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510(k) Data Aggregation

    K Number
    K031523
    Device Name
    OLYMPUS ULTRASONIC SURGICAL SYSTEM
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Date Cleared
    2003-10-01

    (139 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K002981,K972114,K990430,K000095
    Predicate For
    K041566,K042160,K050885,K111202
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intraabdominal procedures in general (open) surgery. It is also designed to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery.

    Device Description

    The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

    • (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
    • (2) Olympus SonoSurg Transducer SonoSurg-T2H.
    • (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
      This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery.
    AI/ML Overview

    This medical device submission for the Olympus Ultrasonic Surgical System (K031523) does not contain acceptance criteria or a study demonstrating the device meets such criteria in the context of an AI/ML algorithm evaluation.

    The provided documents describe a traditional medical device (an ultrasonic surgical system) and its substantial equivalence to predicate devices based on technological characteristics and intended use. The submission explicitly states:

    "G. Reason for not requiring clinical data: When compared to the predicate devices, 'Olympus Ultrasonic Surgical System' does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."

    This indicates that the approval was based on a comparison to existing devices, not on a performance study against specific acceptance criteria for an AI/ML component.

    Therefore, I cannot provide the requested information for an AI/ML study because it is not present in the provided text.

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