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510(k) Data Aggregation

    K Number
    K965118
    Device Name
    ENDOCARE MONOPOLAR ELECTRODE
    Manufacturer
    ENDOCARE, INC.
    Date Cleared
    1997-02-25

    (67 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K952587,K944540,K945191
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ENDOcare Electrosurgical Electrodes are designed for use in general surgery, urology, gynecology and orthopedics for cutting, coagulation, resection and vaporization of tissue including BPH (Benign Prostatic Hyperplasia), tumors, fibroids, cysts and obstructive tissue.

    Device Description

    The ENDOcare Electrosurgical Electrodes are accessories that fit commercially available resectoscopes, cystoscopes, laproscopes and hysteroscopes, pencil grips and pistol grips. Each model has a different configuration which offers the surgeon a variety of tissue interaction tips depending on the specific surgical application.

    AI/ML Overview

    The provided text describes an medical device 510(k) submission for "ENDOcare Electrosurgical Electrodes." However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance, clinical efficacy, or algorithm-based performance.

    Instead, the document focuses on:

    • Device Description: A general description of the electrosurgical electrodes and their intended uses.
    • Biocompatibility: States that requirements were met based on ISO-10993 and substantial equivalence to a previously marketed device, without presenting new studies.
    • Substantial Equivalence Support: Argues for substantial equivalence to existing predicate devices (K952587, K944540, K945191) based on intended use and device type, not performance metrics.
    • Sterilization Methodology: Describes the methods (Ethylene Oxide and Gamma Radiation) and related guidelines (ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 11137) to achieve a specified Sterility Assurance Level (SAL), along with residual limits for EtO. This is about sterilization validation, not device performance.

    Therefore, I cannot provide the requested information in the format of acceptance criteria and a study proving their fulfillment because such details are absent from the provided text.

    Based on the prompt's expectation for details like "sample size," "ground truth," "MRMC," and "standalone performance," it seems the prompt is geared towards an AI/ML-driven medical device, which the ENDOcare Electrosurgical Electrodes are not. They are physical surgical instruments.

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