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510(k) Data Aggregation

    K Number
    K094021
    Device Name
    ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I
    Manufacturer
    MICROSULIS MEDICAL LIMITED
    Date Cleared
    2010-08-06

    (219 days)

    Product Code
    NEY
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I

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

    The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

    Device Description

    Acculis Accu2i pMTA Microwave Tissue Ablation Applicator

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device (Acculis Accu2i pMTA Microwave Tissue Ablation Applicator) and focuses on establishing substantial equivalence to a predicate device. It does not contain information about a study that proves the device meets specific performance acceptance criteria as would typically be found in a clinical trial report or a comprehensive validation study.

    Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because it is not present in the provided text.

    The document primarily states:

    • The device's name and regulation information.
    • Its intended use: "intraoperative coagulation of soft tissue."
    • That it is substantially equivalent to a legally marketed predicate device.

    There is no mention of:

    • Specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity, temperature ranges, ablation zone size).
    • A study design (e.g., test set, training set, experts, ground truth, MRMC study).
    • Any performance metrics or results.
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