(368 days)
The text states "Reference Device(s) Not Found". Therefore, there are no reference devices listed.
No
The document explicitly states that the sEMG-based seizure monitoring algorithm is identical to the predicate device and does not mention any AI or ML components. The performance studies focus on the ability of trained clinicians to interpret the sEMG data, not on the performance of an automated AI/ML system.
No.
The device is intended for seizure monitoring and alerting, providing diagnostic information and alarms, rather than directly treating or curing a medical condition.
Yes
The "Intended Use" states that trained healthcare professionals may use the sEMG data "with other contextual data, to characterize upper-extremity motor activity (UEMA) ipsilateral to the activity." Additionally, the "Device Description" states, "SPEAC data gives healthcare professionals another diagnostic tool to characterize seizure events in a home or hospital setting." and "When trained appropriately, clinicians may use the subject device to perform post-hoc analysis of the sEMG data from the device, with other contextual patient data, to characterize seizures with upper-extremity motor activity ipsilateral to the device from other activity." These statements indicate the device is used for diagnostic purposes.
No
The device description explicitly states it is a "wireless, non-invasive, physiological, surface electromyography (sEMG) recording, monitoring, and alerting system." This indicates the presence of hardware components for recording sEMG data.
Based on the provided information, the SPEAC® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- SPEAC System Function: The SPEAC System works by recording and analyzing surface electromyographic (sEMG) data directly from the surface of the skin (on the biceps muscle). This is a non-invasive method of measuring electrical activity in muscles within the body.
- Intended Use: The intended use is for seizure monitoring and characterizing upper-extremity motor activity based on physiological signals measured from the body. It does not involve the analysis of specimens taken from the body.
Therefore, the SPEAC System falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SPEAC® System is intended for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest.
The non-EEG Physiological Signal Based Seizure Monitoring System continuously records and stores surface electromyographic (sEMG) data for subsequent review.
Trained healthcare professionals may use the electrophysiological sEMG data during a post-hoc review, with other contextual data, to characterize upper-extremity motor activity (UEMA) ipsilateral to the activity.
Audio data recorded during seizure monitoring may be available for review by a trained healthcare professional.
The device is to be used on the belly of the biceps muscle to analyze sEMG signals. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers.
Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review.
Product codes
POS
Device Description
The SPEAC System is a wireless, non-invasive, physiological, surface electromyography (sEMG) recording, monitoring, and alerting system to be used as an adjunct to seizure monitoring during periods of rest. The System continuously records and stores surface electromyographic (sEMG) data for subsequent review by a physician. Trained healthcare professionals may use the electrophysiological sEMG data, with other contextual data, to characterize seizures with upper-extremity motor activity ipsilateral to the device from other activity. SPEAC data gives healthcare professionals another diagnostic tool to characterize seizure events in a home or hospital setting.
The System continuously records and distributes sEMG data at 1,000 Hz (and audio around detected events) for post-hoc review by physicians (or other trained healthcare professionals) for the characterization of seizure events. A physician may perform post-hoc review of the SPEAC System data to characterize motor events that may be associated with seizures.
The seizure monitoring algorithm is able to send alarms to notify patients and caregivers when a pattern that may be associated with a generalized tonic-clonic (GTC) seizure is measured. Physicians may order the System with or without alarms and may order threshold adjustments to customize the level at which the System alarms.
Data collected by the System is uploaded to Brain Sentinel's secure remote storage, the Data Distribution System (DDS), and is remotely accessible for physician review. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Belly of the biceps muscle
Indicated Patient Age Range
Adults
Intended User / Care Setting
Trained healthcare professionals/physicians. Home or 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
Study 1 (CLN0055.001): "Using sEMG to Identify Epileptic Seizure Semiology"
Study 2 (CLN0053.001): "Differentiation of Epileptic and Psychogenic Non-Epileptic Seizures Using Single-Channel Surface Electromyography"
Data Source: Patients with a history of epileptic seizures or psychogenic non epileptic seizures with positive motor involvement of the upper extremities admitted to the EMU for routine seizure characterization. Simultaneously captured vEEG and sEMG data.
