Not Cleared Direct

DEN220066 - BrainSee (FDA 510(k) Clearance)

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220066 · Darmiyan, Inc. · Neurology device
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Jan 2024
Decision
469d
Days
Class 2
Risk

DEN220066 is an FDA 510(k) submission (not cleared) for the BrainSee. Classified as Prognostic Assessment Software Of Mild Cognitive Impairment (product code QWT), Class II - Special Controls.

Submitted by Darmiyan, Inc. (Berkeley, US). The FDA issued a Not Cleared (DENG) decision on January 11, 2024 after a review of 469 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1454 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 469 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Darmiyan, Inc. devices

Submission Details

510(k) Number DEN220066 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2022
Decision Date January 11, 2024
Days to Decision 469 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 148d · This submission: 469d
Pathway characteristics

Device Classification

Product Code QWT Prognostic Assessment Software Of Mild Cognitive Impairment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1454
Definition Prognostic Assessment Software Of Mild Cognitive Impairment. Prognostic Assessment Software Of Mild Cognitive Impairment Is A Prescription-only Device That Combines Information From Multiple Clinical Data Sources To Produce An Output Indicative Of The Likelihood That A Patient Diagnosed With Mild Cognitive Impairment Will Progress To More Severe Forms Of Cognitive Impairment, Or Will Develop Dementia, Such As Alzheimer’s Disease Dementia, Within A Specified Period Of Time. This Device Is Intended For Adjunctive Use And Not Intended As A Stand-alone Diagnostic Or Prognostic Too.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.