LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040623
    Device Name
    AMS PERIGEE SYSTEM
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Date Cleared
    2004-05-17

    (69 days)

    Product Code
    OTP,PAI
    Regulation Number
    884.5980
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K011251,K023516,K030123,K033636,K040521
    Why did this record match?
    Device Name :

    AMS PERIGEE SYSTEM

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

    The Perigee™ System is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior vaginal wall prolapse.

    Device Description

    The Perigee™ System consists of needles and connectors used to pass a polypropylene mesh for support of the anterior vaginal wall.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the AMS Perigee™ System, a surgical mesh device. The review of the provided text reveals that it does not contain the information requested in the prompt regarding acceptance criteria and a study to prove device performance.

    The document primarily focuses on:

    • Administrative details: Submitter contact, device name and classification, manufacturing location, summary preparation date, and 510(k) number.
    • Predicate devices: A list of previously cleared AMS sling and mesh systems.
    • Intended Use: "The Perigee™ System is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior vaginal wall prolapse."
    • Device Description: The system consists of needles and connectors for passing a polypropylene mesh.
    • Summary of Testing (limited): It states the mesh was tested according to FDA guidance and shown to be equivalent to predicate devices, and other components demonstrated substantial equivalence in mechanical performance and biocompatibility.
    • FDA Communication: A letter from the FDA confirming substantial equivalence and outlining regulatory responsibilities.
    • Indications for Use Statement: A form reiterating the intended use.

    Therefore, I cannot provide the requested information as it is not present in the provided text.

    To answer your prompt, specific study reports, performance data, and detailed acceptance criteria for the AMS Perigee™ System would be necessary. This type of detailed performance data is typically found in the full 510(k) submission, particularly in sections like "Performance Data" or "Non-Clinical Studies."

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1