BlueStar Rx

K203434 · Welldoc, Inc. · NDC · Sep 8, 2021 · Anesthesiology

Device Facts

• Record ID: K203434
• Device Name: BlueStar Rx
• Applicant: Welldoc, Inc.
• Product Code: NDC · Anesthesiology
• Decision Date: Sep 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

Intended Use

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 analyzes, and reports blood glucose test results and supports medication adherence. In addition, BlueStar® Rx provides coaching messages (motivational, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information to aid in diabetes self-management. For bolus insulin users with type 1 or 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 blood 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. For bolus insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen. For premixed insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin. The algorithms for the IAP are not designed for the titration of NPH, regular human premixed insulins. The healthcare provider must activate the IAP and configure it with patient-specific parameters. BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Device Story

BlueStar® Rx is a software-based insulin dose calculator and titration system for patients with type 1 or type 2 diabetes. It operates on mobile phones and PCs in home or clinical settings. Patients input blood glucose values, carbohydrate intake, and actual insulin doses; HCPs configure titration parameters (e.g., insulin type, increments, targets) via a web portal. The device uses evidence-based algorithms (AUTONOMY, INITIATE, Adjust to Target, Real-World Approach) to calculate recommended insulin dose adjustments for basal, bolus, and premixed insulins. Outputs include coaching messages, dose recommendations, and progress reports for both patients and HCPs. The system incorporates safety constraints, such as maximum dose limits and frequency restrictions (e.g., Q3D bolus increases). It assists in diabetes management by providing structured titration guidance, potentially improving glycemic control for patients failing to reach targets on current regimens. It does not replace professional clinical care.

Clinical Evidence

No clinical trial data provided. Evidence consists of human factors studies confirming users can perform critical tasks associated with new titration features, and software verification/validation documentation.

Technological Characteristics

Software-based medical device (SaMD) operating on mobile phones and PCs. Features an Insulin Adjustment Program (IAP) algorithm for insulin titration. Connectivity via web/mobile interfaces. Major level of concern software. Operates with glucose values in mg/dL.

Indications for Use

Indicated for patients aged 18+ with type 1 or type 2 diabetes. Contraindicated for gestational diabetes or insulin pump users. Requires use with glucose meters reporting in mg/dL.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• BlueStar® Rx (K193654)

Submission Summary (Full Text)

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September 8, 2021

WellDoc. Inc. Sabyasachi Roy Vice President, Regulatory Affairs and Quality Systems 10221 Wincopin Circle, Suite 150 Columbia, Maryland 21044

Re: K203434

Trade/Device Name: BlueStar® Rx Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: November 20, 2020 Received: November 23, 2020

Dear Sabyasachi Roy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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542 of the Act); 21 CFR 1000-1050.

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Marianela Perez-torres -S

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K203434

Device Name BlueStar® Rx

#### Indications for Use (Describe)

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 analyzes, and reports blood glucose test results and supports medication adherence. In addition, BlueStar® Rx provides coaching messages (motivational, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information to aid in diabetes self-management.

· For bolus insulin users with type 1 or 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 blood 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.

• For bolus insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen.

· For premixed insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of

premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin.

The algorithms for the IAP are not designed for the titration of NPH, regular human premixed insulins. The healthcare provider must activate the IAP and configure it with patient-specific parameters.

BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span style="font-size:16px">☑</span> </div> |
|----------------------------------------------|----------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span style="font-size:16px">☐</span> </div> |

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510(k) Number: K203434

## 510(k) Summary

| Date Prepared: | September 03, 2021 |
|----------------------------|-------------------------------------------------------------------|
| Name of Manufacturer: | WellDoc, Inc. |
| Address: | 10221 Wincopin Circle, Suite 150<br>Columbia, MD 21044 |
| Contact Person: | Sabyasachi Roy, MSEE, Ph.D.<br>Vice President, Regulatory Affairs |
| Phone: | [phone] |
| Fax: | [phone] |
| Trade or Proprietary Name: | BlueStar® Rx |
| Common or Usual Name: | Calculator, Drug Dose |
| Product Codes: | NDC |
| Regulation: | 21 CFR 868.1890 - Calculator, Drug dose |
| Regulatory Class: | II |
| Classification Panel: | Clinical Chemistry |
| Predicate Device: | BlueStar® Rx (K193654) |

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### Device Description

Subject device (BlueStar® Rx) is a modified version of the predicate (BlueStar® Rx cleared under K193654). BlueStar® Rx maintains the basic features / functionality of the predicate and adds the titration of fast-acting bolus insulin doses and premixed insulins for qualified type 2 diabetes patients. Qualified patients are those with type 2 diabetes whose blood glucose is not adequately managed on current insulin therapies (e.g., using basal insulin) and/or non-insulin therapies.

