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. The BlueStar® Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, the 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.
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.
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 knowledgeable in the care and management of diabetes. The healthcare provider must activate the Insulin Adjustment Program and configure it for patient-specific parameters.
The BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Device Description

BlueStar Rx is a modified version of the primary predicate (WellDoc BlueStar Rx cleared under K190013). BlueStar Rx maintains all of the features of the primary predicate and adds the titration of long-acting basal insulin doses for qualified type 2 diabetes patients who are not using bolus insulin. This long-acting basal insulin titration feature is included as part of the Insulin Adjustment Program (IAP) in BlueStar Rx. WellDoc BlueStar® as cleared under K190013, is a stand-alone 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. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. There are two versions of the primary predicate WellDoc BlueStar® (cleared under K190013) -BlueStar® (OTC version) and BlueStar® Rx (prescription only) applications. In this submission, Welldoc does not propose to change the OTC version of BlueStar application. Like the bolus insulin dose calculator already included in the primary predicate (BlueStar Rx), the new long-acting basal insulin titration feature is also limited to the prescription use (Rx) version. The bolus insulin calculator feature will be disabled in patients using long-acting basal insulin titration feature in the BlueStar Rx. Health care providers (HCPs) will be required to initiate and manage the basal 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 long-acting basal insulin doses for the qualified type 2 diabetes patients.
Web and mobile patient interface for use by patients to follow provider's basal insulin titration plan.
The IAP feature in BlueStar Rx provides directions to the patients based on prescription by their HCP for titrating long-acting insulin doses only.
BlueStar® Rx will also maintain the following features of the primary predicate (WellDoc BlueStar Rx cleared under K190013): (1) ability to connect to the One Touch Verio Flex Blood Glucose Meter via Bluetooth which allows users to send data from their BG meter to the BlueStar® Rx app. which will provide coaching messages (motivational, and educational) based on the real-time blood glucose values and trends. (2) The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (from FDA Guidence)	Reported Device Performance
Software verification and validation per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a Major Level of Concern and "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices".	"Software verification and validation per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a Major Level of Concern FDA Guidance “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices”" (It's stated that this bench testing was performed).
Cybersecurity evaluation per the FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff, (October 2, 2014). Specifically, addressing: Identify and Protect, Detect, Response and Recover.	"Cybersecurity was evaluated per the FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff, (October 2, 2014). Specifically, addressing the following areas: Identify and Protect, Detect, Response and Recover" (It's stated that this bench testing was performed).
Human factors validation (user interface adequately validated for use per labeling) with intended user populations.	"Human factors testing was conducted with the intended user populations of patients and healthcare providers. The human factors, design, and labeling information provided in the submission confirm that the user interface has been adequately validated for use per the labeling." (It's stated that this testing was conducted).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Performance testing" including "Software verification and validation," "Cybersecurity," and "Human Factors" testing. However, it does not specify sample sizes for any test sets, nor does it provide information about the data provenance (e.g., country of origin or whether it was retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document mentions "intended user populations of patients and healthcare providers" for human factors testing, but does not specify the number or qualifications of experts used to establish ground truth for any of the performance tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not specify any adjudication method for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not specifically mentioned or described in the provided text. The document refers to the device assisting self-management and providing calculated insulin doses, but not in the context of human reader performance improvement with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document describes the "Insulin Adjustment Program (IAP)" which calculates appropriate long-acting basal insulin doses based on configuration by a healthcare provider. While the calculation itself is algorithmic, the system requires a "human-in-the-loop" for activation, configuration, and management by the healthcare provider, and the patient follows directions. Therefore, a purely standalone algorithm-only performance study in isolation from human interaction is not explicitly described in the context of the device's function. The performance testing focuses on software, cybersecurity, and human factors interaction with the system, implying a human-in-the-loop context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for the performance testing. For software verification and validation, ground truth would typically be derived from functional specifications and expected outputs. For human factors, it would likely involve observations and feedback from users regarding usability and clarity.

8. The sample size for the training set

The document does not provide any information regarding the sample size for a training set. This is generally because the device is a rule-based system (an "Insulin Adjustment Program" that "calculates appropriate long-acting basal insulin doses based on configuration by a healthcare provider") rather than a machine learning model that requires explicit training data.

