LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980417
    Device Name
    MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V
    Manufacturer
    MEDRAD, INC.
    Date Cleared
    1998-05-04

    (90 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K935668,K810624,K790062,K942391,K800823,K943189
    Why did this record match?
    Reference Devices :

    K935668, K810624, K790062, K942391, K800823

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

    The Medrad Disposable MRI Kit with Check Valve is indicated for use in an MRI environment. The components of the kit are used to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates.

    Device Description

    The Medrad Disposable MRI Kit with Check valve is substantially equivalent to the current Medrad Qwik-Fit MRI Disposables Kit (K943189). The Medrad Disposable MRI Kit with Check valve has the same intended use as the predicate device - to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates in an MR application. The kit may consist of one or all of the following:

    • 2- 65 ml syringes (K935668)
    • 96" Low Pressure Connector Tube/T-connector assembly (K943189) .
    • . Fluid Delivery Device (Spike) - (K810624)
    • Normally closed check-valve B. Braun/Burron (K790062) ●
    • Female/Female Luer Adapter B.Braun/Burron (K942391) .
      The only difference between this kit and the predicate device is that this kit contains a normally closed check valve and a female/female luer Adapter. Device Verification and Validation Testing has been performed.
      The normally closed check-valve is a attached to the 96" LLPCT at the Tconnector (K943189) and is used to restrict flow in one of two directions. The device is normally closed requiring a minimum amount of force to open. The check-valve attaches to the 'A' syringe and remains closed during saline flush from the 'B' syringe to prevent contrast trickle during this process.
      The Female/Female Luer Adapter is a disposable device used to provide a fluid path between two vessels with male luer terminations. This device can be compared to the Medrad Ouick Fill Tube (K800823) which is also a filling device.
      All other components of the kit are identical to those in K943189.
      The devices are sterilized using Ethylene Oxide gas. Validation is performed according to AAMI guidelines.
    AI/ML Overview

    Here's an analysis of the provided text regarding the Medrad Disposable MRI Kit with Check Valve, focusing on acceptance criteria and the supporting study information:

    It's important to note that this document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, the level of detail regarding comprehensive studies and acceptance criteria is different from what might be found in a full efficacy study report for a new drug or high-risk medical device. The focus here is on demonstrating that the new device does not raise new issues of safety or effectiveness compared to its predicate.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided 510(k) summary does not explicitly present acceptance criteria in a quantitative, pass/fail table format, nor does it detail a standalone study proving the device meets specific performance metrics with numerical results for each criterion regarding its primary function (fluid delivery). Instead, it demonstrates substantial equivalence by comparing features and performing validation tests related to manufacturing and safety attributes.

    However, we can infer some "acceptance criteria" based on the validation tests performed and the comparison to the predicate devices. The "reported device performance" is primarily stated as compliance with established standards and equivalence to the predicate.

    Acceptance Criterion (Inferred from Validation/Comparison)Reported Device Performance
    Sterility (Microbial Challenge-Overkill Method)Achieves a Sterility Assurance Level (SAL) of $10^{-6}$ using biological indicators of Bacillus Subtilis var. niger ($1 \times 10^6$ spores per indicator).
    Residual Ethylene Oxide (EtO) LevelsBiological Reactivity Test (Invitro and Invivo) for Cytotoxicity, Sensitization, Systemic Tox, Intracutaneous Tox, Pyrogen Mat'l Mediated, Hemolysis, Particulate analysis, Bacterio-/Fungistasis, Physicochemical analysis (aqueous/non-aqueous), and Infrared analysis.
    Packaging Compatibility with SterilizationThe polystyrene tray and Tyvek lid are heat-sealed and compatible with an EtO Sterilization Cycle.
    Shelf LifeConfirmed at least a two-year shelf life from the date of sterilization using an accelerated aging sequence (1 week at 130°F/70-80% RH, 1 day at -4°F, 1 week at 130°F/), and luer fitting compliance (ANSI 70.1). These external, validated standards serve as the "ground truth" for compliance.
    • Predicate Device Characteristics: The existing Medrad Qwik-Fit MRI Disposables Kit (K943189) and its components serve as a ground truth for substantial equivalence, specifically for features that are identical or closely matched.
    • Functional Specifications: The intended behavior of the check-valve (restricting flow, preventing trickle) and the luer adapter (fluid transfer) define the functional "ground truth" against which device performance is validated internally.

    8. The Sample Size for the Training Set

    This is not applicable. A "training set" refers to data used to train a machine learning algorithm. This device is not an AI/ML product.

    9. How the Ground Truth for the Training Set Was Established

    This is not applicable for the same reason as point 8.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1