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510(k) Data Aggregation

    K Number
    K024109
    Device Name
    BD ULTRA-FINE III PEN NEEDLE
    Manufacturer
    BECTON DICKINSON & CO.
    Date Cleared
    2002-12-30

    (17 days)

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

    Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

    Device Description

    The Becton Dickinson Ultra-Fine™ III Pen Needle is designed for use with a pen injector for subcutaneous injection of a desired dose of insulin. The pen needle consists of a needle, hub, and shield assembly. The Becton Dickinson Ultra-Fine™ III 31G pen needles are offered in two lengths, 5/16" and 3/16". The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. BD Pen Needles are disposable, single use devices.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the BD Ultra-Fine™ III Pen Needle:

    Based on the provided 510(k) summary, the device is a BD Ultra-Fine™ III Pen Needle, and the study is focused on demonstrating its substantial equivalence to a predicate device, the BD Ultra-Fine™ III Pen Needle (presumably an earlier version or identical in core design).

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance
    Acceptance Criteria CategoryReported Device Performance (Summary)
    Equivalence to Predicate DeviceThe B-D ULTRA-FINE ® III 31G Pen Needle and the predicate device have identical technological characteristics and perform equivalently.
    Needle Pull-out ForceResults demonstrate performance equivalent to the predicate device.
    Hub Pull-off ForcesResults demonstrate performance equivalent to the predicate device.
    Needle AngularityResults demonstrate performance equivalent to the predicate device.
    Needle Break-off TestingResults demonstrate performance equivalent to the predicate device.
    Dose AccuracyResults demonstrate performance equivalent to the predicate device.
    Safety and EffectivenessThe device is safe and effective when used as intended, based on equivalence to the predicate.

    Note: The document states that the only difference between the new device and the predicate is the "inner bore diameter." The performance tests implicitly confirm that this difference does not compromise the device's functional equivalence or safety.

    1. Sample Size Used for the Test Set and Data Provenance

      • Sample Size: The document does not explicitly state the sample size used for the bench tests. It only mentions that "Bench tests relating to the performance of the pen needle were conducted."
      • Data Provenance: Not explicitly stated. Given that it's a 510(k) for a medical device by a US-based company, the tests would typically be conducted according to relevant US standards and within the company's testing facilities or by contracted labs. The data would be prospective in the sense that the tests were specifically designed and executed for this submission.

    1. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

      • The concept of "ground truth" established by experts (like radiologists for imaging) is not applicable here. This study is a series of bench tests on physical device characteristics, not a diagnostic or clinical study requiring expert interpretation of results. The "ground truth" would be the measurable physical properties of the device as determined by the testing equipment and protocols.

    1. Adjudication Method for the Test Set

      • Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical trials or studies where human interpretation or consensus is required (e.g., classifying medical images). These are bench tests measuring physical parameters.

    1. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

      • No, an MRMC comparative effectiveness study was not done. This is a physical device (pen needle) and the study is for substantial equivalence through bench testing, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI assistance" is entirely irrelevant to this submission.

    1. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

      • No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not software or an algorithm.

    1. The Type of Ground Truth Used

      • The "ground truth" for this study was based on measurable physical properties and functional performance as determined through standard engineering and quality control bench tests (e.g., force measurements for pull-out and hub pull-off, dimensional checks for angularity and bore diameter, and functional testing for dose accuracy). The comparison was made against the established performance of the predicate device.

    1. The Sample Size for the Training Set

      • Not applicable. This is a study comparing a physical device to a predicate based on explicit bench testing demonstrating equivalence. There is no AI model involved, and therefore no "training set."

    1. How the Ground Truth for the Training Set was Established

      • Not applicable, as there is no AI model or training set.
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