(147 days)
The Z-800 Infusion pump is intended to provide accurate delivery of parenteral fluids to a human patient under the direction or supervision of physician or other certified health care professional.
The Z-800 Infusion pump contains the filter assemblies. The electronics subsequently contains all of the electronics in the microprocessors that run the software. The electronics assembly also contains communications electronics. The pump has two microprocessors, one master processor which controls operation of the device, another pump processor which controls operation of the motor and sensors specific to the pump.
This document does not contain the information required to answer the request. The provided text is a 510(k) summary for an infusion pump, which focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria and ground truth establishment.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance related to specific endpoints. The document provides a general intended use statement ("accurate delivery of parenteral fluids") and a comparison table of basic parameters (pump type, intended use) with predicate devices, but no quantified performance metrics or acceptance criteria are listed.
- Study details: There is no mention of a specific study design, sample sizes for test or training sets, data provenance, ground truth establishment, expert involvement, or adjudication methods.
- Comparative effectiveness or standalone performance studies: The document does not describe any MRMC comparative effectiveness studies or standalone algorithm performance studies. The approval is based on equivalence to existing devices.
§ 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).