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510(k) Data Aggregation

    K Number
    K233120
    Device Name
    CWM-930S, FIXER DV9
    Manufacturer
    Chungwoo Co., Ltd.
    Date Cleared
    2024-05-23

    (239 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K210084,K193070
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for use in dermatologic and general surgical procedures for electro coagulation.

    Device Description

    This device is a Fractional RF Surgical Unit with Sterile Micro Needle, which is composed of the main device (generator and user interface display, handpiece, foot switch, neutral electrode, and monopolar microneedle electrodes. It is designed for applying radiofrequency therapy with microneedles, which coagulates skin tissue using 1 MHz or 2 MHz radiofrequency energy delivered from the generator to the microneedles. A Bipolar Handpiece suction filter is also available for use to remove unwanted debris from the skin application site and safeguarding the equipment by preventing foreign substances from entering during use.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device (CWM-930S Radio Frequency Therapy System). It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on studies involving AI or human reader performance.

    Therefore, the document does not contain the information requested regarding acceptance criteria for AI device performance, sample size for test sets (in the context of AI models), data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI models, training set sample size, or how ground truth for training was established.

    The "Performance Testing" section does mention some non-clinical performance tests for the CWM-930S device itself, but these are not related to AI model performance or human reader studies. Specifically, it mentions:

    • Non-Clinical Test Summary [21 CFR 807.92(b)(1)]:
      • Electrical Safety, Electromagnetic Compatibility Testing: Compliance with IEC 60601 series standards.
      • Software Validation: CWM-930S has a MODERATE level of concern software that was designed, developed, verified, and validated according to FDA guidance.
      • Biocompatibility: Tested parts include the Cap, Electrode (needle and coating) made of SUS, and Neutral Electrode composed of Hydrogel, Cloth, Aluminum Film, Transparent Film, and Loctite Dura-Tak 129a. All showed biocompatibility for intact skin contact for limited duration (
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