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510(k) Data Aggregation

    K Number
    K071567
    Device Name
    AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE
    Manufacturer
    AUTOSAFE-REFELX INC.
    Date Cleared
    2007-09-14

    (99 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AutoSafe Safety Needles are indicated to be used to inject fluids into or withdraw fluid from the body. They are compatible for use with standard luer slip and luer lock syringes. Additionally, the passive needle safety shield is designed to help prevent needlestick injuries by shielding the needle before use, between steps and after use.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the "AutoSafe-Reflex® Safety Needle" and "AutoSafe Advantage Safety Needle." This letter grants market clearance based on substantial equivalence to predicate devices.

    However, the document does NOT contain information about:

    • Acceptance criteria and reported device performance.
    • Any specific study data, sample sizes, data provenance, expert qualifications, or ground truth establishment.
    • Any details regarding AI/ML powered devices, MRMC studies, or standalone algorithm performance.

    Therefore, I cannot provide the requested table or answer the questions related to studies and acceptance criteria from the given text. The document is solely a regulatory clearance letter.

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