(111 days)
General surgical fluid irrigation and infiltration.
The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.
The principles of operation and technology incorporated in the Psi-Tec Svringe Infusion Pump and accessories are to provide controlled fluid delivery by utilizing a disposable, pneumatically driven syringe cartridge attached to tubing, that can propel and monitor fluid volumes delivered into a surgical site by the system.
This document is a 510(k) summary for the Byron Medical Psi-Tec Syringe Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to previously cleared devices for the purpose of market clearance, rather than presenting performance study data against specific acceptance criteria.
§ 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).