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510(k) Data Aggregation

    K Number
    K152472
    Device Name
    Disposable Pressure Transducer
    Manufacturer
    ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
    Date Cleared
    2016-10-31

    (427 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K061573
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.

    Device Description

    The Disposable Blood Pressure Transducer (DBPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the DBPT include the DBPT module that houses a ceramic, a luer connector with locking collar that can connect to an intravascular catheter, a transducer cable that can connect to a compatible pressure monitor and a stopcock for altering direction of fluid flow. The DBPT is provided sterile and for single use.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a Disposable Blood Pressure Transducer (DBPT). It does not contain information related to the acceptance criteria or study results for AI/ML-based devices. The discussion of non-clinical testing refers to traditional medical device testing standards (biocompatibility, product performance, safety) and a predicate device (Transpac® Disposable Straight Pressure Transducer (DSPT)), which are typical for non-AI medical devices.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria based on the provided text. The document is for a traditional medical device, not an AI/ML-driven one.

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