Proposed Use

Intended Use of MMT-7305NA

Decocare is an open source driver for a commercially available device, the MMT-7305NA. The user’s guide: http://www.medtronicdiabetes.com/sites/default/files/library/support/carelink_usb_user_guide.pdf indicates intended use is:

Indications for use The Medtronic CareLink™ USB is indicated for use by patients at home and clinicians in a medical office setting to facilitate communication between Medtronic diabetes therapy management devices that use Paradigm-compatible RF telemetry (MWT1)* and a personal computer that uses data management application software.

Intended Use of decocare

Provides methods and utilities to facilitate communication between Paradigm-compatible devices and data management application software.

Observing device behavior

Decocare helps observe the behavior of MMT-7305NA and compatible medical devices in greater detail. The tools expose diagnostic information regarding successful transmission of messages to the device, as well as allows users to precisely audit and log device behavior.

A user may use the mm-send-comm.py tool to request and save a page of data, as it existed on the pump.

Creating data management software

Decocare allows python authors to create data management tools. Decocare transfers messages from a data management application to remote devices and back. An application developer can use this facility to create a program which uses the ReadHistoryData command, decodes the information, and presents it to the user or saves it for later use.

Frequency of use

We are unsure what Medtronic’s recommendation is regarding how frequently remote equipment may communicate with application software.

Please provide sufficient information regarding the proposed intended use/indications for use,

which may include:

• identification of the disease or condition the device is indicated to prevent, mitigate, screen, monitor, treat, or diagnose;
• identification of the target population;
• part of the body or type of tissue to which applied or with which the device is interacting;
• frequency of use;
• physiological use; and
• statement of whether the device is intended for prescription and/or over-the-counter use.

For an IVD device, this information should include a detailed draft of the intended use of the device including the intended use population, the analyte/condition to detect, and the assay methodology (see Section F of Appendix 1 for more detailed information).