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510(k) Data Aggregation

    K Number
    K191885
    Device Name
    Standard Bougie
    Manufacturer
    Standard Bariatrics
    Date Cleared
    2020-04-08

    (268 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K173355,K130483
    Why did this record match?
    Reference Devices :

    K173355

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

    The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

    Device Description

    The Standard Bougie is a single patient use, non-sterile device which consists of an 80 cm long, 18 French diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide.

    The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.

    AI/ML Overview

    The provided text is a 510(k) summary for the Standard Bougie device. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.

    The "Performance Data" section (VII) lists several types of verification and testing, such as "Drainage Flow Rate Verification," "Balloon Strength Verification," and "Device Usability." These tests are likely related to the physical and functional performance of the bougie itself, not to an AI system's diagnostic accuracy or a human-AI team's effectiveness.

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them from the provided text. The document describes a medical device (a bougie) used in bariatric surgery, not an AI or imaging diagnostic device.

    To answer your request, I would need a different document that details the development, validation, and performance studies of an AI-powered medical device.

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