LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K173548
    Device Name
    Merit Pursue Microcatheter
    Manufacturer
    Merit Medical Systems, Inc.
    Date Cleared
    2018-03-30

    (134 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K172081,K042568
    Why did this record match?
    Device Name :

    Merit Pursue Microcatheter

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

    The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the Microcatheter can be used for the controlled and selective infusion of diagnostics, embolic, or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.

    Device Description

    The Merit Pursue Microcatheter is available in two French configurations, 2.9F (proximal) / 2.0F (distal) and 2.8F (proximal / 1.7F (distal) and 110cm, 130cm and 150cm lengths. The distal tip of the microcatheter is offered in straight or pre-shaped 45 degree and swan neck configurations. The proximal end of the microcatheter consists of a molded winged hub with a tapered strain relief. The outer surface of the distal 80cm of the microcatheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the microcatheter into the vasculature. The microcatheter incorporates a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The Merit Pursue Microcatheter is offered with two 3mL syringes.

    AI/ML Overview

    I'm sorry, but without further context, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

    The provided text is an FDA 510(k) clearance letter and a 510(k) summary for the Merit Pursue Microcatheter. This document details the regulatory clearance process and the summary of testing performed to demonstrate substantial equivalence to a predicate device, rather than a specific clinical study with acceptance criteria for an AI/CADe device.

    The document lists performance data and testing based on international standards (ISO, ASTM, USP) for the physical and biological properties of the microcatheter (e.g., biocompatibility, resistance to leakage, lubricity, torque strength). It does not describe:

    • Acceptance criteria in terms of medical outcomes or diagnostic performance.
    • A study proving the device meets these criteria for an AI/CADe system.
    • Sample sizes, data provenance, expert qualifications, or ground truth establishment for a diagnostic performance study.
    • MRMC studies or standalone performance for an AI algorithm.

    Therefore, I cannot fulfill your request for information related to AI/CADe device acceptance criteria and studies from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1