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510(k) Data Aggregation

    K Number
    K250492
    Device Name
    FlexiGo 3D Delivery Catheter
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2025-06-18

    (118 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K190475
    Why did this record match?
    Reference Devices :

    K190475

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

    The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.

    Device Description

    The modified Delivery Catheter (FlexiGo 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.

    The modified Delivery Catheter is packaged with a dilator and two (2) trans vavular introducers for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.

    AI/ML Overview

    This document describes the FDA 510(k) Clearance Letter for the "FlexiGo 3D Delivery Catheter." This is a medical device, and the information provided details its intended use, comparison to a predicate device, and the performance data submitted for its clearance. However, the provided document does not contain any information related to an AI/ML (Artificial Intelligence/Machine Learning) device or study.

    Therefore, I cannot provide a response that describes "Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria" in the context of an AI/ML device, nor can I fill in a table of acceptance criteria for an AI/ML device or discuss MRMC studies, training/test sets, or ground truth establishment relevant to AI/ML.

    The provided text pertains to a traditional medical device (a catheter) and discusses its physical and functional characteristics, material compatibility, and standard medical device performance testing (biocompatibility, sterilization, dimensional verification, etc.).

    To address your request, I would need a document describing an AI/ML medical device and its associated clinical study, statistical methodology, and performance metrics relevant to AI/ML algorithm evaluation.

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