Not Cleared Direct

DEN190029 - Acumen Assisted Fluid Management (AFM) Software Feature (FDA 510(k) Clearance)

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

DEN190029 · Edwards Lifesciences · Cardiovascular device
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Nov 2020
Decision
529d
Days
Class 2
Risk

DEN190029 is an FDA 510(k) submission (not cleared) for the Acumen Assisted Fluid Management (AFM) Software Feature. Classified as Adjunctive Open Loop Fluid Therapy Recommender (product code QMS), Class II - Special Controls.

Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Not Cleared (DENG) decision on November 13, 2020 after a review of 529 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5600 - the FDA cardiovascular device oversight 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 529 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 DEN190029 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 03, 2019
Decision Date November 13, 2020
Days to Decision 529 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
404d slower than avg
Panel avg: 125d · This submission: 529d
Pathway characteristics

Device Classification

Product Code QMS Adjunctive Open Loop Fluid Therapy Recommender
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5600
Definition The Adjunctive Open Loop Fluid Therapy Recommender Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict A Patient’s Estimated Response To Fluid Therapy. The Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy.
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 Cardiovascular devices follow this clearance model.