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

The Unity Subcutaneous Delivery System for Remodulin® (Unity 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 Unity System consists of several components: a wearable pump assembly, a remote interface, a filling and priming aid, and accessories (e.g., rechargeable batteries, battery charging cable, power adapter). A commercially available subcutaneous infusion set is connected to the pump assembly via a standard Luer connector for the subcutaneous delivery of Remodulin from the Unity System to the patient.

The pump assembly is composed of a reusable pump and a disposable single-use cassette 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 Unity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.

Cassettes are identical to those cleared under K190182, with the specialty pharmacy will take the cassettes out of their sterile packaging, cap the cassette and aseptically fill the cassette reservoir through the cassette filling septum following USP 797 Compounding Sterile Preparations. The specialty pharmacy will then package these filled cassettes and ship to the intended end user under controlled conditions outlined in the labeling. The pharmacy-filled cassette is intended to be stored (inclusive of shipping item) up to 14-days and is intended to be in use for up to 72-hours.

The device is prescription use only.

Here's a summary of the acceptance criteria and the study information based on the provided text, formatted to address your specific questions.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a previously cleared device (predicate device K190182). Therefore, much of the performance evaluation for this submission (K191313) builds upon the predicate device's data and specifically addresses changes related to the pre-filled cassettes. A full, comprehensive study proving all acceptance criteria might have been conducted for the original K190182 clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Same" performance characteristics compared to the predicate device, which would have had its own established performance targets. The "Discussion of Differences" column indicates how the current submission evaluated the impact of the specific changes.

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