Specific Questions

Intended use

• What is intended use of carelink stick MMT-7305NA?
• What are intended use of commands/messages sent to MMT-7305NA from application
• Does Medtronic/FDA know of any bugs triggered by these commands sent to/from MMT-7305NA that may cause unexpected behavior, or behavior other than originally intended?

Use of MMT-7305NA

The instruction manual indicates that the usb stick is intended for use by patient or doctor to exchange messages between a data management application and compatible medical devices. The instruction manual does not seem to include any instructions demonstrating use of the usb stick. It also does not indicate semantics for messages transferred to remote equipment.

The MMT-7305NA was designed to exchange all messages that remote equipment supports, but no instructions on usage are available from its sponsor.

The messages facilitate creating a record of treatment. Should patients be able to get a copy of their records as the pump produces them?

• What if the vendor software does not work?

• How does use of MMT-7305NA affect remote equipment, ie battery life of pump, total number of capitance charge cycles, etc...
  • Is this part of intended use of MMT-7305NA?

Commands

The MMT-7305NA is capable of exchanging many different types of commands, each with a different intended purpose. Are each of these certified/pre-subed separately? Different equipment and models respond differently to different commands. Are there any indications how these commands are intended to be used with these devices?

• What if decocare only sends commands supported by each device?
  • Does it stay within the intended use of vendor?
• What is intended use case for the remote control?
  • If the remote exchanges a message to bolus, a new tool, eg, mm-send-bolus-example.py both send the exact same message, is the tool covered by the remote’s use case?
• Are there commands which trigger otherwise unexpected behavior?
  • Are there firmware bugs known to exist in different models, eg 1.16 vs 1.17, suspend bug?
  • If some commands are less stable with regard to behavior in the firmware, should the vendor share this information with users of the device? Should it be in the instruction manual?

Should MWT1’s commands be documented so that users know what each command is intended to do?

Fault / responsibility

If something goes wrong who is at fault? Depends on what goes wrong whether or not device was used according to intended use or not. What is the intended use of the MMT-7305NA, how will users use it, how do users get support?

Future software devices

Authors using decocare could create additional tools:

• logging
  • log all history
  • query for recent history
• audit
  • create log of device behavior
  • injury/adverse event reporting tool might automatically compile report of all injurious events in therapy history and submit to FDA
• bolus wizard
  • bolus wizard on the web/browser
  • bolus wizard on mobile
  • bolus wizard from laptop
  • bolus wizard from data management software
• artificial pancreas
  • auto suspend
  • auto temp basal
  • auto bolus

g. Specific Questions

The Pre-Sub should include specific questions regarding review issues relevant to a planned IDE, or marketing application (e.g., questions regarding pre-clinical and clinical testing protocols or data requirements) as our advice will be guided by your questions and may not identify all submission requirements. Appendix 1 of this guidance contains sections specific to IDE, 510(k), PMA, and HDE that list examples of questions appropriate to each submission and application type.