DEVICE: SPEAC System Electrode Patch SPC15-90018 (B481SPC15900181)
Device Identifier (DI) Information
SPEAC System Electrode Patch SPC15-90018
SPC15
In Commercial Distribution
SPC15-90018
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
SPC15-90018
BRAIN SENTINEL, INC.
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.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61288 | Home seizure monitoring system |
An assembly of devices intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. It typically consists of a mains electricity (AC-powered) central monitor that wirelessly receives, records, and displays the data, and one or more battery-powered body-worn sensor(s); it may have alarms and data may be transmitted to a cloud-based storage, server or mobile device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
POS | Physiological Signal Based Seizure Monitoring System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 45 and 85 Percent (%) Relative Humidity |
Storage Environment Humidity: between 45 and 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 5 and 35 Degrees Celsius |
Storage Environment Temperature: between 5 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f38d1de3-4985-4cac-bf4d-f87d00d6197f
August 21, 2019
1
August 13, 2019
August 21, 2019
1
August 13, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined