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510(k) Data Aggregation

    K Number
    K953819
    Device Name
    DIAGNOSTIC ULTRASOUND TRANDUCER
    Manufacturer
    BIOSOUND, INC.
    Date Cleared
    1996-03-01

    (199 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K884644
    Why did this record match?
    Reference Devices :

    K884644

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

    The INT13 is a diagnostic ultrasound intraoperative transducer for use in abdominal surgery. The transducer can be used to image abdominal anatomy during abdominal surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels.

    Device Description

    The Esaote INT13 intraoperative transducer is designed and intended to be used in open (open as opposed to laparoscopic used with a trocar) abdominal surgical procedures. More specifically, the transducer is intended to be used to image abdominal anatomy during open surgical procedures.

    AI/ML Overview

    This document describes a 510(k) premarket notification for a new diagnostic ultrasound transducer, the INT13 Intraoperative Transducer by Biosound, Inc. This submission focuses on establishing substantial equivalence to a predicate device, the Hitachi Intraoperative Ultrasound Transducer EUP - 033J (K884644), rather than presenting a study with acceptance criteria for device performance.

    Therefore, the requested information regarding acceptance criteria and a study to prove the device meets them cannot be extracted from the provided text because such a study is not described.

    The document primarily focuses on:

    • Device Description: Specifications, materials, sterilization process.
    • Intended Use: Diagnostic ultrasound intraoperative transducer for abdominal surgery, including Doppler mode for blood flow.
    • Substantial Equivalence Comparison: A table comparing the INT13 to the predicate device (Hitachi EUP 088 J) based on intended use, technology, frequencies, operating modes, cable length, and safety standard.

    In summary, the provided text does not contain information about acceptance criteria or a study demonstrating the device meets performance metrics. The core of this 510(k) submission is to argue for substantial equivalence to an existing device, which is a different regulatory pathway than proving specific performance against predefined acceptance criteria from a new clinical study.

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