9. How the ground truth for the training set was established

Since the document does not mention a training set, it does not describe how ground truth for a training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

May 21, 2024

Re: K193654

Trade/Device Name: BlueStar® Rx - IAP Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: MRZ, NDC

Dear Sabyasachi Roy:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 7, 2020. Specifically, FDA is updating this SE letter as an administrative correction. A secondary product code, LNX, was inadvertently included.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Marianela Perez-Torres, OHT7: Office of In Vitro Diagnostics Devices, 301-796-1489, Marianela.Perez-Torres@fda.hhs.gov.

Sincerely,

Marianela Perez-torres -S

Marianela Perez-Torres, Ph.D. Director DHT7: Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

April 7, 2020

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

Re: K193654

Trade/Device Name: BlueStar® Rx Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRZ, NDC, LNX Dated: March 4, 2020 Received: March 4, 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 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

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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 531-542 of the Act); 21 CFR 1000-1050.

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 mediation-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 (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Marianela Perez-torres -S

Marianela Perez-Torres, Ph.D. Acting 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) K193654

Device Name BlueStar® Rx

Indications for Use (Describe)

• 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 knowledgeable in the care and management of diabetes. The healthcare provider must activate the Insulin Adjustment Program and configure it for patient-specific parameters.

The 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)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared:	December 30, 2019
Name of Manufacturer:	WellDoc, Inc.
Address:	10221 Wincopin Circle, Suite 150Columbia, MD 21044
Contact Person:	Sabyasachi Roy, MSEE, Ph.D.VP, Regulatory and Quality Systems
Phone:	(443) 692-3100
Fax:	(443) 692-3099
Trade or Proprietary Name:	BlueStar® Rx
Common or Usual Name:	Medical computers and softwareInfusion pump accessories
Product Codes:	Classification: MRZ,Secondary: NDC, LNX
Regulation:	21 CFR 880.5725 – Accessories, Pump, Infusion21 CFR 868.1890 – Calculator, Drug dose
Regulatory Class:	II
Classification Panel:	General Hospital, Clinical Chemistry
Primary Predicate Device:	K190013 (WellDoc® BlueStar® and WellDoc® BlueStar® Rx System)
Secondary Predicate Device:	K171450 (Glooko Mobile Insulin Dosing System (MIDS))

Device Description

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diabetes patients to self-manage their disease. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. There are two versions of the primary predicate WellDoc BlueStar® (cleared under K190013) -BlueStar® (OTC version) and BlueStar® Rx (prescription only) applications. In this submission, Welldoc does not propose to change the OTC version of BlueStar application. Like the bolus insulin dose calculator already included in the primary predicate (BlueStar Rx), the new long-acting basal insulin titration feature is also limited to the prescription use (Rx) version. The bolus insulin calculator feature will be disabled in patients using long-acting basal insulin titration feature in the BlueStar Rx. Health care providers (HCPs) will be required to initiate and manage the basal 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 long-acting basal insulin doses for the qualified type 2 diabetes patients.
Web and mobile patient interface for use by patients to follow provider's basal insulin titration plan.

The IAP feature in BlueStar Rx provides directions to the patients based on prescription by their HCP for titrating long-acting insulin doses only.

BlueStar® Rx will also maintain the following features of the primary predicate (WellDoc BlueStar Rx cleared under K190013): (1) ability to connect to the One Touch Verio Flex Blood Glucose Meter via Bluetooth which allows users to send data from their BG meter to the BlueStar® Rx app. which will provide coaching messages (motivational, and educational) based on the real-time blood glucose values and trends. (2) The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only.

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. The BlueStar® Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, the 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.

. 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.

