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The Remunity Subcutaneous Infusion System (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin® (treprostinil) Injection for use in adults (greater than 22 years of age).

The Remunity Subcutaneous Delivery System for Remodulin® (Remunity System) is a wearable infusion pump designed to deliver Remodulin® for the treatment of pulmonary arterial hypertension (PAH). It is intended for continuous subcutaneous delivery of FDA-approved Remodulin® (treprostinil) (hereinafter referred to as 'Remodulin®' or 'Remodulin® (treprostinil)'), NDA 021272. The Remunity System consists of several components: a wearable pump assembly, a remote interface, a filling and priming aid, 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 Remunity System to the patient. The pump assembly is composed of a reusable pump and a disposable single-use cassette with a pharmacy-filled drug reservoir, which 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 Remunity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy. The pharmacy-filled cassette is intended to be stored (inclusive of shipping time) up to 14-days and is intended to be in use for up to 72-hours. The cassettes are identical to those cleared under K191313, with the exception that the luer lock cap material was changed from Polycarbonate to ABS. The device is prescription use only.

Here's an analysis of the acceptance criteria and study information for the Remunity Subcutaneous Delivery System for Remodulin, based on the provided document:

This document is a 510(k) Premarket Notification, which is generally used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials for a novel device. The primary change in this submission is a material change to a luer lock cap. Therefore, the "study" described is focused on validating this specific change against established standards and functions.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are largely derived from the predicate device (Unity Subcutaneous Delivery System for Remodulin K191313) and are confirmed to be the same for the subject device (Remunity Subcutaneous Delivery System for Remodulin). The primary focus of the reported performance is to confirm that the change in a material does not compromise these established criteria.

Study Proving Device Meets Acceptance Criteria

The study described is non-clinical performance testing focused on the specific change introduced: the material of the Luer Lock Cap.

1. Sample size used for the test set and the data provenance:

   • The document does not specify numerical sample sizes for the non-clinical tests (e.g., how many luer lock caps were tested for container closure or biocompatibility).
   • The data provenance is internal to DEKA Research & Development ("DEKA's design control process"). No specific country of origin for test data is mentioned, but DEKA is a U.S.-based company. The retrospective/prospective nature of the tests is not explicitly stated. These are typically controlled laboratory tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable to the non-clinical testing described. The "ground truth" for non-clinical performance evaluation comes from established engineering standards, regulatory guidance (like ISO 10993-1 and FDA Infusion Pumps guidance), and predefined specifications, rather than expert consensus on individual cases.

3. Adjudication method for the test set:

   • Not applicable in the human-reader sense. The "adjudication" is against established engineering and regulatory standards for biocompatibility and container closure performance.

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 MRMC or human reader study was done, as this device is an infusion pump, not an imaging or diagnostic AI-driven device.

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

   • This is not directly applicable in the terms of typical AI/software performance. However, standalone non-clinical testing of the device components (specifically the luer lock cap material change) was performed to ensure it met functional and safety standards without human interaction during the test itself. This included:
     • Container Closure performance testing: This evaluated the device's ability to maintain protection against microbial ingress.
     • Biocompatibility testing: This confirmed that the new material complies with ISO 10993-1 and relevant FDA guidance.
     • Functional (container closure) testing: This was performed to demonstrate equivalence to the predicate device.

6. The type of ground truth used:

   • Regulatory Standards: ISO 10993-1:2009 for biocompatibility and FDA's "Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process."
   • Engineering Specifications: Performance metrics listed in the table (e.g., infusion accuracy, maximum infusion pressure, alarm parameters) are based on established design specifications and validated against the predicate device's performance.
   • Functional Equivalence: The primary ground truth for this 510(k) submission is demonstrating equivalence in safety and effectiveness to the predicate device (Unity Subcutaneous Delivery System for Remodulin K191313), despite the material change.

7. The sample size for the training set:

   • No "training set" in the machine learning sense is relevant here, as this is a hardware medical device with a minor material change, not an AI/ML algorithm.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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