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510(k) Data Aggregation

    K Number
    K153367
    Device Name
    S698 Symbioz flow
    Manufacturer
    SOPRO - ACTEON GROUP
    Date Cleared
    2016-06-17

    (207 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    S698 Symbioz flow

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

    This apparatus is an insufflator for performing laparoscopic procedures. It was designed for the purpose of creating the pneumoperitoneum (distension of the abdominal cavity with CO2) as part of these procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided document does not contain any information regarding acceptance criteria or a study proving device performance related to AI/algorithm performance.

    The document is a 510(k) clearance letter for a laparoscopic insufflator (S698 Symbioz Flow), indicating it has been deemed substantially equivalent to a legally marketed predicate device. This type of clearance focuses on demonstrating equivalence in terms of safety and effectiveness, often through comparison to existing devices and adherence to relevant standards, rather than conducting a detailed performance study with acceptance criteria in the way you've described for an AI/algorithm-based device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information (e.g., sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) is relevant to the evaluation of AI/ML-driven medical devices, which is not what this document addresses.

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