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510(k) Data Aggregation

    K Number
    K994384
    Device Name
    CLICKER
    Manufacturer
    BIOJECT, INC.
    Date Cleared
    2000-06-22

    (177 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K962625,K960285
    Why did this record match?
    Reference Devices :

    K962625

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

    This product is indicated for use with Saizen® [somatropin (rDNAorigin) for injection] for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.

    Device Description

    Clicker™ Needle-Free Self-Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection]. This submission changes the labeling of the Vitajet 3, (Innova) (K962625) to allow the device to be used for needle-free subcutaneous administration of Saizen® [somatropin (rDNAorigin) for injection]. There are no other significant changes to the Vitajet 3 (Innova) in device design or function.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study details for the Bioject Clicker™ Needle-Free Self-Injection Device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Pharmacokinetic Equivalence (Adults)
    AUC (Area Under the Curve) 90% Confidence Interval (CI) for Test/Reference Ratio(0.95, 1.12), falling within the (80%, 125%) required interval.
    Cmax (Maximum Concentration) 90% Confidence Interval (CI) for Test/Reference Ratio(0.81, 1.20), falling within the (80%, 125%) required interval.
    tmax (Time to Maximum Concentration)Not statistically different between needle and needle-free.
    t1/2 (Half-life)Assessed for assumptions, no significant difference.
    Pharmacodynamic Equivalence (Adults)
    Serum IGF-1 levels (24 hours)Very similar to needle injection.
    User Experience (Adults)
    PainTrend toward less pain with jet-injector (p = 0.093).
    Ease of UseHighly significant preference for jet-injector (p = 0.017).
    ConvenienceHighly significant preference for jet-injector (p = 0.004).
    PleasantnessHighly significant preference for jet-injector (p = 0.011).
    Less ApprehensionHighly significant preference for jet-injector (p = 0.0110).
    Overall PreferenceHighly significant preference for jet-injector (p = 0.053).
    User Experience (Children)
    PainHighly significant difference favoring needle-free (p
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