(144 days)
The MicroFuse Dual Rate infuser is intended to be used for the intermittent administration of I.V. medication.
The Numia Medical Technology Dual Rate Infuser, or MicroFuse, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. The MicroFuse was originally developed and cleared through FDA by Baxa Corporation of Englewood Colorado under K983321. Each MicroFuse has two predetermined rates that are preset at the manufacturing facility. These preset rates cannot be modified by the user or patient. The MicroFuse is used in conjunction with a sterile administration set for injecting the medication into a syringe, the contents of meaned of the syringe at a controlled, pre-determined rate, delivering the dose in patient it depresses the praiger of the MicroFuse is offered in thee models a standard dual the synnge over an extended ported on extended infuse model. The only difference between these being the prodet, and infusion rates programmed into the device's software. The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration I he Microruse and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field.
The provided text describes a 510(k) premarket notification for a medical device called the MicroFuse Dual Rate Infuser. The documentation confirms its substantial equivalence to a legally marketed predicate device (K983321) and states its intended use for the intermittent administration of I.V. medication.
However, the provided text does not contain information related to acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance. The document is a 510(k) summary and FDA clearance letter, which focuses on device description, intended use, and comparison to a predicate device for substantial equivalence, rather than detailed performance study results.
Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, experts, or ground truth based on the given input. The information would typically be found in a separate section of a 510(k) submission, such as performance testing reports, which are not included here.
§ 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).