(71 days)
The MiniMed insulin pump, model 507c, is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellius in persons requiring insulin.
The 507c career insulin punp is a rac-programmable syringe infusion punp, designed for continuous delivery of insulin, at set and variable ratos, as prescribed by the user's plysician. The 507c is restricted to sale by or on the order of a physician. It is not intended or indicated for the delivery of blood or blood products. The principal modifications described in this submission are: 1) Soveral of the purnp electronics have been integrated into an application spacific intograted circuit (ASIC) Approximately 12 K of momory has been added to the Random Access Memory. "The device now stores the lust 90 days of basel and bolus delivery information, compared with three days in the momory will also store the last 200 events and last 50 alarms, as well as the device serial number. 2) The basal rate option has been increasod. The user noy now program up to 48 basal rates, compared with 12, 3) The delivery capacity has been increased. The 507c may deliver up to 35.0 units per hour, compared to 25.0; 4) A sereen has been added to account for the priming bolus. This is a new feature that is intended to discount from the delivery history insulin used to primo the infusion sol(9) but not actually delivered to the patient; 5) A "Dual Wave" bolus delivery pattern has been added, which allows the device were to program the pump to deliver a percentage of the bolus immediately, with the rest to be delivered in a diminishing nauch over time: () A new screen has been added to allow the language the wishes the wishes the pump to use in presenting messages. Currently, only English is offered: novever, in the fitture other language options will be provided. The likely languages include French, German, Spanish, Judius, and possibly others. This Is designed to address the needs of device users more comfortable with languages other than English.
The provided text is a 510(k) summary for the MiniMed model 507c Insulin Pump. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided input. The document focuses on regulatory approval and device specifications, not on detailed performance validation studies.
§ 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).