Annotation Protocol: Three sEMG reviewers, three of whom were common to both studies. Physicians were provided with a brief (less than an hour) sEMG data training session describing characteristics of: voluntary activity, epileptic and non-epileptic seizure events, and artifact from the device. False positives were non-seizure events that could have resulted from either voluntary movement, signal spikes or RF noise from loose electrodes, or ambient background signals with no associated event data. Physicians were asked to evaluate normalized, transformed, and raw sEMG data. Epileptologists reviewing sEMG data were blinded to all other data. The combined data from the three common sEMG reviewers was analyzed for accuracy for the intended goal in both studies. A "committee" style approach (majority rules, 2/3) was also analyzed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective clinical trials (Study 1: "Using sEMG to Identify Epileptic Seizure Semiology", Study 2: "Differentiation of Epileptic and Psychogenic Non-Epileptic Seizures Using Single-Channel Surface Electromyography").
Sample Size:
Total events analyzed (n): 81
Individual assessments (n): 243 (81 events * 3 reviewers)
Tonic-Clonic (n=26), Simple Motor ES (Tonic & Clonic, n=14), Complex Motor ES ("Other", n=22), All ES (n=62), PNES, whole body involvement (n=4), PNES, arm jerks/hand tremors only (n=15), All PNES (n=19).
Key Results:
The overall accuracy for individual assessments was 83% (95% CI [0.78 0.88], n = 243), and the overall accuracy for the committee approach was 86% (95% CI [0.77 0.93], n = 81).
Specific Accuracies:
- Tonic-Clonic (n = 26): Individual Average 92% (95% CI [0.84 0.97]), Committee 92% (95% CI [0.75 0.99])
- Simple Motor ES (Tonic & Clonic, n = 14): Individual Average 71% (95% CI [0.55 0.84]), Committee 79% (95% CI [0.49 0.95])
- Complex Motor ES ("Other", n = 22): Individual Average 68% (95% CI [0.56 0.79]), Committee 73% (95% CI [0.50 0.89])
- All ES (n = 62): Individual Average 79% (95% CI [0.72 0.85]), Committee 82% (95% CI [0.70 0.91])
- PNES, whole body involvement (n = 4): Individual Average 100% (95% CI [0.67 0.88]), Committee 100% (95% CI [0.40 1.00])
- PNES, arm jerks/hand tremors only (n = 15): Individual Average 96% (95% CI [0.85 0.99]), Committee 100% (95% CI [0.78 1.00])
- All PNES (n = 19): Individual Average 96% (95% CI [0.88 1.00]), Committee 100% (95% CI [0.82 1.00])
- Overall Accuracy (n = 81): Individual Average 83% (95% CI [0.78 0.88]), Committee 86% (95% CI [0.77 0.93])
These results support how the device can be used by clinicians to characterize upper-extremity motor activity (UEMA) ipsilateral to the device from other activity. No automated processing for seizure characterization was cleared in this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy is provided:
Overall accuracy for individual assessments: 83% (95% CI [0.78 0.88])
Overall accuracy for the committee approach: 86% (95% CI [0.77 0.93])
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
(a)
Identification. A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to achieve its intended use, must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical, thermal, and mechanical safety and electromagnetic compatibility (EMC).
(4) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for monitoring for seizure-related activity in the intended population and for the intended use setting. Performance measurements must include positive percent agreement and false alarm rate.
(5) Training must be provided for intended users that includes information regarding the proper use of the device and factors that may affect the collection of the physiologic data.
(6) The labeling must include health care professional labeling and patient-caregiver labeling. The health care professional and the patient-caregiver labeling must include the following information:
(i) A detailed summary of the clinical performance testing, including any adverse events and complications.
(ii) Any instructions technicians and clinicians should convey to patients and caregivers regarding the proper use of the device and factors that may affect the collection of the physiologic data.
(iii) Instructions to technicians and clinicians regarding how to set the device threshold to achieve the intended performance of the device.
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Brain Sentinel, Inc. Richard Waite Regulatory Consultant 8023 Vantage Drive Suite 216 San Antonio, Texas 78230
Re: K200276
Trade/Device Name: SPEAC System Regulation Number: 21 CFR 882.1580 Regulation Name: Non-Electroencephalogram (EEG) Physiological Signal Based Seizure Monitoring System Regulatory Class: Class II Product Code: POS Dated: January 22, 2021 Received: February 2, 2021
Dear Richard Waite:
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
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) K200276
Device Name SPEAC System
Indications for Use (Describe)
The SPEAC® System is intended for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest.
The non-EEG Physiological Signal Based Seizure Monitoring System continuously records and stores surface electromyographic (sEMG) data for subsequent review.
