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510(k) Data Aggregation

    K Number
    K221085
    Device Name
    LiNA OperaScope Needle
    Manufacturer
    LiNA Medical ApS
    Date Cleared
    2022-09-02

    (142 days)

    Product Code
    FBK,HIH
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K022484
    Why did this record match?
    Device Name :

    LiNA OperaScope Needle

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

    LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as well as for cystoscopic injection in the urinary bladder wall.

    Device Description

    LiNA OperaScope™ Needle is delivered as a sterile, single-use device designed to be used specifically with the LiNA OperaScope for hysteroscopic and cystoscopic injections. The device consists of a handle, a shaft and an injection needle, which is pointed at the distal end and has a luer-lock connection at the proximal end. Devices are packed in Tyvek pouches, with 6 units packed in a box.

    AI/ML Overview

    The provided text does not describe an AI/ML device, therefore, the requested information focusing on acceptance criteria and studies for such devices, including details like test set provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set specifics, is not applicable.

    The document discusses the substantial equivalence of a medical device, the LiNA OperaScope™ Needle, to a predicate device (Cook Injection Needles). The acceptance criteria and supporting studies are related to the physical performance, biocompatibility, and shelf-life of this non-AI medical instrument.

    Here's the relevant information based on the provided text, adapted to the context of a physical medical device:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Functional Bench Testing)Reported Device Performance
    Insertion in Tissue.
    For sterilization and shelf-life, the ground truth is established by validated scientific methods confirming sterility and stability over time.

    8. The sample size for the training set

    Not applicable, as this is a non-AI/ML device. There is no concept of a "training set" for a physical medical instrument.

    9. How the ground truth for the training set was established

    Not applicable, as this is a non-AI/ML device.

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