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510(k) Data Aggregation

    K Number
    K231558
    Device Name
    SMB Luer lock disposable syringe
    Manufacturer
    SMB Corporation of India
    Date Cleared
    2024-01-12

    (227 days)

    Product Code
    FMF,FMI
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K102584,K202432
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SMB Hypodermic Syringe is used to inject fluid into or withdraw fluid from the body. This device is for single use only.

    Device Description

    The SMB Luer lock disposable syringe is a standard Piston Syringe. It is a two-piece Syringe with male 6% luer lock connection. The Syringe is supplied with Hypodermic Needle having a female 6% luer hub. The Syringe and Needle are supplied sterilized by ETO gas. The device is single use device and non-pyrogenic. The device is available with 2ml Syringe and 23G Needle. A detailed description of Syringe and Needle is as follows: Syringe: The Syringe consists of hollow barrel with graduated scale and movable plunger. The barrel has a nozzle with a male luer lock connector that facilitates the connection with female luer lock hub of needle. The graduated scale on the barrel is indicated in the milliliters. The movable plunger is pulled to aspirate and pushed to inject the fluids into barrel. Needle: The Needle consists of Needle tube, Needle cap. The Needle tube is attached to the Needle hub and the Needle hub is attached to the syringe by luer lock system. A cap is provided to protect Needle sharps protection as well as prevention of injury.

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter and associated documentation for a medical device: "SMB Luer lock disposable syringe." This document focuses on demonstrating substantial equivalence to a predicate device, not on proving that a new AI/software-based device meets specific performance criteria through a study with acceptance criteria.

    Therefore, the requested information regarding acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth, training set), and effect sizes for an AI/software device cannot be extracted from this document, as it describes a physical medical device (syringe and needle) and its regulatory clearance based on comparison to existing, already cleared devices.

    In summary, this document does not contain the information required to answer your prompt because it is not about an AI/software medical device or a study proving its performance against acceptance criteria.

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