SPEAC System Electrode Patch SPC15-90018

Basic Information

• Brand Name: SPEAC System Electrode Patch SPC15-90018
• Primary DI: B481SPC15900181
• Version / Model: SPC15
• Catalog Number: SPC15-90018
• Company Name: BRAIN SENTINEL, INC.
• Labeler DUNS: 969967764
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-13
• Public Version: 1
• Public Version Date: 2019-08-21
• Public Version Status: New
• Public Device Record Key: f38d1de3-4985-4cac-bf4d-f87d00d6197f

Device Description

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

• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
POS	Physiological Signal Based Seizure Monitoring System	Neurology	882.1580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B481SPC15900181	HIBCC

Storage Conditions

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