Trained healthcare professionals may use the electrophysiological sEMG data during a post-hoc review, with other contextual data, to characterize upper-extremity motor activity (UEMA) ipsilateral to the activity.
Audio data recorded during seizure monitoring may be available for review by a trained healthcare professional.
The device is to be used on the belly of the biceps muscle to analyze sEMG signals. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers.
Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review.
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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K200276 Traditional 510(k) Summarv
This 510(k) summary is prepared according to the elements outlined in 21 CFR 807.92 Content and format of a 510(k) summary.
| Date Prepared | February 05, 2020 |
|---|---|
| Submitter | Brain Sentinel, Inc |
| 8023 Vantage Drive, Suite 216 | |
| San Antonio, TX 78230 | |
| (210) 951-8681 | |
| Contact Person | Richard Waite, Sr. |
| (214) 662-9277 | |
| Richard Waite@outlook.com |
Subject Device K200276
| Trade Name | SPEAC® System |
|---|---|
| Common Name | Physiological signal-based seizure monitoring system |
| Device Classification | Class II |
| Product Code & | |
| Regulation | POS; Non-EEG physiological signal-based seizure monitoring system |
| 21 CFR 882.1580 | |
| Review Panel | Neurodiagnostic Devices; Neurology |
Predicate Device K182180
Manufacturer Brain Sentinel, Inc. Device Name Brain Sentinel Monitoring and Alerting System Regulation Name Non-EEG physiological signal-based seizure monitoring system Product Code POS Regulation Number 21 CFR 882.1580 Device Classification Class II
Device Description
The SPEAC System is a wireless, non-invasive, physiological, surface electromyography (sEMG) recording, monitoring, and alerting system to be used as an adjunct to seizure monitoring during periods of rest. The System continuously records and stores surface electromyographic (sEMG) data for subsequent review by a physician. Trained healthcare professionals may use the electrophysiological sEMG data, with other contextual data, to characterize seizures with upper-extremity motor activity ipsilateral to the device from other
4
activity. SPEAC data gives healthcare professionals another diagnostic tool to characterize seizure events in a home or hospital setting.
The System continuously records and distributes sEMG data at 1,000 Hz (and audio around detected events) for post-hoc review by physicians (or other trained healthcare professionals) for the characterization of seizure events. A physician may perform post-hoc review of the SPEAC System data to characterize motor events that may be associated with seizures.
The seizure monitoring algorithm is able to send alarms to notify patients and caregivers when a pattern that may be associated with a generalized tonic-clonic (GTC) seizure is measured. Physicians may order the System with or without alarms and may order threshold adjustments to customize the level at which the System alarms.
Data collected by the System is uploaded to Brain Sentinel's secure remote storage, the Data Distribution System (DDS), and is remotely accessible for physician review. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. Below, Tables 1 and 2 list the functional and operational outputs designed to provide feedback to the patient and caregiver. These modes and outputs are identical to those cleared in the predicate, K182180.
The SPEAC System remains the same with no alterations of any kind. The sEMG-based seizure monitoring algorithm is identical to the predicate SPEAC System. The purpose of this submission is to expand the indications for use based on clinical performance testing that was submitted to support a determination of substantial equivalence. When trained appropriately, clinicians may use the subject device to perform post-hoc analysis of the sEMG data from the device, with other contextual patient data, to characterize seizures with upper-extremity motor activity ipsilateral to the device from other activity.
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Image /page/5/Figure/0 description: This image describes the SPEAC system functional modes. The table describes the seizure monitoring mode, seizure alarm mode, record only mode activated, loose electrode alert, sEMG monitor critical battery alert, laptop base station critical battery alert, and lost connection out of Wi-Fi range alert. The table also describes the left and right LED light colors, daily monitoring application screen view, and a description of the functional mode. For example, the seizure monitoring mode has green solid lights for both the left and right LEDs, and the daily monitoring application screen view shows a green checkmark with the text "You are being monitored".
