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510(k) Data Aggregation

    K Number
    K201642
    Device Name
    Paragon Adult Maxi PMP Oxygenator with Tubing Pack
    Manufacturer
    Chalice Medical Ltd
    Date Cleared
    2020-09-18

    (93 days)

    Product Code
    DTZ,DTR,DWF
    Regulation Number
    870.4350
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K122254,K771692
    Why did this record match?
    Reference Devices :

    K122254, K771692

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

    The Paragon Adult Maxi PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.

    Device Description

    The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) with Tubing Pack is a hollow fiber membrane oxygenator with an integrated heat exchanger pre-connected to blood line and gas line tubing. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the requlation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces.

    The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.

    The Tubing Pack is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.

    AI/ML Overview

    The document provided is a 510(k) summary for a medical device (Paragon Adult Maxi PMP Oxygenator with Tubing Pack) and does not contain information about an AI/ML powered device or study that determines acceptance criteria based on AI/ML performance.

    The provided text details the regulatory review of a conventional medical device (oxygenator and tubing pack) and focuses on its substantial equivalence to predicate devices, in vitro and non-clinical test results. There is no mention of acceptance criteria related to a study proving an AI/ML device meets them. Therefore, I cannot extract the requested information from the provided document.

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