(458 days)
The intended use for the IVAC enteral administration sets is to provide nutrition to patients who have an impaired ability to orally ingest their food. The pumping segment or cassette of the enteral administration set interacts with the pumping mechanism of the infusion pump to regulate fluid flow at the desired rate.
The IVAC enteral administration sets (Series 28XXX, 28XX6, 52XXX, 52XX6, 59XXX, 59XX6) incorporate standard IVAC set components and materials. The sets include an enteral adapter and. with some configurations, a pre-attached bag which holds the enteral formula during delivery. The enteral adapter is incompatible with standard ANSI IV set luers which prevents the user from accidentally attaching the enteral adapter to an intravenous set. The infusion pumps regulate fluid flow at the desired rate.
The provided text is a 510(k) summary for medical devices, specifically enteral administration sets and infusion pumps. It describes the devices, their intended use, and technological characteristics compared to predicate devices to establish substantial equivalence.
However, the document does not contain any information regarding clinical studies, acceptance criteria for device performance based on measurable outcomes, or any of the detailed data provenance, expert ground truth establishment, or multi-reader studies that your request asks for.
The text focuses on demonstrating "substantial equivalence" based on manufacturing methods, components, and primary functions, which is common for 510(k) submissions for devices that are not high-risk and are similar to already marketed devices. It does not include performance metrics or clinical trial data in the way an AI/ML device submission would.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
§ 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).