Table 1: System Functional and Operational Outputs
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Table 2: SPEAC System Outputs Intended for Patients and Caregivers
| Name | Application View | Description |
|---|---|---|
| Settings Button | Image: SETTINGS | Click the Settings button to swap functional modes between Seizure Monitoring Mode and Record Only Mode. |
| Night Mode | ||
| Button | Image: NIGHT MODE | To help the patient sleep soundly, the Laptop Base Station display screen and lights on the sEMG Monitor may be |
| dimmed. Click the Night Mode button to turn Night Mode ON. | ||
| Night Mode | ||
| On Button | Image: NIGHT MODE ON | Click the dark grey Night Mode ON button to disable Night Mode setting and return the SPEAC System |
| display screen to regular brightness. You can alternate between Night Mode OFF and Night Mode ON as | ||
| often as necessary. | ||
| Electrode Setup | ||
| Button | Image: ELECTRODE SETUP | Click the Electrode Setup button every time a new Electrode Patch is placed on a patient. Calibration of a new |
| Electrode Patch should be performed daily when using the System in Seizure Monitoring Mode or Record Only Mode. | ||
| Alarm History | ||
| Button | Image: ALARM HISTORY | Click the Alarm History button to display a list of all Seizure Alarms and Operational Alerts that have occurred |
| during the prescribed monitoring period. Use the scroll bar to review the cumulative list. A new or existing | ||
| Seizure Diary entry can be accessed from this list, as well as using the Seizure Diary button noted below. | ||
| Seizure Diary | ||
| Button | Image: SEIZURE DIARY | A yellow exclamation point will appear over the Seizure Diary button to indicate a new Seizure Diary entry has |
| been automatically created. Click the Seizure Diary Button to open the electronic form that will allow the | ||
| patient or caregiver to record specific details about the event. | ||
| Wi-Fi-Status | ||
| Indicator Bar | Image: Wi-Fi signal strength bars | The Laptop Base Station serves as the control hub for the entire SPEAC System. The Wireless Router provides |
| a communications link between the sEMG Monitor in use and the Laptop Base Station. The Wireless Router | ||
| can communicate with the sEMG Monitor up to a 200-foot range (approximate). The Wi-Fi Status Bars indicate | ||
| connection signal strength. |
Intended Use
The SPEAC® System is intended for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The non-EEG Physiological Signal Based Seizure Monitoring System continuously records and stores surface electromyographic (sEMG) data for subsequent review. Trained healthcare professionals may use the electrophysiological sEMG data during a post-hoc review, with other contextual data, to characterize upper-extremity motor activity ipsilateral to the device from other activity. Audio data recorded during seizure monitoring may be available for review by a trained healthcare professional.
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The device is to be used on the belly of the biceps muscle to analyze sEMG signals. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers. Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review.
Clinical Performance Testing
Prospective clinical trials entitled, "Using sEMG to Identify Epileptic Seizure Semiology" (Study 1), and "Differentiation of Epileptic and Psychogenic Non-Epileptic Seizures Using Single-Channel Surface Electromyography'' (Study 2) evaluated the ability of trained clinicians to differentiate and characterize different types of seizure events using the sEMG data collected by the SPEAC System.
Once characterized, the results of these sEMG-trained healthcare professionals were compared to characterizations of the same seizure events using EEG data interpreted by epileptologists and compared to automated processing for characterization of the seizures.
Clinical Inclusion and Exclusion Criteria
Enrollment in the studies was limited to patients who met the following selection criteria: Patients with a history of epileptic seizures or psychogenic non epileptic seizures with positive motor involvement of the upper extremities admitted to the EMU for routine seizure characterization were eligible for inclusion. Subjects were not eligible if intracranial EEG monitoring was used.
Training of Physicians in the Study
Physicians were provided with a brief (less than an hour) sEMG data training session describing characteristics of: voluntary activity, epileptic and non-epileptic seizure events, and artifact from the device. False positives were non-seizure events that could have resulted from either voluntary movement, signal spikes or RF noise from loose electrodes, or ambient background signals with no associated event data. Physicians were asked to evaluate normalized, transformed, and raw sEMG data. Epileptologists reviewing sEMG data were blinded to all other data.
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Clinical Endpoints. Trained clinicians were evaluated by determining if they could characterize and differentiate types of seizure events with sEMG data collected by the SPEAC System, and then those results were compared to vEEG data as well as automated event characterization.
Study Methods
Expert Review
Both Study 1 (CLN0055.001) and Study 2 (CLN0053.001) simultaneously captured vEEG and sEMG data, and three of the total four sEMG reviewers were the same in both studies. The goal in Study 1 was to review epileptic seizures and try to describe the semiology. The goal in Study 2 was to review both epileptic and non-epileptic seizures and to try to properly classify events into those two categories. The similarity between these studies is that epileptic seizures included GTC seizures (referred to as TC seizures in the studies), and focal seizures that contained clonic jerking and complex motor activity (automatisms). Tonic seizures were only recorded during Study 1, and PNES was only recorded during Study 2.
