Not Cleared Direct

DEN210003 - SureTune4 Software (FDA 510(k) Clearance)

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

DEN210003 · Medtronic Neuromodulation · Neurology device
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Aug 2021
Decision
201d
Days
Class 2
Risk

DEN210003 is an FDA 510(k) submission (not cleared) for the SureTune4 Software. Classified as Brain Stimulation Programming Planning Software. (product code QQC), Class II - Special Controls.

Submitted by Medtronic Neuromodulation (Minneapolis, US). The FDA issued a Not Cleared (DENG) decision on August 23, 2021 after a review of 201 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5855 - the FDA neurology device 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 Neurology review framework.

View all Medtronic Neuromodulation devices

Submission Details

510(k) Number DEN210003 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 03, 2021
Decision Date August 23, 2021
Days to Decision 201 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 148d · This submission: 201d
Pathway characteristics

Device Classification

Product Code QQC Brain Stimulation Programming Planning Software.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5855
Definition The Brain Stimulation Programming Planning Software Is A Prescription Device Intended To Assist In Planning Stimulation Programming For Implanted Brain Stimulators.
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 Neurology devices follow this clearance model.