(340 days)
The Symbiq™ Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute Facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.
Symbiq™ Infusion System includes a volumetric piston-driven infusion pump and utilizes dedicated disposable administration sets for fluid delivery to the patient. The pump's plunger cyclically pressurizes the administration set's cassette pumping chamber through an elastomeric diaphragm to deliver fluid. The device has a touchscreen user interface to program various therapies. At low flow rates the infusion pump is designed to maintain low flow continuity. The infusion pump utilizes drug safety software to set hospital drug dosing parameters. The system can communicate wired or wirelessly over the hospitals network infrastructure through Hospira MedNet™ server software with Hospital Information Systems. The pump is available in one-channel and two-channel configurations.
Here's a breakdown of the acceptance criteria and study information for the Symbiq™ Infusion System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the "Accuracy" row in the comparison table with the predicate device. The results summary for the non-clinical tests all state "Pass," indicating conformity with the respective standards.
| Characteristic | Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (Symbiq™ Infusion System) |
|---|---|---|
| Accuracy | ± 5% for rates > 1 mL/hour. | |
| ± 10% for rates |
§ 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).