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    K Number
    K173955
    Device Name
    Mic-Key* SF Over-the-Wire Stoma Measuring Device
    Manufacturer
    Halyard Health, Inc.
    Date Cleared
    2018-01-26

    (29 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Special
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K122653
    Why did this record match?
    Device Name :

    Mic-Key* SF Over-the-Wire Stoma Measuring Device

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

    MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.

    Device Description

    MIC-KEY* SF Over-the-Wire Stoma Measuring Device is designed for measuring the length of a stoma prior to placement of a low profile feeding tube. The Stoma Measuring Device comprises a tubular shaft 10 Fr with graduated scale, an inflation valve and retaining balloon. The MIC-KEY* SF Over the Wire Stoma Measuring Device is made of polyurethane tubing, EtO sterilized and for single use. Like the predicate device, it is intended to be use in hospital environment.

    AI/ML Overview

    This document describes the non-clinical tests performed on the MIC-KEY* SF Over-the-Wire Stoma Measuring Device to demonstrate its performance and substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriterionResult
    Tensile Strength, Head/Tube≥ 15 N per EN 1615:2000Pass
    Balloon Concentricity
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