(182 days)
Unknown
The summary describes an algorithm that analyzes EEG waveforms to identify patterns consistent with electrographic status epilepticus. While this type of analysis often utilizes AI/ML techniques, the summary does not explicitly mention AI, ML, DNN, or provide details about the algorithm's architecture or training that would confirm the use of these technologies. The description of the clinical validation study and performance metrics are consistent with either traditional signal processing algorithms or AI/ML approaches.
No.
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnosis of Electrographic Status Epilepticus only" and its output "is intended to be used as an aid for determining patient treatment," not to provide treatment itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software "is indicated for the diagnosis of Electrographic Status Epilepticus" and that "The diagnostic output of the Ceribell Status Epilepticus Monitor is intended to be used as an aid for determining patient treatment".
Yes
The device description explicitly states "The Ceribell Status Epilepticus Monitor is a software as medical device". While it is intended for use with specific hardware (Ceribell Pocket EEG Device and Instant EEG Headband), the submitted device itself is described as the software component that performs the analysis.
Based on the provided information, the Ceribell Status Epilepticus Monitor software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Ceribell's Function: The Ceribell Status Epilepticus Monitor software analyzes EEG waveforms, which are electrical signals recorded from the brain. It does not analyze specimens taken from the body.
- Input Modality: The input is EEG waveforms, not biological samples.
Therefore, while it is a diagnostic device, it falls under the category of devices that analyze physiological signals rather than in vitro samples.
N/A
Intended Use / Indications for Use
The Ceribell Status Epilepticus Monitor software is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The Ceribell Status Epilepticus Monitor software analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epileptious as defined in the American Clinical Neurophysiology Society's Guideline 14.
The diagnostic output of the Ceribell Status Epilepticus Monitor is intended to be used as an aid for determining patient treatment in acute-care environments. The device's diagnosis of Electrographic Status Epilepticus provides one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient.
The Ceribell Status Epilepticus Monitor is intended for diagnosis of Electrographic Status Epilepticus only. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The device is not intended for use in Epilepsy Monitoring Units.
Product codes
OMB
Device Description
The Ceribell Status Epilepticus Monitor is a software as medical device that analyzes EEG waveforms for the intended use of recognizing electrographic status epilepticus (ESE). The subject device software is intended for use only with the Ceribell Pocket EEG Device (K191301), which is also the predicate device. The predicate device contains a software module that performs detection of seizures in a similar manner as the subject device. The user workflow and instructions for starting an EEG recording on a patient are unchanged compared to the predicate device.
The user places the Ceribell Instant EEG Headband (K210805) on the patient, the headband contains 10 electrodes that are arranged in a bipolar montage and correspond to the following locations following the 10-20 electrode naming convention: Fp1, F7, T3, T5, O1, Fp2, F8, T3, T6, O2. The 10 electrodes form 8 channels (4 on the left hemisphere, 4 on the right hemisphere) that are analyzed by the subject device's ESE detection algorithm. The American Clinical Neurophysiology Society's (ACNS) Guideline 14 ("Standardized Critical Care EEG Terminology: 2021 Edition") defines ESE as follows:
ESE is defined as an ESz [electrographic seizure] for ≥ 10 continuous minutes or for a total duration of ≥ 20% of any 60-minute period of recording.
By definition, ESE is a finding that is based solely on the characteristics of the subject's EEG waveforms. The are no other clinical considerations or sources of clinical information that are used in the determination of ESE. The subject device is intended for use in the recognition of ESE in acute care environments only. The absence of a detection of ESE by the subject device does not preclude the possibility that seizures, other epileptiform patterns, or other pathologies are present in the EEG recording. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG waveforms
Anatomical Site
Not Found
Indicated Patient Age Range
The Ceribell Status Epilepticus Monitor software is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure.