The data from the three common sEMG reviewers was combined from both studies to assess the accuracy for the intended goal in both studies. This analysis combines data that has two different goals but testing the same types of events. The combined accuracy for the studies given a "committee" style approach (majority rules, 2/3) was also analyzed to make the reviews more comparable to the format for used for vEEG.
Results
Expert Reviewer Accuracy
The accuracy from the three reviewers that participated in both studies was combined for each event. The accuracies are presented for each individual reviewer as well as a committee approach for each event. The objective of Study 1 was to categorize ES by semiology. The objective of Study 2 was to categorize seizures as epileptic or non-epileptic. The overall accuracy for individual assessments was 83% (95% CI [0.78 0.88], n = 243), and the overall accuracy for the committee approach was 86% (95% CI [0.77 0.93], n = 81). Table 1 summarizes the accuracies from the reviewers. These results support how the device can be used by clinicians to characterize upper-extremity motor activity (UEMA) ipsilateral to the device from other activity.
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| Committee Review of
sEMG Classification | Reviewer 1 | Reviewer 2 | Reviewer 3 | Average (Ind.
Assess.)
(N = n*3) a | Committee |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|------------------------------|------------------------------------------|------------------------------|
| Tonic-Clonic (n = 26) | 88% (95% CI
[0.70 0.98]) | 88% (95% CI
[0.70 0.98]) | 100% (95% CI
[0.87 1.00]) | 92% (95% CI
[0.84 0.97]) | 92% (95% CI
[0.75 0.99]) |
| Simple Motor ES (Tonic
& Clonic, n = 14) | 71% (95% CI
[0.42 0.92]) | 79% (95% CI
[0.49 0.95]) | 64% (95% CI
[0.35 0.87]) | 71% (95% CI
[0.55 0.84]) | 79% (95% CI
[0.49 0.95]) |
| Complex Motor ES
("Other", n = 22) | 73% (95% CI
[0.50 0.89]) | 68% (95% CI
[0.45 0.86]) | 63% (95% CI
[0.40 0.83]) | 68% (95% CI
[0.56 0.79]) | 73% (95% CI
[0.50 0.89]) |
| All ES (n = 62) | 79% (95% CI
[0.67 0.88]) | 79% (95% CI
[0.67 0.88]) | 79% (95% CI
[0.67 0.88]) | 79% (95% CI
[0.72 0.85]) | 82% (95% CI
[0.70 0.91]) |
| PNES, whole body
involvement (n = 4) | 100% (95% CI
[0.40 1.00]) | 100% (95% CI
[0.40 1.00]) | 100% (95% CI
[0.74 1.00]) | 100% (95% CI
[0.67 0.88]) | 100% (95% CI
[0.40 1.00]) |
| PNES, arm
jerks/hand tremors
only (n = 15) | 100% (95% CI
[0.78 1.00]) | 93% (95% CI
[0.68 1.00]) | 93% (95% CI
[0.68 1.00]) | 96% (95% CI
[0.85 0.99]) | 100% (95% CI
[0.78 1.00]) |
| All PNES (n = 19) | 100% (95% CI
[0.82 1.00]) | 95% (95% CI
[0.74 1.00]) | 95% (95% CI
[0.74 1.00]) | 96% (95% CI
[0.88 1.00]) | 100% (95% CI
[0.82 1.00]) |
| Overall Accuracy (n =
81) | 84% (95% CI
[0.74 0.91]) | 83% (95% CI
[0.73 0.90]) | 83% (95% CI
[0.73 0.90]) | 83% (95% CI
[0.78 0.88]) | 86% (95% CI
[0.77 0.93]) |
| a - The sample size for this column is: TC: 78, Simple Motor ES: 42, Complex Motor ES: 66, All ES: 186,
PNES whole body: 12, PNES arm jerks/hand tremors: 45, PNES: 57, Total: 243 | | | | | |
Table 1– Accuracy of (Common) Expert Reviewers' Classification of Events from Studies 1 and 2
The device used in the studies which represent the data collected were the same as the commercial version of the SPEAC System previously cleared by the FDA. sEMG collected using the SPEAC System has been used by clinicians to characterize seizures. Data provided by the SPEAC System provides healthcare professionals a diagnostic tool based on bicep sEMG signal monitoring to characterize seizure events measured in a home or hospital setting.
