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 530G System
PMA Applicant: Medtronic MiniMed
Address: 18000 Devonshire Street,
Northridge, CA 91325
Approval Date: September 26, 2013
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf12/p120010.pdf
What is it? The MiniMed 530G System is an externally worn system that continuously measures and displays glucose values, and also continuously delivers basal insulin to the user. The MiniMed 530G System can be programmed to automatically stop (suspend) delivery of insulin for two hours when the sensor glucose value detects that interstitial glucose levels have fallen below a value set by the user (a predefined threshold). The system reports glucose trending information in real-time for up to six days.
How does it work? The MiniMed 530G System includes several components: glucose sensor and insulin pump (both externally worn), transmitter, glucose meter, and therapy management software. The glucose sensor is inserted through the skin on the abdomen and measures glucose values in the interstitial fluid. The glucose values are sent through the transmitter to the insulin pump where they are displayed for the user. In addition to receiving glucose values, the insulin pump delivers insulin to the user through use of an insulin infusion set that is inserted under the skin. The system can be programmed by the user to automatically stop insulin delivery if the sensor detects a glucose level below a predefined threshold.
When is it used? The MiniMed 530G System 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 diabetes mellitus in persons, sixteen years of age and older, who require insulin. It also provides continuous monitoring and trending of glucose levels in the interstitial fluid. The MiniMed 530G System can be programmed to automatically suspend delivery of insulin when the sensor glucose value falls below a predefined threshold value.
The MiniMed 530G System consists of the following devices: MiniMed 530G Insulin Pump, Enlite™ Sensor, Enlite™ Serter, the MiniLink Real-Time System, CareLink® Pro Therapy Management Software for Diabetes, and CareLink® Personal Therapy Management Software for Diabetes. The MiniMed 530G System requires a prescription.
The MiniMed 530G System is not intended to be used directly for making therapy adjustments, but rather to indicate when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 530G System.
What will it accomplish? People with diabetes can use the tracking and trending glucose information to help determine patterns in their glucose levels. The MiniMed 530G 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 threshold suspend feature of the insulin pump provides additional diabetes management assistance by temporarily suspending insulin delivery when the glucose sensor detects a glucose value that is set by the user. 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? Pump therapy is not recommended for people:
- who are unwilling or unable to perform a minimum of four blood glucose finger tests per day.
- who are unwilling or unable to maintain contact with their healthcare professional.
- whose vision or hearing does not allow recognition of pump signals and alarms.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available.