(243 days)
Not Found
No
The document explicitly states, "The software does not contain automated detection algorithms." and describes the device as performing calculations of standard quantitative EEG measures based on user-defined parameters and thresholds. There is no mention of AI, ML, or training/test data sets typically associated with such technologies.
No.
The device is described as a software-only device intended for post-hoc analysis of EEG data, providing quantitative measures to monitor and analyze EEG data, and providing notifications based on user-defined thresholds. It explicitly states, "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." Its function is analytical and monitoring, not therapeutic intervention.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "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." It is intended for post-hoc analysis by qualified medical practitioners who will exercise professional judgment and interpret the results in conjunction with the original EEG data.
Yes
The device is explicitly described as a "software-only device" in both the Intended Use and Device Description sections. It performs analysis on existing EEG data and does not include any hardware components for data acquisition or patient interaction.
Based on the provided information, the Cadwell Bolt device is not an In Vitro Diagnostic (IVD). Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. The tests are performed outside of the body (in vitro).
- Cadwell Bolt's Function: Cadwell Bolt analyzes EEG data, which is electrical activity recorded from the brain. This data is acquired directly from the patient's body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it's for "post-hoc analysis of EEG data" and "to monitor and analyze the EEG data." It does not mention analyzing biological samples.
- Device Description: The device description confirms it "receives EEG data as an input" and calculates quantitative measures based on this data.
Therefore, because Cadwell Bolt analyzes data acquired directly from the patient's body rather than from an in vitro sample, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- 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.
Product codes (comma separated list FDA assigned to the subject device)
OLT, OMA, ORT
Device Description
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 user-defined 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 user-defined 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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG data
Anatomical Site
Not Found
Indicated Patient Age Range
all ages.
Intended User / Care Setting
qualified medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation
Percent Difference
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.
Key metrics from studies:
Peak Envelope:
15-minute: 0.896 - 0.951
1-hour: 0.917 - 0.946
4-hour: 0.911 - 0.931
8-hour: 0.879 - 0.898
Envelope Asymmetry:
15-minute: 0.909 - 0.913
1-hour: 0.857 - 0.859
4-hour: 0.850 - 0.857
8-hour: 0.817 - 0.819
Spectrogram:
15-minute: 0.934 - 0.969
1-hour: 0.947 - 0.969
4-hour: 0.825 - 0.848
8-hour: 0.851 - 0.852
Band Power:
15-minute: 0.927 - 0.955
1-hour: 0.870 - 0.910
4-hour: 0.874 - 0.929
8-hour: 0.857 - 0.933
Power Ratio:
15-minute: 0.896 - 0.966
1-hour: 0.902 - 0.923
4-hour: 0.843 - 0.902
8-hour: 0.850 - 0.867
Spectral Entropy:
Correlation: 0.957 - 0.998
Percent Difference: 3.4 - 8.7
Burst Suppression:
Correlation:
IBI: 0.992
BSR: 0.999
BPM: 0.999
Percent Difference:
IBI: 1.25
BSR: 1.37
BPM: 1.94
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
2
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.
3
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4
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 Street
Kennewick, Washington 99336
509-735-6481 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Emily Whitehead, Project Engineer
emilyw@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 quantitative
electroencephalograph (EEG) software
ORT (secondary) burst suppression detection software for
electroencephalograph
OMA amplitude-integrated electroencephalograph (aEEG) |
| Review Panel: | Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic
Devices (DHT5A) |
| Predicate Device: | K151929 Persyst 13 EEG Review and Analysis Software;
Primary Predicate
K173366 NicoletOne; Secondary predicate
K161027 Cadwell Ampliscan; Secondary predicate |
| Device Description: | 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),
Page 1 of 26 |
5
- (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)
6
| 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. |
| Primary Predicate K151929 | Subject Device K190760 | Comments |
|---|---|---|
| Persyst 13 Software | Cadwell Bolt | |
| 1. Persyst 13 EEG Review and Analysis | ||
| Software is intended for the review, | ||
| monitoring and analysis of EEG | ||
| recordings made by | ||
| electroencephalogram (EEG) devices | ||
| using scalp electrodes and to aid | ||
| neurologists in the assessment of | ||
| EEG. This device is intended to be | ||
| used by qualified medical | ||
| practitioners who will exercise | ||
| professional judgment in using the | ||
| information. |
-
The Seizure Detection and Seizure
Probability component of Persyst 13 is
intended to mark previously acquired
sections of the adult (greater than or
equal to 18 years old) 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 a | 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. -
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 | The propose IFU is a subset of the
predicate device. Quantitative measures
are listed in the Cadwell Bolt indications
for use (#2); Additional quantitative
measures not included with K151929 are
covered by the secondary predicate
devices that were cleared in the same
regulation for the same intended use.
