Not Cleared Direct

DEN230021 - ensoETM (FDA 510(k) Clearance)

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

DEN230021 · Advanced Cooling Therapy, Inc. D/B/A Attune Medical · Cardiovascular device
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Sep 2023
Decision
167d
Days
Class 2
Risk

DEN230021 is an FDA 510(k) submission (not cleared) for the ensoETM. Classified as Temperature Regulation Device For Esophageal Protection During Cardiac Ablation (product code QXV), Class II - Special Controls.

Submitted by Advanced Cooling Therapy, Inc. D/B/A Attune Medical (Chicago, US). The FDA issued a Not Cleared (DENG) decision on September 13, 2023 after a review of 167 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5720 - 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.

View all Advanced Cooling Therapy, Inc. D/B/A Attune Medical devices

Submission Details

510(k) Number DEN230021 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 30, 2023
Decision Date September 13, 2023
Days to Decision 167 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 125d · This submission: 167d
Pathway characteristics

Device Classification

Product Code QXV Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5720
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 Temperature Regulation To Control The Temperature Of The Esophagus During Cardiac Ablation.
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.