This bolus insulin and premixed titration feature is included as part of the expanded Insulin Adjustment Program (IAP) in BlueStar® Rx. The predicate (BlueStar® Rx, K193654) is a standalone software system intended to be used by healthcare providers (HCPs) and their patients aged 18 years and older - who have type 1 or type 2 diabetes. The system is intended to assist type 1 and type 2 diabetes patients to self-manage their disease. Like the predicate, the subject device (BlueStar® Rx) is intended to provide secure capture, storage, and transmission of blood glucose data as well as other information to aid in diabetes self-management. Patients receive guidance on diabetes self-management, are encouraged to reach out to their healthcare team when needed and have access to a bolus insulin calculator'. The insulin adjustment program (IAP) of the predicate (BlueStar® Rx, K193654) already includes the ability to titrate long-acting basal insulin for patients with type 2 diabetes. In this submission, fast-acting bolus insulin and premixed insulin titration features are added to the subject device's (BlueStar® Rx) IAP for patients with type 2 diabetes.

Health care providers (HCPs) will be required to initiate and manage the titration of basal, bolus and premixed insulin titration for their qualified type 2 diabetes patients using the following two interfaces:

- Web based HCP interface for use by the providers to prescribe insulin doses for the qualified type 2 diabetes patients.
- . Web and mobile patient interface for use by patients to follow provider's insulin titration plan.

The IAP feature in subject device (BlueStar® Rx) provides directions to the patients based on prescription by their HCP for titrating basal, bolus and premixed insulin doses.

### Indications for Use

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 analyzes, and reports blood glucose test results and supports medication adherence. In addition, BlueStar® Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information to aid in diabetes self-management.

- For bolus insulin users with type 1 or type 2 diabetes, BlueStar® Rx includes an insulin ●
¹ Bolus insulin calculator was previously cleared for Welldoc BlueStar® Rx under K190013.

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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 blood 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.
- For bolus insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate . dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen.
- For premixed insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates . appropriate dose adjustments of premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin.

The algorithms for the IAP are not designed for the titration of NPH, regular human insulin, or human premixed insulins. The healthcare provider must activate the IAP and configure it with patient-specific parameters.

BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

| Feature | BlueStar® Rx<br>(Subject Device) | BlueStar® Rx<br>(Predicate Device) |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | NDC | MRZ, NDC, LNX |
| Class | II | II |
| Regulation | 21 CFR 868.1890: Calculator, Drug dose | 21 CFR 880.5725: Accessories, Pump, Infusion<br>21 CFR 868.1890: Calculator, Drug dose |
| 510(k) Number | K203434 | K193654 |
| Target<br>Population for<br>insulin<br>titration | Qualified Type 2 diabetes patients ≥18 years<br>requiring intensification of insulin; and their<br>provider | Qualified Type 2 diabetes patients ≥18 years<br>requiring intensification of insulin; and their<br>provider |
| Environment<br>of Use | Home under direction of HCP and Clinic | Home under direction of HCP and Clinic |
| Indications for<br>Use | BlueStar® Rx is indicated for use by<br>healthcare providers (HCPs) and their patients<br>– aged 18 years and older - who have type 1 or<br>type 2 diabetes. BlueStar® Rx analyzes, and<br>reports blood glucose test results and supports<br>medication adherence. In addition, BlueStar®<br>Rx provides coaching messages (motivational,<br>behavioral, and educational) based on real-<br>time blood glucose values and trends. It<br>includes software intended for use on mobile<br>phones or personal computers in the home or<br>in professional healthcare settings. The<br>software also allows for entry of other | The WellDoc BlueStar® Rx is indicated for<br>use by healthcare providers (HCPs) and their<br>patients – aged 18 years and older - who have<br>type 1 or type 2 diabetes. The BlueStar® Rx is<br>intended to provide secure capture, storage, and<br>transmission of blood glucose data as well as<br>information to aid in diabetes self-management.<br>The BlueStar® Rx analyzes and reports blood<br>glucose test results and supports medication<br>adherence. In addition, the BlueStar® Rx<br>provides coaching messages (motivational,<br>behavioral, and educational) based on real-time<br>blood glucose values and trends. It includes |
| Feature | BlueStar® Rx<br>(Subject Device) | BlueStar® Rx<br>(Predicate Device) |
| | diabetes-related healthcare information and provides educational information to aid in diabetes self-management.<br>• For bolus insulin users with type 1 or 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 blood glucose value.<br>• 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.<br>• For bolus insulin users with type 2 diabetes, BlueStar® Rx 's IAP calculates appropriate dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen.<br>• For premixed insulin users with type 2 diabetes, BlueStar® Rx 's IAP calculates appropriate dose adjustments of premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin.<br>The algorithms for the IAP are not designed for the titration of NPH, regular human insulin, or human premixed insulins. The healthcare provider must activate the IAP and configure it with patient-specific parameters.<br>BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. | software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.<br>• 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 blood glucose value.<br>• 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 Insulin Adjustment Program and configure it for patient-specific parameters.<br>The BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. |
| Software<br>Based | Yes | Yes |
| Platform | Patient interface – web and mobile application<br>HCP interface - web<br><br>Includes support for iOS, Android and web browsers such as Internet Explorer, Chrome, Firefox, Safari and Edge. | Patient interface – web and mobile application<br>HCP interface - web<br><br>Includes support for iOS, Android and web browsers such as Internet Explorer, Chrome, Firefox, Safari and Edge. |
| Basal Insulin<br>Titrated | Basal (long-acting) Insulins:<br>- glargine - U100 (Lantus, Basaglar)<br>- glargine - U300 (Toujeo)<br>- detemir (Levemir)<br>- degludec (Tresiba) | Basal (long-acting) Insulins:<br>- glargine - U100 (Lantus, Basaglar)<br>- glargine - U300 (Toujeo)<br>- detemir (Levemir)<br>- degludec (Tresiba) |
| Feature | BlueStar® Rx<br>(Subject Device) | BlueStar® Rx<br>(Predicate Device) |
| | Basal Insulin + GLP-1 agonist<br>- glargine/Lixisenatide (Soliqua)<br>- degludec/liraglutide (Xultophy) | Basal Insulin + GLP-1 agonist<br>- glargine/Lixisenatide (Soliqua)<br>- degludec/liraglutide (Xultophy) |
| Bolus insulin<br>titrated | Admelog U-100 Apidra U-100 Fiasp U-100 Humalog U-100 Humalog U-200 Novolog U-100 See Note-3 | None |
| Premixed<br>insulin titrated | Humalog Mix 75-25(U-100) Insulin Novolog Mix 70-30 FlexPen U-100 Novolog Mix 70-30 U-100 Insulin Humalog Mix 75-25 KwikPen See Note-3 | None |
| HCP<br>Involvement | HCP inputs are entered and confirmed using<br>the HCP web portal. HCP can monitor and<br>adjust treatment plan. | HCP inputs are entered and confirmed using<br>the HCP web portal. HCP can monitor and<br>adjust treatment plan. |
| Patient<br>Involvement | Patient can record actual dose taken | Patient can record actual dose taken. |
| Primary HCP<br>Inputs<br>(titration) | Insulin type<br>Titration parameters & rules<br>- Initial insulin dose<br>- Maximum dose<br>- Optional (correction factor and IOB)<br>- Algorithm<br>Titration parameters (e.g., insulin increment,<br>interval, BG target) are set based on evidence<br>based titration algorithms. | Insulin type<br>Titration parameters & rules<br>- Initial insulin dose<br>- Interval of titration<br>- Increment of insulin<br>- Maximum dose<br>- Fasting BG target range<br>- Below / above BG target &<br>- corresponding insulin adjustment<br>Titration parameters may be selected from<br>evidence-based titration algorithms or HCP's<br>custom prescription for basal insulin. |
| Patient inputs | Glucose: Fasting, Current (e.g., Pre-Meal, Bedtime) Dose: record insulin dose to reflect actual dose taken Event Type for current glucose reading (e.g., Breakfast) Carbs for Basal-bolus with Carb counting (in app support for carb counting) | Glucose: Fasting, Current (e.g., Pre-Meal, Bedtime) Dose: record insulin dose to reflect actual dose taken Event Type for current glucose reading (e.g., Breakfast) Carbs for Basal-bolus with Carb counting (in app support for carb counting) No support for bolus and premixed insulin<br>titration / IAP. |
| Primary<br>Output for<br>Diabetes | To Patient- Provides warnings and coaching /<br>RTFB when blood glucose values exceed<br>hypoglycemic or hyperglycemic limits; | Basal algorithms see K193654 510(k)<br>Summary |
| Feature | BlueStar® Rx<br>(Subject Device)…