The WellDoc BlueStar® System 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 System 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® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System 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.

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

The WellDoc BlueStar® Rx System 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 System 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 System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System 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. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.

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

Device Description

WellDoc® BlueStar® 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, as cleared under K162532. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® - BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a licensed HCP with prescribing authority.

BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications:

Enterprise Director Portal
HCP Service
Patient Mobile Application
Patient Web Portal

The Enterprise Director application is used for administrative purposes. The HCP Service houses the Medication Reconciliation feature, which allows for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273).

The Patient Web Portal and the Patient Mobile application have a similar feature set. Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications are stored in the database and can be retrieved for display in either application. Both applications require the initial web- or mobile-based registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers.

In BlueStar® Rx, the patient web portal and mobile application also provide an insulin calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. This submission introduces Insulin on Board to be considered in the calculation. The insulin dose calculator is indicated for prescription-use only.

Furthermore, as cleared under K162225, BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the 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 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. These modifications do not change the fundamental scientific technology of the device.

AI/ML Overview

This document describes the WellDoc BlueStar and BlueStar Rx System, a software system for diabetes self-management. This 510(k) summary (K190013) references K162532 as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria with specific performance metrics (e.g., accuracy percentages, error rates). Instead, it states that the device's performance was evaluated through various non-clinical tests to demonstrate substantial equivalence to its predicate.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Software	Compliance with 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." Implied acceptance of proper functionality and reliability of the 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”" (No specific performance metrics are given, but compliance with these guidances indicates successful V&V.)
Cybersecurity	Evaluation per FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2, 2014), specifically addressing Identify, Protect, Detect, Response, and Recover areas. Implied acceptance of robust cybersecurity measures.	"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" (No specific performance metrics are given, but evaluation against this guidance implies successful implementation of cybersecurity.)
Human Factors	Adequate validation of the user interface for use per the labeling for both patients and healthcare providers, ensuring safe and effective interaction for the 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." (This indicates successful human factors testing that supports the user interface's validity for its intended use.)
Insulin on Board	No new questions of safety or effectiveness are raised by the addition of Insulin on Board (IOB) to the insulin dose calculator function. The linear decay model used must be "well-understood and accepted."	"Both the subject device and reference device use a well-understood and accepted linear decay model to model the Insulin on Board decay. There are no notable differences with regards to this technological characteristic to a previously-cleared device." (This confirms the successful application of the IOB feature without raising new safety/effectiveness concerns, aligning with the implied criteria.)
CGM Data Access	No new questions with regards to software or cybersecurity due to the ability to receive 3-hour delayed data from continuous glucose monitoring devices via API for data visualization only. Compliance with special controls stated in 21 CFR 862.1350 (related to CGM secondary display regulation).	"The subject device does not use Bluetooth to connect to a Continuous Glucose Meter directly. There are no new questions with regards to software or cybersecurity. De Novo DEN140038 classified CGM secondary display regulation. BlueStar has complied per the special controls stated in 21 CFR 862.1350." (This indicates successful integration of CGM data access without introducing new software or cybersecurity risks, and compliance with relevant regulations.)
Overall Equivalence	The differences between the subject and predicate devices (expanded patient population, IOB, CGM data access) do not raise different questions of safety or effectiveness, and performance data demonstrates substantially equivalent performance to the predicate.	"The differences between the predicate and the subject devices do not raise any new or different questions of safety or effectiveness. The WellDoc® BlueStar® and BlueStar® Rx System is substantially equivalent to WellDoc® BlueStar® and BlueStar® Rx System cleared under K162532 with respect to the indications for use, target populations, treatment method, and technological characteristics." "Performance data provided in the submission, including human factors, design, and labeling information, demonstrate substantially equivalent performance to the predicate." (This is the overarching conclusion of the submission, confirming the device meets the substantial equivalence criteria.)

