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510(k) Data Aggregation

    K Number
    K250357
    Device Name
    RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
    Manufacturer
    DEKA Research & Development Corp.
    Date Cleared
    2025-03-11

    (32 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K991759,K162812,K042172,K192647,K241736
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (the RemunityPRO System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in patients, ages 17 and older.

    Device Description

    The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is a wearable infusion pump designed to deliver Remodulin® (treprostinil) subcutaneously for the treatment of pulmonary arterial hypertension (PAH). Remodulin® was FDA-approved under NDA 021272. The system consists of several components: a wearable pump assembly, a remote interface, and accessories (e.g., rechargeable batteries, battery charger, charging cable, power adapter). A commercially available subcutaneous infusion set is connected to the pump assembly via a standard luer connector for the delivery of Remodulin® from the system to the patient. The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is prescription use only. The pump assembly is composed of a durable pump and a disposable, single-use cassette with a userfilled drug reservoir. The pump infuses Remodulin® subcutaneously into the patient based on an individualized programmed rate. Each disposable cassette may be used for up to 72 hours after attachment to the pump. The subject system utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy. The subject device has updated branding and also modifies the predicate device to be used with an additional infusion set.

    AI/ML Overview

    The provided text describes a 510(k) summary for the RemunityPRO™ Pump for Remodulin® (treprostinil) Injection. This is a submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to establish acceptance criteria for an entirely new device or an AI algorithm. Therefore, many of the requested categories related to medical AI studies (like expert involvement, MRMC studies, or training sets) are not applicable.

    The core of this submission is to show that the minor changes to an existing device (the RemunityPRO™ Pump compared to the Remunity® 2.0 Pump) do not raise new questions of safety or effectiveness. The primary change highlighted is the addition of compatibility with an additional infusion set.

    Here's an attempt to fill in the requested information based on the provided text, noting where information is not applicable to this type of regulatory submission:

    Acceptance Criteria and Device Performance

    The provided document details a comparison between the subject device (RemunityPRO™ Pump) and its predicate (Remunity® 2.0 Pump). The "acceptance criteria" can be inferred from the performance characteristics of the predicate device, which the subject device is shown to match or be equivalent to.

    Acceptance Criteria (Based on Predicate Performance)Reported Device Performance (Subject Device)
    Device Classification: Class II Infusion Pump, 21 CFR 880.5725, Product Code: FRNNo change (Equivalent)
    Indications for Use: Continuous subcutaneous delivery of Remodulin (treprostinil) Injection for patients, ages 17 and older.No change (Equivalent)
    Prescription Use or OTC: PrescriptionNo change (Equivalent)
    Intended Patient Population: Age 17 years and olderNo change (Equivalent)
    Patient Environment: On-body wearable ambulatory pumpNo change (Equivalent)
    Delivery Method: Microprocessor controlled micro-dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracyNo change (Equivalent)
    Delivery type: Subcutaneous infusionNo change (Equivalent)
    Dimensions: 6 cm x 6 cm x 2 cm (2.4 in x 2.4 in x 0.4 in)No change (Equivalent)
    Weight: 50 g (1.76 oz.)No change (Equivalent)
    Basal Delivery Rate Range: 8 µL/hr – 225 µL/hr, with increments of 1 µL/hrNo change (Equivalent)
    Basal Accuracy: ±6%±6% (No change/Equivalent)
    Bolus Volume after Occlusion Release: < 8 µL at all rates< 8 µL at all rates (No change/Equivalent)
    Time to Occlusion Alarm: Maximum time to occlusion alarm: • ≥ 100 µL/hr: 12 minutes • < 100 µL/hr: 8 hoursMaximum time to occlusion alarm: • ≥ 100 µL/hr: 12 minutes • < 100 µL/hr: 8 hours (No change/Equivalent)
    Material Biocompatibility: Fluid contacting: Polycarbonate (PC), COP, Bromobutyl, SEBS, Polyurethane. Patient contacting: PC, Acrylic, Polyurethane, ABS, Aluminum.No change (Equivalent)
    Cassette Shelf Life: 2 years2 years (No change/Equivalent)
    Service Life: 3 years3 years (No change/Equivalent)
    Applicable Safety Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, ISO 11137-1, ISO 10993-1, ISO 14971, IEC 60601-4-2, ANSI C63.27, AIM 7351731No change (Equivalent)
    Power Source: Rechargeable Lithium Ion BatteryNo change (Equivalent)
    Pump Storage Conditions: Temperature: -25 °C to 70 °C (-13 °F to 158 °F), Non-condensing humidity: up to 90%, Pressure: 50 kPa to 106 kPaNo change (Equivalent)
    Operating Conditions: Temperature: 5 °C to 40 °C (41 °F to 104 °F), Non-condensing humidity: up to 90%, Pressure: 70 kPa to 106 kPaNo change (Equivalent)
    Remote Interface System User Feedback: Touchscreen Device, Visual, audible, vibratoryNo change (Equivalent)
    Battery Operating Time: 72 hours72 hours (No change/Equivalent)
    Infusion Set Compatibility: Medtronic Quick-set, Medtronic Silhouette, Smiths Medical Cleo 90 Infusion SetsEquivalent - The subject device adds compatibility with the Neria Guard Infusion Set. Performance testing with Neria Guard demonstrated equivalent performance to the predicate device with established methods and acceptance criteria.
    Cassette: Unity 2.0 Cassettes, 3 mL, user-filledNo change (Equivalent)
    Priming Method: Primed by Pump after Cassette attachment to the PumpNo change (Equivalent)

    Study Details

    1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

      • The document states: "Bench performance testing was conducted in order to qualify the additional infusion set for use with the subject device, and to establish substantial equivalence to the predicate device in terms of safety and effectiveness."
      • Specific sample sizes for these bench tests are not provided in the summary.
      • Data provenance is not specified, but it would typically be internal laboratory testing by DEKA Research & Development Corp.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

      • Not Applicable. This is a bench performance study for a physical medical device (infusion pump), not a study involving interpretation of medical data by experts to establish ground truth for an AI algorithm. The performance metrics are objective and measurable (e.g., flow rate accuracy, occlusion alarm time).

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

      • Not Applicable. As this is a bench performance study of a physical device, there is no "adjudication" in the sense of resolving discrepancies between human readers or AI outputs. The tests involve direct measurement against established physical standards.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • No. This is not an AI-assisted diagnostic or interpretative device; it's an infusion pump. Therefore, an MRMC study is not relevant.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Not Applicable. While the pump contains a microprocessor and control algorithms, the "standalone" context typically refers to the performance of an AI algorithm in isolation for diagnostic tasks. This device is a complete system with mechanical, electronic, and software components, and its performance is evaluated as a whole in bench testing.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

      • The "ground truth" for this type of device performance would be established physical and electrical measurement standards, regulatory standards (e.g., IEC 60601-2-24 for infusion pumps), and the known performance characteristics of the predicate device. These are objective engineering and regulatory requirements, not medical "ground truth" derived from patient data or expert consensus.

    7. The sample size for the training set:

      • Not Applicable. This device, while containing software, is not an AI/ML-driven device that undergoes a "training" phase in the context of machine learning. Its operation is based on programmed control logic and physical components.

    8. How the ground truth for the training set was established:

      • Not Applicable. As there is no AI/ML training set, this question is not relevant.
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