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    K Number
    K040328
    Device Name
    15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
    Manufacturer
    MEDCOMP
    Date Cleared
    2004-11-24

    (288 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K040328
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K040328

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

    THE FREE FLOW™ DIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN OF AN ADULT PATIENT. ALTERNATE INSERTION SITES INCLUDE SUBCLAVIAN VEIN AS REQUIRED. THE CURVED FREE-FLOW™ CATHETER IS INTENDED FOR INTERNAL JUGULAR VEIN INSERTION. THIS CATHETER IS INDICATED FOR A DURATION NOT TO EXCEED (12) MONTHS.

    Device Description

    The Free Flow™ Long-Term Coaxial Catheter is manufactured by Medcomp. The catheter is polyurethane (Carbothane) that provides two dedicated (arterial/venous) access lumens. Each lumen is connected through an extension line with female luer connectors. The transition between lumen and extension is housed within & molded hub. To prevent recirculation, the venous end of the lumen is approximately 1. J" longer than the arterial. The catheter is capable of providing consistent flows up to 450 ml/min at a pressure of less than 200mm Hg. The catheter lumen is composed of a soft, thermo sensitive, Product Features: polyurethane material that is rigid upon insertion and once it reaches body temperature it becomes soft to reduce vessel trauma. The catheter assembly contains a pre-loaded stylet for ease of insertion. The catheter hub is molded from soft, pliable polyurethane to increase patient comfort. The dialysis extensions are color coded with a red luer and a clamp for the arterial lumen, a blue luer and a clamp for the venous lumen for easy identification. Physical Dimensions: The 15.5 French catheter will be available in a straight lumen design in 24, 28 and 32cm.

    AI/ML Overview

    The provided text describes a 510(k) submission for the Free Flow™ Catheter, a hemodialysis device, and focuses on demonstrating its substantial equivalence to a predicate device through in vitro performance testing. It does not involve AI/ML, clinical studies, or human image interpretation, thus many of the requested categories are not applicable.

    Here's an attempt to answer based on the provided text, indicating "Not Applicable" where the information is not present or relevant to this type of device submission:

    Acceptance Criteria and Device Performance

    The acceptance criteria for the Free Flow™ Catheter are implicitly derived from the performance of the legally marketed predicate device (Medcomp Ash Split-Cath® II Catheter, K040328). The study's goal was to demonstrate "substantial equivalence" to this predicate device by ensuring the Free Flow™ Catheter's in vitro performance was comparable.

    Acceptance Criteria/Performance MetricReported Device Performance
    Force @ BreakMet (demonstrated substantial equivalence to predicate)
    Air/Liquid LeakMet (demonstrated substantial equivalence to predicate)
    RecirculationMet (demonstrated substantial equivalence to predicate)
    Flow vs. PressureMet (demonstrated substantial equivalence to predicate)
    Cuff ShearMet (demonstrated substantial equivalence to predicate)
    Gravity FlowMet (demonstrated substantial equivalence to predicate)
    Flow Rate (up to)450 ml/min at < 200mm Hg. (This is a design specification, implied to be met).

    Study Details (with AI/ML context in mind, noting non-applicability)

    1. Sample size used for the test set and the data provenance: Not Applicable. This was an in vitro performance study comparing a new device to a predicate, not an AI/ML model test set. The "test set" would refer to the physical catheters and the conditions under which they were tested in a lab. The data provenance is in vitro testing conducted by Medcomp.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable. Ground truth as typically defined for AI/ML (e.g., expert consensus on medical images) does not apply here. The "ground truth" for this device is its physical and functional performance as measured in in vitro tests against established engineering and performance benchmarks, and in comparison to a predicate device.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not Applicable. This is not an AI/ML study involving human adjudication of results.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not Applicable. No MRMC study was performed. This is a medical device (hemodialysis catheter) approval, not an AI/ML algorithm.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Applicable. No AI/ML algorithm was involved.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this submission is the in vitro performance specifications and the established performance of the predicate device (Medcomp Ash Split-Cath® II Catheter, K040328), against which the Free Flow™ Catheter was compared to demonstrate substantial equivalence across various physical and hydrodynamic parameters.

    7. The sample size for the training set: Not Applicable. There is no AI/ML model or "training set" in this context.

    8. How the ground truth for the training set was established: Not Applicable. There is no AI/ML model or "training set" in this context.

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