(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 |
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.