater than 0.80 and percent difference values less than 10% were considered to be substantially equivalent. Known/generated inputs were analyzed for applicable trends and all correlation values were greater than or equal to 0.900. Quantitative analysis was also performed on sample EEG data at various time scales and with various montages and/or frequency bands. These results are summarized in the tables to follow:
Peak Envelope
| 15-minute | 1-hour | 4-hour | 8-hour | |
|---|---|---|---|---|
| All 10/20 | .951 | .917 | .913 | .896 |
| Left Hemi | .933 | .933 | .931 | .879 |
| Right Hemi | .949 | .946 | .911 | .898 |
Envelope Asymmetry
| 15-minute | 1-hour | 4-hour | 8-hour | |
|---|---|---|---|---|
| 6-14Hz | .909 | .859 | .857 | .819 |
| 2-18Hz | .913 | .857 | .850 | .817 |
Spectrogram
| 15-minute | 1-hour | 4-hour | 8-hour | |
|---|---|---|---|---|
| All 10/20 | .938 | .969 | .825 | .852 |
| Left Hemi | .934 | .958 | .826 | .851 |
| Right Hemi | .969 | .947 | .848 | .852 |
Band Power
| 15-minute | 1-hour | 4-hour | 8-hour | |
|---|---|---|---|---|
| All 10/207-12Hz | .955 | .898 | .874 | .891 |
| Right Hemi8-13Hz | .935 | .870 | .890 | .857 |
| Left Hemi8-13Hz | .939 | .901 | .894 | .892 |
| Right Hemi13-20Hz | .944 | .910 | .915 | .917 |
| Left Hemi13-20Hz | .927 | .897 | .929 | .933 |
Power Ratio
| 15-minute | 1-hour | 4-hour | 8-hour | |
|---|---|---|---|---|
| All 10/20 | .938 | .923 | .902 | .867 |
| Left Hemi | .966 | .914 | .845 | .850 |
| Right Hemi | .896 | .902 | .843 | .850 |
Spectral Entropy
| 15-minute | 1-hour | 4-hour | 8-hour | |
|---|---|---|---|---|
| Correlation | .957 | .961 | .998 | .972 |
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| Percent | 5.3 | 3.4 | 8.7 | 7.2 |
|---|---|---|---|---|
| Difference |
Burst Suppression
| IBI | BSR | BPM | |
|---|---|---|---|
| Correlation | 0.992 | 0.999 | 0.999 |
| Percent Difference | 1.25 | 1.37 | 1.94 |
The resulting correlation coefficients and percent differences supported the determination of substantial equivalence.
Verification and validation activities were performed to Conclusion: demonstrate that the Cadwell Bolt Software is substantially equivalent to the predicate device.
§ 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).