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    K Number
    K193355
    Device Name
    Electrodes Handpieces for Mygen V-1000 RF System
    Manufacturer
    RF Medical Co., Ltd
    Date Cleared
    2020-08-03

    (243 days)

    Product Code
    GEI,JOS
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K181249,K180999
    Why did this record match?
    Reference Devices :

    K181249

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

    Electrodes Handpieces (BT, JET) are indicated for coagulation and ablation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator.

    Device Description

    Electrodes Handpieces (BT, JET) are sterile, single-use electrosurgical electordes intended to be use in conjunction with Mygen V-1000 RF generator (K180999).

    Electrodes Handpieces (BT, JET) consist of electrode tip, insulation part, handle.

    Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (BT, JET), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.

    AI/ML Overview

    This document (K193355/S002) is not for an AI/ML medical device, but rather for "Electrode Handpieces (BT, JET)" which are electrosurgical electrodes used for coagulation and ablation of soft tissue. Therefore, the questions related to AI/ML device acceptance criteria, study details, and human-in-the-loop performance are not applicable.

    However, I can extract the acceptance criteria and study details that were performed for this specific medical device from the provided text.

    Here's a breakdown of the information found, specifically addressing the device's performance data and acceptance criteria:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/CriteriaAcceptance CriteriaReported Device Performance
    Biocompatibility (ISO10993-1;2009)Patient contact components and materials must meet ISO10993-1;2009 standards.Tested and validated according to ISO10993-1;2009. Patient contact components and materials are identical to the predicate device.
    Shelf-Life TestingPackaging seal strength, packaging dye penetration, appearance, conduction, and sterility must meet acceptance criteria (ASTM F 1980 Accelerated Aging).All testing results passed the acceptance criteria for packaging seal strength, packaging dye penetration, appearance, conduction, and sterility, in accordance with ASTM F 1980 Accelerated Aging method for a valid shelf life.
    Medical Electrical Equipment Safety (IEC 60601-1)General Requirements for basic safety and essential performance must be fulfilled.The requirements of specified standards (IEC 60601-1) were fulfilled.
    Electromagnetic Compatibility (IEC 60601-1-2)General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility) must be fulfilled.The requirements of specified standards (IEC 60601-1-2) were fulfilled.
    High Frequency Surgical Equipment Safety (IEC 60601-2-2:2009)Particular requirements for the basic safety and essential performance must be fulfilled.The requirements of specified standards (IEC 60601-2-2:2009) were fulfilled.
    Temperature Sensor Accuracy (of V-1000 generator)Measured values by the temperature sensor of V-1000 and the temperature calibrator must be within ±3°.The test results confirmed that the values measured by the temperature sensor of V-1000 and the temperature calibrator were within the acceptance criteria (±3°). Tested in multiple power modes, three times for each power setting.
    Bacterial Endotoxin Concentration (LAL Test)Bacterial endotoxin concentration should be
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