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510(k) Data Aggregation

    K Number
    K052165
    Device Name
    RX ACCUNET EMBOLIC PROTECTION SYSTEM
    Manufacturer
    GUIDANT CORPORATION
    Date Cleared
    2005-08-16

    (7 days)

    Product Code
    NTE
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K024418,K042908,K042218
    Why did this record match?
    Reference Devices :

    K024418, K042908

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

    The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.

    Device Description

    The RX ACCUNET™ Embolic Protection System is a filtration type embolic protection system consisting of the RX ACCUNET™ Guide Wire, the RX ACCUNET™ Delivery System and the RX ACCUNET™ Recovery Catheter. The RX ACCUNET™ Embolic Protection System is delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery Catheter. Once collapsed, the entire system is removed as a single unit. The Recovery Catheter has a radiopaque tip to facilitate movement though tortuous anatomy

    AI/ML Overview

    This document is a 510(k) summary for the RX ACCUNET™ Embolic Protection System. It does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/ML device.

    The provided text focuses on demonstrating substantial equivalence of the RX ACCUNET™ Embolic Protection System to a legally marketed predicate device (K042218). This is a regulatory filing for a medical device that appears to be a physical device (embolic protection system) and not an AI/ML-driven software device. Therefore, the questions related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information contained in this document.

    The document discusses:

    • Device Name: RX ACCUNET™ Embolic Protection System
    • Intended Use: As a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) during angioplasty and stenting in carotid arteries, for artery diameters between 3.25 mm and 7.0 mm.
    • Substantial Equivalence: The device is stated to be substantially equivalent to the RX ACCUNET™ Embolic Protection System (K042218) with minor design refinements to the filter basket end and additional in-process testing.

    Without a study described in the provided text that evaluates the device against specific performance criteria (as would be typical for an AI/ML driven system), it is not possible to answer the questions about acceptance criteria, device performance, sample sizes, ground truth, or expert involvement.

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