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510(k) Data Aggregation

    K Number
    K213390
    Device Name
    Benchmark BMX96 Access System
    Manufacturer
    Penumbra, Inc.
    Date Cleared
    2022-08-18

    (307 days)

    Product Code
    QJP,DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K201271
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Benchmark BMX96 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

    Device Description

    The Benchmark BMX96 Access System is a three-component system comprised of the Benchmark BMX96 Delivery Catheter, Neuron 6F Select Catheter, and a Dilator. The Benchmark BMX96 Delivery Catheter can be used individually with a 0.038 in. [0.97 mm] guidewire or together with the Neuron 6F Select Catheter to access the desired anatomy.

    AI/ML Overview

    This document describes the premarket notification (510(k)) for the Benchmark BMX96 Access System. However, it does not contain information about an AI/ML-driven medical device. Instead, it focuses on the substantial equivalence of a medical device (catheter system) to a predicate device, primarily based on bench-top performance testing.

    Therefore, I cannot provide a description of acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a traditional medical device (catheter) and its physical performance, not an AI/ML diagnostic or prognostic system.

    The closest relevant information from the provided text that could potentially be misinterpreted as "acceptance criteria and device performance" for an AI system would be:

    • Bench-top Performance: "The subject device met all established requirements." and "The following bench-top performance tests were performed on the subject device and all have met acceptance criteria: Particulate Testing and Coating Integrity Testing, Simulated Use Testing."
    • Biocompatibility: Stated as not requiring additional testing due to identical materials, processing, and sterilization as previously tested products.

    However, these refer to the physical and material properties of a catheter, not the performance metrics of an AI/ML algorithm.

    In summary, the provided text does not contain the necessary information to answer the request regarding acceptance criteria and a study proving an AI/ML device meets those criteria.

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