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 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.

AI/ML Overview

The document describes the BlueStar® Rx device, a modified version of a previously cleared device (K193654), which now includes expanded Insulin Adjustment Program (IAP) capabilities for fast-acting bolus insulin and premixed insulin titration for qualified type 2 diabetes patients.

The document does not provide a table of acceptance criteria and reported device performance in a numerical format. Instead, it states that "Performance testing demonstrated that the BlueStar® Rx performed as intended." The performance testing listed are:

Software verification and validation per FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a Major Level of Concern.
Cybersecurity evaluation per 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.
Human Factors testing conducted with intended user populations of patients and healthcare providers. The submission confirmed that the user interface was adequately validated.

Based on the information provided, here are the answers to your questions:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Reported Device Performance (as described)
Software Functionality	Performed as intended, validated per FDA guidance for Major Level of Concern.
Cybersecurity	Evaluated per FDA guidance, addressing Identify and Protect, Detect, Response, and Recover.
Human Factors/Usability	Adequately validated for use by intended user populations (patients and HCPs) per labeling.

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 does not explicitly state the sample size for the test set or the data provenance for the software, cybersecurity, or human factors testing. It refers to human factors testing being conducted with "the intended user populations of patients and healthcare providers" but doesn't specify numbers.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the document. For the software testing, the ground truth would likely be the expected output of the algorithms given specific inputs, which would be established during development and verified against known medical protocols, but no specifics are given regarding expert involvement in establishing this "ground truth" for the test set.

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

This information is not provided in the document.

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 conducted, as stated under "Clinical Tests" where it says "Not Applicable." The device is a 'Drug Dose Calculator' and primarily provides recommendations based on algorithms, rather than being an AI-assisted diagnostic tool that human readers would interpret.

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

The document implies that the performance testing (software verification and validation) for the algorithms, particularly the new bolus and premixed insulin titration features, would inherently be standalone algorithm testing. The IAP "calculates appropriate dose adjustments" (page 2), indicating the algorithm's direct output. However, the system is designed to operate under the supervision of a healthcare provider ("HCP inputs are entered and confirmed using the HCP web portal. HCP can monitor and adjust treatment plan." - page 6). So, while the calculation itself is standalone, the overall system is not without human-in-the-loop. The human factors testing would assess the interaction with the human users, but the core algorithmic performance would be tested standalone.

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

The ground truth for the algorithms is implicitly based on evidence-based titration algorithms from clinical studies (e.g., AUTONOMY study, INITIATE study, Adjust to Target in Type 2 Diabetes, Real-World Approach) as referenced in Note-2 on page 9 and the detailed comparison table (page 6). This effectively means the ground truth is derived from established clinical protocols and research outcomes.

8. The sample size for the training set:

The document does not specify a training set sample size. The BlueStar® Rx is a software medical device that uses predefined algorithms and does not appear to be a machine learning model that undergoes a typical training phase with a distinct training dataset. Its functionality is based on established clinical algorithms rather than learned patterns from a large dataset.

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

As the device uses predefined, evidence-based clinical algorithms rather than having a machine learning training set, the concept of establishing ground truth for a "training set" in the traditional AI sense is not applicable. The underlying algorithms (e.g., AUTONOMY, INITIATE) were developed and validated through prior clinical research and studies, which would have established their efficacy and safety based on patient outcomes and expert consensus in those original studies.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

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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 150Columbia, MD 21044
Contact Person:	Sabyasachi Roy, MSEE, Ph.D.Vice President, Regulatory Affairs
Phone:	(443) 692-3100
Fax:	(443) 692-3099
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

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.

