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510(k) Data Aggregation

    K Number
    K141275
    Device Name
    ENDOPHYS PRESSURE SENSING SHEATH KIT
    Manufacturer
    ENDOPHYS, INC.
    Date Cleared
    2015-01-07

    (236 days)

    Product Code
    DYB,CAT,DXO
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K052557,K120212,K093111,K132474
    Why did this record match?
    Reference Devices :

    K052557, K120212, K093111, K132474

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

    The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure when used with the Endophys Blood Pressure Monitor.

    Device Description

    The Pressure Sensing Sheath ("PSS") is an introducer sheath with an integrated fiber optic pressure transducer. The PSS is provided with a dilator and a guidewire, which together make up the Endophys Pressure Sensing Sheath Kit ("PSS Kit"). The PSS Kit is intended to be used with the Endophys Blood Pressure Monitor ("BPM"), which connects to the PSS and displays the blood pressure measurements. Together with the BPM, the PSS is used to continuously monitor patient blood pressure during procedures requiring vascular access.

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets them. The text primarily consists of an FDA 510(k) clearance letter and a summary of the device, its indications for use, and a general statement about testing to support substantial equivalence.

    Specifically, the text does not include:

    • A table of acceptance criteria and reported device performance.
    • Details on the sample size for the test set or data provenance (country, retrospective/prospective).
    • Number or qualifications of experts used for ground truth.
    • Adjudication method.
    • Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
    • Information on a standalone algorithm performance study.
    • Specifics on the type of ground truth used (e.g., pathology, outcomes data).
    • Sample size for the training set.
    • How ground truth for the training set was established.

    The text generally states that "All necessary testing was conducted on the PSS Kit to support a determination of substantial equivalence" and lists types of testing like "Design verification testing," "Sterilization validation," "Biocompatibility testing," "Shelf life and packaging testing," and "In vivo testing." However, it does not provide any specific results, acceptance criteria, or methodological details for these studies.

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