LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K133296
    Device Name
    XCATH
    Manufacturer
    ALSEAL
    Date Cleared
    2014-02-14

    (112 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K113849,K121185
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    XCath (model 2064-XC) is intended to be inserted into the HQS Introducer (model 2064-HQS) to establish multiple and simultaneous conduits through the same vascular access (previously established by the HQS introducer).

    The whole XCath / HQS allows insertion of several endovascular devices at the same time while minimizing blood loss associated with such insertions.

    Device Description

    The XCath (model 2064-XC) consists of a multiple ways access (2, 3 or 4 ways) adapted to the HQS Introducer (K113849) to optimize the sealing when several vascular tools up to 9,3F need to be introduced through the same vascular access.

    The device features include (1) a flexible multilumen body, with 2, 3 or 4 channels compatible with the open valve of HQS Introducer; (2) a base with 2, 3 or 4 valves, (3) Extension line for each valve with stopcock and Luer Lock connection.

    Once the XCath is connected to the HQS Introducer, the device can accommodate vascular tools up to 9,3 French (3,1mm). The XCath (accessory) is fixed in proximal position of the HQS introducer body and allows the simultaneous insertion of several vascular tools.

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaDevice Performance
    Biocompatibility: In accordance with ISO 10993-1 for external communicating devices, direct circulating blood path, duration ≤ 24 hours.Biocompatibility testing has concluded that the device does not introduce significant questions of safety and is substantially equivalent to the predicate.
    Material/Design Equivalence: Substantially equivalent to predicate device in Indications for Use, Materials and design.Safety and performance testing concluded that the device is substantially equivalent to the predicate.
    Tensile strengthIn compliance with ISO 11070: 1999
    Overpressure resistanceIn compliance with ISO 11070: 1999
    Dimensions and aspectIn compliance with ISO 11070: 1999
    Sealing resistanceIn compliance with ISO 11070: 1999
    Air leak (vacuum) testIn compliance with ISO 11070: 1999
    Compatibility with HQS IntroducerIn compliance with ISO 11070: 1999
    Sealing of the valveIn compliance with ISO 11070: 1999 (ensures sealing while empty or accessed with guide / max dilator)
    Free passage of a guide and 9F vascular toolIn compliance with ISO 11070: 1999
    Validation of luer and extension linesIn compliance with ISO 11070: 1999
    Ease of assemblyIn compliance with ISO 11070: 1999
    Traction resistanceIn compliance with ISO 11070: 1999
    Packaging resistanceIn compliance with ISO 11070: 1999
    Sterilization testsIn compliance with ISO 11070: 1999
    Aging testsIn compliance with ISO 11070: 1999

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

    The document does not explicitly state the specific sample sizes for each non-clinical performance test. It notes that "The following in vitro testing was performed on the XCath ... to assure reliable design and performance." The data provenance is "in vitro" testing performed by ALSEAL, the manufacturer, in France.

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

    This information is not applicable. The device is a medical instrument (catheter introducer accessory), and its performance is evaluated through engineering and biocompatibility bench testing, not through expert review of data like in an AI/diagnostic device study.

    4. Adjudication Method for the Test Set:

    This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human interpretation of data, not for bench testing of a medical device.

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

    No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or imaging devices where human readers interpret medical data, often with and without AI assistance. The XCath is a hardware device tested for its physical and functional performance.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

    No, a standalone study in the context of an algorithm's performance was not done. This device is a physical medical instrument, not an algorithm. Its "standalone" performance refers to its ability to meet engineering specifications through bench testing.

    7. Type of Ground Truth Used:

    The "ground truth" for this device's performance is established by engineering specifications, ISO standards (specifically ISO 11070: 1999 for intravascular catheters introducers), and internal procedures. For biocompatibility, the ground truth is defined by ISO 10993-1 standards.

    8. Sample Size for the Training Set:

    This information is not applicable. There is no "training set" as this device is not an AI/machine learning algorithm. The engineering tests are to verify the final product's performance against predefined criteria.

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

    This information is not applicable, as there is no training set for this type of device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1