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510(k) Data Aggregation

    K Number
    K142073
    Device Name
    ST'RIM
    Manufacturer
    Date Cleared
    2015-04-29

    (272 days)

    Product Code
    Regulation Number
    878.5040
    Reference & Predicate Devices
    Why did this record match?
    Applicant Name (Manufacturer) :

    THIEBAUD SAS

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

    The st'rim™ fat tissue harvest and injection cannula set is intended for use in aesthetic body contouring.

    Device Description

    The st'rim™ set consists of one tissue harvesting cannula, three injection (application) cannulas, two incision needles, all made of stainless steel, and a capped double-ended female Luer Lock connector for transfer of the fat tissue from the collection syringe to an injection syringe. The body contacting material is medical grade stainless steel and the contact duration is short-term. All components are provided in a preformed plastic tray. The set is a sterile, single-use device.

    AI/ML Overview

    The provided document is a 510(k) premarket notification decision letter and summary for the "st'rim™" fat tissue harvest and injection cannula set. This document does not contain information about the acceptance criteria and study proving device performance in the context of an AI/ML powered device.

    The document indicates that the device is a Class II medical device, product code MUU (Suction lipoplasty system). It describes its intended use, its components (cannulas, incision needles, connector), materials (stainless steel), and sterilization. It also outlines the testing performed for the device's Luer Lock connectors, packaging, sterilization, shelf life, and biocompatibility.

    The "st'rim™" device is compared to a predicate device (K060089, Tulip Disposable Cannulas) and found to be substantially equivalent based on intended use, principles of operation, and materials, despite minor technological differences in cannula dimensions, coating, and sterilization methods.

    Therefore, I cannot fulfill the request to describe the AI model's acceptance criteria and study details because this document pertains to a traditional medical device (cannulas) and does not involve AI/ML.

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