Intended User / Care Setting
Intended User: Qualified healthcare professional
Intended Location of Use: Acute-care environments within professional healthcare facilities
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
A retrospective clinical validation study was performed by analyzing the subject device algorithm's performance using previously-collected EEG data. The objective of the study design was to obtain a dataset that is representative of the intended patient population, and this was accomplished by using real-world data. The methodology of data collection was as follows:
- For each of 6 hospitals of varying size and geographic location: .
- Collect all clinically performed Ceribell EEGs from a fixed one-year time period o
- Exclude any EEGs from patients
§ 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
May 23, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized caduceus symbol. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Ceribell, Inc. Raymond Woo, Ph.D. Chief Technology Officer 360 N Pastoria Ave. Sunnyvale, CA 94085
Re: K223504
Trade/Device Name: Ceribell Status Epilepticus Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB Dated: April 28, 2023 Received: April 28, 2023
Dear Raymond Woo:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Patrick Antkowiak -S
Patrick Antkowiak, Ph.D. Acting 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) K223504
Device Name Ceribell Status Epilepticus Monitor
Indications for Use (Describe)
The Ceribell Status Epilepticus Monitor software is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The Ceribell Status Epilepticus Monitor software analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epileptious as defined in the American Clinical Neurophysiology Society's Guideline 14.
The diagnostic output of the Ceribell Status Epilepticus Monitor is intended to be used as an aid for determining patient treatment in acute-care environments. The device's diagnosis of Electrographic Status Epilepticus provides one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient.
The Ceribell Status Epilepticus Monitor is intended for diagnosis of Electrographic Status Epilepticus only. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The device is not intended for use in Epilepsy Monitoring Units.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant Information:
Ceribell, Inc. 360 N Pastoria Ave Sunnyvale, CA 94085
Contact Person:
Raymond Woo, Ph.D. CTO Telephone: (650) 556-4349 E-mail: ray@ceribell.com
Subject Device Information:
| Trade Name: | Ceribell Status Epilepticus Monitor |
|---|---|
| Classification Name: | Electroencephalograph |
| Device Class: | II; 21 CFR 882.1400 |
| Product Code: | OMB |
| OMB Device: | Automatic Event Detection Software for Full-Montage Electroencephalograph |
Predicate Device:
K191301 Ceribell Pocket EEG Device 882.1400, OMB (automatic event detection software for full-montage electroencephalograph), OMC, GWO
Date Prepared:
May 18, 2023
Device Description:
The Ceribell Status Epilepticus Monitor is a software as medical device that analyzes EEG waveforms for the intended use of recognizing electrographic status epilepticus (ESE). The subject device software is intended for use only with the Ceribell Pocket EEG Device (K191301), which is also the predicate device. The predicate device contains a software module that performs detection of seizures in a similar manner as the subject device. The user workflow and instructions for starting an EEG recording on a patient are unchanged compared to the predicate device.
The user places the Ceribell Instant EEG Headband (K210805) on the patient, the headband contains 10 electrodes that are arranged in a bipolar montage and correspond to the following locations following the
4
10-20 electrode naming convention: Fp1, F7, T3, T5, O1, Fp2, F8, T3, T6, O2. The 10 electrodes form 8 channels (4 on the left hemisphere, 4 on the right hemisphere) that are analyzed by the subject device's ESE detection algorithm. The American Clinical Neurophysiology Society's (ACNS) Guideline 14 ("Standardized Critical Care EEG Terminology: 2021 Edition") defines ESE as follows:
ESE is defined as an ESz [electrographic seizure] for ≥ 10 continuous minutes or for a total duration of ≥ 20% of any 60-minute period of recording.
By definition, ESE is a finding that is based solely on the characteristics of the subject's EEG waveforms. The are no other clinical considerations or sources of clinical information that are used in the determination of ESE. The subject device is intended for use in the recognition of ESE in acute care environments only. The absence of a detection of ESE by the subject device does not preclude the possibility that seizures, other epileptiform patterns, or other pathologies are present in the EEG recording. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns.
