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510(k) Data Aggregation

    K Number
    K961895
    Device Name
    FLEXILOG LS 13921
    Manufacturer
    OAKFIELD INSTRUMENTS, LTD.
    Date Cleared
    1996-11-04

    (172 days)

    Product Code
    KLA
    Regulation Number
    876.1725
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FLEXILOG LS is used for the location of the lower esophageal sphincter and the measuring of the nares to lower esophageal sphincter distance. This procedure being carried out prior to the accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux.

    Device Description

    The FLEXILOG LS is a single channel, pressure monitoring system comprising of a module of electronics that provides transducer excitation, amplification and transmission of the signal to a computer via an optically isolated RS232 connector. The pressure signal is displayed on the computer VDU via a Microsoft Windows display program. The program does not provide any analysis or data saving options. The electronics module is designed to be compatible with catheter tip and water perfused pressure transducers currently available in the US market.

    AI/ML Overview

    This document is a 510K submission for the FLEXILOG LS device, a Lower Esophageal Sphincter Detector. The provided text outlines the device's description, indications for use, and technological characteristics, along with a claim of substantial equivalence to predicate devices. However, it does not contain the detailed study information required to answer your questions about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or specialized studies like MRMC or standalone performance evaluations.

    The only statement related to performance and testing is: "The FLEXILOG LS has been shown to accurately measure and display pressure." This sentence is too vague to extract specific acceptance criteria or study details.

    Therefore,Based on the provided text, I cannot answer your questions as the document does not contain the detailed study results, acceptance criteria table, sample sizes, ground truth information, or specific study types (e.g., MRMC, standalone) you are looking for. The document only states that "The FLEXILOG LS has been shown to accurately measure and display pressure," which is a general claim and not specific performance data.

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