Cleared Traditional

K213930 - Brainlab Elements Guide XT, Guide 3.0 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213930 · Brainlab AG · Neurology device
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Apr 2022
Decision
124d
Days
Class 2
Risk

K213930 is an FDA 510(k) clearance for the Brainlab Elements Guide XT, Guide 3.0. Classified as Brain Stimulation Programming Planning Software. (product code QQC), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on April 19, 2022 after a review of 124 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K213930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2021
Decision Date April 19, 2022
Days to Decision 124 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 148d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.