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    K Number
    K023023
    Device Name
    LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA
    Manufacturer
    VASCA, INC.
    Date Cleared
    2003-12-04

    (449 days)

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

    LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA

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

    The LifeSite Hemodialysis Access System provides fully implantable blood access for chronic (long term) hemodialysis. It is intended for use in patients who would otherwise be treated with standard cuffed hemodialysis catheters. A 70% isopropyl alcohol solution is used in conjunction with the LifeSite System for the localized cleansing of the access site (buttonhole), valve pocket and LifeSite valve.

    Device Description

    The LifeSite Hemodialysis Access System is a dialysis access device comprised of two separate valves and cannulas. One valve/cannula is used as the draw and the other valveleannula is the return. The cannulas are placed in cither the internal or external jugular or subclavian veins. They are manufactured from radiopaque silicone. The cannula ends connect to the valves, which are placed in a subcutancous pocket. The values are manufactured from titanium and stainless steel. When accessed with a 14 gauge, fistula needle the valves internal pinch clamp opens allowing access to the vein via the cannula.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the LifeSite® Hemodialysis Access System:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document provides acceptance criteria mainly through a simulated use test for device longevity and a clinical study for patient safety and equivalence.

    Acceptance CriteriaReported Device Performance
    Simulated Use Testing:
    Device functionality over long-term use (6000 actuations, approximately 38 years)All valves operated properly for 6000 actuations.
    Leak-testing after every 100 actuationsNo leaks were observed after every 100 actuations.
    Clinical Study:
    Patient safety for chronic (long-term) hemodialysis useSafe for use in patients who require chronic (long-term) hemodialysis when used with 70% isopropyl alcohol.
    Substantial equivalence to predicate device (LifeSite Hemodialysis Access System and Medical Components Inc. Tesio®-Cath Catheter)Found to be substantially equivalent to the predicate device.

    2. Sample Size and Data Provenance

    • Test Set (Clinical Study): 67 patients, with 25 of those patients on dialysis using LifeSite for 12 months in the alcohol trial.
    • Data Provenance: The document does not explicitly state the country of origin. It is a clinical study, implying prospective data collection.

    3. Number of Experts and Qualifications for Ground Truth

    • The document does not mention the use of experts to establish a "ground truth" in the traditional sense of image interpretation or diagnostic accuracy for this device. The evaluation is based on direct device performance (simulated use) and clinical outcomes (patient safety and equivalence).

    4. Adjudication Method

    • Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic accuracy studies where expert consensus is needed to determine the true positive/negative status of a case. This is not applicable to the studies described for the LifeSite system, which focus on device function and clinical safety/equivalence.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of the studies presented for the LifeSite Hemodialysis Access System.

    6. Standalone Performance Study

    • Yes, a form of standalone performance was done through the "Simulated use testing of the LifeSite Valve." This test evaluated the device's functionality and integrity (leak-testing) independent of human interaction during its long-term simulation. The clinical study also assesses the device's performance in a standalone capacity within patients, albeit with human use involved.

    7. Type of Ground Truth Used

    • Simulated Use Testing: The "ground truth" was the physical performance and integrity of the device itself (e.g., proper operation, absence of leaks).
    • Clinical Study: The "ground truth" was established through patient safety outcomes and a comparison of the device's performance against a predicate device to determine substantial equivalence. This would involve clinical observations, adverse event tracking, and potentially various clinical measurements relevant to hemodialysis access.

    8. Sample Size for the Training Set

    • The document does not describe a "training set" in the context of an AI/machine learning model. The studies described are for the validation of a medical device, not the development of an algorithm.

    9. How Ground Truth for the Training Set Was Established

    • Not applicable, as no training set for an AI/machine learning model is described in the provided text.
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