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    K Number
    K140492
    Device Name
    NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
    Manufacturer
    MARVAO MEDICAL DEVICES, LTD.
    Date Cleared
    2014-11-13

    (259 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K121933,K133796,K030502
    Predicate For
    K161026
    Why did this record match?
    Reference Devices :

    K121933, K133796

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

    The NexSite™ HD, Hemodialysis Catheter for long term use is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm long are intended for femoral vein insertion.

    Device Description

    The NexSite HD (55 cm), Hemodialysis Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The NexSite HD, Hemodialysis Catheter for long term use is available in a range of lengths up to 55cm. The NexSite HD (55cm) Hemodialysis Catheter is manufactured from polyurethane and has a Dacron cuff distal to the bifurcation junction. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and DISC are provided with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement. The NexSite HD (55 cm) Hemodialysis Catheter for long term use is provided as a sterile, singleuse device, and is sterilized using a validated ethylene oxide process. The NexSite HD (55 cm) Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.

    AI/ML Overview

    This document describes the premarket notification for the NexSite™ HD, Hemodialysis Catheter for long term use. The notification focuses on establishing substantial equivalence to previously marketed devices. No AI device or associated study is described within this document. Therefore, I cannot provide acceptance criteria and study details related to an AI device.

    The document discusses performance data for the NexSite™ HD catheter, which includes:

    • In vitro testing to assure reliable design and performance in accordance with ISO 10555-1:2004. This testing for the 55cm catheter included visual and dimensional analysis, priming volume, and catheter pressure vs. flow testing.
    • In vivo implantation studies to demonstrate that the device would perform as intended.

    The submission concludes that the NexSite™ HD (55cm) Hemodialysis Catheter for long term use is substantially equivalent to predicate products, with identical or substantially equivalent indications for use, methods of operation, design, and materials.

    Based on the provided text, there is no mention of an AI device, acceptance criteria specifically for an AI device, or a study that evaluates the performance of an AI device.

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