Not Cleared Direct

DEN230006 - esolution (FDA 510(k) Clearance)

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

DEN230006 · S4 Medical Corp. · Cardiovascular device
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Sep 2023
Decision
225d
Days
Class 2
Risk

DEN230006 is an FDA 510(k) submission (not cleared) for the esolution. Classified as Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation (product code QXU), Class II - Special Controls.

Submitted by S4 Medical Corp. (Chagrin Falls, US). The FDA issued a Not Cleared (DENG) decision on September 6, 2023 after a review of 225 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5710 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

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Submission Details

510(k) Number DEN230006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 24, 2023
Decision Date September 06, 2023
Days to Decision 225 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 125d · This submission: 225d
Pathway characteristics

Device Classification

Product Code QXU Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5710
Definition This Device Is Placed In The Lumen Of The Esophagus To Reduce The Likelihood Of Esophageal Injury Or A Specific Adverse Event During Cardiac Ablation Procedures. The Device Uses Mechanical Means To Deviate The Esophagus Away From The Source Of Ablation Energy
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.