Not Cleared Direct

DEN200030 - FEops HEARTguide (FDA 510(k) Clearance)

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

DEN200030 · Feops NV · Cardiovascular device
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Sep 2021
Decision
489d
Days
Class 2
Risk

DEN200030 is an FDA 510(k) submission (not cleared) for the FEops HEARTguide. Classified as Interventional Cardiovascular Implant Simulation Software Device (product code QQI), Class II - Special Controls.

Submitted by Feops NV (Gent-Zwijnaarde, BE). The FDA issued a Not Cleared (DENG) decision on September 8, 2021 after a review of 489 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1405 - 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 489 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 DEN200030 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 07, 2020
Decision Date September 08, 2021
Days to Decision 489 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
364d slower than avg
Panel avg: 125d · This submission: 489d
Pathway characteristics

Device Classification

Product Code QQI Interventional Cardiovascular Implant Simulation Software Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1405
Definition An Interventional Cardiovascular Implant Simulation Software Device Is A Prescription Device That Provides A Computer Simulation Of An Interventional Cardiovascular Implant Device Inside A Patient’s Cardiovascular Anatomy. It Performs Computational Modeling To Predict The Interaction Of The Interventional Cardiovascular Implant Device With The Patient-specific Anatomical Environment.
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.