(26 days)
Intended for use in parenteral, enteral, and epidural therapies and the administration of whole blood and blood products.
Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
The Hospira Plum A+ and Hospira Plum A+ 3 Infusion Pump Systems are a family of single channel and triple channel software controlled, electromechanical infusion pumps that operate on a volumetric, piston-driven, fluid displacement principle. The infusers use a stepper motor in conjunction with an inline cassette to meter and deliver IV fluids through sterile intravenous administration sets desirent to be used exclusively with both the Plum A+ and Plum A+ 3. The infusers can be pole nounted.
The provided text is a 510(k) Summary for the Hospira Plum A+ Infusion Pump System, v11.5 and Hospira Plum A+ 3 Infusion Pump System, v11.5. This document describes a medical device, its intended use, and its equivalence to predicate devices, but it does not contain information about acceptance criteria for device performance, nor the detailed results of a study proving the device meets said criteria.
The summary states:
- "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for intravenous infusion pumps." This directly indicates that formal, FDA-mandated acceptance criteria for performance are not applicable in the way they might be for some other device types.
- The comparison table lists "Performance Features" such as "Delivery Rates, VTBI Range, Dose Units, Delivery Accuracy, Delivery Modes, Therapies, Distal Occlusion Limits, Proximal Occlusion Limits, Alarm Types and Conditions, Default Drug Library." It notes the subject device's performance features are "Similar" to the predicate, with an "Improved Battery Charge Monitoring Algorithm in v11.5 and v13.x only." This suggests that the performance features were evaluated against established norms for infusion pumps, or against the predicate device's performance, but specific quantitative acceptance criteria and detailed study results are not provided.
- The document concludes with a "Statement of Safety and Effectiveness" affirming that the upgraded systems "meet the functional claims and intended use as described in the product labeling, and are as safe and effective in terms of substantial equivalence as the predicate devices described in this submission." This is a general statement required for 510(k) submissions, not a summary of specific study findings against acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. The document is primarily concerned with establishing substantial equivalence to previously cleared predicate devices based on intended use, indications, operating principle, physical features, and similar (or improved) performance features, rather than presenting a detailed performance study against specific acceptance criteria.
§ 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).