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(Subject Device)	BlueStar® Rx(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, Infusion21 CFR 868.1890: Calculator, Drug dose
510(k) Number	K203434	K193654
TargetPopulation forinsulintitration	Qualified Type 2 diabetes patients ≥18 yearsrequiring intensification of insulin; and theirprovider	Qualified Type 2 diabetes patients ≥18 yearsrequiring intensification of insulin; and theirprovider
Environmentof Use	Home under direction of HCP and Clinic	Home under direction of HCP and Clinic
Indications forUse	BlueStar® Rx is indicated for use byhealthcare providers (HCPs) and their patients– aged 18 years and older - who have type 1 ortype 2 diabetes. BlueStar® Rx analyzes, andreports blood glucose test results and supportsmedication adherence. In addition, BlueStar®Rx provides coaching messages (motivational,behavioral, and educational) based on real-time blood glucose values and trends. Itincludes software intended for use on mobilephones or personal computers in the home orin professional healthcare settings. Thesoftware also allows for entry of other	The WellDoc BlueStar® Rx is indicated foruse by healthcare providers (HCPs) and theirpatients – aged 18 years and older - who havetype 1 or type 2 diabetes. The BlueStar® Rx isintended to provide secure capture, storage, andtransmission of blood glucose data as well asinformation to aid in diabetes self-management.The BlueStar® Rx analyzes and reports bloodglucose test results and supports medicationadherence. In addition, the BlueStar® Rxprovides coaching messages (motivational,behavioral, and educational) based on real-timeblood glucose values and trends. It includes
Feature	BlueStar® Rx(Subject Device)	BlueStar® Rx(Predicate Device)
	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 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.	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. 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.
SoftwareBased	Yes	Yes
Platform	Patient interface – web and mobile applicationHCP interface - webIncludes support for iOS, Android and web browsers such as Internet Explorer, Chrome, Firefox, Safari and Edge.	Patient interface – web and mobile applicationHCP interface - webIncludes support for iOS, Android and web browsers such as Internet Explorer, Chrome, Firefox, Safari and Edge.
Basal InsulinTitrated	Basal (long-acting) Insulins:- glargine - U100 (Lantus, Basaglar)- glargine - U300 (Toujeo)- detemir (Levemir)- degludec (Tresiba)	Basal (long-acting) Insulins:- glargine - U100 (Lantus, Basaglar)- glargine - U300 (Toujeo)- detemir (Levemir)- degludec (Tresiba)
Feature	BlueStar® Rx(Subject Device)	BlueStar® Rx(Predicate Device)
	Basal Insulin + GLP-1 agonist- glargine/Lixisenatide (Soliqua)- degludec/liraglutide (Xultophy)	Basal Insulin + GLP-1 agonist- glargine/Lixisenatide (Soliqua)- degludec/liraglutide (Xultophy)
Bolus insulintitrated	Admelog U-100 Apidra U-100 Fiasp U-100 Humalog U-100 Humalog U-200 Novolog U-100 See Note-3	None
Premixedinsulin 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
HCPInvolvement	HCP inputs are entered and confirmed usingthe HCP web portal. HCP can monitor andadjust treatment plan.	HCP inputs are entered and confirmed usingthe HCP web portal. HCP can monitor andadjust treatment plan.
PatientInvolvement	Patient can record actual dose taken	Patient can record actual dose taken.
