(94 days)
The Unity Subcutaneous Delivery System for Remodulin® (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® (treprostimil) (hereinafter referred to as 'Remodulin (treprostinily), 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 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 with a user-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 Unity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.
The device is prescription use only.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided FDA 510(k) summary for the Unity Subcutaneous Delivery System for Remodulin.
It's important to note that this document is a 510(k) summary, which provides a brief overview of the information submitted to the FDA for a substantial equivalence determination. It does not contain the full details of all studies, such as raw data, complete study protocols, or detailed statistical analyses that would be found in a full study report. Therefore, some information might be less granular than typically expected for a detailed study description.
Acceptance Criteria and Device Performance for Unity Subcutaneous Delivery System for Remodulin
The provided document describes the Unity Subcutaneous Delivery System for Remodulin, an infusion pump. The "acceptance criteria" for a 510(k) device are primarily the demonstration of substantial equivalence to a predicate device. This is achieved by showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness. The performance metrics below are compared to the predicate device and justified against the intended use and Remodulin's specific requirements.
1. Table of Acceptance Criteria and Reported Device Performance
For an infusion pump, key performance characteristics related to safety and effectiveness often revolve around accurate and reliable fluid delivery, safety features (e.g., occlusion detection), and robust design. The document highlights various performance aspects and compares them to the predicate device.
| Characteristic | Predicate Device (CADD-MS 3 Ambulatory Infusion Pump: K051568) | Proposed Device (Unity Subcutaneous Delivery System for Remodulin: K190182) | Acceptance Criteria (Implicit from Substantial Equivalence Justification) | Reported Device Performance/Justification |
|---|---|---|---|---|
| Infusion Accuracy | ±3% (nominal) | ±6% | Meets Remodulin USPI (United States Pharmacopeia) requirements for subcutaneous administration. | "Compliant with Remodulin USPI an infusion accuracy of ±6% satisfies the Remodulin delivery accuracy requirement for administration by subcutaneous injection." Clinical study demonstrated majority of measured data fell within accuracy specification, with brief intervals outside of -6% attributed to measurement uncertainty or air bubbles (within 25%). |
| Maximum Infusion Pressure | 23 psi (159 kPa) |
§ 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).