(23 days)
The Animas Model R1000 IR Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. The accessories to the Model R1000 IR, the Animas RS-232 IR serial interface adator (the "dongle"), the Animas R1000 IR cradle to hold the pump and the Animas ezLink™ software are intended to transfer data stored in the pump to the personal computer of a patient or a physician, where it may be displayed, printed, and saved.
This device is intended for home use and is a prescription device.
The Animas Model R1000 IR Insulin Infusion Pump is an external syringe pump and delivery system that provides subcutaneous delivery of insulin for patients with diabetes mellitus who would benefit from a continuous insulin infusion process. The Model R1000 IR is used with an infusion set, e.g., the Animas ezSet™. The pump incorporates serial communications via an infrared (IR) interface. The Animas RS-232 IR serial interface adaptor (the "dongle"), the Animas R1000 IR cradle to hold the pump, and the Animas ezLink™ software for the user's personal computer are the remaining components of the system. The ezLink™ software will allow the user to download records from the pump for Daily Totals, Alarm History, Bolus History, as well as Basal Rate programs and PUMP Settings. A leather case and a belt clip are provided as accessories. The pump is intended for multiple years of use and the insulin syringe is a sterile, single use disposable manufactured for Animas.
The system will deliver a prescribed dosage of insulin as a single programmable bolus or at multiple programmable basal rates. The system will also provide set up information, dosage history, alarms, error and warning messages, device status, and self test capabilities.
This document is a 510(k) premarket notification for the Animas Model R1000 IR Insulin Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device by describing the device, its intended use, and emphasizing that the only difference from the predicate is the addition of an infrared (IR) communication capability. It explicitly states: "This difference between the modified device and the predicate device does not affect the safety or effectiveness of the device."
Therefore, I cannot provide the requested information as it is not present in the provided text. This type of regulatory submission often relies on the established safety and effectiveness of the predicate device for minor modifications, rather than requiring new, extensive performance studies with 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).