(413 days)
The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous, and intraosseous using dedicated administration sets.
The Agilia SP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood, and blood derivatives through clinically accepted parenteral routes of administration and critical drugs under specific conditions. These routes of administration include intravenous, intraarterial, and subcutaneous using dedicated administration sets.
It is intended for use by trained healthcare professionals in healthcare facilities
The Agilia SP Infusion System includes the Agilia SP MC WiFi Syringe Infusion Pump which is a programmable electronic medical system dedicated to administering a predetermined volume of an infusion product at a programmed rate, in combination with compatible third-party syringes and extension sets along with optional accessories. The optional accessories are identified as follows:
- Agilia Link 4, 6 and 8 Stacking rack system intended to power and organize 4, 6 or 8 pumps at the patient bedside.
- Agilia Duo - two-channel accessory designed to power two Agilia infusion pumps.
- Agilia USB Cable - intended to connect the Agilia SP infusion pump to a PC for serial communication.
The provided document describes the FDA 510(k) clearance for the Agilia SP Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical specifications, rather than a clinical study evaluating the device's performance against specific acceptance criteria for diagnostic or clinical outcomes.
Therefore, many of the requested detailed points regarding acceptance criteria and performance against a test set (especially those related to AI/MRMC studies, ground truth establishment, and expert adjudication) are not applicable directly to this type of device clearance and the information provided in this document.
However, I can extract information related to the acceptance criteria for the non-clinical performance of the infusion pump and the methods used to prove that performance.
Here's a breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document primarily focuses on demonstrating equivalence in technical specifications and safety/performance characteristics. The most direct mention of a performance criterion is for flow rate accuracy.
| Characteristic | Acceptance Criterion (Predicate Device) | Reported Device Performance (Subject Device) | Comment/Comparison |
|---|---|---|---|
| Flow Rate Accuracy | ±5% for 1-999 mL/h; ±5.5% for |
§ 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).