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510(k) Data Aggregation

    K Number
    K241376
    Device Name
    HyperSuture All Blue Extension Line
    Manufacturer
    Threadstone L.L.C.
    Date Cleared
    2024-08-09

    (86 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K181774,K230311
    Why did this record match?
    Device Name :

    HyperSuture All Blue Extension Line

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

    HyperSuture All Blue Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

    Device Description

    HyperSuture All Blue Extension Line cables are non-absorbable, sterile, surgical sutures, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture All Blue Extension Line cables are available in USP 2 and USP 5 and meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures.

    HyperSuture All Blue Extension Line tapes are non-absorbable, sterile, surgical braids, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in 1.5mm tape (USP 2 equivalent) and 2.0mm tape (USP 5 equivalent).

    Both HyperSuture All Blue Extension Line cables and tapes are available in blue, 36 inches in length, and with or without pre-attached needles.

    AI/ML Overview

    The provided text is a 510(k) summary for the HyperSuture All Blue Extension Line. This document is a regulatory submission to the FDA for a medical device and describes its equivalence to a predicate device. It does not contain information related to software performance, clinical studies, or AI algorithm validation. The device in question is a surgical suture, not a software or AI-powered diagnostic tool.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) because these are concepts applicable to software or AI device validation, which is not what this document addresses.

    The document focuses on establishing substantial equivalence to a predicate device based on material, manufacturing, and physical performance characteristics, primarily adhering to USP (United States Pharmacopeia) standards for surgical sutures.

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