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510(k) Data Aggregation

    K Number
    K111424
    Device Name
    VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH
    Manufacturer
    MEDPRO SAFETY PRODUCTS, INC.
    Date Cleared
    2011-07-29

    (67 days)

    Product Code
    FMI,MEG
    Regulation Number
    880.5570
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K072602
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VACUETTE® PREMIUM Safety Needle System Tube-Touch is used in routine venipuncture procedures. The Needle System is designed with an integrated, multiple sample needle and safety shield. The safety shield is automatically activated and released upon insertion of the first blood collection tube and covers the needle immediately following blood collection from patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

    Device Description

    The VACUETTE® PREMIUM Safety Needle System Tube-Touch is a single-use, sterile needle system, non-toxic, designed with an integrated, multiple use drawing needle and safety shield to provide protection against needlestick injury during venipuncture. This device has no components made of dry natural rubber.

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device and does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

    The document is a regulatory approval summary for the "VACUETTE® PREMIUM Safety Needle System Tube-Touch." It establishes substantial equivalence to a predicate device (VACUETTE® PREMIUM Safety Needle System, K072602) for its intended use and materials. This type of submission typically relies on demonstrating that the new device is as safe and effective as a previously cleared device, rather than requiring a detailed clinical study with specific acceptance criteria and performance data.

    Therefore, I cannot provide the requested information, including:

    • A table of acceptance criteria and reported device performance
    • Sample size used for the test set and data provenance
    • Number of experts and their qualifications for ground truth
    • Adjudication method
    • MRMC comparative effectiveness study results or effect size
    • Standalone algorithm performance
    • Type of ground truth used
    • Sample size for the training set
    • How ground truth for the training set was established

    The document focuses on the regulatory process for clearance, not on a detailed performance study of the device against specific acceptance criteria.

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