SPEAC System
Brain Sentinel, Inc.
BRAIN SENTINEL INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012995918 | 3012995918 | BRAIN SENTINEL INC. | 1 | N | 2020-04-25 | 8023 Vantage Dr Ste 216 San Antonio TX US 78230 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 199233 | 1426325631 | K182180 | SPEAC System | POS | 2019-05-11 |
| 199233 | 1641141622 | DEN140033 | Companion | POS | 2017-02-16 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| POS | 2 | 2019-05-11 |
PMN#
SPEAC System
Brain Sentinel, Inc.
GUDID#
AccuSense Sensitive Electrode Patch-SPC15-90054 US - The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and AlertingSystem, is a physiological, surface electromyography (sEMG) monitor with or without alarms that recordsand stores data for review by a physician for characterization of seizure events.The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed withan algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTCseizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern thatmay be associated with such seizures are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcareprofessionals) for post-hoc review so that they may quantify and qualify the types of seizure events thattheir patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replacedwith the second sEMG Monitor on the opposite arm of the patient.The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting thesEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the BaseStation. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-securedwithin Microsoft Azure which is FedRAMP certified.
2019-11-07
AccuSense Sensitive Electrode Patch SPC15-90055 EU - The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and AlertingSystem, is a physiological, surface electromyography (sEMG) monitor with or without alarms that recordsand stores data for review by a physician for characterization of seizure events.The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed withan algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTCseizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern thatmay be associated with such seizures are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcareprofessionals) for post-hoc review so that they may quantify and qualify the types of seizure events thattheir patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replacedwith the second sEMG Monitor on the opposite arm of the patient.The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting thesEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the BaseStation. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-securedwithin Microsoft Azure which is FedRAMP certified.
2019-11-07
SPEAC System Assy, Mini Monitor, EU - The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events.Page 2 of 13The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC seizures and provide local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures that are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient.The sEMG that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit, Data Distribution System (DDS), where they await review by a physician. 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.
2019-09-05
SPEAC System Electrode Patch SPC15-90018 - The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and AlertingSystem, is a physiological, surface electromyography (sEMG) monitor with or without alarms that recordsand stores data for review by a physician for characterization of seizure events.The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed withan algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTCseizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern thatmay be associated with such seizures are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcareprofessionals) for post-hoc review so that they may quantify and qualify the types of seizure events thattheir patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replacedwith the second sEMG Monitor on the opposite arm of the patient.The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting thesEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the BaseStation. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-securedwithin Microsoft Azure which is FedRAMP certified.
2019-09-04
SPEAC System Electrode Patch-SPC15-900431 - The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and AlertingSystem, is a physiological, surface electromyography (sEMG) monitor with or without alarms that recordsand stores data for review by a physician for characterization of seizure events.The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed withan algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTCseizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern thatmay be associated with such seizures are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcareprofessionals) for post-hoc review so that they may quantify and qualify the types of seizure events thattheir patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replacedwith the second sEMG Monitor on the opposite arm of the patient.The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting thesEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the BaseStation. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-securedwithin Microsoft Azure which is FedRAMP certified.
2019-09-04
SPEAC System Electrode Patch SPC15-90044, EU - The Brain Sentinel® Seizure Detection and Warning System is an ambulatory systemdesigned to monitor and analyze electromyography (EMG) data to detect the onsetof a generalized tonic-clonic (GTC) seizure whether primary or focal onset withsecondary generalization and to provide a warning signal to alert caregivers that aseizure is occurring. The system records EMG data (24/7) and is available for analysisof other motor events.The Brain Sentinel Seizure Detection and Warning System is intended for monitoringadults with a history or significant risk of generalized tonic-clonic seizures in thehome or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs,and for continuous monitoring, night time or any other time of day, of individuals dueto their history or risk of generalized tonic-clonic seizures and will withstand activitiesof daily living including showers and sleep. The Brain Sentinel Seizure Detection andWarning System is available by prescription only.
