(406 days)
The Model P7000 is intended to be used for intravenous administration of drugs, blood, and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application. The specific purpose for the P7000 is to offer users a fully featured variable pressure syringe pump suitable for critical care applications.
The P7000 is a variable pressure syringe pump suitable for critical care applications.
The provided document is a 510(k) Premarket Notification for the ALARIS Medical Systems Model P7000 Variable Pressure Syringe Pump. This document is a regulatory submission for a medical device and does not contain the type of study data and acceptance criteria information typically associated with AI/ML-based diagnostic devices. It primarily focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for device performance as it is not present in this document. The document describes the device, its intended use, and states its technological characteristics are similar to a predicate device (Baxter Corporation Auto Syringe AS40A Infusion Pump, K940147). This equivalence is the basis for its approval, not a separate performance study with specific metrics.
§ 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).