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510(k) Data Aggregation

    K Number
    K060141
    Device Name
    DAI-R
    Manufacturer
    Date Cleared
    2006-06-12

    (144 days)

    Product Code
    Regulation Number
    880.6920
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DAI-R™ Autoinjector is a hand-held mechanical device intended for the automated, selfadministration of FDA-approved drugs and biologics. The DAI-R™ Autoinjector is designed to be used with a standard Glass Barrel 1mL Long Syringe with Luer Lock Tip that has been prefilled prior to an injection. The DAI-R™ Autoinjector is for use in the home environment to aid and support prescribed treatment and therapy.

    Device Description

    The DAI-R is an automatic drug delivery device that is used for the injection of drugs and biologics from standard Glass Barrel 1mL Long syringes with Luer Lock Tip that have been prefilled prior to use in the DAI-R. The DAI-R is a single-use, disposable, syringe needle introducer device. It is spring-powered and designed to administer the entire contents of the prefilled syringe in one dose. The DAI-R injection has three operational steps: 1) the automatic insertion of the syringe needle to a predetermined depth into the body, 2) the automatic delivery of the syringe contents, and 3) the withdrawal of the needle from the body.

    The DAI-R consists of a main body and a syringe carrier assembly. The syringe carrier is used to load the prefilled syringe into the main body to make a complete DAI-R delivery system. The complete DAI-R is a plastic tube with the loaded prefilled syringe, a front needle shield and a rear power assembly. The components of DAI-R are made of plastic and steel. The DAI-R does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.

    AI/ML Overview

    The provided text describes the acceptance criteria and a study for the DAI-R™ Autoinjector.

    1. Table of Acceptance Criteria and Reported Device Performance

    The device was assessed using sections and methods specified in ISO 11608:2000 "Pen injectors for medical use-Part 1: Pen injectors - Requirements and test methods."

    Acceptance Criteria (from ISO 11608:2000)Reported Device Performance
    Activation forceMet requirements
    Needle extensionMet requirements
    Injection timeMet requirements
    Completeness of injectionMet requirements
    FunctionalityMet requirements
    RobustnessMet requirements

    2. Sample Size and Data Provenance

    The provided document does not specify the exact sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the DAI-R met the requirements of ISO 11608:2000.

    3. Number of Experts and Qualifications for Ground Truth

    This information is not applicable and not provided in the document. The device is a mechanical autoinjector, and its performance evaluation against ISO standards typically involves engineering and functional testing rather than expert-established ground truth in a clinical or diagnostic sense.

    4. Adjudication Method

    This information is not applicable and not provided. Performance against an ISO standard for a mechanical device does not typically involve an adjudication method in the way medical imaging or clinical studies do.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No. An MRMC comparative effectiveness study is not applicable and was not done for this type of mechanical device.

    6. Standalone (Algorithm Only) Performance

    No. This concept is not applicable to a mechanical autoinjector. The performance described is inherently "standalone" in a functional sense, as it refers to the device's ability to meet its operational specifications.

    7. Type of Ground Truth Used

    The "ground truth" for evaluating the DAI-R's performance was the requirements and specifications identified in ISO 11608:2000. This standard sets objective, measurable criteria for pen injectors.

    8. Sample Size for the Training Set

    This information is not applicable and not provided in the document. Mechanical devices are typically developed and validated through engineering design, testing, and adherence to standards, not through "training sets" in the context of machine learning or AI.

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

    This information is not applicable and not provided. The development and validation process for this mechanical device would not involve establishing ground truth for a training set in the way AI models are trained.

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