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510(k) Data Aggregation

    K Number
    K172146
    Device Name
    MERISTEEL
    Manufacturer
    M/s. Meril Endo Surgery Private Limited
    Date Cleared
    2018-02-01

    (199 days)

    Product Code
    GAQ,GAO
    Regulation Number
    878.4495
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K030351
    Why did this record match?
    Device Name :

    MERISTEEL

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

    MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.

    Device Description

    MERISTEEL™ Stainless steel suture is a monofilament, non-absorbable sterile surgical suture composed of stainless steel. This suture is available undyed and uncoated. MERISTEEL™ suture is available in a range of gauge sizes and lengths, and attached to standard stainless steel needles of various types and sizes. Stainless steel suture complies with the requirements of the United States Pharmacopoeia for Non Absorbable Surgical suture and European Pharmacopoeia for Sterile Non-Absorbable surgical strands

    AI/ML Overview

    This looks like a 510(k) summary for a medical device (MERISTEEL™ Stainless Steel Surgical Suture). However, the document does not contain acceptance criteria for an AI/ML-driven device or study details proving those criteria are met.

    The provided document describes a traditional medical device (surgical sutures) and outlines tests conducted to demonstrate equivalence to a predicate device, such as:

    • **Diameter USP **
    • **Tensile strength USP **
    • **Needle attachment USP **
    • Suture Length
    • Biocompatibility as per ISO 10993-1

    These are performance standards for the physical properties and biological safety of the suture material, not criteria related to AI/ML performance.

    Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document is about a conventional medical device submission.

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