Cadwell Bolt Software

K190760 · Cadwell Industries, Inc. · OLT · Nov 23, 2019 · Neurology

Device Facts

• Record ID: K190760
• Device Name: Cadwell Bolt Software
• Applicant: Cadwell Industries, Inc.
• Product Code: OLT · Neurology
• Decision Date: Nov 23, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

Cadwell Bolt is intended to be used in conjunction with Cadwell Acquisition Software. The Cadwell Bolt device is for use by qualified medical practitioners and does not provide any diagnostic conclusions about the patient's condition to the user. The Cadwell Bolt Software is intended to be used for post-hoc analysis of EEG software to analyze electroencephalograph (EEG) data using conventional methodology to output and display standard EEG parameters for interpretation by a qualified user. The device uses software algorithms as a tool to analyze EEG recordings to calculate conventional EEG parameters. (e.g. spectral edge frequency, percent alpha, asymmetry). 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.

Device Story

Cadwell Bolt is a software-only device for post-hoc analysis of EEG data. It accepts user-selected EEG channels as input and calculates ten quantitative measures: aEEG, peak envelope, envelope asymmetry, spectrogram, band power, power ratio, spectral entropy, burst suppression ratio, inter-burst interval, and bursts-per-minute. The device displays these measures graphically for interpretation by qualified medical practitioners. Users can define thresholds for specific trends; the software provides visual notifications (yellow indicator) and optional data highlighting when thresholds are exceeded. It does not provide diagnostic conclusions or automated detection. Used in clinical settings by medical professionals, the device aids in monitoring brain state and analyzing EEG recordings. It benefits patients by providing quantitative trends to assist clinicians in reviewing EEG data.

Clinical Evidence

Bench testing only. No clinical data. Performance validated by comparing Bolt outputs against predicate device outputs using known arbitrary EEG data and sample EEG recordings. Metrics included correlation coefficients (all >=0.900) and percent differences (all <10%) for all 10 quantitative analyzers across various time scales (15-min to 8-hour) and montages.

Technological Characteristics

Software-only device operating on a computer. Implements 10 quantitative EEG analysis algorithms (aEEG, spectral, burst suppression). Features include user-defined thresholding, notch filtering, and graphical trend display. No hardware components. Connectivity is via integration with Cadwell Acquisition Software.

Indications for Use

Indicated for post-hoc analysis of EEG data in patients of all ages. Intended for use by qualified medical practitioners to calculate and display quantitative measures (aEEG, Peak Envelope, Envelope Asymmetry, Spectrogram, Band Power, Power Ratio, Spectral Entropy, Burst Suppression Ratio, Inter-burst Interval, Bursts-per-Minute).

Regulatory Classification

Identification

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

Predicate Devices

• Persyst 13 EEG Review and Analysis Software (K151929)
• NicoletOne (K173366)
• Cadwell Ampliscan (K161027)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

1. 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.

2. 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.

3. The aEEG functionality included in Cadwell Bolt is intended to monitor the state of the brain.

4. 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)

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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.<br>909 N. Kellogg Street<br>Kennewick, Washington 99336<br>509-735-6481 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Emily Whitehead, Project Engineer<br>[e-mail] |
| 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 quantitative<br>electroencephalograph (EEG) software<br>ORT (secondary) burst suppression detection software for<br>electroencephalograph<br>OMA amplitude-integrated electroencephalograph (aEEG) |
| Review Panel: | Neurological and Physical Medicine Devices (OHT5)<br>Neurosurgical, Neurointerventional and Neurodiagnostic<br>Devices (DHT5A) |
| Predicate Device: | K151929 Persyst 13 EEG Review and Analysis Software;<br>Primary Predicate<br>K173366 NicoletOne; Secondary predicate<br>K161027 Cadwell Ampliscan; Secondary predicate |
| Device Description: | Cadwell Bolt is a software-only device for use with EEG<br>data. The Cadwell Bolt receives EEG data as an input and<br>uses this input to calculate and display the following<br>quantitative measures of electroencephalographic data:<br>(1) amplitude integrated EEG (aEEG),<br>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 with<br>Cadwell Acquisition Software. The Cadwell Bolt device is<br>for use by qualified medical practitioners and does not<br>provide any diagnostic conclusions about the patient's<br>condition to the user. |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Cadwell Bolt Software is intended to be used for post-<br>hoc analysis of EEG software to analyze<br>electroencephalograph (EEG) data using conventional<br>methodology to output and display standard EEG<br>parameters for interpretation by a qualified user.<br>The device uses software algorithms as a tool to analyze<br>EEG recordings to calculate conventional EEG parameters.<br>(e.g. spectral edge frequency, percent alpha, asymmetry). |
| | This device does not provide any diagnostic conclusion<br>about the patient's condition to the user as part of its output.<br>The software does not contain automated detection<br>algorithms. |

