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510(k) Data Aggregation

    K Number
    K033099
    Device Name
    ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109
    Manufacturer
    APPLIED DIABETES RESEARCH, INCORPORATED
    Date Cleared
    2003-10-16

    (17 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K012429
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ADR THINSet Infusion Set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products.

    Device Description

    The ADR THINSet Insulin Infusion Set facilitates the flow of medication from an infusion pump reservoir into the subcutaneous tissue of the user. The infusion set consists of a female luer, tubing, Needle Grip with introducer needle and Base Assembly. The Base Assembly consists of three components: the Needle Grip, Connector and Base. The Needle Grip contains the 26 guage introducer needle that penetrates the subcutaneous tissue. The infusion set tubing attaches to the Connector. The Connector may be removed from the Base. The Base houses the 24 gauge Cannual and has a medical grade adhesive dressing attached to the bottom. The infusion set is packaged sterile in a Tray Pack. The infusion set is available with 23 and 43 inch tubing lines and 6 and 9 mm Cannulas.

    AI/ML Overview

    The provided 510(k) summary for the ADR THINSet Insulin Infusion Set (K033099) describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria values or detailed performance metrics in a quantified format as requested by the user for a comprehensive table.

    Instead, the document primarily focuses on qualifying the testing performed and stating that the device "meets the requirements" or that "differences were insignificant." It also lacks details about ground truth establishment, expert qualifications, sample sizes for specific tests, or a multi-reader multi-case (MRMC) study.

    Therefore, the response below will reconstruct the information available as closely as possible to the requested format, clearly indicating where specific numerical data is absent in the original document.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Test/RequirementAcceptance Criteria (Stated or Implied)Reported Device Performance/Conclusion
    BiocompatibilityCytotoxicityMeet requirements of ISO-FDA Modified Matrix, FDA/ODE G95-1, ANSI/AAMI/ISO 10993-1:1997 for an External communicating device, Blood path, indirect for
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