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510(k) Data Aggregation
(71 days)
The SideKick Infusion Kit is intended to provide continuous infusion of 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 SideKick Infusion Kit is identical to the I-Flow Paragon Infusion Kit with the exception of the SideKick pump and administration set replacing the Paragon pump and administration set. The kit is comprised of a SideKick pump and administration set and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case. The SideKick 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 SideKick administration set is a disposable device intended for single patient use. The SideKick pump is reusable. The SideKick is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
This document describes the SideKick Infusion Kit, an infusion pump kit. Here's an analysis of the acceptance criteria and supporting study information:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Operational Specification) | Reported Device Performance (Flow Rate Performance Data) |
|---|---|
| Residual Volume: < 5 ml | Not explicitly stated in "Flow Rate Performance Data," but listed as a standard operating condition. |
| Operating Temperature: 31°C skin temperature (90°F) | Testing occurred at standard operating conditions (which include this temperature). |
| Test Solution: 0.9% NaCl | Testing occurred at standard operating conditions (which include this solution). |
| Operating Pressure: 9 to 1 psi pressure source | Testing occurred at standard operating conditions (which include this pressure). |
| Head Height: 0" | Testing occurred at standard operating conditions (which include this head height). |
| Accuracy: ±15% at 95% confidence interval | All models produced an average flow rate within the ±15% accuracy claim. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set. It mentions "All models produced an average flow rate within the ±15% accuracy claim," implying multiple units were tested for each model.
The data provenance is internal to I-Flow Corporation ("Testing occurred at standard operating conditions"). No information is given about the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for infusion pump performance is based on direct physical measurements and engineering specifications, not expert consensus or interpretation.
4. Adjudication Method for the Test Set
This is not applicable. As stated above, the evaluation of infusion pump performance relies on direct measurement against predefined specifications, not on an adjudication process involving human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance. The SideKick Infusion Kit is a physical medical device (infusion pump) and its performance is evaluated through engineering and functional testing, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not done. This concept is applicable to AI/ML software. The SideKick Infusion Kit is a mechanical infusion pump, and its performance is inherently "standalone" in the sense that it operates according to its mechanical design without an "algorithm" in the AI/ML sense or human-in-the-loop performance influencing its fundamental flow rate accuracy. Its performance is tested as a direct measure of its function.
7. The Type of Ground Truth Used
The "ground truth" for the performance (specifically accuracy) of the SideKick Infusion Kit is based on engineering specifications and direct physical measurement of flow rates under controlled standard operating conditions using a 0.9% NaCl test solution. The accuracy is defined as ±15% at a 95% confidence interval.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. The SideKick Infusion Kit is a mechanical device, not an AI/ML algorithm that is "trained" on data. Its design and manufacturing ensure its performance characteristics.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for a mechanical device.
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