| Primary Predicate K151929 | Subject Device K190760 | Comments |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Persyst 13 Software | Cadwell Bolt | |
| 1. Persyst 13 EEG Review and Analysis<br>Software is intended for the review,<br>monitoring and analysis of EEG<br>recordings made by<br>electroencephalogram (EEG) devices<br>using scalp electrodes and to aid<br>neurologists in the assessment of<br>EEG. This device is intended to be<br>used by qualified medical<br>practitioners who will exercise<br>professional judgment in using the<br>information.<br><br>2. The Seizure Detection and Seizure<br>Probability component of Persyst 13 is<br>intended to mark previously acquired<br>sections of the adult (greater than or<br>equal to 18 years old) EEG recordings<br>that may correspond to<br>electrographic seizures, in order to<br>assist qualified clinical practitioners in<br>the assessment of EEG traces. EEG<br>recordings should be obtained with a | 1. Cadwell Bolt is a software-only device<br>intended for post-hoc analysis of EEG<br>data. This device is intended to be<br>used by qualified medical<br>practitioners who will exercise<br>professional judgment in using the<br>information. This device is intended<br>to be used with EEG data from<br>patients of all ages.<br><br>2. Cadwell Bolt includes the calculation<br>and display of a set of quantitative<br>measures intended to monitor and<br>analyze the EEG data. These include<br>the following 10 analyzers:<br>-Amplitude Integrated EEG (aEEG),<br>-Peak Envelope,<br>-Envelope Asymmetry,<br>-Spectrogram,<br>-Band Power,<br>-Power Ratio,<br>-Spectral Entropy,<br>-Burst Suppression Ratio,<br>-Inter-burst Interval, and | The propose IFU is a subset of the<br>predicate device. Quantitative measures<br>are listed in the Cadwell Bolt indications<br>for use (#2); Additional quantitative<br>measures not included with K151929 are<br>covered by the secondary predicate<br>devices that were cleared in the same<br>regulation for the same intended use.<br><br>All newly proposed quantitative measures<br>are verified against Cadwell internal<br>requirements and validated to demonstrate<br>substantial equivalence as compared to the<br>predicate device implementation; the<br>validation testing was submitted as part of<br>this 510(k) submission. Both devices are<br>prescription use only, are intended to be<br>used with EEG data for post-hoc analysis,<br>and are intended to be used by medical<br>professionals. Neither Bolt nor the primary<br>predicate device provide diagnostic<br>conclusions to the user as part of the<br>output.<br><br>Wording differences appear for the sake of<br>clarification purposes only. Differences in |
| Primary Predicate K151929 | Subject Device K190760 | Comments |
| Persyst 13 Software | Cadwell Bolt | |
| full scalp montage according to the<br>standard 10/20 system.<br>3. The Spike Detection component of<br>Persyst 13 is intended to mark<br>previously acquired sections of the<br>patient's EEG recordings that may<br>correspond to spikes, in order to<br>assist qualified clinical practitioners in<br>the assessment of EEG traces. The<br>Spike Detection component is<br>intended to be used in patients at<br>least one month old. Persyst 13 Spike<br>Detection performance has not been<br>assessed for intracranial recordings.<br>4. Persyst 13 includes the calculation<br>and display of a set of quantitative<br>measures intended to monitor and<br>analyze the EEG waveform. These<br>include FFT, Rhythmicity, Peak<br>Envelope, Artifact Intensity,<br>Amplitude, Relative Symmetry and<br>Suppression Ratio. Automatic event<br>marking is not applicable to the<br>quantitative measures. These<br>quantitative EEG measures should<br>always be interpreted in conjunction | -Bursts-per-Minute.<br>These quantitative EEG measures<br>should always be interpreted in<br>conjunction with review of the<br>original EEG data. A minimum of one<br>epoch of data is required to perform<br>Bolt analysis.<br>3. The aEEG functionality included in<br>Cadwell Bolt is intended to monitor<br>the state of the brain.<br>4. Cadwell Bolt can provide<br>notifications, based on user-defined<br>thresholds, for quantitative EEG<br>measures such as a notification within<br>the application software that can be<br>used when processing a record during<br>acquisition. Delays can occur between<br>the beginning of an event and when<br>the Bolt notification will be shown to<br>a user. Cadwell Bolt notifications<br>cannot be used as a substitute for<br>real-time monitoring of the<br>underlying EEG data by a trained<br>expert. | the IFUs between the subject and predicate<br>devices do not change the intended use<br>between the devices. |
| with review of the original EEG<br>waveforms.<br>5. The aEEG functionality included in<br>Persyst 13 is intended to monitor the<br>state of the brain. The automated<br>event marking function of Persyst 13<br>is not applicable to aEEG. | This device does not provide any<br>diagnostic conclusion about the patient's<br>condition to the user as part of its output.<br>The software does not contain automated<br>detection algorithms. | |
| 6. Persyst 13 provides notifications for<br>seizure detection, quantitative EEG<br>and aEEG that can be used when<br>processing a record during<br>acquisition. These include an on<br>screen display and the optional<br>sending of an email message. Delays<br>of up to several minutes can occur<br>between the beginning of a seizure<br>and when the Persyst 13<br>notifications will be shown to a user.<br>Persyst 13 notifications cannot be<br>used as a substitute for real time<br>monitoring of the underlying EEG by<br>a trained expert. | | |
| Primary Predicate K151929 | Subject Device K190760 | Comments |
| Persyst 13 Software | Cadwell Bolt | |
| 7. Persyst AR (Artifact Reduction) is<br>intended to reduce EMG, eye<br>movement, and electrode artifacts<br>in a standard 10-20 EEG recording.<br>AR does not remove the entire<br>artifact signal, and is not effective<br>for other types of artifacts. AR may<br>modify portions of waveforms<br>representing cerebral activity.<br>Waveforms must still be read by a<br>qualified medical practitioner<br>trained in recognizing artifact, and<br>any interpretation or diagnosis must<br>be made with reference to the<br>original waveforms.<br>This device does not provide any<br>diagnostic conclusion about the patient's<br>condition 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) →<br>Item of Comparison<br>(Below) | NicoletOne<br>K173366 | Persyst 13 EEG Review<br>and Analysis Software<br>Primary Predicate<br>K151929 | Cadwell Ampliscan<br>K161027 | Cadwell Bolt<br>Subject Device<br>K190760 | 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 |
| Classifying<br>Regulation | 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 are<br>software-only and<br>operate on a computer. |
| Amplitude-integrated EEG Trend | | | | | |
| Trend Available | Yes | Yes | Yes | Yes | Same |
| Notification Available | N/A | Yes | No | No | The predicate device<br>offers notifications for<br>the amplitude<br>integrated EEG trend.<br>whereas Bolt does not<br>offer notifications for<br>this specific trend.<br>Page 2 of this |