Intended Use
The Ceribell Status Epilepticus Monitor is a software as medical device that is intended to analyze EEG recordings captured with the Ceribell Pocket EEG Device and the Ceribell Instant EEG Headband and diagnose electrographic status epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The software analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epilepticus as defined in the American Clinical Neurophysiology Society's Guideline 14.
The diagnostic output of the Ceribell Status Epilepticus Monitor is intended to be used as an aid for determining patient treatment in acute-care environments. The device's diagnosis of Electrographic Status Epilepticus provides one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient.
The Ceribell Status Epilepticus Monitor is intended for diagnosis of Electrographic Status Epilepticus only. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The device is not intended for use in Epilepsy Monitoring Units.
Comparison of Intended Use and Technological Characteristics with the Predicate Device:
The subject device is substantially equivalent to the seizure detection module of the predicate device in terms of intended use, operating principles, and design. The subject device and predicate devices both contain algorithms to detect electrographic seizures, and in both the subject device and predicate device the design of the electrographic seizure detection is the subject device additionally processes the electrographic seizure detections to make a determination regarding ESE. The ESE determination serves as the final output of the subject device output is binary: ESE is either detected or not detected.
5
| Attribute | Subject Device | Predicate Device |
|---|---|---|
| Ceribell Status Epilepticus Monitor | Ceribell Pocket EEG Device (K191301) | |
| Intended Use | The Ceribell Status Epilepticus Monitor is a software as | |
| medical device that is intended to analyze EEG recordings | ||
| captured with the Ceribell Pocket EEG Device and the | ||
| Ceribell Instant EEG Headband and diagnose | ||
| electrographic status epilepticus in patients greater than | ||
| or equal to 18 years of age who are at risk for seizure. The | ||
| software analyzes EEG waveforms and identifies patterns | ||
| that may be consistent with electrographic status | ||
| epilepticus as defined in the American Clinical | ||
| Neurophysiology Society's Guideline 14. |
The diagnostic output of the Ceribell Status Epilepticus
Monitor is intended to be used as an aid for determining
patient treatment in acute-care environments. The
device's diagnosis of Electrographic Status Epilepticus
provides one input to the clinician that is intended to be
used in conjunction with other elements of clinical practice
to determine the appropriate treatment course for the
patient.
The Ceribell Status Epilepticus Monitor is intended for
diagnosis of Electrographic Status Epilepticus only. The
device does not substitute for the review of the underlying
EEG by a qualified clinician with respect to any other types
of pathological EEG patterns. The device is not intended
for use in Epilepsy Monitoring Units. | The Ceribell Pocket EEG Device is a portable EEG monitoring
system that records, stores and presents EEG signals in
visual and audible formats in real time. The visual and
audible signals assist trained medical staff to make
neurological diagnoses. The Pocket EEG Device EEG
Recording Viewer software incorporates a seizure detection
component is intended to analyze EEG recordings captured
with the Ceribell Pocket EEG Device and identify areas that
may correspond to electrographic seizures in patients
greater or equal to 18 years of age. The Pocket EEG Device
seizure detection module is not intended to provide clinical
conclusions about the subject's condition and the output of
the seizure detection module is intended to be used by
qualified clinical practitioners in coordination with other
clinical observations. |
| Indications for
Use | The Ceribell Status Epilepticus Monitor software is
indicated for the diagnosis of Electrographic Status
Epilepticus in patients greater than or equal to 18 years of
age who are at risk for seizure. The Ceribell Status
Epilepticus Monitor software analyzes EEG waveforms and
identifies patterns that may be consistent with
electrographic status epilepticus as defined in the
American Clinical Neurophysiology Society's Guideline 14.
The diagnostic output of the Ceribell Status Epilepticus
Monitor is intended to be used as an aid for determining
patient treatment in acute-care environments. The
device's diagnosis of Electrographic Status Epilepticus
provides one input to the clinician that is intended to be
used in conjunction with other elements of clinical practice
to determine the appropriate treatment course for the
patient.