Primary HCPInputs(titration)	Insulin typeTitration parameters & rules- Initial insulin dose- Maximum dose- Optional (correction factor and IOB)- AlgorithmTitration parameters (e.g., insulin increment,interval, BG target) are set based on evidencebased titration algorithms.	Insulin typeTitration parameters & rules- Initial insulin dose- Interval of titration- Increment of insulin- Maximum dose- Fasting BG target range- Below / above BG target &- corresponding insulin adjustmentTitration parameters may be selected fromevidence-based titration algorithms or HCP'scustom 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 insulintitration / IAP.
PrimaryOutput forDiabetes	To Patient- Provides warnings and coaching /RTFB when blood glucose values exceedhypoglycemic or hyperglycemic limits;	Basal algorithms see K193654 510(k)Summary
Feature	BlueStar® Rx(Subject Device)	BlueStar® Rx(Predicate Device)
Management	provides recommended adjustments to the prescribedinsulin dose; tracks blood glucose and insulindata; send SMART visit report to HCP.To HCP - alerts when blood glucose valuesexceed hypoglycemic or hyperglycemic limitsor patient deviates from prescribed regimen;and view titration progress and summaryreport.See Note-3	No bolus or premixed titration algorithms.
Limits forSafety	The system provides hypoglycemia coachinginstructions; bolus insulin algorithm isconstrained to a 4 unit dosage increase over a 3day period (Q3D); maximum insulin dose is 30units per dose for both bolus (Insulin-to-Carbohydrate Ratio) and 70 units premixinsulin (see Note-1).See Note-3	Basal algorithms see K193654 510(k)SummaryNo bolus or premixed algorithms.
Warnings	Hypoglycemia and Hyperglycemia coachinginstructions; patient deviates from prescribedregimen; Alerts sent to HCPs.See Note-3	Basal algorithms see K193654 510(k)SummaryNo bolus or premixed algorithms.
Logbook	Yes	Yes
Reports &Statistics	Yes	Yes
SecureDatabase	Yes	Yes
Data TransferMode	Internet	Internet
AlgorithmUsed	Bolus InsulinsHumalog, Apidra, Novolog - AUTONOMYICRApidra - Adjust to TargetPremixed InsulinINITIATEReal-World Approach (Hirsch et al. 2005)See Note-2 and Note-3	Basal algorithms see K193654 510(k)SummaryNo bolus or premixed titration algorithms.
GlucoseTarget	Q1D or Q3D - BG Target Range (not-editable)85 - 114 mg/dLQ7D-ICR - BG Target Range (not-editable) 80- 130 mg/dL	Basal algorithms see K193654 510(k)SummaryNo bolus or premixed titration algorithms.
Magnitude ofinsulinadjustment asafunction oftarget	The incremental dose adjustment does notchange as a function of target; the doseadjustment is based on the algorithm used inclinical studies.	Basal algorithms see K193654 510(k)SummaryNo bolus or premixed titration algorithms.
Feature	BlueStar® Rx(Subject Device)	BlueStar® Rx(Predicate Device)
insulinadjustment	Bolus insulin algorithm is constrained to a4unit dosage increase per 3-day period (Q3D);maximum insulin dose is 30 units per dose forbolus (Insulin-to-Carbohydrate Ratio) and 70units for premix insulin.	SummaryNo bolus or premixed titration algorithms.
Frequency ofinsulinadjustment(increase)	No more than once daily.	Basal algorithms see K193654 510(k)SummaryNo bolus or premixed titration algorithms.
Frequency ofinsulinadjustment(decrease)	Daily decrease allowed.	Basal algorithms see K193654 510(k)SummaryNo bolus or premixed titration algorithms.

