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MiniMed 630G System with SmartGuard - P150001/S021

Image of MiniMed 630G System with SmartGuard - P150001/S021

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: MiniMed 630G System with SmartGuard
PMA Applicant: Medtronic MiniMed
Address: 18000 Devonshire Street, Northridge, CA 91325
Approval Date: February 13, 2018
Approval Letter: Approval Letter

What is it? The Medtronic MiniMed 630G System with SmartGuard is a hybrid closed loop system that monitors glucose and automatically adjusts the delivery of long acting or basal insulin based on the user's glucose reading. This device was approved on June 2, 2017 under P150001/S008. The current approval adds a new indication to insert the sensor into the patients' the upper arm.

How does it work? The MiniMed 630G System with SmartGuard consists of a continuous glucose monitor (CGM) that measures the user's glucose levels for up to seven days, an insulin pump that delivers insulin to the user, and a glucose meter used to calibrate the CGM.

The system can decrease or stop insulin delivery when it detects the user's glucose is low, or increase the insulin delivery when the system detects the user's glucose levels are high with no input from the user. The glucose sensor contains a wire that is inserted under the skin on the abdomen or, as approved in this current supplement, the upper arm, and measures glucose values in the tissue fluid. The glucose values are wirelessly sent to the insulin pump, and displayed along with glucose trend information, alerts, and alarms on the pump screen. The insulin pump is a battery-powered infusion pump that delivers a prescribed dosage of insulin through as a single programmable bolus or at multiple programmable basal rates. The insulin pump can automatically adjust the delivery of insulin using a mathematical equation, or algorithm that incorporates information from the CGM.

When is, it used? The MiniMed 630G System with SmartGuard is intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons sixteen years of age and older. The system requires a prescription.

The MiniMed 630G System with SmartGuard is not intended to be used directly for making manual insulin therapy adjustments, but rather to provide an indication of when a glucose measurement should be taken. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 630G System with SmartGuard.

What will it accomplish? People with diabetes can use the glucose information from the CGM to help determine patterns in their glucose levels. The System can alert users when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels. People with diabetes can use the insulin delivered from the pump to help keep their blood glucose levels at a safe level. The system provides additional diabetes management assistance by temporarily suspending insulin delivery when the user's glucose is low. When used along with a blood glucose meter to obtain a more accurate reading of actual blood glucose levels, a continuous glucose monitoring and insulin pump system can also help people with diabetes make long-term adjustments to their treatment plan to keep blood glucose levels in a safe range.

When should it not be used?

  • The MiniMed 630G System with SmartGuard should not be used in:
    • People whose vision or hearing does not allow recognition of pump signals and alarm
    • Children under 14 years of age. The FDA has not reviewed data to support the safety and effectiveness of the devices in children ages 7-14 as these studies are ongoing.
    • Patients taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise a patient's sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person
  • Anyone unable or unwilling to:
    • Perform blood glucose (BG) tests as recommended by your healthcare provider
    • Demonstrate adequate carbohydrate-counting skills (preferred, not required)
    • Maintain contact with their healthcare provider(s) regularly
    • Carry the Medical Emergency Card provided with the system when traveling. The Medical Emergency Card provides critical information about airport security systems, and pump usage on an airplane

Patients should always remove their pump, sensor, transmitter, and meter before entering a room that has x-ray, MRI, diathermy, or CT scan equipment. The magnetic fields and radiation in the immediate area of this equipment can make the devices nonfunctional or damage the part of the pump that regulates insulin delivery, possibly resulting in over delivery and severe hypoglycemia.

Additional information (including warnings, precautions and adverse events): The Summary of Safety and Effectiveness Data and labeling will be available online.

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