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    K Number
    K163461
    Device Name
    Coolief* Cooled RF Probe
    Manufacturer
    Halyard Health, Inc.
    Date Cleared
    2017-04-13

    (125 days)

    Product Code
    GXI
    Regulation Number
    882.4725
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K031951,K053082
    Why did this record match?
    Device Name :

    Coolief* Cooled RF Probe

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The COOLIEF* Cooled Radiofrequency Probe is to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.

    Device Description

    The COOLIEF* Cooled Radiofrequency (RF) Probe is a sterile, single-use device that delivers RF energy within the area of the active probe tip, while the probe tip is cooled by sterile water that circulates within the probe. Cooling the probe tip creates a larger. more homogenous RF heating area that results in a larger RF lesion in the target tissue. COOLIEF* Cooled RF Probe is used in conjunction with the Halyard RF Generator to create RF lesions in nervous tissue. The shaft of the probe is insulated with a polyimide sheath, and the distal tip consists of a medical grade stainless steel electrode. Sterile water circulates through a cavity in the electrode to cool the electrode tip during the cooled RF ablation procedure. The COOLIEF* Cooled Radiofrequency (RF) Probe is sterilized by ethylene oxide.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state "acceptance criteria" in a singular section for clinical performance. Instead, it describes the effectiveness endpoint and provides the results.

    Characteristic / Test TypeAcceptance Criteria (Implied)Reported Device Performance (COOLIEF* Cooled RF Probe)
    Clinical Effectiveness (Primary Endpoint)Superiority to corticosteroid injection in achieving ≥ 50% pain reduction at 6 months post-treatment in patients with moderate to severe knee pain due to radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.67.2% of the COOLIEF* Cooled RF study group achieved ≥50% pain relief at 6 months, compared to 15.7% of the corticosteroid injection group (p-value for superiority not explicitly stated but implied by "superior to steroid injection").

    Mean NRS pain reduction: 4.9 points (from 7.3 to 2.5) at 6 months.

    Significant functional improvement: 39.7% reported "Satisfactory Joint Function" vs. 3% in comparison group.

    Global Perceived Effect: 91.4% reported "improved" knee condition vs. 23.9% in comparison group. |
    | Cytotoxicity | Qualitative Grade = 0; Quantitative = cell death

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