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510(k) Data Aggregation

    K Number
    K231725
    Device Name
    Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
    Manufacturer
    Hunan Endoso Life Technology Co., Ltd.
    Date Cleared
    2023-10-16

    (125 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K201151
    Why did this record match?
    Device Name :

    Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)

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

    It is used in medical institutions for observation and imaging in abdominal surgery by entering the human body through the wound.

    Device Description

    The Laparoscope (Model: 4KA0、4KA0R、4KA30、4KA30R、4KA45、4KA45R) is used in medical institutions. Laparoscopes are tubular optical instruments used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The Laparoscope transmits light in both the visible and near infrared spectrum to illuminate and image the anatomy, then forms and relays the image of the surgical site to a camera system for processing and display.

    AI/ML Overview

    The provided document is a 510(k) summary for a Laparoscope, which is a medical device for observation and imaging in abdominal surgery. It's a submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This document describes the device's technical specifications and the tests conducted to prove its performance and safety, aligning them with the predicate device and relevant standards.

    However, the document does not contain information related to an AI/ML-driven medical device. Specifically, there is no mention of a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics, or human reader performance with and without AI assistance. The tests described are for a physical medical device (laparoscope), focusing on electrical safety, packaging, biocompatibility, cleaning/disinfection/sterilization, and bench performance (optical and mechanical verification).

    Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided text does not describe such a device or study. The information requested (acceptance criteria, sample size, ground truth, experts, MRMC studies, etc.) is typically associated with the validation of AI/ML software as a medical device (SaMD) or AI-assisted medical devices, which is not the subject of this 510(k) submission.

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