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• 1. 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.
• 2. 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.

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