Cleared Traditional

K163461 - Coolief* Cooled RF Probe

K163461 is an FDA 510(k) clearance for Coolief* Cooled RF Probe, manufactured by Halyard Health, Inc.. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K163461 · Halyard Health, Inc. · Neurology device
Download Printable Device Report (PDF)
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Apr 2017
Decision
125d
Days
Class 2
Risk

K163461 is an FDA 510(k) clearance for the Coolief* Cooled RF Probe. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Halyard Health, Inc. (Alpharetta, US). The FDA issued a Cleared decision on April 13, 2017 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - 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.

View all Halyard Health, Inc. devices

FDA 510(k) Submission Details - K163461

510(k) Number K163461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2016
Decision Date April 13, 2017
Days to Decision 125 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: 149d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

GXI Device Classification - Class 2, Special Controls

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02343003 Completed Interventional Industry-sponsored

Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain

A Prospective, Multi-Center, RCT Evaluating the Safety and Effectiveness of Coolief™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing Corticosteroid Injection in the Management of Knee Pain

151
Patients (actual)
11
Sites
Treatment
Purpose
Open label
Masking
Condition studied Osteoarthritis of the Knee
Study design Parallel
Eligibility All sexes · 21 Years+
Principal investigator David T Curd, MS
Sponsor Halyard Health (industry)
Started 2015-01-01 → Primary completion 2016-08-01 → Completed 2017-03-16
Primary outcome
Numeric Rating Scale (NRS)
Secondary outcome
Numeric Rating Scale
View full study on ClinicalTrials.gov

Regulatory Peers - GXI Probe, Radiofrequency Lesion

All 62
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K163461.
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
K180369 · Relievant Medsystems · Sep 2018
INTRACEPT Intraosseous Nerve Ablation System
K170827 · Relievant Medsystems · Aug 2017
OWL RF INSULATED CANNULAE
K170708 · Diros Technology, Inc. · Jun 2017
COOLIEF Cooled Radiofrequency Kit
K163236 · Halyard Health, Inc. · Dec 2016
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
K152642 · Lccs Products Limited · Aug 2016
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
K153272 · Relievant Medsystems · Jul 2016