Non-clinical Test Summary
| Test | Summary Results | FDA Recognition Number |
|---|---|---|
| IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) (3rd Edition), Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance | Passed | 19-4 |
| IEC 60601-1-2: 2014-02 (4th Edition), Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance, Collateral Standard, Electromagnetic Compatibility | Passed | 19-8 |
| Test | Summary Results | FDA Recognition Number |
| IEC 60601-1-6: Medical electrical equipment - Part 1-6: | ||
| general requirements for basic safety and essential | ||
| performance - collateral standard: usability | Passed | 5-89 |
| IEC 60601-1-8: Medical electrical equipment - Part 1-8: | ||
| general requirements for basic safety and essential | ||
| performance - collateral standard: general requirements, | ||
| tests, and guidance for alarm systems in medical | ||
| electrical equipment and medical electrical systems | Passed | 5-76 |
| IEC 60601-1-11: 2010 (1st Edition) General | ||
| requirements for basic safety and essential performance |
- Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used
in the home healthcare environment. | Passed | This version is no longer FDA
recognized but the changes
evaluated in this 510(k)
submission do not require
additional testing to account for
this lack of recognition. Changes
to the subject device proposed
(indications for use) are outside
the scope of this test. |
| IEC 60601-2-40: 2016 (2nd Edition) Medical electrical
equipment - Part 2-40: Particular requirements for the
basic safety and essential performance of
electromyographs and evoked response equipment | Passed | N/A Not an FDA recognized
standard; This testing has been
voluntarily performed by the
company to demonstrate
performance and validate the
system. |
| Biocompatibility Testing
ISO 10993-1: Biological evaluation of medical devices -
Part 1: Evaluation and testing within a risk management
process. | Passed | 2-220 |
| ISO 10993-5: Biological evaluation of medical devices -
Part 5: Tests for vitro cytotoxicity | Passed | 2-245 |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Passed | 2-174 |
| Shipping and Distribution Test (ISTA 3A) | Passed | 5-110 |
| Software Verification and Validation (Appendix H) | Passed | N/A |
10
SPEAC System Comparison to Predicate Device and Conclusion:
11
| Parameter | SPEAC System | SPEAC System | Comparison | |
|---|---|---|---|---|
| 510(k) | K200276 | K182180 | ||
| Indications for | ||||
| Use | The SPEAC® System is intended | |||
| for use as an adjunct to seizure | ||||
| monitoring in adults in the home | ||||
| or healthcare facilities during | ||||
| periods of rest. | ||||
| The non-EEG Physiological | ||||
| Signal Based Seizure Monitoring | ||||
| System continuously records and | ||||
| stores surface electromyographic | ||||
| (SEMG) data for subsequent | ||||
| review. | ||||
| Trained healthcare professionals | ||||
| may use the electrophysiological | ||||
| sEMG data during a post-hoc | ||||
| review, with other contextual data, | ||||
| to characterize upper-extremity | ||||
| motor activity (UEMA) ipsilateral | The SPEAC® System is indicated | |||
| for use as an adjunct to seizure | ||||
| monitoring in adults in the home | ||||
| or healthcare facilities during | ||||
| periods of rest. | ||||
| The System records and stores | ||||
| surface electromyographic | ||||
| (sEMG) data for subsequent | ||||
| review by a trained healthcare | ||||
| professional. | ||||
| The device is to be used on the | ||||
| belly of the biceps muscle to | ||||
| analyze sEMG signals that may be | ||||
| associated with generalized tonic- | ||||
| clonic (GTC) seizures. | Similar with new | |||
| information added; | ||||
| The indications | ||||
| have been modified | ||||
| to clarify the | ||||
| intended use by | ||||
| specifically stating | ||||
| that the device may | ||||
| be used to | ||||
| characterize upper | ||||
| extremity motor | ||||
| activity by a trained | ||||
| healthcare | ||||
| professional. For | ||||
| to the device from other activity. | ||||
| Audio data recorded during | ||||
| seizure monitoring may be | ||||
| available for review by a trained | ||||
| healthcare professional. | ||||