All newly proposed quantitative measures
are verified against Cadwell internal
requirements and validated to demonstrate
substantial equivalence as compared to the
predicate device implementation; the
validation testing was submitted as part of
this 510(k) submission. Both devices are
prescription use only, are intended to be
used with EEG data for post-hoc analysis,
and are intended to be used by medical
professionals. Neither Bolt nor the primary
predicate device provide diagnostic
conclusions to the user as part of the
output.
Wording differences appear for the sake of
clarification purposes only. Differences in |
| Primary Predicate K151929 | Subject Device K190760 | Comments |
| Persyst 13 Software | Cadwell Bolt | |
| full scalp montage according to the
standard 10/20 system.
3. The Spike Detection component of
Persyst 13 is intended to mark
previously acquired sections of the
patient's EEG recordings that may
correspond to spikes, in order to
assist qualified clinical practitioners in
the assessment of EEG traces. The
Spike Detection component is
intended to be used in patients at
least one month old. Persyst 13 Spike
Detection performance has not been
assessed for intracranial recordings.
4. Persyst 13 includes the calculation
and display of a set of quantitative
measures intended to monitor and
analyze the EEG waveform. These
include FFT, Rhythmicity, Peak
Envelope, Artifact Intensity,
Amplitude, Relative Symmetry and
Suppression Ratio. Automatic event
marking is not applicable to the
quantitative measures. These
quantitative EEG measures should
always be interpreted in conjunction | -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. | the IFUs between the subject and predicate
devices do not change the intended use
between the devices. |
| with review of the original EEG
waveforms.
5. The aEEG functionality included in
Persyst 13 is intended to monitor the
state of the brain. The automated
event marking function of Persyst 13
is not applicable to aEEG. | 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. | |
| 6. Persyst 13 provides notifications for
seizure detection, quantitative EEG
and aEEG that can be used when
processing a record during
acquisition. These include an on
screen display and the optional
sending of an email message. Delays
of up to several minutes can occur
between the beginning of a seizure
and when the Persyst 13
notifications will be shown to a user.
Persyst 13 notifications cannot be
used as a substitute for real time
monitoring of the underlying EEG by
a trained expert. | | |
| Primary Predicate K151929 | Subject Device K190760 | Comments |
| Persyst 13 Software | Cadwell Bolt | |
| 7. Persyst AR (Artifact Reduction) is
intended to reduce EMG, eye
movement, and electrode artifacts
in a standard 10-20 EEG recording.
AR does not remove the entire
artifact signal, and is not effective
for other types of artifacts. AR may
modify portions of waveforms
representing cerebral activity.
Waveforms must still be read by a
qualified medical practitioner
trained in recognizing artifact, and
any interpretation or diagnosis must
be made with reference to the
original waveforms.
This device does not provide any
diagnostic conclusion about the patient's
condition to the user. | | |
Table 1: Comparison of Indications for Use to Primary Predicate
7
8
9
Substantial Equivalence
Table 2: Comparison of Subject Device's Technological Characteristics to Predicates
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
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
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
software-only and
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
offers notifications for
the amplitude
integrated EEG trend.
whereas Bolt does not
offer notifications for
this specific trend.
