(85 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 pump is re-usable. The disposable Paragon administration set is single patient use only. No testing has been conducted to determine the efficacy of the Paragon for the delivery of blood, blood products, lipids or fat emulsions. The Paragon is not intended for the delivery of blood, blood products, lipids or fat emulsions. The Paragon is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
The Paragon Infusion Kit is identical to the I-Flow PainBuster Infusion Kit with the exception of the Paragon pump and administration set replacing the PainBuster pump. The 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.
The provided text describes the "Paragon Infusion Kit" and includes a summary of safety and effectiveness, as well as operational specifications and performance data. The device is an infusion pump kit intended for continuous infusion of local anesthetics for postoperative pain management.
Based on the document, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Flow Rate Accuracy: ±10% at 95% confidence interval (as stated in Section 3.1)
| Model | Targeted Flow Rate (ml/hr) | Reported Average Flow Rate (ml/hr) | Standard Deviation | Number of Samples (N) | Achieved Accuracy (within ±10%) |
|---|---|---|---|---|---|
| 100 ml x 0.5 ml/hr | 0.5 | 0.53 | 0.01 | 5 | Yes (0.45 to 0.55 ml/hr) |
| 100 ml x 1.0 ml/hr | 1.0 | 0.99 | 0.03 | 5 | Yes (0.90 to 1.10 ml/hr) |
| 100 ml x 2.0 ml/hr | 2.0 | 1.99 | 0.07 | 5 | Yes (1.80 to 2.20 ml/hr) |
| 100 ml x 4.0 ml/hr | 4.0 | 4.14 | 0.10 | 5 | Yes (3.60 to 4.40 ml/hr) |
| 100 ml x 10.0 ml/hr | 10.0 | 10.30 | 0.38 | 10 | Yes (9.0 to 11.0 ml/hr) |
Additional Acceptance Criteria / Operational Specifications (Section 3.1):
- 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.