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510(k) Data Aggregation

    K Number
    K210338
    Device Name
    Edge Insulated Blade Electrode
    Manufacturer
    Covidien LLC
    Date Cleared
    2021-04-15

    (69 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K182772,K081791
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Edge™ Insulated Blade Electrode is intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

    Device Description

    The Edge™ Insulated Blade Electrode (E1455G) is a sterile, single-use, monopolar electrode intended to conduct radiofrequency (RF) current. It is a coated stainless-steel electrode blade with insulation. It is compatible with electrosurgical pencils that have a 0.093" insertion diameter or commonly referred to as a standard 3/32" insertion diameter, this includes the Covidien Valleylab™ Rocker Switch Pencil Family (SEP5000, SEP5015) cleared in K182772.

    AI/ML Overview

    The provided FDA 510(k) summary for the Edge™ Insulated Blade Electrode (K210338) describes performance testing, but it fundamentally differs from the study of an AI/ML powered device. This document is for a traditional medical device, an electrosurgical electrode, not a software or AI/ML product. Therefore, the specific questions regarding AI/ML powered devices, such as sample sizes for test/training sets, ground truth establishment for AI, number of experts, adjudication methods, and MRMC studies, are not applicable to this submission.

    The "acceptance criteria" and "reported device performance" in this context refer to traditional engineering and biological testing to ensure the device is safe and effective and substantially equivalent to a predicate device, not evaluation of algorithmic accuracy.

    Here's an interpretation of the available information for a traditional device:

    1. Table of Acceptance Criteria and Reported Device Performance

    For this type of device, "acceptance criteria" are generally derived from recognized standards and internal specifications to demonstrate safety and effectiveness and substantial equivalence to the predicate. The performance reported here relates to meeting those standards, not to a specific quantitative metric like sensitivity or specificity.

    Acceptance Criteria CategorySpecific Tests/Standards MetReported Device Performance
    BiocompatibilityISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity)The subject device complies with the relevant clauses of ISO 10993-1. (Direct tissue contacting materials: stainless steel, silicone, and polymer insulation)
    EMC & Electrical SafetyIEC 60601-1, IEC 60601-2-2 (Electrical Safety), IEC 60601-1-2 (EMC)The subject device complies with relevant clauses of these standards.
    Mechanical/FunctionalRelated design inputs and product specificationsMechanical, electrical, and functional testing verified that the subject device performs as expected and conforms to requirements. (Details of specific tests are not provided in this summary, but would be in the full submission).
    Ex vivo Thermal EffectComparison to predicate deviceMonopolar ex vivo testing evaluated thermal effect across a range of power settings and modes on different tissue types. The subject device demonstrated substantial equivalence to the predicate device.
    Rated Accessory Voltage(Implicitly, that it does not negatively affect electrical safety or performance compared to predicate)Subject Device: <4500Vpk; Predicate Device: <10.8kV. The document states: "Rated accessory voltage does not affect electrical safety or performance." (This implies it either meets a safe threshold or is equivalent to the predicate in terms of safety impact).

    Regarding AI/ML specific questions (2-9):

    Since this is not an AI/ML powered device, the following points are not applicable and cannot be answered from the provided document:

    1. Sample sizes for the test set and data provenance: N/A (No AI/ML test set)
    2. Number of experts used to establish the ground truth for the test set and their qualifications: N/A (No AI/ML ground truth)
    3. Adjudication method: N/A (No AI/ML adjudication)
    4. Multi-reader multi-case (MRMC) comparative effectiveness study: N/A (Not an AI-assisted diagnostic/interpretive device)
    5. Standalone (algorithm only) performance: N/A (No algorithm in this sense)
    6. Type of ground truth used: N/A (No AI/ML ground truth)
    7. Sample size for the training set: N/A (No AI/ML training set)
    8. How the ground truth for the training set was established: N/A (No AI/ML training set)

    This submission demonstrates substantial equivalence for a physical electrosurgical electrode primarily through comparisons of technological characteristics and standard safety and performance testing.

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