(89 days)
The PainBuster 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 and subcutaneous infusion.
The PainBuster Infusion Kit is nearly identical to the PainBuster Infusion System (K980558) marketed by I-Flow Corporation except for some labeling changes and the addition of new models and optional components. The kit is comprised of an elastomeric infusion pump (K944692) and various kit components such as catheter, needle, syringe, dressing, tape, gauze, carry case, Y Adapter, Power Ring and clothing attachment clip (E-Clip). The PainBuster pump is intended to attach to the kit catheter at the distal end of the administration set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management. The PainBuster is single patient use only. The PainBuster is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
The document provided is a 510(k) premarket notification for a medical device (PainBuster Infusion Kit), which seeks to demonstrate substantial equivalence to previously marketed devices. It is not a clinical study report designed to prove the device meets acceptance criteria in the typical sense of a novel device undergoing extensive clinical trials for efficacy and safety from scratch.
However, based on the provided text, we can extract information regarding the device's operational specifications and the testing done to demonstrate these specifications. The "acceptance criteria" here refers to the specified performance accuracy for the elastomeric infusion pump's flow rate, and the "study" refers to the performance testing described.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The primary acceptance criterion and performance data provided relates to the flow rate accuracy of the elastomeric infusion pump.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Flow Rate Accuracy: ± 15% at 95% confidence interval | 60 ml x 2 ml/hr model: Average Flow Rate: 1.80 ml/hr (Range: 1.65 - 1.99 ml/hr). This is within ±15% of 2 ml/hr (1.7-2.3 ml/hr). |
| 110 ml x 0.5 ml/hr model: Average Flow Rate: 0.48 ml/hr (Range: 0.45 - 0.53 ml/hr). This is within ±15% of 0.5 ml/hr (0.425-0.575 ml/hr). | |
| 125 ml x 5 ml/hr model: Average Flow Rate: 4.74 ml/hr (Range: 4.37 - 5.16 ml/hr). This is within ±15% of 5 ml/hr (4.25-5.75 ml/hr). | |
| 270 ml x 1 ml/hr model: Average Flow Rate: 1.01 ml/hr (Range: 0.94 - 1.07 ml/hr). This is within ±15% of 1 ml/hr (0.85-1.15 ml/hr). | |
| 270 ml x 2 ml/hr model: Average Flow Rate: 2.03 ml/hr (Range: 1.84 - 2.17 ml/hr). This is within ±15% of 2 ml/hr (1.7-2.3 ml/hr). | |
| 270 ml x 5 ml/hr model: Average Flow Rate: 4.52 ml/hr (Range: 4.3 - 4.8 ml/hr). This is within ±15% of 5 ml/hr (4.25-5.75 ml/hr). | |
| 270 ml x 10 ml/hr model: Average Flow Rate: 10.8 ml/hr (Range: 10.5 - 11.3 ml/hr). This is within ±15% of 10 ml/hr (8.5-11.5 ml/hr). |
The document states: "Testing occurred at nominal fill volume for each models produced an average flow rate well within the ±15% accuracy claim."
2. Sample size used for the test set and the data provenance
- Sample sizes for flow rate performance testing (test set):
- 60 ml x 2 ml/hr model: n=15
- 110 ml x 0.5 ml/hr model: n=46
- 125 ml x 5 ml/hr model: n=29
- 270 ml x 1 ml/hr model: n=33
- 270 ml x 2 ml/hr model: n=35
- 270 ml x 5 ml/hr model: n=12
- 270 ml x 10 ml/hr model: n=6
- Data Provenance: The data appears to be from internal laboratory testing conducted by I-Flow Corporation. There is no explicit mention of country of origin for the data or whether it's retrospective or prospective, but given it's a premarket notification for a new model/kit, it would generally be prospective testing specific to these models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes performance testing of a physical medical device (an infusion pump), not a diagnostic or AI-driven decision support system. Therefore, the concept of "experts establishing ground truth" in the context of medical imaging interpretation or similar fields does not apply here. The ground truth for flow rate is established by objective physical measurement using standard laboratory equipment.
4. Adjudication method for the test set
Not applicable, as this is objective device performance testing, not interpretation of medical data requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to the physical performance of an infusion pump, not an AI or diagnostic system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the device itself (the infusion pump) in a controlled laboratory setting. All the flow rate performance data listed in section 3.2 is standalone performance of the device without human intervention influencing the flow rate during the test.
7. The type of ground truth used
The ground truth for the flow rate performance testing was established through objective physical measurement of the fluid dispensed over time, in a controlled laboratory environment. The "test solution" used was 0.9% NaCl.
8. The sample size for the training set
Not applicable. This device is a physical pump, not an AI model requiring a training set. The various sample sizes mentioned in point 2 are for performance verification.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).