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510(k) Data Aggregation

    K Number
    K191659
    Device Name
    Instylla Delivery Kit
    Manufacturer
    Instylla, Inc.
    Date Cleared
    2019-10-10

    (111 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K012868,K140194
    Why did this record match?
    Reference Devices :

    K012868

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

    The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

    Device Description

    The Instylla Delivery Kit is comprised of two 1mL delivery syringes, a syringe holder, and a plunger clip (link).

    AI/ML Overview

    This document describes a 510(k) premarket notification for the "Instylla Delivery Kit," a piston syringe for administering medical solutions. The document does not contain any information about acceptance criteria or a study proving the device meets said criteria in the context of performance metrics like sensitivity, specificity, accuracy, or any AI/algorithm performance. The provided text details bench and functional testing for mechanical and material properties, rather than clinical performance or AI evaluation.

    Therefore, I cannot provide the requested information regarding acceptance criteria and performance data in the context of an AI device.

    However, I can extract information related to the device's non-AI performance testing, as detailed in the document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document lists performance testing that was conducted, but it does not explicitly state specific acceptance criteria values or detailed quantitative reported performance metrics. It generally states that these tests were performed "to verify specifications fundamental to the device" and that the syringes are "compliant against FDA recognized standards ISO 7886-1 and ISO 594-2."

    Performance TestAcceptance Criteria (Not explicitly stated with values in document, generally "meets specifications" or "compliant")Reported Device Performance
    Visual InspectionTo verify specifications fundamental to the devicePerformed
    Dimensional VerificationTo verify specifications fundamental to the devicePerformed
    Functional Testing:
    - Syringe Holder and Plunger Clip Connection ForceTo verify specifications fundamental to the devicePerformed
    - Syringe Holder and Plunger Clip Disconnection ForceTo verify specifications fundamental to the devicePerformed
    - Syringe CompatibilityTo verify specifications fundamental to the devicePerformed
    - Syringe Glide Force and Break ForceTo verify specifications fundamental to the devicePerformed
    - Fluids CompatibilityTo verify specifications fundamental to the devicePerformed
    - Delivery IntegrityTo verify specifications fundamental to the devicePerformed
    Particulate Matter TestingTo verify specifications fundamental to the devicePerformed
    Syringe ComplianceFDA recognized standards ISO 7886-1 and ISO 594-2Compliant
    Biocompatibility Testing:In accordance with ISO 10993-1 for indirect blood contact (≤24 hours)Successfully completed
    - CytotoxicityMeets ISO 10993-1 requirementsPerformed
    - SensitizationMeets ISO 10993-1 requirementsPerformed
    - Irritation or Intracutaneous toxicityMeets ISO 10993-1 requirementsPerformed
    - Acute Systemic ToxicityMeets ISO 10993-1 requirementsPerformed
    - Material-Mediated PyrogenicityMeets ISO 10993-1 requirementsPerformed
    - HemolysisMeets ISO 10993-1 requirementsPerformed
    SterilitySterility Assurance Level (SAL) of 10-6 (validated per ISO 11135)Achieved
    Endotoxin Level
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