LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K984441
    Device Name
    KVO CHECK VALVE ACCESSORY, MODEL EV-0001
    Manufacturer
    I-FLOW CORP.
    Date Cleared
    1999-02-22

    (70 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K932740
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KVO Accessory is intended to allow fluid flow in one direction and stop, or check, fluid flow in the opposite direction. The KVO Accessory is intended to be used with the I-Flow One•Step KVO infusion pump.

    Device Description

    The KVO Accessory is simply the Supravalve Check Valve Assembly manufactured by Vernay Laboratories, Inc. The KVO Accessory housing consists of polycarbonate with a standard female luer lock connector on the inlet port and male luer connector with a locking rotating collar on the outlet port. The check valve consists of a one-piece, elastomeric duckbill which allows free flow with positive differential pressure. With negative differential pressure, backflow is checked.

    AI/ML Overview

    The KVO Check Valve Accessory is designed to allow fluid flow in one direction and prevent backflow. The following information summarizes its acceptance criteria and the studies performed to demonstrate compliance.

    1. Acceptance Criteria and Reported Device Performance

    CriteriaAcceptance LimitReported Performance
    Priming/Residual Volume<= 0.5 mlNot explicitly stated in the provided text, but implied to meet the specification.
    Test Solution0.9% NaCl0.9% NaCl
    Cracking Pressure>= 0.1 psiNot explicitly stated as a value, but described as "low cracking pressure to allow use of standard IV gravity drug bags" and that the "check valve performed within specification."
    Backpressure Withstand<= 10 psi"No leaks were observed" at 10 psi. "No backflow incidents observed" at 8 inches H2O.
    Sterilization Assurance Level (SAL)10^-6"Sterilization assurance level (SAL) of 10^-6"
    Packaging Sterility MaintenanceNot specified"maintain sterility in excess of three years"
    Residual Levels (ETO Sterilization)Ethylene Oxide: 25 ppm, Ethylene Chlorohydrin: 25 ppm, Ethylene Glycol: 250 ppm"consistent with the FDA proposed rule" (implied to meet these levels)

    2. Sample Sizes and Data Provenance for Test Set

    • Back Testing (high pressure): 20 samples of the check valve.
    • Back Testing (low pressure): 30 samples of the check valve.
    • Package Aging Tests: Not specified, but stated "results of bacterial dust challenge testing has determined that the pouches used to package the disposable KVO Accessory maintain sterility in excess of three years."
    • Data Provenance: The document does not specify the country of origin. The studies appear to be prospective, conducted specifically for this submission.

    3. Number and Qualifications of Experts for Ground Truth (Test Set)

    • This device is a physical medical accessory (check valve), not a diagnostic or AI-driven device. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not applicable.
    • Performance validation relies on physical and biological testing against established engineering and regulatory standards rather than expert consensus on interpretive data.

    4. Adjudication Method for the Test Set

    • Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments by multiple human readers (e.g., in medical image analysis). Since this involves objective physical testing of a medical device, such adjudication methods are not relevant.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to this physical device.

    6. Standalone (Algorithm Only) Performance

    • No, a standalone (algorithm only) performance study was not done. This device is a physical component, not an algorithm.

    7. Type of Ground Truth Used

    • The ground truth used for the device's performance evaluation is based on objective physical and biological testing against predefined technical specifications and regulatory standards. This includes:
      • Measurement of physical properties (e.g., priming volume, cracking pressure, backpressure withstand).
      • Biological testing for biocompatibility (ISO 10993 Part 1) and sterility (ANSI/AAMI ST32-1991 / EN552 Method 1, ANSI/AAMI/ISO 11135-1994 / EN550).
      • Chemical testing for residual levels after sterilization.
      • Package testing to ensure sterility maintenance.

    8. Sample Size for the Training Set

    • This information is not applicable. The KVO Check Valve Accessory is a physical device, and the concept of a "training set" is typically associated with machine learning or AI algorithms, which are not involved here.

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

    • This information is not applicable, as there is no training set for this type of device.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1