2019-09-04
SPEAC System Electrode Patch-SPC15-90045, EU - The Brain Sentinel® Seizure Detection and Warning System is an ambulatory systemdesigned to monitor and analyze electromyography (EMG) data to detect the onsetof a generalized tonic-clonic (GTC) seizure whether primary or focal onset withsecondary generalization and to provide a warning signal to alert caregivers that aseizure is occurring. The system records EMG data (24/7) and is available for analysisof other motor events.The Brain Sentinel Seizure Detection and Warning System is intended for monitoringadults with a history or significant risk of generalized tonic-clonic seizures in thehome or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs,and for continuous monitoring, night time or any other time of day, of individuals dueto their history or risk of generalized tonic-clonic seizures and will withstand activitiesof daily living including showers and sleep. The Brain Sentinel Seizure Detection andWarning System is available by prescription only.
2019-09-04
SPEAC System Assy, Mini Monitor, US - The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events.Page 2 of 13The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC seizures and provide local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures that are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient.The sEMG that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit, Data Distribution System (DDS), where they await review by a physician. 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.
2019-09-04
SPEAC System Electrode Patch SPC15-90044, EU - The Brain Sentinel® Seizure Detection and Warning System is an ambulatory systemdesigned to monitor and analyze electromyography (EMG) data to detect the onsetof a generalized tonic-clonic (GTC) seizure whether primary or focal onset withsecondary generalization and to provide a warning signal to alert caregivers that aseizure is occurring. The system records EMG data (24/7) and is available for analysisof other motor events.The Brain Sentinel Seizure Detection and Warning System is intended for monitoringadults with a history or significant risk of generalized tonic-clonic seizures in thehome or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs,and for continuous monitoring, night time or any other time of day, of individuals dueto their history or risk of generalized tonic-clonic seizures and will withstand activitiesof daily living including showers and sleep. The Brain Sentinel Seizure Detection andWarning System is available by prescription only.
2019-08-26
SPEAC System Electrode Patch-SPC15-90045, EU - The Brain Sentinel® Seizure Detection and Warning System is an ambulatory systemdesigned to monitor and analyze electromyography (EMG) data to detect the onsetof a generalized tonic-clonic (GTC) seizure whether primary or focal onset withsecondary generalization and to provide a warning signal to alert caregivers that aseizure is occurring. The system records EMG data (24/7) and is available for analysisof other motor events.The Brain Sentinel Seizure Detection and Warning System is intended for monitoringadults with a history or significant risk of generalized tonic-clonic seizures in thehome or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs,and for continuous monitoring, night time or any other time of day, of individuals dueto their history or risk of generalized tonic-clonic seizures and will withstand activitiesof daily living including showers and sleep. The Brain Sentinel Seizure Detection andWarning System is available by prescription only.
2019-08-26
SPEAC System Electrode Patch SPC15-90018 - The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and AlertingSystem, is a physiological, surface electromyography (sEMG) monitor with or without alarms that recordsand stores data for review by a physician for characterization of seizure events.The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed withan algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTCseizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern thatmay be associated with such seizures are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcareprofessionals) for post-hoc review so that they may quantify and qualify the types of seizure events thattheir patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replacedwith the second sEMG Monitor on the opposite arm of the patient.The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting thesEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the BaseStation. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-securedwithin Microsoft Azure which is FedRAMP certified.
2019-08-13
SPEAC System Electrode Patch-SPC15-900431 - The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and AlertingSystem, is a physiological, surface electromyography (sEMG) monitor with or without alarms that recordsand stores data for review by a physician for characterization of seizure events.The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed withan algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTCseizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern thatmay be associated with such seizures are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcareprofessionals) for post-hoc review so that they may quantify and qualify the types of seizure events thattheir patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replacedwith the second sEMG Monitor on the opposite arm of the patient.The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting thesEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the BaseStation. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-securedwithin Microsoft Azure which is FedRAMP certified.
2019-08-13
SPEAC System Assy, Mini Monitor, US - The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events.Page 2 of 13The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC seizures and provide local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures that are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient.The sEMG that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit, Data Distribution System (DDS), where they await review by a physician. 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.
2019-08-13
SPEAC System - The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct toseizure monitoring in adults in the home or healthcare facilities during periods of rest. Thedevice is to be used on the belly of the biceps muscle to analyze surface electromyographs(sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and toprovide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could beassociated with a GTC seizure. The System records and stores sEMG data for subsequentreview by a trained healthcare professional.
2017-09-01