Not Cleared Direct

DEN230020 - BioTraceIO Lite (FDA 510(k) Clearance)

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

DEN230020 · Techsomed Medical Technologies , Ltd. · Radiology device
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Dec 2023
Decision
267d
Days
Class 2
Risk

DEN230020 is an FDA 510(k) submission (not cleared) for the BioTraceIO Lite. Classified as Post-ablation Tissue Response Prediction Software (product code QZL), Class II - Special Controls.

Submitted by Techsomed Medical Technologies , Ltd. (Rehovot, IL). The FDA issued a Not Cleared (DENG) decision on December 22, 2023 after a review of 267 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2052 - the FDA radiology and imaging software 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. Elevated predicate reliance profile. With 267 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 DEN230020 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 30, 2023
Decision Date December 22, 2023
Days to Decision 267 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 107d · This submission: 267d
Pathway characteristics

Device Classification

Product Code QZL Post-ablation Tissue Response Prediction Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2052
Definition A Post-ablation Tissue Response Prediction Software Is An Image Processing Device Intended To Aid Physicians With Adjunctive Information In Their Clinical Assessment Of The Ablation Zone Following A Tissue Ablation Procedure. This Device Uses Information Extracted From Medical Images Along With Other Clinical Data To Predict The Ablation Zone Post Treatment.
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 Radiology devices follow this clearance model.