(223 days)
The MiniMed 3.0 ml Reservoir Model 103/193 is indicated for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not intented for use with blood or blood products.
The MiniMed 3.0 ml Reservoir Model 103/193 is a single use 3.0 ml piston syringe consisting of a hollow barrel, movable plunger with O-rings for sealing, and a male Luce lock fitting at the distal end of the barrel. The device is used in conjunction with an external infusion punp and infusion set to deliver medication subcutancously. The male Luer lock fitting of the reserved is connected to the female Luer fitting of an infusion set, and the reservoir is placed in an externs. Infusion pump. The 103/193 reservoir is designed for use with MiniMed infusion purpos. Models 103 and 193 differ only in end configuration and packaging. The 103 is individually packaged with a covered needly attached to the male connector, while the 193 is multi-packed with a vented cap instead of a necdle.
The provided document is a 510(k) summary for the MiniMed 3.0 ml Reservoir Model 103/193. It details the device's description, intended use, and comparison to a predicate device. However, the document does not contain information on acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the ground truth used.
The document states: "The modifications which are the subject of this premarket notification have no unloward effect on the safety and effectiveness of the device." This general statement implies that the manufacturer believes the modified device functions equivalently to the original, but no specific data or study details are provided to elaborate on this claim. The FDA's letter concurs with the substantial equivalence finding based on the information provided in the 510(k) submission, but this letter itself does not contain the study details.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details about a study, 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).