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    K Number
    K212522
    Device Name
    Lilliput APD System
    Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC
    Date Cleared
    2022-04-15

    (247 days)

    Product Code
    FKX
    Regulation Number
    876.5630
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K141145,K181108
    Why did this record match?
    Device Name :

    Lilliput APD System

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

    The Lilliput™ APD System is indicated for adult chronic peritoneal dialysis in home and clinical settings.

    Device Description

    The Lilliput APD System is available in one (1) configuration that includes an electromechanical cycler (hereinafter referred to as "Cycler"), disposable set (hereinafter referred to as "Disposable Set''), USB key, and Kinexus Gateway. The Disposable Sets are available in three (3) configurations:

    • . Lilliput Disposable Set, One Patient Connector (Low feature)
    • Lilliput Disposable Set, One Patient Connector with Extended Drain and Patient Lines (Medium Feature)
    • . Lilliput Disposable Set, Two Patient Connectors with Extended Drain and Patient Lines (High Feature)

    The Cycler is a software-controlled electromechanical device. The Disposable Sets are single-use Class II devices designed to operate with the Cycler to perform Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Disposable Sets are provided sterile and non-pyrogenic and are sterilized using ethylene oxide (EO).

    AI/ML Overview

    The provided text describes the acceptance criteria and performance data for the Lilliput™ APD System, but it does not detail a study proving the device meets acceptance criteria in the context of diagnostic performance involving human readers or ground truth established by experts/pathology. Instead, the document focuses on engineering and safety performance criteria typical for a medical device.

    Therefore, many of the requested fields cannot be filled as the information is not present in the provided text, particularly for AI/diagnostic performance studies.

    Here's a breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document lists "Essential Performance Specifications/Characteristic" in Table 4 and also describes various performance tests. The reported device performance is generally stated as "verified," "determined," or "acceptable results obtained," without specific numerical outcomes in all cases.

    FeatureSpecification (Acceptance Criteria)Reported Device Performance
    Dialyzing solution flow rate during inflow150-300 mL/minSystem essential performance was verified.
    Dialyzing solution flow rate during outflow100-250 mL/minSystem essential performance was verified.
    Dialyzing solution volume balancing (inflow volume) (FILL)Larger of (at 2X standard deviation): $\leq$ 15 mL or ± 5%System essential performance was verified.
    Dialyzing solution volume balancing (outflow volume) (DRAIN)Larger of (at 2X standard deviation): $\leq$ 15 mL or ± 5%System essential performance was verified.
    Volume Balancing (Symmetric Volume Accuracy)Larger of (at 2X standard deviation): $\leq$ 12 mL or ± 2%System essential performance was verified.
    PD dwell timeDependent on prescription. Dwell time accuracy ± 1 minute for the calculated dwell timeSystem essential performance was verified.
    Dialyzing solution temperature37°C ± 2°CSystem essential performance was verified.
    EO Residuals (Disposable Sets)
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