Search Results

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:

Flow Rate Performance Data:

Other Specifications:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Sizes:
  • For 100 ml x 0.5 ml/hr, 1.0 ml/hr, 2.0 ml/hr, and 4.0 ml/hr models: N = 5 pieces each.
  • For 100 ml x 10.0 ml/hr model: N = 10 pieces.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer for regulatory approval. The country of origin is I-Flow Corporation, based in Lake Forest, CA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. This study is a performance evaluation of a mechanical device (infusion pump and administration set) against physical specifications (flow rate accuracy). It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in a medical imaging or diagnostic context.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a performance test for a mechanical device against objective, quantitative metrics (flow rate, standard deviation), there is no human adjudication process involved. The results are directly measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is not relevant for this type of device and performance testing. MRMC studies are typically used to evaluate the impact of a diagnostic tool or AI algorithm on human reader performance in interpreting medical images or data.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device is a mechanical infusion pump, not an algorithm or AI system. The performance testing is inherently "standalone" in the sense that it measures the device's physical output (flow rate) directly.

7. The Type of Ground Truth Used:

• The "ground truth" for this study is the predefined design specification of ±10% accuracy for the flow rate of the infusion pump across its various models. The device's measured flow rates are compared directly against these quantitative specifications. The measurements are taken under "standard operating conditions" (e.g., operating temperature, test solution, operating pressure, head height).

8. The Sample Size for the Training Set:

• Not Applicable. This is a mechanical device, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there is no training set, this question is irrelevant.

Ask a specific question about this device