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510(k) Data Aggregation

    K Number
    K153682
    Device Name
    Chocolate XD PTCA Balloon Catheter
    Manufacturer
    TriReme Medical, LLC
    Date Cleared
    2016-06-23

    (184 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K133632,K150292
    Why did this record match?
    Device Name :

    Chocolate XD PTCA Balloon Catheter

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

    The Chocolate™ XD PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.

    Device Description

    The Chocolate XD PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape, and is removed from the vessel along with the balloon catheter. Two Radiopaque markers define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire.

    AI/ML Overview

    The provided document is a 510(k) summary for the TriReme Medical Chocolate XD PTCA Balloon Catheter. This document does not contain information on the acceptance criteria, study design, or results for an AI/ML powered device. It describes a medical device, a balloon catheter, and its equivalence to a predicate device, based on standard performance testing for devices of this type, not for an AI/ML algorithm.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device from this document.

    The document discusses standard device performance testing for a physical medical catheter, such as:

    • Dimensional Verification
    • Balloon Preparation, Deployment & Retraction
    • Flexibility & Kink
    • Balloon Rated Burst Pressure (RBP)
    • Rate Burst Pressure in Stent
    • Balloon Fatigue
    • Balloon Fatigue in Stent
    • Balloon Compliance
    • Balloon Inflation and Deflation
    • Catheter Bond Strength
    • Tip Pull Test
    • Torque Strength
    • Radiopacity
    • Particulate Evaluation
    • Biocompatibility Testing

    These are physical and material property tests to ensure the catheter functions safely and effectively, not diagnostic performance metrics for an AI system.

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