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510(k) Data Aggregation

    K Number
    K040302
    Device Name
    VERSAPOINT RESECTOSCOPIC SYSTEM
    Manufacturer
    GYNECARE, A DIV. OF ETHICON, INC.
    Date Cleared
    2004-03-09

    (29 days)

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

    VERSAPOINT RESECTOSCOPIC SYSTEM

    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, and 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 telescopic clip is a component of the VRS resectoscopic electrodes, and is designed to secure the distal portion of the electrode within the resectoscope. The telescopic clip is currently manufactured with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).

    AI/ML Overview

    This document describes a 510(k) premarket notification for a modified medical device, the VERSAPOINT* Resectoscopic System. The modification involves changing the material of a component, the telescopic clip, from Polypropylene (PP) to Polybutyleneterephthalate (PBT).

    Here's an analysis of the acceptance criteria and study information provided:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Performance RequirementsNot explicitly stated in terms of quantitative metrics or thresholds. The general requirement is for the modified device to meet the "performance requirements described" for the predicate device."Biocompatibility and bench testing have been performed to verify that the product meets the performance requirements described."
    BiocompatibilityImplicitly, that the new material (PBT) is biocompatible and safe for its intended use within the human body."Biocompatibility and bench testing have been performed..."
    Material EquivalenceThe new material (PBT) must perform functionally equivalently to the original material (PP) for the telescopic clip within the resectoscope. This would include mechanical strength, durability, resistance to sterilization, and electrical insulation properties (if applicable)."...bench testing have been performed to verify that the product meets the performance requirements described."

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

    • Test Set Sample Size: Not specified. The document only mentions "Biocompatibility and bench testing" were performed. There is no information on the number of units tested or the specific conditions of these tests.
    • Data Provenance: Not specified. Given this is a 510(k) submission to the FDA, it is expected that the testing was conducted under controlled conditions, likely in a laboratory setting, in compliance with relevant standards. However, the country of origin of the data or whether it was retrospective or prospective is not mentioned.

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

    • Number of Experts: Not applicable. The "ground truth" in this context refers to the device meeting its performance requirements, which is established through technical testing (biocompatibility and bench testing), not through expert consensus on observational data.
    • Qualifications of Experts: Not applicable for establishing ground truth in this type of submission. The performance testing would be conducted by qualified engineers and technicians.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or imaging data. For bench and biocompatibility testing, the results are typically evaluated against pre-defined specifications and standards.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

    • MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI-assisted diagnostic tool on human reader performance, typically in imaging. This submission focuses on a material change to a surgical instrument, not an AI-based diagnostic tool.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    • Standalone Performance Study: No, a standalone performance study was not done. This concept is also specific to AI algorithms. The device in question is a surgical instrument.

    7. The Type of Ground Truth Used

    • Type of Ground Truth: The "ground truth" for this device modification is the established performance requirements for the predicate device and relevant industry standards concerning material properties, biocompatibility, and functional integrity for surgical instruments. The testing aims to demonstrate that the modified device, despite the material change, continues to meet these pre-defined engineering and safety standards.

    8. The Sample Size for the Training Set

    • Training Set Sample Size: Not applicable. This submission is for a physical device with a material change, not a machine learning model that requires a training set.

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

    • Ground Truth for Training Set: Not applicable. As there is no machine learning model, there is no training set or associated ground truth to establish.
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