(195 days)
Infusions Of volumes between 50 mL to 100 ml. Via Intravenous catheter or central IV line or subcutaneous route In Ambulatory , Home or Hospital Setting For General Use
The Eureka Infusion Pump and predicate devices functions with the use of restriction tubing. Pressure is exerted on a IV solution containers. When the air is pumped in to the bladder enlarges. The pressure against the IV solution container forces the IV solution to flow through the administration set. The Eureka Infusion Pump is designed to house a pre-filled IV solution container. The housing consists of Polycarbonate material for srtength. The administration sets are a PVC tubing set and attached spike of ABS plastic. Performance characteristics also include the ability of sensors to determine pressure being exerted on the bag and the logic control to regulate this pressure by powering on and off the air pump, and venting pressure through a relief valve. Each Eureka Pump Model is supplied with the following optional component/accessories Pump, Recharger/Power Supply, Battery Pack, Carry Pack, Manual The Eureka-IP and Eureka-LF Infusion Pumps are reusable.
Here's a breakdown of the acceptance criteria and the study that proves the Eureka Infusion Pump meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Labeled flow rate accuracy | +/- 12% |
| Percentage of volume infused | 97-99% of volume infused |
| Flow accuracy based on profile | 97% flow accuracy based on profile |
| Operating Temperature | 65-90° F |
| Biocompatibility (fluid path components) | Conforms with ISO 10993 Part 1 |
| Sterilization of Administration Sets | Suitable for radiation or ETO sterilization (packaging), uses Gamma Radiation (sterilization) |
| Equivalence to predicate devices (functional) | Works by utilizing flow restriction tubing and pressure |
| Equivalence to predicate devices (non-clinical) | Equivalent flow rate profiles, residual volume amounts |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "non-clinical tests" but does not provide details on the number of units or test runs performed.
- Data Provenance: Not explicitly stated. Given it's a non-clinical trial conducted for regulatory submission in the US, it's highly likely the tests were conducted in a controlled lab environment. Neither country of origin nor retrospective/prospective nature is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. The evaluation relies on non-clinical performance testing against pre-defined engineering and performance standards, not on human expert judgment for "ground truth."
4. Adjudication Method for the Test Set
- Not Applicable. As the evaluation is based on objective measurements from non-clinical trials, an adjudication method for human experts is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not done. The document explicitly states: "Clinical trials are not required." This indicates that a human-in-the-loop or MRMC study comparing human readers with and without AI assistance was not performed or deemed necessary for this device's approval.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Performance Studied (implicitly). The "non-clinical trials" measured the device's inherent performance characteristics (flow rate, accuracy, volume infused) independent of human interaction during the measurement process. While not an "algorithm" in the modern AI sense, the device's automated functions were tested in a standalone manner.
7. Type of Ground Truth Used
- Defined Performance Specifications/Standards. The "ground truth" for the non-clinical tests was likely established by engineering specifications, validated measurement techniques, and comparison to the performance of predicate devices. For biocompatibility, it was adherence to ISO 10993 Part 1.
8. Sample Size for the Training Set
- Not Applicable. This device is an infusion pump, operating on mechanical and electronic principles. It does not utilize machine learning or AI that would require a "training set" in the computational sense. The "training" for the device would be its design, manufacturing, and calibration processes.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no "training set" in the context of AI/ML, there is no ground truth established for it. The design and validation of this medical device follow traditional engineering and quality control principles.
§ 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).