Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K181346
    Manufacturer
    Date Cleared
    2018-08-06

    (77 days)

    Product Code
    Regulation Number
    876.5130
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CystoSure® Plus catheter provides access and visualization for the female urinary bladder.

    The single-use CystoSure® Plus catheter provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of an endoscope. It is suitable for medium- to long-term use with a maximum patient indwelling time

    Device Description

    The CystoSure® and CystoSure® Plus catheters are intended for use in the diagnostic visualization of the female bladder with a port to allow for the insertion of an endoscope. They are made from silicone and they are used in both surgical and diagnostic procedures for draining the bladder and enabling the visualization of internal bladder surfaces.

    AI/ML Overview

    The provided text is a 510(k) summary for the CystoSure® Plus Catheter. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-based medical device performance study.

    The document states: "The CystoSure Plus catheter meets all performance criteria of the predicate CystoSure catheter." However, it does not elaborate on what these performance criteria are, nor does it present data from a specific study demonstrating compliance with these criteria for the CystoSure Plus device itself. Instead, the submission relies on the concept of "substantial equivalence" to a legally marketed predicate device (K142194 CystoSure Urinary Access System) and modifications for improved patient comfort and ease of insertion.

    Therefore, I cannot provide the requested information. The text does not describe an AI/ML device, nor does it include a study with acceptance criteria specific to the performance of such a device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1