Not Cleared Post-NSE

DEN110019 - NEBA SYSTEM (FDA 510(k) Clearance)

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

DEN110019 · Lexicor Medical Technology, LLC · Neurology device
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Jul 2013
Decision
585d
Days
Class 2
Risk

DEN110019 is an FDA 510(k) submission (not cleared) for the NEBA SYSTEM. Classified as Neuropsychiatric Interpretative Electroencephalograph Assessment Aid (product code NCG), Class II - Special Controls.

Submitted by Lexicor Medical Technology, LLC (Augusta, US). The FDA issued a Not Cleared (DENG) decision on July 15, 2013 after a review of 585 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1440 - 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 585 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.

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Submission Details

510(k) Number DEN110019 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 08, 2011
Decision Date July 15, 2013
Days to Decision 585 days
Submission Type Post-NSE
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
437d slower than avg
Panel avg: 148d · This submission: 585d
Pathway characteristics

Device Classification

Product Code NCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1440
Definition Uses A Patient's Electroencephalograph (eeg) To Provide An Interpretation Of The Patient's Neuropsychiatric Condition. It Is Also Used 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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.