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510(k) Data Aggregation

    K Number
    K193018
    Device Name
    Surgical Direct Hand-held Laparoscopic Instruments
    Manufacturer
    Surgical Direct, Inc.
    Date Cleared
    2019-12-20

    (52 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K151567
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Surgical Direct Hand-held Laparoscopic Instruments are intended for grasping, dissecting, retracting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation. Using an instrument improperly for a task which it was not intended may result in a damaged or broken instrument.

    Device Description

    The SURGICAL DIRECT Hand-held Laparoscopic Instruments are commonly named hand-held laparoscopic instruments. Specifically, each instrument has a different tip or jaw to define the functional use, such as scissors, forceps, graspers, biopsy, dissectors or needle holders. The devices are designed to be used through a portal, the opening maintained by an introducer or cannula which allows for insertion and removal of the device without damage to surrounding soft tissue. The devices have a linkage mechanism connecting the working tips, or jaws to a handle. This allows the surgeon to cut, dissect, grasp, clamp, cauterize, palpate, or retract at the operating site in conjunction with a laparoscope.

    AI/ML Overview

    The provided text is a 510(k) summary for the Surgical Direct Hand-held Laparoscopic Instruments. It describes the device, its indications for use, comparison to a predicate device, and performance data. However, this document does not contain acceptance criteria or study results for an AI-powered device.

    The document states:

    • "No clinical study was conducted."
    • The performance data includes safety testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, EMC Validation Test), cleaning and sterilization validation (AAMI TIR30:2011, Steam Pre-vacuum Efficacy, Steam Sterilization, Shelf Life), biocompatibility (ISO 10993-1 tests), and performance testing (Ex-Vivo Thermal Tissue Testing, Electrical Safety, Scissors Performance, Expected Life Testing).

    Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI-powered device, nor can I answer the specific questions about sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these are not relevant to the information presented in this document.

    The document is for traditional, non-AI-powered surgical instruments and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing.

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