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    K Number
    K141479
    Device Name
    KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
    Manufacturer
    COVIDIEN
    Date Cleared
    2014-12-23

    (202 days)

    Product Code
    LZH
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K040196
    Why did this record match?
    Device Name :

    KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS

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

    The Kangaroo™ Enteral Feeding Set with ENFit connectors delivers nutritional formula to the gastrointestinal system of a patient age Infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.

    Device Description

    Enteral Feeding sets for use with Kangaroo Feeding pumps. The pump set incorporates 5 basic segments: Fluid reservoir(s), which may be an attached bag (500ml or 1000ml) or a spike for connection to a formula container; Tubing from fluid reservoir to pump (9 or 24 inch); Pump interface module (peristaltic tubing); Tubing from pump to patient connector (66 inches); Patient connector (ENFit connector compliant to ISO 80369-3).

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot fulfill your request. This document is a 510(k) premarket notification for a medical device (Kangaroo™ Enteral Feeding Sets with ENFit connectors) and does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/algorithm-driven device.

    The document primarily focuses on:

    • Substantial equivalence to a predicate device.
    • Device description and intended use.
    • Comparison of technological characteristics between the proposed and predicate devices, highlighting the change to an ENFit connector compliant with ISO 80369-3.
    • Nonclinical testing (biocompatibility, stability, usability/human factors related to the ENFit connector).
    • Explicitly stating that clinical testing was not relied upon for evidence of safety, effectiveness, or substantial equivalence.

    Therefore, there is no information regarding:

    • A table of acceptance criteria and reported device performance for an algorithm.
    • Sample sizes for test or training sets, data provenance, ground truth establishment, or expert involvement for an AI study.
    • MRMC comparative effectiveness studies or standalone algorithm performance.
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