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510(k) Data Aggregation

    K Number
    K211911
    Device Name
    Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
    Manufacturer
    Coloplast Corp
    Date Cleared
    2022-03-10

    (262 days)

    Product Code
    LJE,FAD
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K180057,K140085
    Why did this record match?
    Reference Devices :

    K180057

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

    For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients.

    Device Description

    The Kolibri® Percutaneous Nephrostomy Catheters are available in two configurations based on the tip configuration termed either J or Malecot. The distal end of the J catheter resembles a loop, and the distal end of the Malecot catheter has 4-wings which form an open basket to hold the catheter in place. J and Malecot catheters are single lumen catheters with outer diameters ranging from 6 Fr to 20 Fr. The J and Malecot catheters are manufactured from the material branded Vortek by Coloplast. The catheters are supplied either individually or as part of a kit. The following components are included depending on the specific configuration:

    • · Stylet
    • · Silicone sleeve
    • · Stopcock
    • Female Luer
    • Urine bag connector
    • Guidewire (kits only)
    • · Dilator set(s) (kits only)
    • · Chiba needles (kits only)
      The dilators. Chiba Needles, and quidewires are all packaged separately. The J and Malecot catheters are supplied sterile via ethylene oxide for single use.

    Kolibri Direct Puncture Set
    The Direct Puncture Set consists of an 8 Fr or 10 Fr J catheter with a silicone sleeve, stopcock, urine bag connector, transparent reinforced tube, stainless-steel trocar needle, and stainlesssteel stylet. The Direct Puncture Set is supplied sterile via ethylene oxide for single use.

    AI/ML Overview

    The provided text is a 510(k) summary for the Kolibri® Percutaneous Nephrostomy Catheters, Kolibri® Percutaneous Nephrostomy Kits, and Kolibri® Direct Puncture Sets. This document is a premarket notification to the FDA, demonstrating that the new device is substantially equivalent to a legally marketed predicate device.

    However, the document does not describe an acceptance criteria table or a study that proves the device meets specific performance acceptance criteria related to a diagnostic or AI-driven medical device. Instead, it outlines the device's technical characteristics, its comparison to a predicate device, and a list of biocompatibility, sterilization, and bench tests performed to demonstrate substantial equivalence for a mechanical catheter device.

    Therefore, I cannot extract the information required for your request in the format you specified, as the input document does not contain data related to a clinical study or performance metrics for a diagnostic or AI-based device. The device described is a medical instrument (catheter), and the "performance data" refers to its physical and material properties, not diagnostic accuracy, sensitivity, specificity, or AI performance.

    If you have a document that describes the acceptance criteria and study for a diagnostic or AI-driven medical device, please provide that, and I will do my best to extract the requested information.

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