Page 2 of this |
10
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
|---------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | Summary includes the
notifications that are
included with other
analyzers. This feature
is a convenience and is
based on user-defined
thresholds which are
pre-set and lack of this
feature does not affect
the intended use of the
device. |
| | | | 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-threshold
notification | Graph | Graph | Same |
| X-Axis | Linear scale; units of
time; user-adjustable | Linear scale; units of
time; user-adjustable | Linear scale; units of
time; user-adjustable | Linear scale; units of
time; user-adjustable | Same |
| Y-Axis | Semi-log scale; units of
uV; user-adjustable | Semi-log scale; units of
uV; fixed scale | Semi-log scale; units of
uV; fixed scale | Semi-log scale; units of
uV (microvolts); fixed
scale | Same |
11
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
|---------------------------------------------------|---------------------------------|--------------------------------------------------------------------------------|------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Adjustable
Filters | High cut and low-cut
filters | Notch, high-cut, and
low-cut filters | Notch filter | Notch filter | Filtering is performed
as a preliminary step,
before the trend
analysis. Lack of high
and low-cut filters does
not change the
intended use and it
does not raise different
questions of safety and
effectiveness as
performance testing
(validation of the
analyzers) has been
submitted to
demonstrate substantial
equivalence. |
| Power Ratio Trend | | | | | |
| Trend Available | No | Yes | No | Yes | - |
12
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
|---------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Ratio Trend | | | | | |
| Notification Available | NA | Yes | - | Yes | Bolt notification
consists of a yellow
indicator adjacent to
the trend. Optionally,
Bolt notification
highlights the EEG
data for the duration
that the trend is over-
threshold. The
predicate, K151929
Persyst 13, marks and
displays notifications
in the EEG data and
can optionally send an
email to the user if a
trend is over-threshold.
Although the
notification |
| Device (Right) → | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| Item of Comparison
(Below) | | | | | methodology is slightly
different, both the
subject device and
predicate device
perform threshold
notifications in a
similar manner. |
| Power Ratio Trend | | | | | |
| Analysis Input | - | EEG data; user-
selected channels | - | EEG data; user-
selected channels | Same |
| Analysis Output | - | Graph; over-threshold
notification | - | Graph; over-threshold
notification | Same |
| X-Axis | - | Linear scale; units of
time; user-adjustable | - | Linear scale; units of
time; user-adjustable | Same |
| Y-Axis | - | Linear scale; numerical
values; user-adjustable | - | Linear scale; numerical
values; user-adjustable | Same |
| User Adjustable
Filters | - | Notch, high cut, and
low-cut filters | - | Notch filter only | Filtering is performed
as a preliminary step,
before the trend
analysis. Lack of high
and low-cut filters does
not change the
intended use and it
does not raise different
questions of safety and
effectiveness as
performance testing |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| | | | | | (validation of the
analyzers) has been
submitted to
demonstrate substantial
equivalence. |
| Band Power Trend | | | | | |
| Trend Available | Yes | Yes | No | Yes | - |
| Notification Available | NA | Yes | - | Yes | Bolt notification
consists of a yellow
indicator adjacent to
the trend. Optionally,
Bolt notification
highlights the EEG
data for the duration
that the trend is over-
threshold. The
predicate, K151929
Persyst 13, marks and
displays notifications
in the EEG data and
can optionally send on |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| | | | | | email to the user if a
trend is over-threshold.
Although the
notification
methodology is slightly
different, both the
subject device and
predicate device
perform threshold
notifications in a
similar 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-threshold
notification | - | Graph; over-threshold
notification | Same |
| X-Axis | Linear scale; units of
time; user-adjustable | Linear scale; units of
time; user-adjustable | - | Linear scale; units of
time; user-adjustable | Same |
| Y-Axis | Linear or Log scale;
units of percent; user-
adjustable | Linear scale: numerical
values; user-adjustable | - | Linear scale; units of
percent; user-
adjustable | Same |
| User Adjustable
Filters | High cut and low-cut
filters | Notch, high cut, and
low-cut filters | - | Notch filter | Filtering is performed
as a preliminary step,
before the trend
analysis. Lack of high
and low-cut filters does
not change the |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| | | | | | intended use and it
does not raise different
questions of safety and
effectiveness as
performance testing
(validation of the
analyzers) has been
submitted to
demonstrate substantial
equivalence. |
| | | | Spectrogram Trend | | |
| Trend Available | Yes | Yes | No | Yes | - |
| Notification Available | NA | No | - | Yes | The predicate device
offers notifications for
the amplitude
integrated EEG trend,
whereas Bolt does not
offer notifications for
this specific trend.
