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510(k) Data Aggregation

    K Number
    K173860
    Device Name
    s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
    Manufacturer
    Volcano Corporation
    Date Cleared
    2018-04-11

    (112 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K133641,K140291,K150441,K153369,K133323,K170133
    Why did this record match?
    Reference Devices :

    K133641, K140291, K150441, K153369

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

    The Volcano System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

    ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

    VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

    The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

    Rotational 45MHz feature is intended for the qualitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the imaging core within the protective sheath for a maximum of 15 cm.

    The FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure angiography and/or interventional procedures.

    The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

    Device Description

    The Volcano s5 TM/s5i/CORETM Mobile Precision Guided Therapy System is a mobile imaging and pressure management system as previously described in K133323. The subject device incorporates the Volcano iFR® Modality cleared in K133323.

    Pressure measurement is captured through the use of currently marketed pressure wires compatible with the currently marketed s5/s5i/CORE/CORE Mobile imaging and pressure measurement system.

    AI/ML Overview

    This FDA 510(k) submission describes the Volcano s5/s5i/CORE/CORE Mobile Precision Guided Therapy System and focuses on a change in the Indications for Use for its iFR Modality. The submission aims to adopt a new, single diagnostic cut-point for iFR guided revascularization based on recent clinical evidence, replacing a previous 'hybrid' approach.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria here re-frame the iFR Modality's diagnostic cut-point. The previous approach was likely a range (e.g., 0.75-0.80), and the new acceptance criteria is a single, dichotomous cut-point of 0.89. The device performance is evaluated against this new cut-point in terms of its clinical outcomes compared to FFR guidance.

    Acceptance Criteria (for iFR Modality)Reported Device Performance (as demonstrated by clinical studies)
    iFR Modality has a diagnostic cut-point of 0.89.ADVISE II study demonstrated that an iFR cut-point of 0.89 matches best with an FFR ischemic cut-point of 0.80 with a specificity of 87.8% and sensitivity of 73.0% (C statistic: 0.90).
    iFR Modality can reliably guide revascularization decisions.DEFINE-FLAIR Study: iFR-guided revascularization (6.8%) was non-inferior to FFR-guided revascularization (7.0%) for the composite primary endpoint (all-cause mortality, non-fatal MI, or unplanned revascularization within 12 months). D = -0.2%; 95% CI, -2.3 to 1.8; P
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