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510(k) Data Aggregation

    K Number
    K072093
    Device Name
    PRISMAFLEX SYSTEM, VERSION 3.20
    Manufacturer
    GAMBRO
    Date Cleared
    2008-02-01

    (186 days)

    Product Code
    KDI,78K
    Regulation Number
    876.5860
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRISMAFLEX SYSTEM, VERSION 3.20

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

    The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician.

    Device Description

    The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician. The goals of acute renal failure treatments are removal of waste products, restoration of acid-base balance; correction of electrolyte imbalances (e.g., hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. Prismaflex® System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD), and Continuous Veno-venous Hemodialfiltration (CVVHDF).

    AI/ML Overview

    The provided text is a 510(k) summary for the Prismaflex® System 3.20. It details the device's intended use, comparison to a predicate device, and non-clinical testing. However, it does not include the specific information requested about acceptance criteria for device performance studies, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, or any information regarding multi-reader multi-case studies or standalone algorithm performance.

    The document states that the non-clinical testing for the Prismaflex® System 3.20 demonstrated its safety and effectiveness and that it "performs as well as or better than the legally marketed predicate device." This implies that the acceptance criteria for the new device were alignment with or improvement upon the performance of the predicate device (Prismaflex™ System 1.04).

    Below is a summary of the available information and an explicit statement of what is missing based on your request:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document implicitly uses the performance of the predicate device as the acceptance criteria for the modified device. The table below compares the specifications of the modified device to the predicate device. For some parameters, the modified device's performance aligns with the predicate, while for others (like Dialysate Flow Rate Accuracy, Replacement Flow Rate Accuracy, Pre-Blood Pump Accuracy, and Patient Fluid Removal Performance Range Accuracy), the modified device states a specific accuracy, which could be considered its performance target (acceptance criteria) and reported performance.

    ParameterPredicate Device (Prismaflex™ System 1.04) Acceptance Criteria (Implied)Modified Device (Prismaflex® System 3.20) Reported Performance
    Indications for UseFor continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.For Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. Prescribed by a physician.
    Dedicated Disposable Sets Available in U.S.M60/M100, HF1000 & HF1400M60/M100, HF1000 & HF1400
    Syringe Sizes10, 20 & 30 ml10, 20, 30 & 50 ml
    AnticoagulationUser-controllable as continuous or bolusUser-controllable as continuous or bolus
    Dialysate Flow Rate (CVVHD & CVVHDF)0 to 8000 ml/hr (CVVHD), 0 to 4000 ml/hr (CVVHDF); Increment: 50 ml/hr0 to 8000 ml/hr; Increment: 50 ml/hr
    Dialysate Flow Rate Accuracy±10% of user-set rate± 30 ml/hr
    Replacement Flow Rate (CVVH & CVVHDF)0 to 8000 ml/hr (CVVH), 0 to 4000 ml/hr (CVVHDF); Increment: 50 ml/hr0 to 8000 ml/hr; Increment: 50 ml/hr
    Replacement Flow Rate Accuracy±10% of user-set rate± 30 ml/hr
    Blood Flow Rate10-450 ml/min. (depends on therapy/set combination)10-450 ml/min. (depends on therapy/set combination)
    Blood Flow Rate Accuracy±10% of user set point (maintained under specific pressure conditions)±10% of user set point (maintained under specific pressure conditions)
    Pre-Blood Pump Flow Rate (SCUF)0 to 1,000 ml/hr0 to 1,000 ml/hr
    Pre-Blood Pump Flow Rate (CVVH, CVVHD, CVVHDF)0 to 8,000 ml/hr0 to 8,000 ml/hr
    Pre-Blood Pump Accuracy±10% of user-set rate± 30 ml/hr
    Effluent Pump Flow Rate0 to 10,000 ml/hr (depending on therapy)0 to 10,000 ml/hr (depending on therapy)
    ECG DischargerYESYES
    TherapiesSCUF, CVVH, CVVHD, CVVHDFSCUF, CVVH, CVVHD, CVVHDF
    PumpsBlood access line, Dialysate inlet line, Effluent outlet line, Replacement solution line, Pre blood pump lineBlood access line, Dialysate inlet line, Effluent outlet line, Replacement solution line, Pre blood pump line
    ScalesDialysate, Replacement, Effluent, Pre blood pumpDialysate, Replacement, Effluent, Pre blood pump
    Transmembrane PressureUser settable: +70 to +300 mmHg; Default: +300 mmHgUser settable: +70 to +300 mmHg; Default: +300 mmHg
    Dialysate Conductivity and TemperatureNot controlled by PrismaflexNot controlled by Prismaflex
    Patient Fluid Removal Performance Range0 to 2,000 ml/hr; Increment: 10 ml/hr0 to 2,000 ml/hr; Increment: 10 ml/hr
    Patient Fluid Removal Performance Range Accuracy± 30 ml/hr, ± 600 ml/24hr (Scales calibrated at ambient temperature, change
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