AccuSense Sensitive Electrode Patch SPC15-90055 EU SPC15-90055

GUDID B481SPC15900551

The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System, 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. The 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 provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures 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 Monitor 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 it awaits review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified.

BRAIN SENTINEL, INC.

Home seizure monitoring system
Primary Device IDB481SPC15900551
NIH Device Record Key120aed13-0342-45b9-aff3-89597ca1c17b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuSense Sensitive Electrode Patch SPC15-90055 EU
Version Model NumberSPC15
Catalog NumberSPC15-90055
Company DUNS969967764
Company NameBRAIN SENTINEL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB481SPC15900551 [Primary]

FDA Product Code

POSPhysiological Signal Based Seizure Monitoring System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

Devices Manufactured by BRAIN SENTINEL, INC.

B481SPC15900541 - AccuSense Sensitive Electrode Patch-SPC15-90054 US2019-11-15 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System, is a physiological, surface electromy
B481SPC15900551 - AccuSense Sensitive Electrode Patch SPC15-90055 EU2019-11-15The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System, 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. The 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 provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures 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 Monitor 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 it awaits review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified.
B481SPC15900551 - AccuSense Sensitive Electrode Patch SPC15-90055 EU2019-11-15 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System, is a physiological, surface electromy
B481SPC15900580 - SPEAC System Assy, Mini Monitor, EU2019-09-13 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surfa
B481SPC150 - SPEAC System2018-07-06 The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.