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510(k) Data Aggregation

    K Number
    K221521

    Validate with FDA (Live)

    Device Name
    Disposable Safety Lancet
    Manufacturer
    SteriLance Medical (Suzhou) Inc.
    Date Cleared
    2022-10-28

    (156 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K101145,K192666
    Predicate For
    K233796
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The disposable safety lancet is used to obtain capillary blood samples. The device has an integral sharps injury prevention feature

    Device Description

    The disposable safety lancet is sterile, single use, spring loaded and designed to draw a capillary blood sample. The device is mainly comprised of a single use needle/blade attached to a needle core by injection molding and then assembled with spring, press button, depth adjusting ring (optional) and shell parts, which also forming an integral sharps injury prevention feature. The device is used to puncture the skin to obtain a drop of blood for testing purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

    Flex 3 model is the only adjustable lancet, and all other models (Press, Press Plus, Press2, Press2 Plus, Lite3) are provided at various single depths.

    The device is intended to be used by professionals and individuals.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called "Disposable Safety Lancet". It does not describe an AI/ML device or its acceptance criteria and study. Therefore, I cannot generate the requested information based on the provided text.

    Here's why the request cannot be fulfilled:

    • No AI/ML Device: The document is about a "Disposable Safety Lancet," a physical medical device used for drawing capillary blood samples. It does not mention any artificial intelligence or machine learning components.
    • No Acceptance Criteria for AI/ML: Since it's not an AI/ML device, there are no acceptance criteria related to its performance in tasks like image interpretation, prediction, or classification. The document outlines bench testing for physical characteristics (e.g., appearance, dimensions, needle sharpness, safety).
    • No "Ground Truth," "Experts," or "Training Set": These terms are specific to the evaluation of AI/ML models. A physical medical device does not have a "ground truth" in the same sense, nor does it require experts to establish a ground truth or a training set for an algorithm.

    If you intended to provide a different document describing an AI/ML medical device, please provide that text.

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