(53 days)
The Animas Model IR1250 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 Animas Model IR1250 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 IR1250 is used with any insulin infusion set which incorporates a luer style connection. The pump incorporates serial communications via an infrared (IR) interface with accessories which include the Animas IR to RS-232 serial interface adaptor (the "dongle"), the Animas IR1200 cradle to hold the pump and the Animas ezManager Plus software for the user's personal computer. As with the IR1200, this connection allows the user and/or the physician to transfer (download) data stored in the pump to the personal computer where it may be displayed, printed and saved. With the IR1250 this same connection will allow the user to program the pump, via the PC with ezManager Plus software, with selected user pump settings (basal program, bolus limits, etc.) and non-operational, personalized information including user selection of names for basal settings and musical tunes for initial alert/reminder warnings prior to the present pump alert/warning sounds. Also available to the user is the option to use a PC with ezManager Plus software, to upload and/or modify selected food items and related carbohydrate information, for storage in, and reference/use directly from, pump memory. The pump is intended for multiple years of use. To hold the insulin for subcutaneous delivery, Animas provides sterile, single use, disposable insulin cartridges for use specifically with the IR1200 series pumps. As with the IR1200, the IR1250 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) summary for the Animas Model IR1250 Insulin Infusion Pump and does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document focuses on:
- Device Description: The Animas Model IR1250 is an external syringe pump for subcutaneous insulin delivery.
- Predicate Device: Animas Model IR1200 Insulin Infusion Pump.
- Modifications: Increased storage capability and minor software modifications allowing PC programming and storage of food/carbohydrate information.
- Intended Use: Same as the predicate device – programmable basal and bolus insulin delivery for diabetes management.
- Comparison of Technological Features: The modified device and predicate are identical in design, materials, and construction. The changes are minor and do not affect safety or effectiveness.
- FDA Determination: Substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment as it is not present in the provided text. The document is primarily a regulatory submission establishing substantial equivalence to a predicate device, rather than a performance study report.
§ 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).