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510(k) Data Aggregation

    K Number
    K200517
    Device Name
    Standard Trocar
    Manufacturer
    Standard Bariatrics
    Date Cleared
    2020-04-09

    (38 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K060096,K083638
    Why did this record match?
    Device Name :

    Standard Trocar

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

    The Standard Trocar is a sterile, single-use device consisting of an obturator, a cannula, a 5mm adapter and introducer sheath. This system is indicated for use in general and abdominal minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

    Device Description

    The Standard Trocar is a single-patient-use disposable trocar manufactured from biocompatible medical plastics. The device is comprised of a trocar cannula, obturator, 5 mm adaptor, and introducer sheath. The Standard Trocar is a sterile, single patient use surgical instrument intended to establish a port of entry for 19mm outer diameter instruments to be used during minimally invasive procedures. The 5 mm adaptor provides the means for the trocar to also be used with 5 mm diameter instruments. The trocar is compatible with commercially available laparoscopic instruments. In addition, as Standard Bariatrics develops additional laparoscopic instruments, the Standard Trocar will accommodate those devices. The Standard Trocar is sterilized using gamma irradiation and provided to the user in a Tyvek tray with peel lid.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the "Standard Trocar" and compares it to a predicate device, the "Applied Medical Modular Trocar." This document is a regulatory submission to the FDA, not a study report on an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI-powered device.

    The document discusses performance testing for a medical device (trocar) in terms of its physical and mechanical properties, biocompatibility, and usability, demonstrating substantial equivalence to a predicate device. It does not involve any AI components, ground truth, expert consensus for AI model evaluation, or MRMC studies.

    Therefore, I cannot extract the requested information from the provided text as it is not relevant to AI/ML device evaluation.

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