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510(k) Data Aggregation

    K Number
    K242073
    Device Name
    STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
    Manufacturer
    TSK Laboratory International Japan KK
    Date Cleared
    2024-10-23

    (99 days)

    Product Code
    QYM
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K231734,K230951
    Why did this record match?
    Device Name :

    STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

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

    The device is intended to inject into or aspirate from, the body. The device is intended for intravitreal use.

    Device Description

    The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a luer lock or luer slip piston syringe. The device can be used by health care professionals. The hub of the needle can be a standard size or a reduced size (low dead space) that is designed to reduce medication waste. The device is operated manually by attaching it to a piston syringe. Target injection sites include subcutaneous, intramuscular, intradermal, and intravitreal.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device (STERiJECT Ophthalmic Needle) and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria for an AI/software-based medical device.

    Therefore, the information required to answer your specific questions about acceptance criteria and a study proving device performance (including sample sizes, expert involvement, ground truth, MRMC studies, etc.) for an AI/software device is not present in the provided text.

    The document primarily discusses:

    • The device's physical characteristics (needle dimensions, materials, connector types).
    • Its intended use (injection/aspiration, specifically intravitreal).
    • Comparison to a predicate device regarding technological characteristics (e.g., gauge, length, materials, sterilization method).
    • Non-clinical testing for safety and effectiveness, conforming to recognized standards (ISO standards for sterility, biocompatibility, needle tubing, etc.). This testing is standard for physical medical devices to demonstrate functional performance and safety, not AI/software performance.

    In summary, this document does not contain the type of study data or acceptance criteria relevant to an AI/software medical device as implied by your detailed questions. The acceptance criteria discussed are for the physical properties and safety of a hypodermic needle.

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