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510(k) Data Aggregation

    K Number
    K031810
    Device Name
    AMPLATZER VASCULAR PLUG
    Manufacturer
    AGA MEDICAL CORP.
    Date Cleared
    2003-09-09

    (89 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K940189,K993455,K955293,K951256,K960705,K962503
    Predicate For
    K043371,K071125,K123696,K182944,K250133
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AMPLATZER Vascular Plug is indicated for arterial and venous embolizations in the peripheral vasculature.

    Device Description

    The AMPLATZER Vascular Plug is provided sterile and is intended for one-time use. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. The delivery system is comprised of a 135 cm long, stainless steel delivery cable and a PTFE loader. The AMPLATZER Vascular Plug is preloaded in a loader and delivered through currently available standard 5 or 6 French guiding catheters.

    AI/ML Overview

    Here's an analysis of the provided text regarding acceptance criteria and the supporting study for the AMPLATZER® Vascular Plug:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document describes various tests performed on the AMPLATZER Vascular Plug and its delivery system, primarily focusing on mechanical performance, biocompatibility, and comparing its embolization efficacy to existing coil devices in an animal model. Unlike typical AI/software device submissions, this document focuses on a physical medical device. Therefore, the "acceptance criteria" are more about demonstrating safety and functional equivalence to predicate devices, rather than specific performance metrics like sensitivity, specificity, or AUC as seen in AI/ML applications.

    Acceptance Criterion CategorySpecific Criterion / Test PerformedReported Device Performance (Results)
    Efficacy (Animal Study)Shorter occlusion time compared to standard coilsOcclusion time: 5.0 ± 3.5 minutes (AMPLATZER) vs. 10.2 ± 9.8 minutes (Cook coils), P
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