Comparison to Predicates

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Note-1: Premixed insulin is a combination of long-acting (bolus) insulin in one injection. In a 70/30 premix, only 30% of the insulin is bolus. The total max dose for premix can be higher than the max dose for bolus.

Note-2: Edelman et al. 2014 (AUTONOMY study / algorithm); Raskin et al 2005 (INITIATE study / algorithm); Bergenstal et al. 2008 (Adjust to Target in Type 2 Diabetes); Hirsch et al. 2005 (Real-World Approach).

Note-3: Similar to other devices such as Go Dose System (K160949) and d-Nav System (K181916).

Discussions of similarities and differences in Indications for Use statement:

The subject device (BlueStar® Rx), and predicate (BlueStar® Rx, K193654) share the following similarities:

. Devices use blood glucose value to calculate a recommended insulin dose in order to aid in optimal insulin management.
Devices are used by similar target population. With regards to insulin titration feature, ● both devices are intended for patients with type 2 diabetes.
Devices are prescription use and used in home and clinical settings. ●
Device software operate on the basic setup where an HCP configures, initiates and then ● oversees the insulin titration process.
Information for diabetes management is provided in both devices.
None of the devices are intended to be a substitute for professional clinical advice.

Compared to the predicate (BlueStar® Rx, K193654), the subject device proposes to make the following changes:

-Expand the Insulin Adjustment Program (IAP) to include fast-acting bolus insulin and premixed insulin titration for qualified type 2 diabetes patients
The indications for use of the subject device (BlueStar® Rx) clearly reflects this expansion of the IAP capability in the two additional statement included:

"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.

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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."

These statements are equivalent to the indications of the predicate (BlueStar® Rx, K193654) and other devices such as (Go Dose System, K160949: d-Nav System, K181916),

The difference in indications for use do not raise any new questions of safety or effectiveness. The subject device and predicate have similar intended population and intended use.

Discussions of similarities and differences in technological characteristics:

The core technological characteristics between the subject device (BlueStar® Rx) and predicate (BlueStar® Rx) cleared under K193654 remain the same. The subject device (BlueStar® Rx) is built upon the predicate's software application platform. The subject device (BlueStar® Rx) incorporates the bolus and premixed insulin titrations features to the existing capabilities of the predicate without requiring any software architecture or fundamental design change. The bolus and premixed insulin titration features utilized the basic building blocks of adjusting patient's insulin under the supervision of an HCP as cleared under K193654. The bolus insulin titration features in the subject device (BlueStar® Rx) are similar to other devices such as Go Dose System cleared under K160949. The premixed insulin titration features in the subject device (BlueStar® Rx) are similar to other devices such as d-Nav System cleared under K181916. A thorough comparison of the subject device with its predicate is outlined in the table above.

The similarities between the subject device and predicate are outline as follows:

. All are insulin dose calculator software systems
Include separate software components for use by HCP and patient ●
. Enable HCP to initiate and adjust insulin dosage based on individual patient's treatment plan
Support a variety of insulin drugs, including basal, premixed and bolus insulins.
. Subject device (BlueStar® Rx) uses the identical algorithm (AUTONOMY study2) for bolus insulin titration as that used in device such as Go Dose System (K160949). The eligible insulins for bolus titration in the subject device are those that are fast-acting insulin analogs which is the type of insulin used in devices such as Go Dose System.
. Provide a history of responses (e.g., glucose reading) and insulin doses to both HCP and patients
Incorporate safety features (e.g., limit max change in next dose) and warnings (e.g., ● hyperglycemia, hypoglycemia).

The implementation of the bolus and premixed insulin titration in the subject device (BlueStar® Rx) did not require significant changes to existing design of the predicate (BlueStar® Rx, K193654) application except:

2 Edelman SV, Liu R, Johnson J, Glass LC. AUTONOMY: the first randomized trial comparing two patient-driven approaches to initiate and titrate prandial insulin lispro in type 2 diabetes Care. 2014 Aug;37(8): 2132-40. doi: 10.2337/dc13-2664. Epub 2014 Apr 17. PMID: 24742662.

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. There are now RTFB / coaching messages specific to bolus titration or premixed titration; standard RTFB / coaching is turned off for users in the IAP.
Weekly insights, trends, weekly challenge, rewards, and CGM connection are disabled . (off) for users in the IAP.
Users cannot change their diabetes type. ●
. Users undergoing titration cannot add other insulin (basal, bolus, or premixed) to their med list and cannot edit the insulins prescribed in their titration program.
Users cannot undergo basal titration while in bolus or premixed titration. ●
. The design and function of the insulin calculator is unchanged other than a banner alerting user to an updated dosing regimen while in titration.
The UI of the home screen and some sub-menus were updated but is not expected to . significantly impact device function including usability.

The inclusion of the bolus and premixed insulin titration under the Insulin Adjustment Program (IAP) in the subject device did not interfere with the existing functionality cleared in the BlueStar® Rx app under K193654.

In terms of technological characteristics, the subject device (BlueStar® Rx) and the predicate device differ in certain minor details. However, those difference do NOT raise new questions of safety or effectiveness.

Performance Testing

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

Software	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”
Cybersecurity	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
Human Factors	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.

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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 device (BlueStar® Rx, K193654).

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 predicate cited.

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).