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510(k) Data Aggregation

    K Number
    K211148
    Device Name
    CORE-Trocar
    Manufacturer
    Incore CO., LTD.
    Date Cleared
    2022-06-21

    (428 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K141594
    Why did this record match?
    Device Name :

    CORE-Trocar

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

    The CORE-Trocar is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.

    Device Description

    The CORE-Trocar has a port to insert endoscopic instruments during endoscopic procedures. It consist of a cannula and a obturator. The Trocar is available in nine (9) models(IC-TC02, IC-TC02S, IC-TC03, IC-TC03S, IC-TC05S, IC-TC05S, IC-TC08, IC-TC10, IC-TC12) and the models are divided into six (6) types according to the kinds of diameter Type : 2mm Type(IC-TC02, IC-TC02S), 3mm Type(IC-TC03, IC-TC03S), 5mm Type(IC-TC05, IC-TC05S), 8mm Type(IC-TC08), 10mm Type(IC-TC10) and 12mm Type(IC-TC12). The cannula assembly have seals(main, secondary), a valve and a stopcock. The obturator has non-bladed tip. Sterilization is done with EO gas and Sterilization Assurance Level(SAL) 10-6. The seals prevent loss of CO2 pneumoperitoneum pressure when instruments are inserted or withdrawn.

    AI/ML Overview

    The provided text is a 510(k) summary for the CORE-Trocar device and describes acceptance criteria and performance data from various tests. However, it does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/human-in-the-loop performance evaluation or a standalone AI algorithm performance study. It focuses on the mechanical, biological, and physical/chemical properties of the trocar itself.

    Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document as they pertain to the performance evaluation of AI/ML-based medical devices, which the CORE-Trocar is not.

    Here's the information that can be extracted from the provided text:

    Acceptance Criteria and Reported Device Performance

    The device underwent various non-clinical performance bench tests and comparative tests against a predicate device.

    TestAcceptance CriteriaReported Device Performance
    Safety Test
    Sterility10⁻⁶ SAL (Sterility Assurance Level); No evidence of microbial growth.Passed. No evidence of microbial growth found.
    Biocompatibility (various tests)Compliance with ISO 10993-1:2018 (Cytotoxicity, Maximization Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen).Passed all tests. Device is considered tissue contacting for
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