The Ceribell Status Epilepticus Monitor is intended for
diagnosis of Electrographic Status Epilepticus only. The
device does not substitute for the review of the underlying
EEG by a qualified clinician with respect to any other types
of pathological EEG patterns. The device is not intended
for use in Epilepsy Monitoring Units. | The Ceribell Pocket EEG Device is intended to record and
store EEG signals, and to present the EEG signals in visual
and audible formats in real time. The visual and audible
signals assist trained medical staff to make neurological
diagnoses. The Pocket EEG Device is intended to be used in
a professional healthcare facility environment.
Additionally, the EEG Recording Viewer Software
component of the Pocket EEG Device incorporates a Seizure
Detection component that is intended to mark previously
acquired sections of EEG recordings in patients greater than
or equal to 18 years of age that may correspond to
electrographic seizures in order to assist qualified clinical
practitioners in the assessment of EEG traces. The Seizure
Detection component provides notifications to the user
when detected seizure prevalence is "Frequent,"
"Abundant," or "Continuous," per the definitions of the
American Clinical Neurophysiology Society Guideline 14.
Notifications include an on-screen display on the Pocket EEG
Device and the optional sending of an e-mail message to a
clinician. Delays of up to several minutes can occur between
the beginning of a seizure and when the Seizure Detection
notifications will be shown to a user.
The Pocket EEG Device does not provide any diagnostic
conclusion about the subject's condition and Seizure
Detection notifications cannot be used as a substitute for
real time monitoring of the underlying EEG by a trained
expert. |
| Intended User | Qualified healthcare professional | Qualified healthcare professional |
| Attribute | Subject Device | Predicate Device |
| | Ceribell Status Epilepticus Monitor | Ceribell Pocket EEG Device (K191301) |
| Intended
Patient
population | Patients greater or equal to 18 years of age. | All ages. The seizure detection module is intended only for
patients greater or equal to 18 years of age. |
| Intended
Location of Use | Acute-care environments within professional healthcare
facilities | Professional healthcare facility |
Table 1. Comparison between the subject device and predicate device.
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Performance Data:
Bench-top verification testing was performed on the subject device. The verification tests were completed in accordance with relevant standards and pre-approved protocols to evaluate the safety and performance of the subject device, and all tests were passed.
Table 2. Summary of bench-top verification testing.
| Test Description | Acceptance Criteria | Test Results |
|---|---|---|
| ESE Monitor System Level Test: | ||
| Integration and system level test that verifies | ||
| and validates the processing of ESE data and the | ||
| display of ESE output (ESE detected/ESE not | ||
| detected). | Various functional acceptance criteria | |
| based on the expected behavior of the | ||
| system. | All tests passed. | |
| Regression Testing: | ||
| Per the V&V Summary Report, several test | ||
| protocols were executed to ensure that the | ||
| Status Epilepticus Monitor did not have any | ||
| unexpected effect or cause unintended | ||
| regressions with the underlying Pocket EEG | ||
| Device software. |
Because these test reports do not directly verify
any of the subject device software
requirements, all of these regression test
reports are combined into a single appendix for
simplicity. | Various functional acceptance criteria
based on the expected behavior of the
system. | All tests passed. |
Clinical Testing
A retrospective clinical validation study was performed by analyzing the subject device algorithm's performance using previously-collected EEG data. The objective of the study design was to obtain a dataset that is representative of the intended patient population, and this was accomplished by using real-world data. The methodology of data collection was as follows:
- For each of 6 hospitals of varying size and geographic location: .
- Collect all clinically performed Ceribell EEGs from a fixed one-year time period o
- Exclude any EEGs from patients 90 | 15 | 0 | 4% |
| Total: | 350 | 3 | |
| Mean Age of Included
Subjects: | 65.3 | | |
Table 3. Validation dataset age demographics showing included and excluded subjects.
