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The Bigfoot Unity® Diabetes Management System is indicated for the management of diabetes in persons age 12 years and older. Bigfoot Unity® provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring sensor. The system incorporates real time alarm capabilities and is designed to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The device is intended for single patient use only and requires a prescription. Bigfoot Unity® is also intended to communicate autonomously with digitally connected medical devices where the user manually controls therapy decisions.

Bigfoot Unity Diabetes Management System ("Bigfoot Unity System") integrates The continuous glucose monitoring with insulin dose recommendations to support people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. The system consists of the Abbott Diabetes Care, Inc. FreeStyle Libre 2 Flash Glucose Monitoring system ("FreeStyle Libre 2") integrated continuous glucose monitor (iCGM) sensor, two reusable insulin pen caps (one each for rapid-acting and long-acting insulin pens) and a mobile application. The components communicate via near field communication (NFC) and Bluetooth. The device generates glucose data using the FreeStyle Libre 2 sensor and displays the data (value and trend) on the rapid-acting insulin pen cap. The rapid-acting pen cap also displays correction and meal insulin doses based upon settings prescribed by the user's healthcare provider and the available glucose data. The long-acting pen cap displays the long-acting insulin dose prescribed by the user's healthcare provider. From the dose recommendations on the pen caps as well as other contextually relevant information such as glucose trend arrows and current exercise status, users determine the doses to take. Users manually select an insulin dose and administer it using the pens according to the insulin manufacturers' instructions. In addition to dose information, both pen caps track the time of insulin doses. The mobile app provides fixed and configurable system alerts based upon data generated by the FreeStyle Libre 2 sensor. It also enables entry of the healthcare provider prescribed insulin dosing regimen as well as provides system alerts and historical information. In addition, the mobile app manages the secure wireless communication between the system components and enables the transfer of the system data to the cloud.

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 FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes 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 FreeStyle Libre 2 and FreeStyle Libre 3 are integrated continuous glucose monitoring (iCGM) Systems designed to be used alone or in conjunction with digitally connected devices. The FreeStyle Libre 2 System consists of a Sensor and either a Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of a Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device. Both Systems can communicate glucose data and other information wirelessly and securely to and from these digitally connected devices as described below: - Wireless communication from the FreeStyle Libre 2 Sensor or FreeStyle Libre 3 Sensor directly to an interoperable receiver device, which connects with the Sensor using the near field communication (NFC) and Bluetooth Low Energy wireless interfaces provided by the Sensor - The FreeStyle Libre 2 App or FreeStyle Libre 3 App communicates through the cloud to another software device, such as LibreView. Compared to the respective predicate devices, the proposed subject devices include an additional software component, the Libre Data Sharing API. The Libre Data Sharing API is a cloud-based application programming interface (API) that enables communication of glucose data including alarms through the cloud from the FreeStyle Libre 2 System or FreeStyle Libre 3 System to authorized client software on digitally connected devices. The data transmitted by the API to authorized client software can be used for specific and permitted use cases, including nonmedical device applications, medical device data analysis, CGM secondary display alarm, active patient monitoring, and treatment decisions. Use of the Libre Data Sharing API and the CGM information it transmits is limited by the indications for use of the iCGM systems with which it is used. The Libre Data Sharing API does not have any command or control over the client software, nor does it allow for the client software to have any command or control over the FreeStyle Libre 2 or FreeStyle Libre 3 Systems. Additionally, glucose data and alarms from the connected iCGM system are not modified or manipulated by the Libre Data Sharing API through its transmission to the authorized client software. The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms. The current components of the FreeStyle Libre 2 and FreeStyle Libre 3 Systems (sensor/applicator and primary display devices) have not been modified as a result of the added the Libre Data Sharing API.

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with 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 FreeStyle Libre 3 Continuous Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 3 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides real time continuous glucose measurements every minute to provide glucose levels, trends, and alarms. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application, FreeStyle Libre 3 App, downloaded to a compatible smartphone running iOS operating system. The FreeStyle Libre 3 System provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides fixed and configurable alarms designed to warn the user of Low Glucose, High Glucose, or Signal Loss.

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with 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 FreeStyle Libre 3 Continuous Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 3 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides real time continuous glucose measurements every minute to provide glucose levels, trends, and alarms. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application, FreeStyle Libre 3 App, downloaded to a compatible smartphone running on Android operating system. The FreeStyle Libre 3 System provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides fixed and configurable alarms designed to warn the user of Low Glucose, High Glucose, or Signal Loss.

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 with the FreeStyle Libre 2 App -Android (herein referred to as the 'FreeStyle Libre 2 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) 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 System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits yia Bluetooth Low Energy (BLE), a BLE enabled display device (Reader), and an Android or iOS mobile app (FreeStyle Libre 2 App) downloaded to a compatible smartphone. Scanning of the Sensor via Reader or App provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.

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).

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 FreeStyle Libre 2 Flash Glucose Monitoring System with the FreeStyle Libre 2 App (herein referred to as the 'FreeStyle Libre 2 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. The System requires a prescription and is intended for home use. The System consists of the following components: a sensor which transmits via Bluetooth Low Energy (BLE), a BLE enabled display device (Reader), and an iOS mobile app (FreeStyle Libre 2 App) downloaded to a compatible smartphone. Scanning of the sensor via Reader or App provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the sensor glucose results provided by the System. The System also provides configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.

The Bigfoot Unity Diabetes Management System is indicated for the management of diabetes in persons age 12 years and older. Bigfoot Unity provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring sensor. The system incorporates real time alarm capabilities and is designed to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The device is intended for single patient use only and requires a prescription. Bigfoot Unity is also intended to communicate autonomously with digitally connected medical devices where the user manually controls therapy decisions.

The Bigfoot Unity Diabetes Management System ('Bigfoot Unity System') integrates continuous glucose monitoring with insulin dose recommendations to support people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. The system consists of the Abbott Diabetes Care, Inc.'s FreeStyle Libre 2 Flash Glucose Monitoring System ("FreeStyle Libre 2") integrated continuous glucose monitor (iCGM) sensor, two reusable insulin pen caps (one each for rapid-acting and long-acting insulin pens) and a mobile application. The components communicate via near field communication (NFC) and Bluetooth. The device generates glucose data using the FreeStyle Libre 2 sensor and displays the data (value and trend) on the rapid-acting insulin pen cap. The rapid-acting pen cap also displays correction and meal insulin doses based upon settings prescribed by the user's healthcare provider and the available glucose data. The long-acting pen cap displays the long-acting insulin dose prescribed by the user's healthcare provider. From the dose recommendations on the pen caps as well as other contextually relevant information such as glucose trend arrows and current exercise status, users determine the doses to take. Users manually select an insulin dose and administer it using the pens according to the insulin manufacturers' instructions. In addition to dose information, both pen caps track the time of insulin doses. The mobile app provides fixed and configurable system alerts based upon data generated by the FreeStyle Libre 2 sensor. It also enables entry of the healthcare provider prescribed insulin dosing regimen as well as provides system alerts and historical information. In addition, the mobile app manages the secure wireless communication between the system components and enables the transfer of the system data to the cloud.

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 FreeStyle Libre 2 Flash Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 2 System or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. 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 provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may use the sensor glucose results and information provided by the System in making treatment decisions. The System also provides configurable alerts and alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.