Cleared Traditional

K200276 - SPEAC System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K200276 · Brain Sentinel, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Feb 2021
Decision
368d
Days
Class 2
Risk

K200276 is an FDA 510(k) clearance for the SPEAC System. Classified as Physiological Signal Based Seizure Monitoring System (product code POS), Class II - Special Controls.

Submitted by Brain Sentinel, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 6, 2021 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1580 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brain Sentinel, Inc. devices

Submission Details

510(k) Number K200276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2020
Decision Date February 06, 2021
Days to Decision 368 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 148d · This submission: 368d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code POS Physiological Signal Based Seizure Monitoring System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1580
Definition The Physiological Signal Based Seizure Monitoring System Is A Prescription Device That Uses Physiological Signal To Identify Abnormal Physiological Activity That May Be Associated With A Seizure. The System Does Not Predict Seizure Onsets, And Is Not Intended As A Standalone Seizure Monitoring Device.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01874600 Unknown Observational

Seizure Detection and Warning System for Epilepsy Patients

A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

239
Patients (actual)
1
Site
Condition studied Epilepsy
Eligibility All sexes · 13 Years+
Principal investigator Jose' E Cavazos, MD, PhD
Sponsor Brain Sentinel
Started 2013-07-01 → Primary completion 2019-12-01
Primary outcome
Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG.
Secondary outcome
Comparison of study device to self reporting of seizures using a seizure diary.
View full study on ClinicalTrials.gov