Cleared Traditional

K161068 - Ahead 300

K161068 is an FDA 510(k) clearance for Ahead 300, manufactured by Brainscope Company, Inc.. The device is a Class 2 Neurology device with product code PIW cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K161068 · Brainscope Company, Inc. · Neurology device
Download Printable Device Report (PDF)
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Sep 2016
Decision
160d
Days
Class 2
Risk

K161068 is an FDA 510(k) clearance for the Ahead 300. Classified as Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid (product code PIW), Class II - Special Controls.

Submitted by Brainscope Company, Inc. (Bethesda, US). The FDA issued a Cleared decision on September 22, 2016 after a review of 160 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1450 - 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. Standard predicate reliance. 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 Brainscope Company, Inc. devices

FDA 510(k) Submission Details - K161068

510(k) Number K161068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2016
Decision Date September 22, 2016
Days to Decision 160 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
12d slower than avg
Panel avg: 148d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

PIW Device Classification - Class 2, Special Controls

Product Code PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1450
Definition A Prescription Device That Uses A Patient¿s Electroencephalograph (eeg) To Provide An Interpretation Of The Structural Condition Of The Patient¿s Brain In The Setting Of Trauma. The Brain Injury Adjunctive Interpretive Eeg Assessment Aid Is For Use As An Adjunct To Standard Clinical Practice Only As An Assessment Aid For A Medical Condition For Which There Exists Other Valid Methods Of Diagnosis.
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
NCT02367300 Completed Observational Industry-sponsored

Validation Of TBI Detection System For Head Injured Patients

Validation Of Point-Of-Care TBI Detection System For Head Injured Patients

981
Patients (actual)
11
Sites
Condition studied Brain Injuries
Eligibility All sexes · 18 Years+
Principal investigator Douglas C Oberly
Sponsor BrainScope Company, Inc. (industry)
Started 2015-02-01 → Primary completion 2015-12-01 → Completed 2016-01-01
Primary outcome
The primary objective of this study is to validate the clinical utility of the BrainScope Ahead 300 device for the acute identification of structural brain injuries in the TBI population, following closed head injury.
Secondary outcome
To demonstrate the utility of the EEG normality indicator (NI) score from a given subject presented as a percentile of the normal population and an indicator score.
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

All 8
Devices cleared under the same product code (PIW) and FDA review panel - the closest regulatory comparables to K161068.
BrainScope TBI (Model: Ahead 400)
K183241 · Brainscope Company, Inc. · Feb 2019
Modified BrainScope One
K181785 · Brainscope Company, Inc. · Dec 2018
BrainScope One
K181179 · Brainscope Company, Inc. · May 2018
Brainscope Ahead 200
K143643 · Brainscope Company, Inc. · May 2015
BrainScope Ahead 100
DEN140025 · Brainscope Company, Inc. · Nov 2014