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510(k) Data Aggregation

    K Number
    K182146

    Validate with FDA (Live)

    Device Name
    Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
    Manufacturer
    Sol-Millennium Medical, Inc.
    Date Cleared
    2018-12-03

    (117 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K172763
    Predicate For
    K201009
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sol-M Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood.

    The Sol-Care Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

    The Sol-Care Safety Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

    The Sol-M Blood Collecting Set is intended to be used with vacuum blood collection tube for the collection of venous blood.

    Device Description

    The proposed devices are blood collection devices form a channel between patient's vein and the vacuum blood collection tube intended for collection of blood. The proposed devices are divided into several types, the configuration for each type of proposed device are provided as follows: Blood Collection Needle – one piece, Blood Collection Needle – Direct, Blood Collection Needle – Multi piece, Safety Blood Collection Needle – Direct, Safety Blood Collection Needle – Multi piece, Safety Blood Collection Needle w/Holder – One piece, Safety Blood Collection Needle w/Holder - Direct. In addition, the proposed devices are divided into several types and available in different specifications.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from Sol-Millennium Medical, Inc. for blood collection needles and sets. It demonstrates substantial equivalence to a predicate device and outlines the non-clinical tests performed. No acceptance criteria, device performance, or study results are provided in the document.

    Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence through comparison of features and adherence to recognized standards, rather than presenting a performance study with acceptance criteria.

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