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510(k) Data Aggregation

    K Number
    K221945
    Device Name
    Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm
    Manufacturer
    Conmed Corporation
    Date Cleared
    2022-07-28

    (23 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K081644
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Beamer AVEO™ Filter Integrated Argon Probes and Beamer AVEO™ Filter Integrated Argon SideFire Probe are intended to be used for argon enhanced coagulation of tissue.

    Device Description

    The Beamer AVEOTM Argon Probes and Argon SideFire Probe are flexible, single patient use devices which deliver argon for non-contact coagulation when used in conjunction with the Beamer AVEOTM Electrosurgical Generator (ESU) and Argon (ABC) Module. The axial probes are offered in several lengths and diameters to accommodate various endoscope types. The distal end of all the probes has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device (Beamer AVEO™ Filter Integrated Argon Probes) and does not describe a study involving acceptance criteria for an AI/ML powered device. Instead, it details the substantial equivalence of the new device to a predicate device, focusing on changes in mechanical design and integration of components.

    Therefore, I cannot provide the requested information as the document does not contain details about:

    1. Acceptance criteria and device performance table for an AI/ML device.
    2. Sample sizes for test sets, data provenance, number of experts, or adjudication methods for ground truth.
    3. MRMC studies, standalone algorithm performance, or ground truth types, training set size, or ground truth establishment for an AI/ML model.

    The document discusses performance testing for the physical device, such as thermal effects on tissue and mechanical tests (flow rate, insertion/retraction, tensile strength), and states that "All test results were acceptable." However, it does not provide specific acceptance criteria or detailed results of those tests. It also mentions biocompatibility testing confirming material safety.

    The core of this submission is a claim of substantial equivalence for a non-AI/ML medical device, based on similar materials, processes, packaging, and technological characteristics to a predicate device, with minor modifications (like an integrated filter and a new connector).

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