(104 days)
- The PainBuster is intended to provide continuous infusion of a local anesthetic directly into the intraoperative (soft tissue / body cavity) site for postoperative pain management.
- The PainBuster is intended to deliver pain medication percutaneously via an administration set attached to a catheter.
- The PainBuster is single use only.
- The PainBuster is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.
- The PainBuster is not intended for epidural, subcutaneous or vascular drug delivery.
- The PainBuster is not intended for chemotherapy drugs.
- No testing has been conducted to determine the efficacy of the PainBuster for the delivery of blood, blood products or TPN. The PainBuster is not intended for the delivery of blood, blood products or TPN.
The PainBuster Infusion System is a kit that is comprised of an elastomeric infusion pump, a catheter and a needle. The PainBuster pump is the Homepump C-Series with a new intended use. The pump design is identical to the original Homepump C-Series except as follows: The PainBuster pump utilizes the same soft PVC shell that the Homepump Eclipse uses. The two (2) outer natural latex bladders have been replaced by a single thicker natural latex bladder. The PainBuster pump is intended to be used with a catheter that is included with the kit.
The provided document describes the I-Flow PainBuster Infusion System. This is a premarket notification (510(k)) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies for novel acceptance criteria.
The acceptance criteria primarily relate to the device's operational specifications, particularly its flow rate accuracy. The study demonstrating that the device meets these criteria is an engineering performance test rather than a clinical study involving human patients or ground truth established by experts.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Operational Specification) | Reported Device Performance (PainBuster Pump) |
|---|---|
| Accuracy: ±15% at 95% confidence interval (for flow rate) | 65ml x 0.5ml/hr model: Average flow rate 0.48 ml/hr (well within ±15% of 0.5 ml/hr nominal) |
| 125ml x 2.0ml/hr model: Average flow rate 1.98 ml/hr (well within ±15% of 2.0 ml/hr nominal) | |
| Priming Volume: less than 5.0 ml | (Not explicitly stated in performance data, but listed as standard operating condition) |
| Residual Volume: less than 5.0 ml | (Not explicitly stated in performance data, but listed as standard operating condition) |
| Operating Temperature: 31°C (skin temperature) | Testing occurred at 31°C |
| Test Solution: 0.9% NaCl | Testing occurred with 0.9% NaCl, and also compared against 5% Dextrose. |
| Operating Pressure: 9 to 14 psi | (Not explicitly tested for flow rate, but back pressure comparison tests were done on predicate device) |
| Head Height: 16" | Testing occurred at nominal head height of 16" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Flow Rate Performance Data (Test Set):
- 65ml x 0.5ml/hr model: 27 units
- 125ml x 2.0ml/hr model: 26 units
- Sample Size for Back Pressure Comparison (on Homepump Eclipse, a predicate device):
- 65ml x 0.5ml/hr model: 15 units at 16" HH, 10 units at 42" HH, 10 units at 3.1 psi
- 100ml x 2.0ml/hr model: 15 units at 16" HH, 15 units at 42" HH, 15 units at 3.1 psi
- Sample Size for Drug Delivery Comparison (on Homepump Eclipse, a predicate device):
- Saline: 30 units
- 5% Dextrose: 15 units
- Sample Size for Catheter/PICC Line Effects (on Homepump Eclipse, a predicate device):
- PICC Line (Room Temp): Not specified per test, but maximum/minimum/std dev suggest multiple runs/samples
- PICC Line (31°C): Not specified per test
- Epidural Catheter (Room Temp): Not specified per test
- Epidural Catheter (31°C): Not specified per test
- Data Provenance: The data appears to be from prospective in-vitro engineering performance tests conducted by I-Flow Corporation. There is no information about the country of origin of the data, but it can be inferred that it was likely conducted in the US, given the company's address and the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" here is the physical performance of the device (flow rate, residual volume, etc.) determined through engineering measurements, not expert assessment of a condition.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. This concept pertains to expert review of clinical cases. The tests described are objective engineering measurements.
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 is not a diagnostic device involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance of the device itself (the infusion pump), which is what the engineering tests described in "Flow Rate Performance Data" and "Operational Specifications" represent. The device's performance is measured and compared against its defined accuracy criteria. Therefore, the standalone performance data is available.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used is the objective physical measurement of the device's operational parameters (e.g., actual flow rate per hour, volume, pressure) against predetermined engineering specifications and industry standards.
8. The Sample Size for the Training Set
Not applicable. This is an elastomeric infusion pump, not an AI/ML algorithm that requires a training set. The device is designed based on engineering principles and tested for its inherent physical properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).