BlueStar and BlueStar Rx

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ## I Background Information: A 510(k) Number K230813 B Applicant Welldoc, Inc. C Proprietary and Established Names BlueStar® and BlueStar® Rx D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | NDC | Class II | 21 CFR 868.1890 - Predictive Pulmonary-Function Value Calculator | | ## E Purpose for Submission: Modification of a cleared device to add the insulin dose capture feature for use with a compatible insulin pen module. ## II Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: **BlueStar®**: BlueStar® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self- Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} management. BlueStar automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. ## BlueStar® Rx: BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar Rx automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar Rx analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information. For bolus insulin users with type 1 and type 2 diabetes, BlueStar Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or glucose value. For basal insulin users with type 2 diabetes, BlueStar Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the IAP and configure it for patient-specific parameters. BlueStar Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. ## C Special Conditions for Use Statement(s): Rx and OTC BlueStar® Rx is not indicated for people with gestational diabetes or who use an insulin pump. BlueStar® Rx is designed to work with glucose results reported in mg/dL and cannot safely be used with mmol/L values. To avoid harm please ensure that any glucose meter used with BlueStar is set for blood glucose values in mg/dL. K230813 - Page 2 of 7 {2} K230813 - Page 3 of 7 # III Device Description: BlueStar® is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to assist patients in managing their diabetes with guidance from their providers. BlueStar has two versions – BlueStar (Over the Counter, OTC) and BlueStar Rx (prescription use version). BlueStar is comprised of the following software applications (app): - iOS, Android based mobile apps for patients - Web-based app (web-portal) for HCP BlueStar requires initial registration before the patient can access the software applications. The subject device maintains all of the existing diabetes self-management features of previously cleared versions of these devices (Welldoc BlueStar, k190013; BlueStar Rx, k193654), and adds the capability to connect with compatible devices connected with insulin pens via Bluetooth Low Energy (Bluetooth) wireless technology. In this submission, the previously cleared devices are being modified such that they can receive insulin dose-related data when connected to a Tempo Smart Button™ (TSB). The subject device is connected via Bluetooth to the TSB which in turn connects to compatible insulin pens. The TSB when attached to a disposable Tempo Pen (insulin pen) can transfer dose-related data (corresponding to the brand of insulin, dose amount, date, and time) via Bluetooth wireless technology. BlueStar is compatible with devices including Blood Glucose Meters (BGM), Blood Pressure Monitors, Continuous Glucose Monitors (CGM), TSB, Weight Scales, Activity Trackers. Data, including blood glucose values, blood pressure, medications, carbohydrates, physical activity, weight, and sleep are entered, stored and processed in the patient software applications. Data can be entered manually or automatically via Bluetooth for compatible devices. Additionally, the mobile application for patients is capable of automatically receiving, storing, processing, and displaying insulin data from the TSB via Bluetooth. The BlueStar apps for patients function as an information repository (logbook and Personal Health Record) and diabetes education resource (curriculum, articles, videos). Patients also receive in-the-moment coaching (Real Time Feedback messages), Pattern Reports and SMART Visit Reports that can be shared with their providers. Coaching messages are motivational, behavioral, and educational in nature and are based on data (and trends) including real-time glucose, blood pressure, and weight. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. Patients also receive insights based on data entered and trends detected by the app. BlueStar patient apps include a secure communication system (Message Center) as well as a medication information repository (dose and schedule). Qualified type 1 and type 2 diabetes patients have access to a bolus insulin calculator (cleared under k190013). Qualified type 2 diabetes patients have access to the Insulin Adjustment Program (IAP) to titrate long-acting basal insulin (cleared under K193654). Patients use their mobile application to follow their HCP's bolus insulin prescription or basal insulin titration plan. The bolus insulin calculator and basal insulin titration features are only available in BlueStar Rx for use under the direction of their HCP. {3} The provider can review patient information, workflows and decision support information using the web-based software application for HCP. The HCP can initiate and manage the bolus insulin calculator prescription / parameters through the patient's mobile app. The HCP can initiate and manage basal insulin titration (Insulin Adjust Program - IAP) through the web-based software application for HCP. The SMART Visit Report includes data summary, analysis, and decision support for treatment as well as psychosocial issues identified by patient survey responses within the app. The SMART Visit Report can be sent by the patient to his/her HCP from the mobile app or web portal. The HCP can also generate SMART Visit Reports from their web portal. This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review. ## IV Substantial Equivalence Information: A Predicate Device Name(s): BlueStar® Rx B Predicate 510(k) Number(s): K193654 C Comparison with Predicate(s): | Device & Predicate Device(s): | K230813 | K193654 | | --- | --- | --- | | Device Trade Name | BlueStar, BlueStar Rx (Subject Devices) | BlueStar Rx | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | Intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. Determination of insulin dose based on user entered data (BlueStar Rx) | Same | K230813 - Page 4 of 7 {4} K230813 - Page 5 of 7 | Intended Patient Population | For patients aged 18 years and older who have type 1 or type 2 diabetes. Basal insulin titration is for type 2 diabetes patients only. | Same | | --- | --- | --- | | Environment of Use | Home use | Same | | Type of Insulin Dose Calculation | Bolus dose calculation or basal insulin titration (BlueStar Rx) | Same | | Operating Platforms | iOS, Android, and web-based patient software applications. Web-based HCP software application (browsers such as Internet Explorer, Chrome, Firefox, Safari and Edge.) | Same | | Mode of wireless connectivity with other devices | Bluetooth | Same | | General Device Characteristic Differences | | | | Connectivity to Tempo Smart Button | Yes | No | | Insulin dose identification | Automatic with manual edit available | Manual entry only | V Standards/Guidance Documents Referenced: Recognized consensus standards: - ANSI AAMI ISO 14971:2019 Medical devices - Applications of risk management to medical devices - IEC 60601-1-2 Edition 4.1 2020 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEEE ANSI C63.27-2017 - American National Standard for Evaluation of Wireless Coexistence - ANSI AAMI IEC 62366-1:2015+AMD1:2020 - Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 {5} - ANSI AAMI HE75:2009/(R)2018 - Human factors engineering - Design of medical devices - ANSI AAMI IEC 62304:2006/A1:2016 - Medical device software - Software life cycle processes [Including Amendment 1 (2016)] - AAMI TIR69:2017/(R2020) - Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems ## FDA Guidance: - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 28, 2014) - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 02, 2014) - Applying Human Factors and Usability Engineering to Medical Devices (February 03, 2016) - Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (September 06, 2017) - Format for Traditional and Abbreviated 510(k)s (September 13, 2019) - FDA Guidance for Off-the-Shelf Software Use in Medical Devices (September 27, 2019) - eCopy Program for Medical Device Submissions (April 27, 2020) - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Draft) ## VI Performance Characteristics (if/when applicable): ### Usability: Human factors evaluation was conducted to assess whether users can perform all critical tasks associated with the new device features. Subjects were representative of the device’s intended use population, including patients over 18 years of age, caregivers and healthcare providers. The human factors evaluation provided in this premarket submission focused on the essential as well as critical tasks and involved the following activities: - Usability risk analysis - Task analysis to identify each step required to complete all user tasks - Identify potential failure modes and result of failure mode for each task - Assign severity rating for failure effect and mitigation - Formative evaluation: to verify device performance with HCP and patient users - Summative evaluation: to validate device performance with HCP, patient and caregivers The human factors testing evaluated the use of the BlueStar Rx System to support insulin tracking, bolus insulin calculator recommendations, basal insulin titrations, and priming and syncing of insulin data with the Tempo Smart Button. K230813 - Page 6 of 7 {6} K230813 - Page 7 of 7 Software: The firm provided software documentation consistent with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005), and consistent with software with a major level of concern. Software documentation was acceptable EMC & Wireless Coexistence: The firm has provided testing of the ME System created from the app installed on compatible mobile devices that communicate with the TSB. The firm completed evaluation per IEC 60601-1-2:2020 including subclause 8.11, IEEE/ANSI C63.27:2017, and RTCA DO-160G Section 21 Category M in addition to CISPR 11 Class B. Test results support the finding of substantial equivalence for this device. VII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. VIII Conclusion: The device is substantially equivalent to the predicate.