(202 days)
The Kangaroo™ Enteral Feeding Set with ENFit connectors delivers nutritional formula to the gastrointestinal system of a patient age Infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.
Enteral Feeding sets for use with Kangaroo Feeding pumps. The pump set incorporates 5 basic segments: Fluid reservoir(s), which may be an attached bag (500ml or 1000ml) or a spike for connection to a formula container; Tubing from fluid reservoir to pump (9 or 24 inch); Pump interface module (peristaltic tubing); Tubing from pump to patient connector (66 inches); Patient connector (ENFit connector compliant to ISO 80369-3).
I am sorry, but based on the provided document, I cannot fulfill your request. This document is a 510(k) premarket notification for a medical device (Kangaroo™ Enteral Feeding Sets with ENFit connectors) and does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/algorithm-driven device.
The document primarily focuses on:
- Substantial equivalence to a predicate device.
- Device description and intended use.
- Comparison of technological characteristics between the proposed and predicate devices, highlighting the change to an ENFit connector compliant with ISO 80369-3.
- Nonclinical testing (biocompatibility, stability, usability/human factors related to the ENFit connector).
- Explicitly stating that clinical testing was not relied upon for evidence of safety, effectiveness, or substantial equivalence.
Therefore, there is no information regarding:
- A table of acceptance criteria and reported device performance for an algorithm.
- Sample sizes for test or training sets, data provenance, ground truth establishment, or expert involvement for an AI study.
- MRMC comparative effectiveness studies or standalone algorithm performance.
§ 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).