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    K Number
    K021615
    Device Name
    BAXTER ACCURA SYSTEM, MODEL 5M5660
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    2002-11-18

    (186 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K993064,K981681,K946279,K973322
    Why did this record match?
    Reference Devices :

    K993064, K981681, K946279, K973322, K911315/A

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

    The Baxter Accura System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Baxter Accura System may also be used in Therapeutic Plasma Exchange (TPE) therapies.

    Device Description

    The Accura System hardware consists of blood pumps, scales and various monitoring detectors and alarms designed for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange Therapy. This device was developed to provide pump assisted Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD) and Continuous Veno-Venous Hemodiafiltration (CVVHDF); four modalities used for treating acute renal failure and/or fluid overload. Additionally, the Accura System was developed to provide the pump assisted Therapeutic Plasma Exchange (TPE) therapy.

    AI/ML Overview

    The Baxter Accura System is a medical device for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE) therapies. The provided summary states "All functions of the Baxter Accura System were tested and validated according to design specifications. Based on the validation results, all functions meet their respective required specifications." However, specific numerical acceptance criteria and reported device performance metrics are not detailed in the provided document.

    Therefore, the table below will reflect the general statement of compliance rather than explicit numbers.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Device functions meet design specificationsAll functions meet their respective required specifications
    Components of disposable tubing set meet biological requirementsMet ISO 10993-1: Biological Evaluation of Medical devices – Part: Guidance on selection of tests
    Sterilization cycle validatedBased upon ANSI/AAMI/ISO 11135:1994 "Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization"
    Compliance with applicable IEC 60601 standardsMeets IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-2-16

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

    The document does not explicitly state the "sample size used for the test set" in terms of patient data or the number of units tested.
    The validation was conducted on the "functions of the Baxter Accura System" and "components of the disposable tubing set," implying laboratory or engineering testing rather than human subject data.

    Data Provenance: Not applicable as no clinical (human subject) data was used for performance validation. The validation appears to be entirely technical/engineering in nature.

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

    Not applicable. The validation was based on engineering design specifications, biological requirements (ISO 10993-1), and sterilization standards (ANSI/AAMI/ISO 11135), and safety standards (IEC 60601), not on expert consensus regarding clinical ground truth.

    4. Adjudication Method for the Test Set

    Not applicable. There is no mention of an adjudication process as the validation was against predefined technical specifications and standards.

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

    No. The document explicitly states "Clinical Data: N/A". This device validation did not involve human readers or a comparative effectiveness study with or without AI assistance.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    Not applicable. This device is a medical system for physical therapies (CRRT, TPE) and does not involve an algorithm with standalone performance metrics in the way an AI-driven diagnostic tool would. Its performance is related to its mechanical and electrical functions and compliance with safety standards.

    7. Type of Ground Truth Used

    The "ground truth" for this device's validation were:

    • Design Specifications: All functions were tested and validated against their specific design requirements.
    • International Standards:
      • Biological requirements per ISO 10993-1.
      • Sterilization cycle validation per ANSI/AAMI/ISO 11135:1994.
      • Electrical safety and general standards per IEC 60601 series.

    8. Sample Size for the Training Set

    Not applicable. This product is a physical medical device (hardware and disposable tubing set) and its validation did not involve a "training set" in the context of machine learning or AI algorithms. The testing was for compliance with engineering specifications and regulatory standards.

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

    Not applicable, as there was no training set in the context of machine learning or AI. The "ground truth" for the device's development and validation was established through engineering design, international standards, and regulatory requirements.

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