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510(k) Data Aggregation

    K Number
    K070711
    Device Name
    INCIRCLE BI-POLAR RF ABLATION SYSTEM
    Manufacturer
    RFA MEDICAL, INC.
    Date Cleared
    2007-04-24

    (41 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K000241,K983214,K040785,K050361,K060419,K010060
    Why did this record match?
    Applicant Name (Manufacturer) :

    RFA MEDICAL, INC.

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

    The RFA Medical InCircle™ Bi-Polar RF Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

    Device Description

    The RFA Medical InCircle™ Bi-Polar RF Ablation System is a sterile, disposable, bi-polar, Radio Frequency (RF), hand-held electrosurgical device that utilizes opposing sets of Electrodes to coagulate/ablate a region of soft tissue using bi-polar RF energy. The device is designed for in percutaneous, laparoscopic, and intraoperative surgical use procedures. The device is designed for use with standard FDA cleared generators, such as the Boston RF Scientific Corporation (RadioTherapeutics) RF3000 (K000241) and the RITA Medical Systems 1500X (K983214).

    AI/ML Overview

    The provided text describes the "InCircle™ Bi-Polar RF Ablation System" and its 510(k) submission. However, it does not contain information about specific acceptance criteria for a study, a detailed study description, performance data, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

    The document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. It focuses on:

    • Device identification and contact information.
    • Device description and intended use.
    • Comparison to predicate devices.
    • Statements about bench testing/functional testing to ensure substantial equivalence and safety/efficacy.

    Therefore, I cannot answer the specific questions about acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment based solely on the provided text.

    The document states: "Bench testing/functional testing was performed on the RFA Medical InCircle™ Bi-Polar RF Ablation System to ensure that the product is substantially equivalent to the predicate device and to ensure that the new device does not raise new questions of safety and efficacy." This implies testing was done, but the details of those tests, their acceptance criteria, and specific results are not included in this summary.

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