Page 2 of this
Summary includes the
notifications that are
included with other
analyzers. This feature
is a convenience and is
based on user-defined
thresholds which are |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| | | | | | pre-set and lack of this
feature does not affect
the intended use of the
device. |
| Analysis Input | EEG data; user-
selected channels | EEG data; user-
selected channels | - | EEG data; user-
selected channels | Same |
| Analysis Output | Graph | Graph | - | Graph; over-threshold
notification | Additional notification
output is available in
Bolt. This option is
made available for
users' preference and
does not affect the
primary analysis output
which is similar
between the subject
and predicate devices. |
| X-Axis | Linear scale; units of
time; user-adjustable | Linear scale; units of
time; user-adjustable | - | Linear scale; units of
time; user-adjustable | Same |
| Spectrogram Trend | | | | | |
| Y-Axis | Linear or Log scale;
user-adjustable | Linear scale; units of
Hz; user-adjustable | - | Linear scale; units of
Hz; user-adjustable | Same |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| User Adjustable
Filters | High cut and low-cut
filters | Notch, high cut, and
low-cut filters | - | Notch filter | Filtering is performed
as a preliminary step,
before the trend
analysis. Lack of high
and low-cut filters does
not change the
intended use and it
does not raise different
questions of safety and
effectiveness as
performance testing
(validation of the
analyzers) has been
submitted to
demonstrate substantial
equivalence. |
| 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; numerical
entropy value | Same |
| X-Axis | Linear scale; units of
time; user-adjustable | - | - | Linear scale; units of
time; user-adjustable | Same |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| Spectral Entropy Trend | | | | | |
| Y-Axis | Linear or Log scale;
units of entropy; user-
adjustable | - | - | Linear scale; units of
entropy (1-100); fixed
scale | Same |
| User Adjustable
Filters | High cut and low-cut
filters | - | - | Notch filter | Filtering is performed
as a preliminary step,
before the trend
analysis. Lack of notch
filter with respect to
the secondary
predicate, NicoletOne
K173366, predicate
does not change the
intended use and it
does not raise different
questions of safety and
effectiveness as
performance testing
(validation of the
analyzers) has been
submitted to |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| | | | | | demonstrate substantial
equivalence. |
| | | | Peak Envelope Trend | | |
| Trend Available | Yes | Yes | No | Yes | |
| Notification Available | NA | Yes | - | Yes | Bolt notification
consists of a yellow
indicator adjacent to
the trend. Optionally,
Bolt notification
highlights the EEG
data for the duration
that the trend is over-
threshold. The
predicate, K151929
Persyst 13, marks and
displays notifications
in the EEG data and
can optionally send an
email to the user if a
trend is over-threshold.
