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510(k) Data Aggregation

    K Number
    K013944
    Device Name
    JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
    Manufacturer
    JOSTRA AG
    Date Cleared
    2002-02-11

    (74 days)

    Product Code
    DWF,DTL
    Regulation Number
    870.4210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K930006
    Why did this record match?
    Device Name :

    JOSTRA DUAL STAGE VENOUS RETURN CANNULAE

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

    The Jostra Two-Stage Venous Cannulas are designed to be used as perfusion cannulae to divert venous blood from the patient during surgery requiring extracorporeal circulation for up to 6 hours.

    Device Description

    The Jostra Two-Stage Venous Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to divert blood from the patient to the extracorporeal circuit by draining blood simultaneously from the Right atrium and the Inferior vena cava. The cannulae are made from polyvinyl chloride (PVC) and range in size from 32Fr./40Fr. to 36Fr./51Fr. with a variety of tips and with or without attached connectors.

    AI/ML Overview

    This document describes the 510(k) submission for the Jostra Dual-stage Venous Cannulae (K013944), a medical device used in cardiopulmonary bypass surgery. The submission focuses on demonstrating substantial equivalence to a predicate device, the Medtronic DLP Two-Stage Venous Cannulae.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implied by the nature of the tests performed to demonstrate "substantial equivalence" to the predicate device. The goal is to show comparable performance. The document does not explicitly state numerical acceptance criteria for each test but rather describes the types of tests conducted and their stated outcome.

    Acceptance Criteria (Implied)Reported Device Performance
    BiocompatibilityPerformed, demonstrating substantial equivalency to predicate device.
    Flow-Pressure curvesPerformed, demonstrating substantial equivalency to predicate device.
    Kink ResistancePerformed, demonstrating substantial equivalency to predicate device.
    Bond StrengthPerformed, demonstrating substantial equivalency to predicate device.
    Leakage TestPerformed, demonstrating substantial equivalency to predicate device.
    Effects on cellular components (in-vitro)Performed, demonstrating substantial equivalency to predicate device.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify the exact sample sizes used for each of the performance tests (Flow-Pressure curves, Kink Resistance, Bond Strength, Leakage Test, and in-vitro cellular effects). The data provenance is likely from laboratory testing conducted by the manufacturer, Jostra AG, in Germany. The tests are described as in-vitro and performance testing, implying a controlled laboratory setting rather than human or animal studies. The data is retrospective in the sense that it was collected as part of the device development and verification process to support the 510(k) submission.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    Since this is a submission for a physical medical device (venous cannulae) and the tests are in-vitro performance and biocompatibility studies, there is no "ground truth" in the traditional sense established by human experts in the way it would be for an AI/algorithm-based diagnostic device. The "ground truth" for compliance with acceptance criteria is based on objective measurements and established industry standards for device performance and safety, as evaluated by engineers and technical specialists.

    4. Adjudication Method for the Test Set

    Not applicable. This is not an imaging or diagnostic device that requires expert adjudication of results. The performance of the device is assessed through objective physical and biological tests.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. The Jostra Dual-stage Venous Cannulae is a physical medical device.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its physical and material properties.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's performance is based on objective, measurable physical and biological parameters established through engineering and laboratory testing. This includes:

    • Physical measurements (e.g., flow rates, pressure resistance, bond strength).
    • Mechanical properties (e.g., kink resistance).
    • Biocompatibility assessments (e.g., in-vitro effects on cellular components).
    • Comparison to the established performance characteristics of the predicate device.

    8. The Sample Size for the Training Set

    Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. There is no training set for a physical medical device of this nature.

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