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510(k) Data Aggregation

    K Number
    K173917
    Device Name
    neoClose PDS
    Manufacturer
    neoSurgical Ltd
    Date Cleared
    2018-11-08

    (321 days)

    Product Code
    GCJ,GAR,GDW
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K081366,K142903
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    neoClose® PDS is indicated for the approximation of soft tissue or prosthetic material during open or laparoscopic surgical procedures.

    Device Description

    The neoClose PDS device consists of absorbable PDS Anchors and neoClose Drivers. The PDS Anchor consists of an absorbable PDS suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose PDS Anchor x 2 (NCPDSX2-U) and the neoClose PDS Anchor x 4 (NCPDSX4-U). The neoClose PDS Anchors and Drivers are provided sterile (EtO). The neoClose PDS Anchors are pre-loaded on neoClose Drivers, which are passed through soft tissue for subsequent soft tissue or prosthetic material approximation.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the results of a study that proves a device meets these criteria. The document is a 510(k) summary for a medical device called "neoClose PDS Anchor", which mainly focuses on demonstrating its substantial equivalence to a predicate device for regulatory clearance. It discusses the device's description, indications for use, and comparison with predicate devices. However, it does not include details on specific performance acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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