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510(k) Data Aggregation

    K Number
    K173874
    Device Name
    StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
    Manufacturer
    Origami Surgical LLC
    Date Cleared
    2018-05-04

    (134 days)

    Product Code
    GAM,GCJ,NAY,NEW
    Regulation Number
    878.4493
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K123811,K100257,K091087,K051609
    Why did this record match?
    Device Name :

    StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO

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

    StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture within this StitchKit® device is intended for soft tissue approximation where use of an absorbable suture is appropriate.

    Device Description

    StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles. It is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, the used needle is placed into a compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile in a foil pouch.

    Each StitchKit® version contains strands of existing legally-marketed Suturing Materials. The subject StitchKit® versions contain:

    • StitchKit® V-Loc™90: Contains Covidien V-Loc™90 Wound Closure -Devices
    • -StitchKit® V-Loc™180: Contains Covidien V-Loc™180 Wound Closure Devices
    • -StitchKit® Quill™ PDO: Contains Quill™ PDO Synthetic Absorbable Barbed Sutures
    AI/ML Overview

    The provided text is a 510(k) premarket notification for a medical device called StitchKit®. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-based product. As such, it does not contain the information requested regarding acceptance criteria, study methodologies for AI performance, sample sizes for test/training sets, expert involvement in ground truth establishment, or MRMC studies.

    The document primarily discusses the physical characteristics and intended use of the StitchKit® (a suture delivery canister) and conducts performance testing to show it functions comparably to predicate suture materials and delivery systems.

    Therefore, I cannot provide the requested information based on the provided text.

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