(22 days)
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- The Paragon Infusion System is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain medications for general, subcutaneous, intramuscular and epidural.
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- The Paragon Infusion System is also intended for continuous and/or intermittent infusion of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative pain relief via percutaneous or indwelling catheter.
The Paragon Infusion System consists of a reusable mechanical infusion pump and various types of single use administration sets. This special 510(k) proposes a new line of administration sets that incorporates a variable flow rate mechanism.
This document is a 510(k) premarket notification for a medical device (Paragon Infusion System) and does not contain the detailed study information required to populate the acceptance criteria table and answer the specific questions.
The provided text is a summary of safety and effectiveness, focused on demonstrating substantial equivalence to existing devices for regulatory approval, not a scientific study report with performance metrics.
Therefore, I cannot provide the requested information from the given input. To answer these questions, a document detailing the actual performance testing, clinical study results, and ground truth establishment would be needed.
§ 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).