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| Device (Right) →<br>Item of Comparison<br>(Below) | NicoletOne<br>K173366 | Persyst 13 EEG Review<br>and Analysis Software<br>Primary Predicate<br>K151929 | Cadwell Ampliscan<br>K161027 | Cadwell Bolt<br>Subject Device<br>K190760 | Comments |
|---------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | Summary includes the<br>notifications that are<br>included with other<br>analyzers. This feature<br>is a convenience and is<br>based on user-defined<br>thresholds which are<br>pre-set and lack of this<br>feature does not affect<br>the intended use of the<br>device. |
| | | | Amplitude-integrated EEG Trend | | |
| Analysis Input | EEG data; user-<br>selected channels | EEG data; user-<br>selected channels | EEG data; user-<br>selected channels | EEG data; user-<br>selected channels | Same |
| Analysis Output | Graph | Graph; Over-threshold<br>notification | Graph | Graph | Same |
| X-Axis | Linear scale; units of<br>time; user-adjustable | Linear scale; units of<br>time; user-adjustable | Linear scale; units of<br>time; user-adjustable | Linear scale; units of<br>time; user-adjustable | Same |
| Y-Axis | Semi-log scale; units of<br>uV; user-adjustable | Semi-log scale; units of<br>uV; fixed scale | Semi-log scale; units of<br>uV; fixed scale | Semi-log scale; units of<br>uV (microvolts); fixed<br>scale | Same |

