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510(k) Data Aggregation

    K Number
    K143429
    Device Name
    Passage Hemostasis Valve
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Date Cleared
    2014-12-22

    (21 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K140475,K925419
    Why did this record match?
    Device Name :

    Passage Hemostasis Valve

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

    The Passage Hemostasis Valve is recommended for maintaining a fluid-tight seal around percutaneous transluminal angioplasty catheters and guidewires.

    Device Description

    The Passage Hemostasis Valve minimizes blood loss during diagnostic and interventional procedures. The Merit Passage Hemostasis Valve consists of a Y-adaptor with a hemostasis valve which also incorporates a female luer lock connector and a male luer lock rotator. The polycarbonate used to manufacture the adaptor is transparent to aid in visualizing entrapped air. The hemostatic valve adjusts between 0 to 0.097" (approximately 7 French). The Y-body design allows both injection of contrast and placement of interventional devices.

    The Passage Hemostasis Valve is comprised of a stand-alone rotator assembly bonded to the polycarbonate Y-body, using a UV cured adhesive. The seal and washer are inserted into the Y-body valve port. A thin coat of silicone is applied to the threaded portion of the Y-body and the cap is assembled. The standalone rotator assembly is comprised of individually molded polycarbonate parts(housing connector, retaining collar, hub) and an EPDM(Ethylene Propylene Diene Monomer) O-Ring.

    AI/ML Overview

    This document is a 510(k) premarket notification for the "Passage Hemostasis Valve" and primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing a comparative effectiveness study involving AI or human reader performance. Therefore, many of the requested items related to AI device performance and human studies are not present.

    Here's a breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Rotator RotationNot explicitly stated in the provided text, but implied to demonstrate functional rotation.Successfully completed. All test results were comparable to the predicate device and met acceptance criteria.
    Compression Seal – Hemostasis Characteristics (low pressure)Not explicitly stated in the provided text, but implied to achieve a fluid-tight seal to minimize blood loss.Successfully completed. All test results were comparable to the predicate device and met acceptance criteria.
    High Pressure Capability (Maximum 200psi)Withstand maximum 200psiSuccessfully completed. All test results were comparable to the predicate device and met acceptance criteria.
    Air Ingress under VacuumNot explicitly stated in the provided text, but implied to prevent air ingress under vacuum conditions.Successfully completed. All test results were comparable to the predicate device and met acceptance criteria.
    BiocompatibilityMeet ISO 10993-1:2009 and FDA Modified ISO 10993 Test Profile G95-1Successfully completed. All test results were comparable to the predicate device and met acceptance criteria.

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

    The document does not specify the exact sample sizes for each test set. It mentions that "A battery of testing was conducted" and refers to "risk analysis" for determining the extent of testing. The provenance of the data (country of origin, retrospective/prospective) is not mentioned. Given the device is manufactured by Merit Medical Systems, Inc. (with an address in South Jordan, UT, USA, and Merit Medical Ireland Ltd. in Galway, Ireland), the testing could have occurred in either location or a contracted lab.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    Not applicable. This device is a physical medical device (hemostasis valve), not an AI imaging or diagnostic algorithm. Therefore, "ground truth" as typically defined for AI performance studies (e.g., expert consensus on image findings) is not relevant. The performance is assessed through engineering and biological testing.

    4. Adjudication Method for the Test Set

    Not applicable. As described above, this is a physical device and performance is assessed through objective testing against pre-defined engineering and biological criteria, not through expert adjudication of data.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

    No. This is not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

    No. This is a physical medical device. "Standalone performance" in the context of AI algorithms is not applicable here. The device itself is "standalone" in its intended mechanical and fluid dynamic function.

    7. The Type of Ground Truth Used

    The "ground truth" in this context refers to the defined acceptance criteria for the engineering and biocompatibility tests. These criteria are based on:

    • Industry standards (e.g., ISO 11070:1998, ISO 594-2:1998, ISO 11135:2014, ASTM F1980-07, ISO 10993-1:2009).
    • Requirements outlined in guidance documents.
    • Risk analysis.
    • Comparison to the performance of the predicate device.

    8. The Sample Size for the Training Set

    Not applicable. This is not an AI/machine learning device; thus, there is no "training set."

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

    Not applicable. Since there is no training set, there is no ground truth to be established for it.

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