Table 4. Distribution of patient gender in the validation dataset.
| Subject Gender | N | Percent of
Total |
|----------------|-----|---------------------|
| Male | 188 | 54% |
| Female | 162 | 46% |
| Total: | 350 | |
The expert neurologist review of the EEGs resulted in a reference-standard dataset that included 10 ESEpositive subjects out of the 350 total subjects. The ESE-negative cases were further subdivided into ESEnegative cases that contained seizure and/or other epileptiform activity versus ESE-negative cases that do not contain any epileptiform activity. This categorization of the ESE-negative cases is only for data analysis and benefit-risk analysis purposes. The output of the subject device is only ESE-positive or ESEnegative.
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| Ground-Truth Classification | N |
|---|---|
| ESE-positive | 10 |
| ESE-negative: contains seizures and/or | |
| other epileptiform activity | 94 |
| ESE-negative: does not contain any | |
| epileptiform activity | 246 |
| Total: | 350 |
Table 5. Expert neurologist reference standard categorization of the validation dataset.
After the clinical validation dataset was compiled, the subject device algorithm was run on the dataset and the results compared to the reference-standard. The resulting sensitivity was 100% and the specificity was 94%. There were 10 true-positive detections and 0 false-negative detections (100% sensitivity). There were 319 true-negative detections and 21 false-positive detections (94% specificity). Of the 21 falsepositive detections, 19 were determined by the expert reviewers to contain seizures or other epileptiform activity.
Because the algorithm performed with 100% sensitivity in a small sample size of 10 ESE true-positive detections, there are limitations to the utility of calculating 95% confidence interval using the BCa Bootstrap method (as was done with the predicate device). As a result, two additional confidence interval calculation methods were also applied: the Wilson interval and the Jeffreys interval.
Table 6. Sensitivity and specificity results of the clinical performance validation along with the 95% confidence interval computed with three different methodologies.
| | Result | 95% Confidence
Interval
BCa Bootstrap | 95% Confidence
Interval
Wilson | 95% Confidence
Interval
Jeffreys |
|-------------|--------|---------------------------------------------|--------------------------------------|----------------------------------------|
| Sensitivity | 100% | [100%, 100%] | [72%, 100%] | [78%, 100%] |
| Specificity | 94% | [91%, 96%] | [91%, 96%] | [91%, 96%] |
Benefit Risk Analysis
Analysis of the benefits and risks of the subject device is performed according to the FDA guidance document "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics." (September 2018). Ceribell believes that the submitted performance validation data clearly demonstrates significant benefit of the subject device due to the magnitude and the probability of the benefit of faster diagnosis of ESE. At the same time, the identified risks of the subject device are of low probability and low severity, post-mitigation.
The greatest benefits of the subject device are specifically tied to the intended use of diagnosing electrographic status epilepticus. The maximum benefit of the subject device occurs when ESE is recognized and diagnosed during the time prior to the availability of a qualified neurologist to perform a
9
full review of the underlying EEG. Initiation of treatment for Status Epilepticus is highly time sensitive, yet in the standard-of-care workflow it can take 12-24 hours just to get the EEG read by a qualified neurologist. The diagnosis of ESE provided by the subject device allows administration of first-line antiseizure medications (ASMs) and initiation of other time-sensitive actions to be performed as quickly and as accurately as possible by the intensivist and other members of the bedside critical care team. At the same time, the subject device does not replace the full review of the underlying EEG by a qualified neurologist because pathologies other than ESE may be present in the EEG.
Risks of the subject device can be categorized into risks associated with false-positive detections, falsenegative detections, device malfunctions, or device misuse. In general, these risks are all low in part due to the fact that in all potential cases of failure of the subject device, the patient remains no worse off compared to the current standard-of-care, where the intensive care physician is forced to make a treatment decision without having EEG data available.
Table 7 and Table 8 on the following pages provide a detailed analysis of the benefits and risks of the subject device.
Conclusion:
The performance demonstrated in the clinical validation study clearly demonstrate that the benefits of the subject device outweigh the risks.
The Ceribell Status Epilepticus Monitor has the same intended use as the predicate devices. In addition, it has similar technological characteristics and performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the Ceribell Status Epilepticus Monitor is substantially equivalent to the cleared predicate device.
