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    K Number
    K221054
    Device Name
    CORE-INJECTOR
    Manufacturer
    Incore Co., Ltd.
    Date Cleared
    2022-12-21

    (254 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K150434
    Why did this record match?
    Device Name :

    CORE-INJECTOR

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

    The CORE-INJECTOR is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.

    Device Description

    The CORE-INJECTOR, the disposable endoscope injection needle is a disposable device for injecting medicine and medical supplies into a mucous membrane or blood vessel to stop the bleeding or for hardening the vessel during endoscopic procedure. The device consists of a stainless steel needle attached to sheath and handle where a syringe with solution for injection can be attached. It is available in various sizes and working lengths. The needle sizes are 23 gauge and the needle length is 4.0mm. The working length includes 1,200mm, 1,600mm, 1,800mm, 2,300mm. The operating time is less than 1 hour. it contacts with mucosa of the human digestive tract. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10°). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

    AI/ML Overview

    The provided document describes the non-clinical performance testing for the CORE-INJECTOR device to demonstrate its substantial equivalence to a predicate device. It does not contain information about a comparative effectiveness study (MRMC) or a standalone (algorithm-only) study for a medical imaging AI device. The device in question is an endoscope injection needle, not an AI or imaging device. Therefore, many of the requested fields are not applicable.

    Here's the information that can be extracted from the document:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Sterility10⁻⁶ SAL (Sterility Assurance Level) following ISO 11135; meets requirements of ISO 10993-7 (ethylene oxide sterilization residuals). No microbial growth.Achieved 10⁻⁶ SAL; met ISO 10993-7 requirements. No evidence of microbial growth.
    BiocompatibilityPassed tests for Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity, Pyrogen test (in accordance with ISO 10993-1:2018 for tissue contact
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