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

Feature	BlueStar Rx(Subject Device)	WellDoc BlueStar Rx System(Primary Predicate Device)	Glooko Mobile InsulinDosing System (MIDS)(Secondary Predicate)
Product Code	MRZ, NDC, LNX	MRZ, NDC, LNX	NDC
Class	II	II	II
Regulation	21 CFR 880.5725: Accessories,Pump, Infusion21 CFR 868.1890: Calculator,Drug dose	21 CFR 880.5725:Accessories, Pump, Infusion21 CFR 868.1890: Calculator,Drug dose	21 CFR 868.1890: Calculator,Drug dose
510(k)Number	K193654	K190013	K171450
Indicationsfor Use	Rx:BlueStar® Rx is indicated foruse by healthcare providers(HCPs) and their patients –aged 18 years and older - whohave type 1 or type 2 diabetes.The BlueStar® Rx is intendedto provide secure capture,storage, and transmission ofblood glucose data as well asinformation to aid in diabetesself-management. TheBlueStar® Rx analyzes andreports blood glucose testresults and supportsmedication adherence. Inaddition, the BlueStar® Rxprovides coaching messages(motivational, behavioral, andeducational) based on real-timeblood glucose values andtrends. It includes softwareintended for use on mobilephones or personal computers	Rx:The WellDoc BlueStar® RxSystem is indicated for use byhealthcare providers (HCPs)and their patients – aged 18years and older - who havetype 1 or type 2 diabetes. TheBlueStar® Rx System isintended to provide securecapture, storage, andtransmission of blood glucosedata as well as information toaid in diabetes self-management. The BlueStar®Rx System analyzes andreports blood glucose testresults and supportsmedication adherence. Inaddition, the BlueStar® RxSystem provides coachingmessages (motivational,behavioral, and educational)based on real-time bloodglucose values and trends. It	The Glooko Mobile InsulinDosingSystem (MIDS) is indicatedfor themanagement of type 2diabetes by calculatingappropriate long-actingbasal insulin doses fortitrating insulin levels basedon configuration by aphysician or healthcareproviderknowledgeable in the careand management of diabetes.The physician or healthcareprovider must activate theMIDS dose calculator andconfigure the patient-specificparameters. The system is notintended to provide treatmentdecisions or to be used as asubstitute for professionalhealthcare advice.
Feature	BlueStar Rx(Subject Device)	BlueStar Rx System(Primary Predicate Device)	Glooko Mobile InsulinDosing System (MIDS)(Secondary Predicate)
	in the home or in professionalhealthcare settings. Thesoftware also allows for entryof other diabetes-relatedhealthcare information andprovides educationalinformation.For bolus insulin userswith type 1 and type 2diabetes, BlueStar® Rxincludes an insulindose calculator toallow patients to usetheir prescribedregimen to calculate adose of bolus insulinfor a given amount ofcarbohydrates and/orblood glucose value. For basal insulin userswith type 2 diabetes,BlueStar Rx includesan Insulin AdjustmentProgram (IAP) whichcalculates appropriatelong-acting basalinsulin doses fortitrating insulin levelsbased on configurationby a healthcareprovider. Thehealthcare providermust activate theInsulin AdjustmentProgram and configureit for patient-specificparameters. The BlueStar® Rx is notintended to replace the careprovided by a licensedhealthcare professional,including prescriptions,diagnosis, or treatment.	includes software intended foruse on mobile phones orpersonal computers in thehome or in professionalhealthcare settings. Thesoftware also allows for entryof other diabetes-relatedhealthcare information andprovides educationalinformation. BlueStar® Rxincludes an insulin dosecalculator to allow patients touse their prescribed regimento calculate a dose of insulinfor a given amount ofcarbohydrates and/or bloodglucose value.The BlueStar® Rx System isnot intended to replace thecare provided by a licensedhealthcare professional,including prescriptions,diagnosis, or treatment.
Environmentof Use	Home or Clinic	Home or Clinic	Home or Clinic
Feature	BlueStar Rx(Subject Device)	WellDoc BlueStar Rx System(Primary Predicate Device)	Glooko Mobile Insulin Dosing System (MIDS)(Secondary Predicate)
Type ofInsulinAdjustment	Bolus Insulin Calculation andBasal (long-acting) InsulinTitration	Bolus Insulin Calculation	Basal (long-acting) InsulinTitration
TitrationPlan	HCP determined	N/A	HCP determined
BasalTitrationSafetyFeatures	- Suspends titration onhypoglycemia- Suspends titration onunsafe dose- Maximum dose set by HCP(system limits to 100-units)- Fasting BG reminder- Insulin injection reminder- Report to HCP	N/A as Basal Titration notincluded	- Suspends titration onhypoglycemia- Suspends titration onunsafe dose- Maximum dose set byHCP- Fasting BG reminder- Insulin injection reminder- Report to HCP
SafetyNotifications	Yes (Hyper notification withinstructions;Hypo notification withinstructions;Unsafe dose;Maximum dose)	N/A for Basal Titration	Yes (Hyper notification withinstructions;Hypo notification withinstructions;Unsafe dose;Maximum dose)
BasalTitrationStatus	ActiveSuspendedEnded	N/A for Basal Titration	ActiveInactiveAlertAdherenceEnded
Logbook	Yes	Yes	Yes
Technological Characteristics
Interface	Patient interface - web andmobile applicationHCP interface - web	Patient interface - web andmobile applicationHCP interface - web.	Patient interface - web andmobile applicationHCP interface - web
	Includes support for iOS,Android and web browserssuch as Internet Explorer,Chrome, Firefox, Safari.	Includes support for iOS,Android and web browserssuch as Internet Explorer,Chrome, Firefox, Safari andothers.	Includes support for iOS,Android and web browserssuch as Internet Explorer,Chrome, Firefox, Safari.
Reports &Statistics	Yes	Yes	Yes
SecureDatabase	Yes	Yes	Yes
DataTransferMode	Internet	Internet	Internet

