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510(k) Data Aggregation

    K Number
    K042492
    Device Name
    HAND STC, MODEL 60MM
    Manufacturer
    NITI MEDICAL TECHNOLOGIES LTD.
    Date Cleared
    2004-10-19

    (35 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K892927,K843603,K892233,K900129
    Why did this record match?
    Device Name :

    HAND STC, MODEL 60MM

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

    The NiTi HandSTC has applications throughout the alimentary tract in surgeries for resection, transaction, and the creation of anastomoses.

    Device Description

    The NiTi HandSTC is a palm size linear cutter and stapler whose main parts are housed together enabling one hand operation by sequential pressing on the device lever.

    The HandSTC applies 56 titanium staples in a line approximately 60mm long. The unformed staples are "U" shape which closed to form "B" shape. When the device is open the distance between the cartridge and the anvil is 4 cm.

    The HandSTC device is supplied with one cartridge and can be reloaded for a total of 8 firings

    The reloads are available in two sizes:

    Blue- unformed staple leg height is 3.5 mm, staple dimension when closed is 1.5 mm. This cartridge closes to a gap of 0.8 mm and it is used for standard tissue and gastrointestinal applications.

    Green- unformed staple leg height is 4.5 mm, staple dimension when closed is 2.0 mm. This cartridge closes to a gap of 1.3mm and it is used for gastrointestinal tract and thick tissues such as stomach and rectum applications.

    AI/ML Overview

    This document is a 510(k) summary for the HandSTC medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document focuses on establishing substantial equivalence to predicate devices, which is a regulatory pathway for demonstration of safety and effectiveness, rather than performance against pre-defined acceptance criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document states: "Based on validations and performance testing results, NiTi Medical Techologies Ltd. believes that the HandSTC is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues." However, the details of these validations and performance testing results, including acceptance criteria and study designs, are not included in this summary.

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