(71 days)
Intended for use in parenteral, enteral, and epidural therapies and the administration of whole blood and blood products
The proposed device is the Hospira Plum A+ Infusion Pump is a single channel software controlled, electromechanical infusion pump that operates on a volumetric, piston-driven, fluid displacement principle. The infuser uses a stepper motor in conjunction with an inline cassette to meter and deliver IV fluids through sterile intravenous administration sets designed to be used exclusively with both the Plum A+. The infuser can be pole mounted. This pump is IEC/EN 60601-1-2:2001 compliant.
The Plum A+® Infusion Pump is a medical device and therefore the acceptance criteria are not clinical performance measures but rather safety and effectiveness measures, which are assessed through bench testing and comparison to predicate devices.
Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate devices. |
| Operating Principle | Same as predicate devices. |
| Materials of Construction | Similar to predicate devices. |
| Compliance with IEC/EN 60601-1-2:2001 | The proposed device is compliant. |
| Safety and Effectiveness | Bench testing results met acceptance criteria and did not raise new issues of safety and/or effectiveness. |
Study Details:
- Sample size used for the test set and the data provenance: Not applicable. The evaluation was primarily based on bench testing of the device itself, rather than a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of device evaluation relates to meeting engineering and safety standards, which are assessed via bench testing against predetermined specifications, not expert consensus on interpretations of data.
- Adjudication method for the test set: Not applicable. The "adjudication" is inherent in the bench testing results meeting pre-defined engineering and safety criteria.
- 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 device is an infusion pump, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone electromechanical infusion pump. Its performance is evaluated intrinsically through bench testing to ensure it meets its specifications for fluid delivery. There is no "algorithm only" performance in the context of an AI system.
- The type of ground truth used: The ground truth was established through bench testing against predetermined engineering specifications, safety standards, and performance criteria for infusion pumps, along with a direct comparison to the predicate devices' characteristics.
- The sample size for the training set: Not applicable. This device is an electromechanical pump, not a machine learning model that requires a training set.
- 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).