Comparison to Predicates

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Discussions of differences in Indications for Use statement:

As compared to the previously cleared version of the BlueStar® Rx, the subject device of this

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application proposes to make the following changes:

Requires HCPs to initiate and manage long-acting basal insulin titration for their patients with type 2 diabetes
The indications for use of the subject device clearly reflects this new basal insulin titration capability in the statement included:

"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."

This statement is equivalent to the secondary predicate's (Glooko MIDS) indications for use as noted in the table above.

Discussions of differences in technological characteristics:

The subject device includes all of the features of the WellDoc BlueStar® Rx system cleared under K190013 and is technologically similar to the secondary predicate - Glooko MIDS. The subject device maintains all of the technological capabilities of the primary predicate (BlueStar® and BlueStar® Rx) including:

the ability to connect to the One Touch Verio Flex Blood Glucose Meter via Bluetooth. ● This will allow users to send data from their meter to the BlueStar® and BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends.
the BlueStar Server also has the ability to transmit data to the OneTouch Reveal Server. ● With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only.

The inclusion of the basal insulin titration under the Insulin Adjustment (IAP) feature in the subject device does not interfere with the existing functionality cleared in the WellDoc BlueStar® and WellDoc BlueStar® Rx app under K190013.

Performance Testing

The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:

Software	Software verification and validation per the FDA Guidance for theContent of Premarket Submissions for Software Contained in MedicalDevices (May 11, 2005) for a Major Level of Concern FDA Guidance “Guidance for Industry, FDA Reviewers andCompliance on Off-the-Shelf Software Use in Medical Devices”
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Cybersecurity	• Cybersecurity was evaluated per the FDA Guidance Content ofPremarket Submissions for Management of Cybersecurity in MedicalDevices Guidance for Industry and Food and Drug Administration Staff,(October 2, 2014). Specifically, addressing the following areas: Identifyand Protect, Detect, Response and Recover
Human Factors	• Human factors testing was conducted with the intended user populationsof patients and healthcare providers. The human factors, design, andlabeling information provided in the submission confirm that the userinterface has been adequately validated for use per the labeling.

Clinical Tests

Not Applicable.

Conclusions

The subject device in this premarket notification - BlueStar® Rx with the Insulin Adjustment Program (IAP) feature has similar indications for use and technological characteristics as those of the predicate devices (WellDoc BlueStar® Rx cleared under K190013 and Glooko MIDS cleared under K171450).

Performance testing demonstrated that the BlueStar® Rx performed as intended. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The BlueStar Rx is substantially equivalent to the predicates cited.

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).