BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SPEAC System Assy, Mini Monitor, US

    DI: B481SPC15900570 · Model: SPC15 · BRAIN SENTINEL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SPEAC System Assy, Mini Monitor, US
    Primary DI
    B481SPC15900570
    Version / Model
    SPC15
    Catalog Number
    SPC15-90057
    Company Name
    BRAIN SENTINEL, INC.
    Labeler DUNS
    969967764
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-04
    Public Version
    1
    Public Version Date
    2019-09-12
    Public Version Status
    New
    Public Device Record Key
    5643134f-b135-4d81-bc0e-18bc3972ceaa

    Device Description

    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 13 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 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.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    POS Physiological Signal Based Seizure Monitoring System

    GMDN Terms

    Code Name
    61288 Home seizure monitoring system

    Identifiers

    Type ID
    Primary B481SPC15900570

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    5 – 35 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    5 – 35 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    45 – 85 Percent (%) Relative Humidity
    Type
    Handling Environment Humidity
    Temperature Range
    45 – 85 Percent (%) Relative Humidity