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510(k) Data Aggregation
(82 days)
The Paragon Infusion Kit is intended to provide continuous infusion a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion.
The Paragon Infusion Kit is comprised of a Paragon pump and administration set (K923875) and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case. The Paragon administration set is intended to attach to the kit catheter at the distal end of the set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management. The Paragon administration set is a disposable device intended for single patient use. The Paragon pump is reusable. The Paragon is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy | ±10% at 95% confidence interval |
Flow Rate Performance Data:
| Model | Average Flow Rate (ml/hr) | Std. Dev. | N | Within ±10% Accuracy Claim? |
|---|---|---|---|---|
| 100 ml x 0.5 ml/hr | 0.53 | 0.01 | 5 | Yes |
| 100 ml x 1.0 ml/hr | 0.99 | 0.03 | 5 | Yes |
| 100 ml x 2.0 ml/hr | 1.99 | 0.07 | 5 | Yes |
| 100 ml x 4.0 ml/hr | 4.14 | 0.10 | 5 | Yes |
| 100 ml x 10.0 ml/hr | 10.30 | 0.38 | 10 | Yes |
Other Specifications:
| Parameter | Acceptance Criteria |
|---|---|
| Priming/Residual Volume |
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