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510(k) Data Aggregation

    K Number
    K203476
    Device Name
    CAPERE Thrombectomy System
    Manufacturer
    Vascular Medcure, INC.
    Date Cleared
    2020-12-22

    (27 days)

    Product Code
    QEW,KRA,OEW
    Regulation Number
    870.5150
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K201216,K200314
    Why did this record match?
    Reference Devices :

    K201216

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

    The CAPERE® Thrombectomy System is indicated for:

    • Non-surgical removal of soft emboli and thrombi from blood vessels.
    • Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.

    The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

    Device Description

    The CAPERE® Thrombectomy System primarily consists of a Delivery Catheter and Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.

    AI/ML Overview

    The provided text does not contain information about an AI/ML powered device, but rather a medical device for thrombectomy. Therefore, it's not possible to extract the requested information regarding acceptance criteria, study details, and AI/ML specific metrics.

    The document describes the CAPERE Thrombectomy System, a device for non-surgical removal of soft emboli and thrombi from blood vessels. It details the device's characteristics, intended use, and provides evidence of substantial equivalence to a predicate device based on nonclinical performance testing.

    Here's the information that is available in the provided text regarding the device performance and acceptance criteria for this non-AI/ML device:

    1. A table of acceptance criteria and the reported device performance:

    Acceptance Criteria (What was measured)Reported Device Performance (Result)
    Compression resistance and bond jointsCAPERE® Thrombectomy System maintained the predicate characteristics, demonstrating compliance with relevant standards such as ISO 10555-1 and ISO 594-2.
    Force to retract the basket into the funnel catheterThe CAPERE® was determined to meet the same retraction force requirements as the predicate, based on evaluation in accordance with the same simulated-use test method.
    Ability to capture and remove clotThe CAPERE® was determined to completely capture and remove the simulated clot and therefore maintains the characteristics of the predicate, based on evaluation in accordance with the same simulated-use test method.
    Biocompatibility, sterilization, and packaging characteristicsThe materials and packaging are unchanged from the predicate, therefore the biocompatibility, sterilization, and packaging characteristics of the predicate were maintained.

    2. Sample size used for the test set and the data provenance:

    • The document states "nonclinical performance testing has been conducted...In all instances, the CAPERE® Thrombectomy System functioned as intended under the previously established test methods." However, specific sample sizes for the nonclinical tests are not provided.
    • Data provenance is not explicitly stated, but it can be inferred that the testing was conducted by Vascular Medcure, Inc. or a contracted lab, as it refers to "established test methods used in the cleared predicate device" and "simulated-use test method." No country of origin for the data is mentioned, nor is it specified if the tests were retrospective or prospective, though bench and simulated-use testing are inherently prospective in nature.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • This information is not applicable as the described tests are nonclinical bench and simulated-use tests, not studies involving expert adjudication of data like images or patient cases.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • This information is not applicable as the described tests are nonclinical bench and simulated-use tests, not studies requiring expert adjudication methods.

    5. 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:

    • This information is not applicable as the device is not an AI-assisted diagnostic tool but a physical thrombectomy system.

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

    • This information is not applicable as the device is not an AI algorithm.

    7. The type of ground truth used:

    • For the nonclinical performance testing, the "ground truth" was established by predetermined technical specifications and performance characteristics of the predicate device, as well as by compliance with relevant international standards (ISO 10555-1 and ISO 594-2). For example, the ability to capture clot was evaluated against the "complete capture and removal of simulated clot."

    8. The sample size for the training set:

    • This information is not applicable as the device is not an AI algorithm and does not have a "training set."

    9. How the ground truth for the training set was established:

    • This information is not applicable as the device is not an AI algorithm.
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