(164 days)
The device is intended for continuous or intermittent administration of fluid through clinically acceptable routes such as epidural, intravenous, irrigation, or subcutaneous pathways. The device is intended to control and monitor the flow of fluids, which may include:
- Drugs and Electrolytes (e.g., cardiovascular drugs, antibiotics, analgesics, chemotherapy agents, TPN products, lipids, solutions for irrigation procedures, etc.)
- Whole Blood and Blood Products.
The device is intended for use in: - Hospitals (e.g., burn / trauma units, cardiac catheter lab, critical / intensive care, delivery / post-partum, emergency room, general floor, labor / OR / anesthesia, medical / surgical, oncology, pediatrics / neonatal, post-anesthesia / recovery, etc.)
- Outpatient / Surgical Centers
The FluidSense Fluid Delivery System is intended for continuous or intermittent administration of fluid through clinically acceptable routes such as epidural, intravenous, irrigation, or subcutaneous pathways. It is a general purpose fluid delivery system which may be used for small and large volume delivery, PCA, and delivery from bag, bottle, or syringe. The system may be used to control and monitor flow of fluids such as:
- . Drugs and electrolytes ( e.g., cardiovascular drugs, antibiotics, anesthetics, analgesics, chemotherapy agents, TPN products, lipids, solutions for irrigation procedures, etc.)
- Whole blood and blood products .
The pump uses mechanical force (piston-driven diaphragm) to propel fluids through a narrow tube. The pump uses variable pressure, inertially dominated, volumetric metering to control flow. The pump includes means to detect fault conditions, such as air in, or the blockage of, the infusion line and to activate an alarm.
The provided document describes a 510(k) submission for the FluidSense Fluid Delivery System, an infusion pump. However, it explicitly states that "No formal clinical testing has been performed, nor is any believed to be necessary."
Therefore, the document does not contain information about acceptance criteria for device performance based on clinical studies, nor does it describe any study that proves the device meets such criteria.
The 510(k) submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, applicable standards, and non-clinical testing. The "Summary of Safety and Effectiveness" primarily details the device's intended use, technological characteristics, applicable standards, non-clinical testing, and potential adverse health effects, along with mitigation strategies.
As a result, I cannot provide the requested table or information because the document explicitly states that no formal clinical testing was performed.
§ 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).