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510(k) Data Aggregation

    K Number
    K233277
    Device Name
    Filter Needle for Single Use
    Manufacturer
    Hangzhou Qiantang Longyue Biotechnology Co., LTD
    Date Cleared
    2024-05-10

    (224 days)

    Product Code
    FPB
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K801343
    Why did this record match?
    Device Name :

    Filter Needle for Single Use

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

    This product is intended for the aspiration and preparation of medical fluid, not including injection.

    Device Description

    The Filter Needle for Single Use is a single use, irradiation sterilized device that is designed to be used for use in conjunction with luer taper infusion sets conforming to EN ISO 80369-7 for the extraction, filtration and configuration of medicinal solutions and is not intended for injection purposes. Filter Needle for Single Use consists of cap, needle cannula, needle hub, sheath and filter. The cap, needle hub and sheath are made of polycarbonate (PC), the needle tube is made of medical stainless steel (SUS304), and filter is made of polyamide (PA).

    The needle holder is a 6% standard tapered connector with good connectivity to the infusion apparatus.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for a "Filter Needle for Single Use" (K233277) and its substantial equivalence to a predicate device. However, it does not contain information about a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, nor does it refer to performance metrics typically associated with AI/SaMD (e.g., sensitivity, specificity, AUC).

    The document focuses on the substantial equivalence of a physical medical device (a filter needle) based on material, design, performance, biocompatibility, sterilization, and shelf-life testing, primarily against established international standards.

    Therefore, I cannot extract the requested information regarding AI/SaMD acceptance criteria and studies from this document. The tables and study details you've asked for (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth establishment for training and test sets) are relevant to the validation of AI/SaMD, but are not present in this clearance document for a conventional medical device.

    To directly answer your request based on the provided text, I must state that the information is not available.

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