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510(k) Data Aggregation

    K Number
    K992901
    Device Name
    GYNECARE VERSAPOINT G-VAP ELECTRODE
    Manufacturer
    GYNECARE, INC.
    Date Cleared
    2000-01-18

    (141 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GYNECARE VERSAPOINT G-VAP ELECTRODE

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

    Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
    Excision of intrauterine myomas
    Excision of intrauterine polyps
    Lysis of intrauterine adhesions
    Incision of uterine septa
    Endometrial ablation

    Device Description

    The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Versapoint Electrosurgery G-VAP Electrode Accessory:

    Summary of Device Performance and Acceptance Criteria

    Based on the provided documents, limited specific details are given regarding explicit acceptance criteria and corresponding reported device performance values in a quantitative manner. The submission primarily relies on a qualitative statement of performance verification.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria (Inferred/Stated)Reported Device Performance
    Safety and EffectivenessDevice performs safely and effectively."It was determined that the device performs safely and effectively."
    Performance RequirementsMeets all described performance requirements."product meets the performance requirements described."
    Substantial EquivalenceSimilar technological characteristics to predicate device (form, fit, function, method of operation)."The modified device has the same technological characteristics as the predicate devices. The form, fit, function and method of operation are similar."
    Intended UseSuitable for tissue cutting, removal, and desiccation in gynecologic hysteroscopic electrosurgical procedures (myomas, polyps, adhesions, septa, endometrial ablation).Device is intended for these uses and its performance supports them.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: Not explicitly stated. The document mentions "Pre-clinical as well as bench top testing" but does not provide details on the number of samples or tests conducted.
    • Data Provenance: The nature of the testing (pre-clinical, bench top) suggests controlled laboratory environments. There is no information regarding country of origin of data or whether it was retrospective or prospective in a clinical sense.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    • Not applicable. The provided summary describes testing of an electrosurgical electrode and generator, which typically involves engineering and functional performance testing, not diagnostic accuracy requiring expert panel review for ground truth.

    4. Adjudication Method for the Test Set

    • Not applicable. As the testing is described as pre-clinical and bench top for an electrosurgical device, expert adjudication methods (like 2+1, 3+1) are not relevant.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No. There is no mention of a multi-reader multi-case comparative effectiveness study. This type of study is typically relevant for interpretative diagnostic devices, not for an electrosurgical accessory.

    6. Standalone (Algorithm Only) Performance Study

    • Not applicable. This device is an electrosurgical electrode accessory, not a software algorithm or AI-based diagnostic tool. Therefore, a "standalone algorithm only" study is not relevant.

    7. Type of Ground Truth Used

    • Functional/Performance Standards: The ground truth would be established by engineering specifications, safety standards, and performance test protocols for electrosurgical devices (e.g., power output, safety cut-offs, tissue effect characteristics). The document generally states "performance requirements described," implying adherence to such standards.

    8. Sample Size for the Training Set

    • Not applicable. This device is a hardware accessory (electrosurgical electrode). The concept of a "training set" is typically associated with machine learning or AI models, which are not relevant here.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. As mentioned above, the concept of a training set and its ground truth does not apply to this type of medical device.
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