(188 days)
The 505 insulin pump is intended for continuous delivery of insulin for the management of diabetes mellitus in persons requiring exogenous insulin. It is not intended or indicated for the delivery of blood or blood products
The 505 insulin pump is a rate-programmable syringe infusion pump, designed for continuous delivery of insulin, as prescribed by the user's physician. The 50% is restricted to sale by or on the order of a physician. It is not intended or indicated for the delivery of blood products.
The 505 consists of an external case, a microprocessor, a Liquid Crystal Display (LCD), a syringe compartment with a lead screw connecting to a motor. None of these components contact the fluid pathway.
This document is a 510(k) summary for a medical device, the MiniMed Insulin Pump, model 505. It focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed information typically found in a clinical study report regarding acceptance criteria, device performance, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot extract the requested information from the provided text. The document primarily serves as a regulatory filing to introduce a new version of an existing device based on minor modifications. It does not describe a study involving specific performance metrics against defined acceptance criteria in the manner you've outlined.
The document states: "The modification described [does] not negatively affect the safety or effectiveness of the device." This is the general claim, but no specific study design or results are provided to quantitatively support this claim in the context of your questions.
§ 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).