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510(k) Data Aggregation

    K Number
    K220258
    Device Name
    20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
    Manufacturer
    AVIA Vascular
    Date Cleared
    2022-07-14

    (164 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K190604
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ally device is attached to a PIV catheter system for blood sampling into a vacuum tube or syringe.

    Device Description

    The Ally device by Avia Vascular is intended to be attached to a peripheral intravenous (PIV) catheter system for use as a needleless blood draw device into a vacuum tube or syringe. Once attached to a PIV catheter system, the Ally device functions by extending a conduit tube through the internal lumen of the PIV catheter so that the distal tip of the Ally conduit extends beyond the tip of the PIV catheter, allowing for sampling of blood. The Ally device is a sterile, single use device.

    AI/ML Overview

    This document is a 510(k) summary for the Ally Blood Collection Device, a blood specimen collection device. It outlines the device's technical characteristics, its comparison to a predicate device, and the performance testing conducted to demonstrate its safety and effectiveness.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document lists performance tests conducted, but it does not specify quantitative acceptance criteria or detailed numerical results for each test. Instead, it broadly states that "The subject Ally device met all predetermined acceptance criteria." The table below summarizes the listed performance tests:

    Acceptance Criteria (Implied)Reported Device Performance
    Physical/Mechanical Performance
    Flow Conduit Inner DiameterMet predetermined criteria
    Flow Conduit Outer DiameterMet predetermined criteria
    Flow Conduit Effective Length and Flow Conduit Exposure LengthMet predetermined criteria
    Open-System Introducer LengthMet predetermined criteria
    Extension Tubing Inner DiameterMet predetermined criteria
    Flow Conduit-to-Extension Tubing Assembly TensileMet predetermined criteria
    Extension Leg-to-Stop Ring Assembly TensileMet predetermined criteria
    Extension Tubing-to-Proximal Luer Assembly TensileMet predetermined criteria
    Guide Cannula-to-Introducer Assembly TensileMet predetermined criteria
    Introducer to Housing RetentionMet predetermined criteria
    Sheathing Cannula Tensile TestingMet predetermined criteria
    Kink DiameterMet predetermined criteria
    Aspiration Flow RateMet predetermined criteria
    Leak DecayMet predetermined criteria
    Housing Seal Leak Decay TestingMet predetermined criteria
    Particulate testing per USPMet predetermined criteria
    **Biocompatibility (per ISO 10993-1 for external communicating device, limited (
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