(68 days)
The MiniMed Com-Station Communication System is intended for use as an accessory to certain MiniMed infusion purps and LifeScan and Roche blood glucose meters to transmit and display stored data from device memory banks to a user's or physician's personal computer.
The MiniMed Com-Station Communication System is a data transfer system consisting of a hardware component designated by MiniMed model number 7301 and a software component designated by model number 7311. The system is designed for use with MiniMed infusion pumps (models 507, 507C, and 508) and certain popular blood glucose meters (LifeScan® One Touch®; Roche Accu-Chek™). The hardware component of the Com-Station is a cradle-like unit approximately 6" wide by 6" deep by 3" tall, with Infra-Red ports to transfer data electronically from the pump to a personal computer. The Com-Station converts Infra-Red (IR) pulses into RS-232 compatible electrical pulses which are sent through a serial port to the PC. The Com-Station also includes a serial port which allows connection to compatible blood glucose meters.
The device is the MiniMed Com-Station™ (model 7301) and MiniMed Solutions™ software (model 7311). This document does not contain information regarding acceptance criteria or a study proving that the device meets such criteria.
The provided text is a 510(k) Summary and the associated FDA clearance letter. It describes the device, its intended use, and a comparison to a predicate device (Disetronic D-Modem) to establish substantial equivalence. It confirms FDA clearance for marketing based on this substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. This type of detailed performance study information is generally found in a separate study report, not typically summarized in the 510(k) summary itself, which focuses on regulatory compliance and substantial equivalence to a predicate device.
§ 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).