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510(k) Data Aggregation

    K Number
    K043178
    Device Name
    GRANTALDER RHAPSODY ACCESS PORT AND CATHETER
    Manufacturer
    GRANTADLER CORPORTATION
    Date Cleared
    2006-02-02

    (443 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K951814
    Why did this record match?
    Reference Devices :

    K951814

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

    The grantAdler Rhapsody Access Port and Catheter is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood. blood products or the sampling of blood.

    Device Description

    The grantAdler Implantable Access Ports are implantable ports for intraveneous injections. The grantAdler Implantable Access Ports are supplied as sterile devices, and are intended for single patient use only. The ports are available as a single model and are manufactured of the highest quality titanium. They also incorporate a durable high compression self-sealing silicone septum. Catheter materials include flexible, noncompressible, and reinforced silicone. Suture sites are incorporated into the port base to facilitate anchorage to the underlying fascia.

    AI/ML Overview

    The provided text does not contain information about an AI device, its acceptance criteria, or a study that proves it meets those criteria. The document is a 510(k) premarket notification for a medical device called the "grantAdler Rhapsody Access Port and Catheter," which is an implantable port for intravenous injections.

    Therefore, I cannot provide the requested information about acceptance criteria and a study for an AI device based on this input.

    The document discusses:

    • Device Name: grantAdler Rhapsody Access Port and Catheter
    • Intended Use: Reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood.
    • Device Classification: Class II
    • Performance Characteristics: Laboratory testing regarding characteristics was performed to verify safety and performance. Biocompatibility assessments were performed on the materials with satisfactory results.
    • Substantial Equivalence: The device is claimed to be substantially equivalent to the Horizon Medical Products, Inc. (HMP) Triumph-1 Ports K951814.

    None of this pertains to AI performance or studies involving AI.

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