(106 days)
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.
| Acceptance Criterion | Reported Device Performance (Remunity System) |
|---|---|
| Mechanism of action | Same (Microprocessor controlled Micro- dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracy) |
| Infusion Accuracy | Same (± 6%) |
| Maximum Infusion pressure | Same ( |
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).