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510(k) Data Aggregation

    K Number
    K193482
    Device Name
    PrisMax System Version 3
    Manufacturer
    Baxter Healthcare Corporation
    Date Cleared
    2020-03-13

    (87 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K190910
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PrisMax control unit is intended for:
    · Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
    • Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
    All treatments administered via the PrisMax control unit must be prescribed by a physician.

    Device Description

    The PrisMax System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. 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. PrisMax System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous VenoVenous Hemodialysis (CVVHD), and Continuous Venovenous Hemodialfiltration (CVVHDF). The proposed device PrisMax System Version 3 uses the current marketed device PrisMax System Version 2 as the predicate.

    AI/ML Overview

    This document is a 510(k) Pre-market Notification for a medical device, the PrisMax System Version 3. The document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (PrisMax System Version 2), and therefore does not require a new premarket approval application (PMA).

    Here's an analysis of the provided information regarding acceptance criteria and the supporting study, organized by your requested points:

    Acceptance Criteria and Device Performance

    The acceptance criteria are implicitly defined by the technical specifications outlined in the "Substantial Equivalence Summary" tables (Table 3), comparing the PrisMax System Version 3 to the predicate PrisMax System Version 2. The reported device performance is stated as meeting these specifications, thereby achieving "substantial equivalence" to the predicate.

    Table 1: Acceptance Criteria and Reported Device Performance

    FeatureAcceptance Criteria (Predicate PrisMax Version 2)Reported Device Performance (PrisMax Version 3)
    Indications for UseContinuous Renal Replacement Therapy (CRRT) for patients ≥ 20 kg with acute renal failure/fluid overload; Therapeutic Plasma Exchange (TPE) for patients ≥ 20 kg where plasma component removal is indicated. All treatments by physician prescription.Identical to predicate.
    Dedicated Disposable Sets AvailableFor CRRT: M60/M100/M150, HF1000 & HF1400; For TPE: TPE 2000 Set.Identical to predicate.
    Syringe Sizes20 & 50 mlIdentical to predicate.
    AnticoagulationUser-controllable (continuous or bolus)Identical to predicate.
    Dialysate Flow Rate (CVVH & CVVHDF)Range: 0 to 8000 ml/hr, Increment: 10 ml/hrIdentical to predicate.
    Dialysate Flow Rate Accuracy± 30 ml/hrIdentical to predicate.
    Replacement solution / Fluid Flow Rate (CVVH & CVVHDF)Range: 0 to 8000 ml/hr, Increment: 10 ml/hrIdentical to predicate.
    Replacement solution / Fluid Flow Rate (TPE)Range: 0 to 5000 ml/hr, Increment: 10 ml/hrIdentical to predicate.
    Replacement Flow Rate Accuracy± 30 ml/hrIdentical to predicate.
    Blood Flow RateRange: 10-450 ml/minIdentical to predicate.
    Blood Flow Rate Accuracy± 10 % of user set rate at nominal blood flow of 450 ml/min or highest achievable disposable blood flow, 37°C, access pressure -200 mmHg, without PBP flow.Identical to predicate.
    Pre-Blood Pump Flow Rate (SCUF)Range: 0 to 2000 ml/hrIdentical to predicate.
    Pre-Blood Pump Flow Rate (CVVH, CVVHD, CVVHDF)Range: 0 to 4000 ml/hrIdentical to predicate.
    Pre-Blood Pump Flow Rate (TPE)Range: 0 to 1000 ml/hr (Note: PBP Volume 2000 ml/treatment for TPE2000)Identical to predicate.
    Pre-Blood Pump Accuracy± 30 ml/hrIdentical to predicate.
    Effluent Pump Flow RateRange: 0 to 10,000 ml/h (depending on therapy)Identical to predicate.
    ECG DischargerYESIdentical to predicate.
    TherapiesSCUF, CVVH, CVVHD, CVVHDF, TPEIdentical to predicate.
    PumpsPBP solution, Replacement solution, Dialysate solution, Effluent, Blood.Identical to predicate.
    ScalesDialysate, Replacement, Effluent, Pre Blood Pump (PBP)Identical to predicate.
    Trans Membrane Pressure (TMP) Alarms (CRRT)Default: +300 mmHgIdentical to predicate.
    TMPa (TPE)User settable; +50 to +100 mmHg; Default: +100 mmHgIdentical to predicate.
    Dialysate Conductivity and Temperature ControlNot controlled by PrisMaxIdentical to predicate.
    Patient Fluid Removal (CRRT) Range0 to 2000 ml/hr, Increment: 5 ml/hrIdentical to predicate.
    Patient Fluid Removal (TPE) Range0 to 1000 ml/hr, Increment: 5 ml/hrIdentical to predicate.
    Patient Fluid Removal Performance (Accuracy)± 30 ml/hr; ± 70 ml/3hr; ± 300 ml/24hr. Scales calibrated at ambient temperature, change
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