LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K202176
    Device Name
    Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
    Manufacturer
    Medical Components Inc. (Dba Medcomp)
    Date Cleared
    2020-09-03

    (30 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K171618,K173667
    Why did this record match?
    Reference Devices :

    K171618, K173667

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

    The Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

    Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.

    Device Description

    The Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device, the Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes. It states that the device is substantially equivalent to a previously cleared predicate device.

    However, this document does not contain the kind of detailed information requested regarding acceptance criteria and a study proving device performance, particularly related to AI/software performance metrics like sensitivity, specificity, or human reader improvement. The "performance testing" referenced in the document (Table 6.2) refers to non-clinical bench testing and adherence to standards for physical properties, materials, packaging, and biocompatibility, not a clinical study or a study involving AI with human experts.

    Therefore, I cannot provide an answer to your request based on the provided text. The document focuses on demonstrating substantial equivalence through non-clinical testing of the physical catheter and its materials.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1