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Table 7. Benefits analysis of the subject device.
| Benefits | Magnitude of Benefit | Probability of Benefit | Overall Benefit
Evaluation |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------|
| Patient with ESE is treated with
ASMs 12-24 hours faster
compared to the current
standard-of-care when the
subject device correctly
identifies that ESE is present. | High
As discussed above, early
identification and treatment of ESE is
associated with significantly lower
morbidity and mortality. | High
The subject device was 100%
sensitive to ESE in the performance
validation study. | High |
| Patient without ESE avoids
unnecessary treatment with
ASMs when the subject device
correctly determines that ESE is
not present. | Low
Ruling out ESE may avoid
unnecessary patient treatment.
However, this benefit is "low"
because the use of ASMs in hospital
environments is commonplace and
carries relatively low risk because of
the clinicians' familiarity with
management of these medications. | High
The performance validation study
showed that the subject device had
94% specificity. | Low |
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Table 8. Risks analysis of the subject device.
| Risk | Severity | Mitigations | Risk Probability (post-mitigation) | Overall Risk
Evaluation |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| False-positive:
Subject device
diagnoses ESE when
ESE is not present.
Patient is treated with
ASMs even though
they are not in status
epilepticus | Moderate
The use of ASMs in
controlled hospital
environments (with or
without confirmation of
seizures through EEG) is
commonplace and
carries relatively low risk
because of the clinicians'
familiarity with
management of these
medications. As with any
sedative medication,
there is risk of over-
sedation. | • The subject device is designed such
that the majority of "false-positive"
cases still contain seizures or other
abnormal epileptiform patterns. In
these cases, treatment with ASMs
may still be beneficial to the
patient.
• Full review of the EEG by a qualified
neurologist (potentially 12-24 hours
later) may determine that ASM
treatment can be discontinued. | Low
The performance validation study results
showed there were 21 "false positives"
out of 350 cases (6%) and 19 of the 21
"false-positive" cases (90.5%) still
contained seizures or other epileptiform
patterns where treatment with ASMs
may still have been beneficial. | Low |
| False-negative:
Subject device fails to
diagnose ESE when
ESE is present
Treatment with ASMs
is delayed. | High
Delayed treatment of
status epilepticus results
in worse outcomes.
However, this scenario is
equivalent to the
current standard-of-
care. | • The subject device is designed to be
highly sensitive to minimize the risk
of "false-negative" cases.
• The intensivist may still elect to
treat the patient with ASMs based
on other clinical observations; the
EEG will still be reviewed by a
qualified neurologist - the patient is
no worse off than they would have
been in the current standard-of
care without the subject device. | Low
The performance validation study
showed that the subject device was
100% sensitive to ESE. | Low |
| Risk | Severity | Mitigations | Risk Probability (post-mitigation) | Overall Risk
Evaluation |
| Device malfunction:
Subject device fails to
provide output. | Low
The user can revert to
the current standard-of-
care practice | • The subject device alerts the user if
the ESE detected/not-detected
output is not available. The user can
revert to the current standard-of-
care without the subject device
output. | Low
Verification and validation testing
confirm that the subject device meets its
design requirements. | Low |
| Device misuse:
User incorrectly
utilizes the output of
the subject device
(i.e., uses the device
output to make
clinical determinations
outside of the
diagnosis of ESE). | Moderate
Depending on the
patient's condition, this
may involve over-
treatment or delayed-
treatment with ASMs. | • The subject device is only capable
of providing a binary diagnostic
output of ESE detected/ESE not-
detected. A qualified neurologist
must review the EEG for other
possible abnormal epileptiform
findings – this limits the potential
for device misuse.
• The use of ASMs in controlled
hospital environments (with or
without confirmation of seizures
through EEG) is commonplace and
carries relatively low risk because of
the clinicians' familiarity with
management of these medications.
As with any sedative medication,
there is risk of over-sedation. | Low | Low |
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