Although the
notification
methodology is slightly
different, both the
subject device and
predicate device
perform threshold |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| | | | | | notifications in a
similar 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-threshold
notification | - | Graph; over-threshold
notification | Same |
| X-Axis | Linear scale; units of
time; user-adjustable | Linear scale; units of
time; user-adjustable | - | Linear scale; units of
time; user-adjustable | Same |
| Y -Axis | Linear or Log scale;
units of uV; user-
adjustable | Linear scale; units of
uV; user-adjustable | - | Linear scale; units of
uV; user-adjustable | Same |
| User Adjustable
Filters | High cut and low cut
filters | Notch, high cut, and
low cut filters | - | Notch filter | Filtering is performed
as a preliminary step,
before the trend
analysis. Lack of high
and low-cut filters does
not change the
intended use and it
does not raise different
questions of safety and
effectiveness as
performance testing
(validation of the
analyzers) has been |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| | | | | | submitted to
demonstrate substantial
equivalence. |
| Asymmetry Trend | | | | | |
| Trend Available | No | Yes | No | Yes | |
| Asymmetry Trend | | | | | |
| Notification Available | - | Yes | - | Yes | Same |
| Analysis Input | - | EEG data; user-
selected channels
restricted to
homologous inputs | - | EEG data; user-
selected channels
restricted to
homologous inputs | Same |
| Analysis Output | - | Graph; over-threshold
notification | - | Graph; over-threshold
notification | Same |
| X-Axis | - | Linear scale; units of
time; user-adjustable | - | Linear scale; units of
time; user-adjustable | Same |
| Y-Axis | - | Linear scale; units of
percent; user-
adjustable | - | Linear scale; units of
percent; user-
adjustable | Same |
| User Adjustable
Filters | - | Notch, high cut, and
low cut filters | - | Notch filter | Filtering is performed
as a preliminary step,
before the trend
analysis. Lack of high
and low-cut filters does |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| | | | | | not change the
intended use and it
does not raise different
questions of safety and
effectiveness as
performance testing
(validation of the
analyzers) has been
submitted to
demonstrate substantial
equivalence. |
| | | | 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 numerical
value | - | - | Graph and numerical
value | Same |
| X-Axis | Linear scale; units of
time; user-adjustable | - | - | Linear scale; units of
time; user-adjustable | Same |
| Y-Axis | Linear scale; units of
percent; user-adjustable | - | - | Linear scale; units of
percent; fixed scale | Same |
| User Adjustable
Filters | High-cut and low-cut
filters | - | - | Notch filter | Filtering is performed
as a preliminary step,
before the trend |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| | | | | | analysis. Lack of high
and low-cut filters does
not change the
intended use and it
does not raise different
questions of safety and
effectiveness as
performance testing
(validation of the
analyzers) has been
submitted to
demonstrate substantial
equivalence. |
| | | 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 numerical
value | - | - | Graph and numerical
value | Same |
| X-Axis | Linear scale; units of
time; user-adjustable | - | - | Linear scale; units of
time; user-adjustable | Same |
| Device (Right) →
Item of Comparison
(Below) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| Y-Axis | Linear scale; units of
time; user-adjustable | - | - | Linear scale; units of
time; user-adjustable | Same |
| User Adjustable
Filters | High-cut and low-cut
filters | - | - | Notch filter | Filtering is performed
as a preliminary step,
before the trend
analysis. Lack of high
and low-cut filters does
not change the
intended use and it
does not raise different
questions of safety and
effectiveness as
performance testing
(validation of the
analyzers) has been
submitted to
demonstrate substantial
equivalence. |
| 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) | NicoletOne
K173366 | Persyst 13 EEG Review
and Analysis Software
Primary Predicate
K151929 | Cadwell Ampliscan
K161027 | Cadwell Bolt
Subject Device
K190760 | Comments |
| Analysis Output | Graph and numerical
value | - | - | Graph and numerical
value | Same |
| X-Axis | Linear scale; units of
time; user-adjustable | - | - | Linear scale; units of
time; user-adjustable | Same |
| Y-Axis | Linear scale; units of #
of bursts; user-
adjustable | - | - | Linear scale; units of #
of bursts; user-
adjustable | Same |
| User Adjustable
Filters | High-cut and low-cut
filters | - | - | Notch filter | Filtering is performed
as a preliminary step,
before the trend
analysis. Lack of high
and low-cut filters does
not change the
intended use and it
does not raise different
questions of safety and
effectiveness as
performance testing
(validation of the
analyzers) has been
submitted to
demonstrate substantial
equivalence. |
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27
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.
28
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 10/20 | ||||
| 7-12Hz | .955 | .898 | .874 | .891 |
| Right Hemi | ||||
| 8-13Hz | .935 | .870 | .890 | .857 |
| Left Hemi | ||||
| 8-13Hz | .939 | .901 | .894 | .892 |
| Right Hemi | ||||
| 13-20Hz | .944 | .910 | .915 | .917 |
| Left Hemi | ||||
| 13-20Hz | .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 |
29
| 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.