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510(k) Data Aggregation

    K Number
    K233950
    Device Name
    pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
    Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC
    Date Cleared
    2024-05-10

    (148 days)

    Product Code
    KPO
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K233159
    Why did this record match?
    Device Name :

    pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070

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

    pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

    Device Description

    pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, sodium bicarbonate, and glucose. The pureFLOW dialysis are available in four (4) formulations which differ in potassium chloride concentration.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/human reader study or standalone AI performance.

    The document is a 510(k) summary for a medical device called "pureFLOW" solutions, which are dialysate solutions used in Continuous Renal Replacement Therapy (CRRT). The entire summary focuses on demonstrating substantial equivalence of the new pureFLOW solutions (manufactured in Mexico) to a predicate pureFLOW device (manufactured in Germany).

    The performance data section (1.8 Performance Data) does detail various tests conducted to support substantial equivalence. However, these are engineering and chemical tests related to the physical properties and stability of the product and its packaging, not diagnostic performance of an AI or human readers.

    Specifically, the "Performance Data" section discusses:

    • 5 L Bag Hanging: Stability of eyelets.
    • Shipping and Distribution: Integrity and robustness of packaging.
    • Injection Port: Integrity and penetration force of septum and injection port.
    • Temperature and Pressure Resistance: Performance of the bag under varying temperature and pressure.
    • Gas Barrier: Integrity of the bag as a CO2 barrier.
    • Biocompatibility Testing: Chemical characterization, cytotoxicity, sensitization, irritation, material mediated pyrogenicity, hemocompatibility, genotoxicity.
    • Human Factors Validation Testing: Found safe and effective for intended users, uses, and environments (no specific details on methodology or metrics provided in this summary).
    • Electrical Safety and Electromagnetic Compatibility (EMC): Not applicable.
    • Software Verification and Validation Testing: Not applicable.
    • Animal Studies: None performed.
    • Clinical Studies: None performed.

    Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving a device meets them in the context of AI performance, human reader performance, MRMC studies, or related ground truth establishment, as this information is not present in the provided document. The device in question is a medical solution, not a software device that would involve such studies.

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