| The device is to be used on the | ||||
| belly of the biceps muscle to | ||||
| analyze sEMG signals. | ||||
| When sEMG signal patterns | ||||
| associated with a unilateral, | ||||
| appendicular, tonic extension that | ||||
| could be associated with a GTC | ||||
| seizure are detected, the SPEAC | ||||
| System sends adjunctive alarms to | ||||
| alert caregivers. | ||||
| Adjunctive alarms may be | ||||
| disabled by a physician order | ||||
| while continuing to record sEMG | ||||
| data for subsequent review. | When sEMG signal patterns | |||
| associated with a unilateral, | ||||
| appendicular, tonic extension that | ||||
| could be associated with a GTC | ||||
| seizure are detected, the SPEAC | ||||
| System sends adjunctive alarms to | ||||
| alert caregivers. | ||||
| Adjunctive alarms may be | ||||
| disabled by a physician order | ||||
| while continuing to record sEMG | ||||
| data for subsequent review. | clarification, Brain | |||
| Sentinel removed | ||||
| "that may be | ||||
| associated with | ||||
| generalized tonic- | ||||
| clonic (GTC) | ||||
| seizures" in the | ||||
| second paragraph | ||||
| because the | ||||
| SPEAC System | ||||
| analyzes all sEMG | ||||
| to alarm for | ||||
| potential GTC | ||||
| seizures. These | ||||
| changes are | ||||
| supported by | ||||
| clinical | ||||
| performance testing | ||||
| included in the | ||||
| submission. All | ||||
| other claims were | ||||
| preciously cleared | ||||
| in K182180 (the | ||||
| Parameter | SPEAC System | SPEAC System | Comparison | |
| 510(k) | K200276 | K182180 | ||
| Classification | Class II | |||
| 21 CFR 882.1580 | ||||
| Non-EEG physiological | ||||
| signal-based seizure | ||||
| monitoring system | Class II | |||
| 21 CFR 882.1580 | ||||
| Non-EEG physiological | ||||
| signal-based seizure | ||||
| monitoring system | Same, No change | |||
| Product Code | POS | POS | Same, No change | |
| Principle of | ||||
| Operation | sEMG signal, sampled at the | |||
| rate of 1000 Hz, from the | ||||
| biceps brachii are processed | ||||
| by a proprietary algorithm to | ||||
| identify sustained sEMG | ||||
| contraction patterns—during | ||||
| the tonic phase and early | ||||
| transition to the clonic | ||||
| phase—that are | ||||
| pathognomonic of GTC | ||||
| seizures. | sEMG signal, sampled at the | |||
| rate of 1000 Hz, from the | ||||
| biceps brachii are processed | ||||
| by a proprietary algorithm to | ||||
| identify sustained sEMG | ||||
| contraction patterns—during | ||||
| the tonic phase and early | ||||
| transition to the clonic | ||||
| phase—that are | ||||
| pathognomonic of GTC | ||||
| seizures. | Same, No change | |||
| Dimensions | 3.44" x 2.34" x 1.33" | |||
| (H x W x D) | 3.44" x 2.34" x 1.33" | |||
| (H x W x D) | Same, No change | |||
| Mass | 127 g. | 127 g. | Same, No change | |
| Physical | ||||
| Controls | Power On/Off Button | |||
| (Manual) Alarm Button | ||||
| Cancel Button | Power On/Off Button | |||
| (Manual) Alarm Button | ||||
| Cancel Button | Same, No change | |||
| sEMG sampling | ||||
| rate | 1,000 Hz | 1,000 Hz | Same, No change | |
| sEMG | ||||
| Frequency Bands | ||||
| of Interest | 30-40 Hz, 130-240 Hz, and | |||
| 300-400 Hz | 30-40 Hz, 130-240 Hz, and | |||
| 300-400 Hz | Same, No change | |||
| Event Monitored | Potential GTC Seizure | Potential GTC Seizure | Same, No change | |
| Default Alarm | ||||
| Threshold | 135 | 135 | Same, No change | |
| sEMG Monitor | ||||
| Power | Rechargeable Battery | Rechargeable Battery | Same, No change | |
| Parameter | SPEAC System | SPEAC System | Comparison | |
| 510(k) | K200276 | K182180 | ||
| Model | COTS Laptop | COTS Laptop | Same, No change | |
| Input Power | 115/230 VAC 50/60 Hz | 115/230 VAC 50/60 Hz | Same, No change | |
| Graphical User | ||||
| Interface | Laptop Base Station | Laptop Base Station | Same, No change | |
| Software | ||||
| Controls | Alert Mode (adjunctive seizure detection and sEMG recording), | |||
| Record Only (sEMG recording) | Alert Mode (adjunctive seizure detection and sEMG recording), | |||
| Record Only (sEMG recording) | Same, No change | |||
| sEMG Electrode | sEMG Electrode | sEMG Electrode | Same, No change | |
