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510(k) Data Aggregation

    K Number
    K183219
    Device Name
    Trio-CT Triple Lumen Catheter
    Manufacturer
    Medical Components Inc. (dba MedComp)
    Date Cleared
    2019-06-14

    (206 days)

    Product Code
    NIE
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K123292
    Why did this record match?
    Device Name :

    Trio-CT Triple Lumen Catheter

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

    The Trio-CT™ Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.

    The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

    Device Description

    The Trio-CT™ Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.

    AI/ML Overview

    The provided text describes a medical device, the Trio-CT™ Triple Lumen Catheter, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria for a study proving device performance in the context of an AI/algorithm-based medical device.

    The document is a 510(k) summary for a physical medical device (a catheter) and discusses its non-clinical testing, biocompatibility, and comparison to a predicate device. It lacks the specific details requested regarding acceptance criteria, study design for AI evaluation, ground truth establishment for AI, or sample sizes related to AI performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/algorithm. Based on the provided text, such a study was not conducted or reported for this device.

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