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 ID: B481SPC15900551
• NIH Device Record Key: 120aed13-0342-45b9-aff3-89597ca1c17b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuSense Sensitive Electrode Patch SPC15-90055 EU
• Version Model Number: SPC15
• Catalog Number: SPC15-90055
• Company DUNS: 969967764
• Company Name: BRAIN SENTINEL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B481SPC15900551 [Primary]

FDA Product Code

• POS: Physiological Signal Based Seizure Monitoring System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

Devices Manufactured by BRAIN SENTINEL, INC.

• B481SPC15900541 - AccuSense Sensitive Electrode Patch-SPC15-90054 US: 2019-11-15 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 EU: 2019-11-15The 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 EU: 2019-11-15 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System, is a physiological, surface electromy
• B481SPC15900580 - SPEAC System Assy, Mini Monitor, EU: 2019-09-13 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surfa
• B481SPC150 - SPEAC System: 2018-07-06 The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home