| Cellular Router | Cradlepoint Router | Cradlepoint Router | Same, No change | |
| sEMG Monitor | ||||
| Recharging | ||||
| Accessories | USB – Micro-USB | USB – Micro-USB | Same, No change | |
| Laptop Base | ||||
| Station | ||||
| Recharging | ||||
| Accessories | Medical-Grade Power | |||
| Supply | Medical-Grade Power | |||
| Supply | Same, No change | |||
| sEMG Monitor | ||||
| Arm Strap | Black Spandex Arm Strap | Black Spandex Arm Strap | Same, No change | |
| Medical Device | ||||
| Data Systems | Physician Portal | |||
| (SPEAC2ME®) | Physician Portal | |||
| (SPEAC2ME®) | Same, No change | |||
| Limitations/ | ||||
| Warnings | • | The System is available | ||
| by prescription only from | ||||
| a physician or properly | ||||
| licensed practitioner. | Same as subject device | |||
| • | The System should not | |||
| be used as a standalone | ||||
| monitor for monitoring | ||||
| seizures and is not | ||||
| intended to be used | ||||
| during physical activity. | ||||
| • | The device is not a | |||
| seizure detection device. | ||||
| • | The System alarms are | |||
| not for standalone use | ||||
| and should not be used to | ||||
| guide medical therapy | ||||
| decisions. | ||||
| • | The System has not been | |||
| demonstrated to affect | ||||
| any clinical outcome | ||||
| such as status epilepticus, | ||||
| brain damage, or death | ||||
| following a GTC seizure. | ||||
| • | The System does not | |||
| predict sEMG signals | ||||
| that may be associated | ||||
| with GTC seizures. The | ||||
| device provides an alert | ||||
| from -30.82 – 25.06 | ||||
| seconds, with an average | ||||
| of 5.34 seconds (SEM $\pm$ | ||||
| 2.86), following the onset | ||||
| of sEMG activity that | ||||
| may be associated with a | ||||
| GTC seizure. | Same, No change | |||
| • | The System does not | |||
| predict seizure onset. | ||||
| • | The safety and | |||
| effectiveness of the | ||||
| System has not been | ||||
| established in pediatric | ||||
| populations. | ||||
| • | The System has not been | |||
| tested in the home | ||||
| environment. | ||||
| • | The safety and | |||
| effectiveness of the | ||||
| SPEAC System has not | ||||
| Parameter | SPEAC System | SPEAC System | Comparison | |
| 510(k) | K200276 | K182180 | ||
| been established in | ||||
| monitoring sEMG | ||||
| signals that may be | ||||
| associated with seizures | ||||
| other than the GTC | ||||
| seizure. | ||||
| The sEMG Electrode | ||||
| Patch may result in skin | ||||
| irritation that may lead to | ||||
| hypersensitivity in some | ||||
| individuals. Never allow the sEMG | ||||
| Monitor to be submerged | ||||
| in any liquid. Contact | ||||
| Brain Sentinel if the | ||||
| sEMG Monitor or Laptop | ||||
| Base Station has been | ||||
| submerged. Do not | ||||
| attempt to use or service | ||||
| a sEMG Monitor or Base | ||||
| Station that has been | ||||
| submerged. Only Brain Sentinel | ||||
| authorized equipment | ||||
| should be used with or | ||||
| connected to the SPEAC | ||||
| System. The Laptop Base Station | ||||
| is optimized for the | ||||
| functions performed by | ||||
| the SPEAC System. Do | ||||
| not install applications, | ||||
| uninstall applications, or | ||||
| alter the configuration or | ||||
| environment variables of | ||||
| this |
12
13
14
15
Conclusion
The SPEAC System remains the same with no alterations of any kind. The sEMG-based seizure monitoring algorithm is identical to the predicate SPEAC System. The purpose of this submission is to expand the indications for use based on clinical performance testing that was submitted to support a determination of substantial equivalence. When trained appropriately, clinicians may use the subject device to perform post-hoc analysis of the sEMG data from the device, with other contextual patient data, to characterize seizures with upper-extremity motor activity ipsilateral to the device from other activity. Based on device characteristics, indications for use, and testing submitted to support the submission, the SPEAC® System is substantially
16
equivalent to the predicate device, K182180, SPEAC System. No automated processing for seizure characterization was cleared in this 510(k).