Not Cleared Direct

DEN150004 - EPIC ClearView System (FDA 510(k) Clearance)

Class I Neurology device.

DEN150004 · Epic Research & Diagnostics, Inc. · Neurology device
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Jul 2016
Decision
549d
Days
Class 1
Risk

DEN150004 is an FDA 510(k) submission (not cleared) for the EPIC ClearView System. Classified as Evoked Photon Image Capture Device (product code PNA), Class I - General Controls.

Submitted by Epic Research & Diagnostics, Inc. (Scottsdale, US). The FDA issued a Not Cleared (DENG) decision on July 15, 2016 after a review of 549 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1561 - 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 549 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 Epic Research & Diagnostics, Inc. devices

Submission Details

510(k) Number DEN150004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 13, 2015
Decision Date July 15, 2016
Days to Decision 549 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
401d slower than avg
Panel avg: 148d · This submission: 549d
Pathway characteristics

Device Classification

Product Code PNA Evoked Photon Image Capture Device
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1561
Definition The System Reports Two Sets Of Numbers Under Two Different Conditions, One With Capacitive Barrier To Minimize The Effect Of Variables Such As Oils And Sweat On The Image And One Without The Capacitive Barrier. The Response Scale Reports Numerical Measures Of Electrophysiological Signals Emanating From The Skin. The Device Is Limited To Use As A Measurement Tool And Is Not Intended For Diagnostic Purposes Or For Influencing Any Clinical Decisions. This Device Is Only To Be Used To Image And Document Electrophysiological Signals Emanating From The Skin.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.