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510(k) Data Aggregation

    K Number
    K961155
    Device Name
    SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908
    Manufacturer
    DOUGLAS MEDICAL PRODUCTS CORP.
    Date Cleared
    1996-06-18

    (88 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K932211
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SoloPak Peripheral Intravenous Catheter Insertion Kits are intended to be used for the placement of a peripheral catheter.

    Device Description

    The SoloPak Peripheral Intravenous Catheter Insertion Kits include a single lumen catheter, introducer, and the necessary accessories to perform the placement.

    AI/ML Overview

    This document, K961155, is a 510(k) premarket notification for the SoloPak Peripheral Intravenous Catheter Insertion Tray. It does not contain any information regarding acceptance criteria, device performance studies, or AI/algorithm-based assessments.

    The document is a submission stating that the SoloPak Peripheral Intravenous Catheter Insertion Kits are substantially equivalent to predicate devices (Clinicathr Procedural Tray and Per-Q-Cath Tray). The safety and effectiveness are based on the kits utilizing similar and equivalent designs, materials, and components as legally marketed products, and sterilization according to AAMI guidelines.

    Therefore, I cannot provide the requested information. The document does not describe:

    • Acceptance criteria and reported device performance.
    • Sample sizes, data provenance, number of experts, adjudication methods for a test set.
    • MRMC comparative effectiveness studies or human reader improvement data.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Training set sample size or how its ground truth was established.
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