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| Device (Right) →<br>Item of Comparison<br>(Below) | NicoletOne<br>K173366 | Persyst 13 EEG Review<br>and Analysis Software<br>Primary Predicate<br>K151929 | Cadwell Ampliscan<br>K161027 | Cadwell Bolt<br>Subject Device<br>K190760 | Comments |
|---------------------------------------------------|---------------------------------|--------------------------------------------------------------------------------|------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Adjustable<br>Filters | High cut and low-cut<br>filters | Notch, high-cut, and<br>low-cut filters | Notch filter | Notch filter | Filtering is performed<br>as a preliminary step,<br>before the trend<br>analysis. Lack of high<br>and low-cut filters does<br>not change the<br>intended use and it<br>does not raise different<br>questions of safety and<br>effectiveness as<br>performance testing<br>(validation of the<br>analyzers) has been<br>submitted to<br>demonstrate substantial<br>equivalence. |
| Power Ratio Trend | | | | | |
| Trend Available | No | Yes | No | Yes | - |

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| Device (Right) →<br>Item of Comparison<br>(Below) | NicoletOne<br>K173366 | Persyst 13 EEG Review<br>and Analysis Software<br>Primary Predicate<br>K151929 | Cadwell Ampliscan<br>K161027 | Cadwell Bolt<br>Subject Device<br>K190760 | Comments |
|---------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Ratio Trend | | | | | |
| Notification Available | NA | Yes | - | Yes | Bolt notification<br>consists of a yellow<br>indicator adjacent to<br>the trend. Optionally,<br>Bolt notification<br>highlights the EEG<br>data for the duration<br>that the trend is over-<br>threshold. The<br>predicate, K151929<br>Persyst 13, marks and<br>displays notifications<br>in the EEG data and<br>can optionally send an<br>email to the user if a<br>trend is over-threshold.<br>Although the<br>notification |
| Device (Right) → | NicoletOne<br>K173366 | Persyst 13 EEG Review<br>and Analysis Software<br>Primary Predicate<br>K151929 | Cadwell Ampliscan<br>K161027 | Cadwell Bolt<br>Subject Device<br>K190760 | Comments |
| Item of Comparison<br>(Below) | | | | | methodology is slightly<br>different, both the<br>subject device and<br>predicate device<br>perform threshold<br>notifications in a<br>similar manner. |
| Power Ratio Trend | | | | | |
| Analysis Input | - | EEG data; user-<br>selected channels | - | EEG data; user-<br>selected channels | Same |
| Analysis Output | - | Graph; over-threshold<br>notification | - | Graph; over-threshold<br>notification | Same |
| X-Axis | - | Linear scale; units of<br>time; user-adjustable | - | Linear scale; units of<br>time; user-adjustable | Same |
| Y-Axis | - | Linear scale; numerical<br>values; user-adjustable | - | Linear scale; numerical<br>values; user-adjustable | Same |
| User Adjustable<br>Filters | - | Notch, high cut, and<br>low-cut filters | - | Notch filter only | Filtering is performed<br>as a preliminary step,<br>before the trend<br>analysis. Lack of high<br>and low-cut filters does<br>not change the<br>intended use and it<br>does not raise different<br>questions of safety and<br>effectiveness as<br>performance testing |
| Device (Right) →<br>Item of Comparison<br>(Below) | NicoletOne<br>K173366 | Persyst 13 EEG Review<br>and Analysis Software<br>Primary Predicate<br>K151929 | Cadwell Ampliscan<br>K161027 | Cadwell Bolt<br>Subject Device<br>K190760 | Comments |
| | | | | | (validation of the<br>analyzers) has been<br>submitted to<br>demonstrate substantial<br>equivalence. |
| Band Power Trend | | | | | |
| Trend Available | Yes | Yes | No | Yes | - |
| Notification Available | NA | Yes | - | Yes | Bolt notification<br>consists of a yellow<br>indicator adjacent to<br>the trend. Optionally,<br>Bolt notification<br>highlights the EEG<br>data for the duration<br>that the trend is over-<br>threshold. The<br>predicate, K151929<br>Persyst 13, marks and<br>displays notifications<br>in the EEG data and<br>can optionally send on |
| Device (Right) →<br>Item of Comparison<br>(Below) | NicoletOne<br>K173366 | Persyst 13 EEG Review<br>and Analysis Software<br>Primary Predicate<br>K151929 | Cadwell Ampliscan<br>K161027 | Cadwell Bolt<br>Subject Device<br>K190760 | Comments |
| | | | | | email to the user if a<br>trend is over-threshold.<br>Although the<br>notification<br>methodology is slightly<br>different, both the<br>subject device and<br>predicate device<br>perform threshold<br>notifications in a<br>similar manner. |
| | | | Band Power Trend | | |
| Analysis Input | EEG data; user-<br>selected channels | EEG data; user-<br>selected channels | - | EEG data; user-<br>selected channels | Same |
| Analysis Output | Graph…