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    K Number
    K123729
    Device Name
    VERSARATE FLOW RATE CONTROLER
    Manufacturer
    EMED TECHNOLOGIES CORPORATION
    Date Cleared
    2012-12-21

    (16 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K890489
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.

    Device Description

    The EMED VersaRate™ Flow Rate Controller is a disposable device allowing users to adjust the flow rate of fluids. The EMED VersaRate™ Flow Rate Controller can be connected to commercially available administration sets and fluid sources utilizing standard luer lock connectors.

    AI/ML Overview

    The EMED VersaRate™ Flow Rate Controller (K123729) is intended for use in the intravascular infusion of fluids delivered to the patient in a precise manner for no longer than 72 hours.
    The device's performance was evaluated against internal product specifications and requirements, as well as by comparison to a predicate device, the Baxter Extension Set w/Flow Regulator (K890489).

    Here's a breakdown of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / Performance CharacteristicVersaRate™ Flow Rate Controller Reported PerformancePredicate Device (Baxter Extension Set w/Flow Regulator) Performance
    Flow Rate Control Range5 – 230 mL/hr at 80 cm head height5 – 250 mL/hr
    Residual Volume of Set< 0.25 ml2.9 mL
    Duration of UsePerformance remains within tolerance up to 72 hrs.Performance remains within tolerance up to 24 hrs.
    PressureUp to 25 psiUp to 3 psi

    In addition, the following biocompatibility tests were performed with "Pass" results, indicating compliance with the respective standards:

    • Biocompatibility (ISO 10993-5): Cytotoxicity (Neutral Red Uptake) - Pass
    • Biocompatibility (ISO 10993-10): Sensitization (Kligman Maximization) - Pass
    • Biocompatibility (ISO 10993-10): Irritation (Intracutaneous Injection) - Pass
    • Biocompatibility (ISO 10993-11): Acute systemic toxicity (Systemic Injection) - Pass
    • Biocompatibility (ISO 10993-11): Pyrogenicity (Rabbit Pyrogen) - Pass
    • Biocompatibility (ISO 10993-4): Hemocompatibility (Unactivated Partial Thromboplastin Time) - Pass
    • Biocompatibility (ASTM 756): Hemolysis (complete) - Pass

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not explicitly state the sample size for the test set for the performance characteristics. The results are presented as summary performance metrics (e.g., flow rate range, residual volume). The data provenance is not specified beyond "testing results performed to establish conformance of the VersaRate™ Flow Rate Controller to internal product specifications and requirements, as well as equivalence to the predicate device." It's indicated as laboratory testing, not human patient data, and is retrospective for the predicate comparison.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    Not applicable. The "ground truth" for the performance tests (flow rate, residual volume, duration of use, pressure) would be objective measurements obtained through laboratory testing, not human expert assessment. Biocompatibility tests are standardized protocols.

    4. Adjudication Method for the Test Set

    Not applicable. As described above, the performance and biocompatibility data are derived from objective measurements and standardized tests, not expert adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No. This is a medical device for fluid control, not an imaging or diagnostic device that would typically involve a multi-reader multi-case study with human readers and AI assistance. The study focuses on direct device performance and equivalence to a predicate.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Yes, in essence, the performance testing described is a "standalone" evaluation of the device's physical and functional capabilities, independent of human interaction beyond operating the test equipment. No AI algorithm is involved in this device.

    7. The Type of Ground Truth Used

    The ground truth used for these performance tests is based on objective physical measurements and standardized laboratory test results. For example:

    • Flow Rate Control Range: Measured flow rates at specified conditions.
    • Residual Volume: Measured volume.
    • Duration of Use: Time until performance deviates from tolerance.
    • Pressure: Measured pressure.
    • Biocompatibility: Results of standardized biological assays conforming to ISO and ASTM standards.

    8. The Sample Size for the Training Set

    Not applicable. This device is a mechanical flow controller, not an AI/ML-based device that requires a training set for an algorithm.

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

    Not applicable, as no training set for an algorithm was used.

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