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The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The System can be used with the FreeStyle Libre 2 Sensor (14 day) or the FreeStyle Libre 2 MediRx Sensor (10 day).

The FreeStyle Libre 2 Flash Glucose Monitoring System is an integrated continuous glucose monitoring (iCGM) system that provides continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FreeStyle Libre 2 System consists of two primary components: a Sensor that transmits via Bluetooth Low Energy (BLE), and a BLE enabled display device (Reader). User initiated RFID scanning of the Sensor via Reader provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). Users may use the Sensor glucose results and information provided by the System in making treatment decisions. The System also provides configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The system is intended for single-patient use at home and requires a prescription. The Sensor is single use, disposable, and powered by a silver oxide battery. The Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (electron beam sterilized device) which are used to assemble and apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted about 5.5 millimeters below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days. The Reader is a small handheld device that is powered by a lithium-ion rechargeable battery and uses RFID communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The Reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features. The proposed subject device is a modified FreeStyle Libre 2 Flash Glucose Monitoring System that adds compatibility with the FreeStyle Libre 2 MediRx Sensor, which can be worn for up to 10 days. The FreeStyle Libre 2 MediRx Sensor design is unchanged from that of the predicate FreeStyle Libre 2 Sensor, which remains compatible with the modified System. In addition, the Sensor glucose algorithm and Reader design of the modified System remain unchanged from those of the predicate. The alternate 10-day wear duration of the FreeStyle Libre 2 MediRx Sensor is achieved by changing a Sensor configuration parameter at manufacturing, which is detected by the predicate Reader to automatically determine the wear duration and accordingly adjust the user interface display of remaining Sensor wear time and ensure the Sensor cannot report data beyond the configured wear duration. In addition, each Sensor type has an end of life parameter, which determines when the Sensor will automatically shut down. This functionality is already built into the Sensor and Reader and was validated as part of previously conducted software validation under K193371. Other than the differences related to wear duration, the FreeStyle Libre 2 MediRx Sensor is identical to the predicate Sensor, and the predicate Reader functions as intended with either the predicate FreeStyle Libre 2 Sensor (14 day) or FreeStyle Libre 2 MediRx Sensor (10 day).