2. Sample Sizes used for the Test Set and Data Provenance

The document explicitly states: "Clinical Tests: Not Applicable."
Therefore, there is no test set or information regarding sample sizes, country of origin, or retrospective/prospective nature of data for clinical validation of device performance. The performance claim is based on non-clinical testing and substantial equivalence to a predicate device.

For the Human Factors testing, it mentions: "Human factors testing was conducted with the intended user populations of patients and healthcare providers." However, specific sample sizes for these user populations are not provided. The data provenance is not stated (e.g., country of origin, prospective or retrospective).

3. Number of Experts used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts

As there were no clinical tests and no explicit "test set" in the context of clinical performance evaluation (only non-clinical V&V and human factors), there is no information provided about experts establishing ground truth for a test set.

For the human factors study, "healthcare providers" were part of the intended user population, implying experts were involved as participants, but not in establishing ground truth in the traditional sense of diagnostic accuracy. Their qualifications beyond being "healthcare providers" are not detailed.

4. Adjudication Method for the Test Set

Since there was no clinical "test set" requiring ground truth establishment, no adjudication method (e.g., 2+1, 3+1, none) is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document states "Clinical Tests: Not Applicable."

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

The document primarily focuses on the software system's functionality and its ability to process data, provide coaching messages, and calculate insulin doses. The "Software verification and validation" would assess the algorithm's standalone performance in terms of its intended functions. However, there isn't a separate, explicit study titled "standalone performance study" with specific metrics beyond the general software V&V. The human factors testing then evaluates it with human interaction. The insulin dose calculator performs its calculations algorithmically, and its "performance" is implicitly evaluated through software V&V and comparison to a well-understood linear decay model.

7. The type of ground truth used

For the software validation, the "ground truth" would be the expected output of the algorithms and software logic based on design specifications and established clinical models (e.g., for the insulin dose calculator, the "ground truth" is a correct calculation based on inputted parameters and a 'well-understood and accepted linear decay model'). For cybersecurity, the ground truth is adherence to security best practices and robustness against known vulnerabilities. For human factors, the ground truth is the usability and safety of the interface as determined by user interaction and expert review. No pathology or outcomes data is mentioned as ground truth.

8. The sample size for the training set

The document does not mention a training set or its sample size. This is a software medical device, and the evaluation is primarily focused on verification and validation of its deterministic functions, safety, cybersecurity, and human factors, rather than a machine learning model that would require a distinct training set.

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

Since no training set is mentioned, the method for establishing its ground truth is not applicable.

Summary

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November 4, 2019

WellDoc. Inc. Caroline York Senior Vice President, Operations 10221 Wincopin Circle, Suite 150 Columbia, Maryland 21044

Re: K190013

Trade/Device Name: WellDoc BlueStar Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRZ, NDC Dated: October 25, 2019 Received: October 28, 2019

Dear Caroline York:

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

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801); 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 531-542 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 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,

Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices 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) K190013

Device Name WellDoc® BlueStar®

Indications for Use (Describe)

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

The BlueStar® System 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)

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

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Indications for Use

510(k) Number (if known) K190013

Device Name WellDoc® BlueStar®

Indications for Use (Describe)

The WellDoc BlueStar® Rx System 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 System 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 System and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System provides coaching messages (motivational, behavioral) 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. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.

The BlueStar® Rx System 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)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K190013 510(k) Summary

Date of Summary Preparation:	November 1, 2019
Name of Manufacturer:	WellDoc, Inc.
Address:	10221 Wincopin Circle, Suite 150
	Columbia, MD 21044
Contact Person:	Kevin McRaith
	Chief Executive Officer
Phone:	(443) 692-3100
Fax:	(443) 692-3099
Trade or Proprietary Name:	WellDoc® BlueStar®
Common or Usual Name:	Medical computers and software
	Infusion pump accessories
Product Codes:	MRZ, NDC
Regulation:	21 CFR 880.5725 - Accessories, Pump, Infusion
	21 CFR 868.1890 - Calculator, Drug dose
Regulatory Class:	II
Classification Panel:	General Hospital
Predicate Device:	K162532 (WellDoc® BlueStar® and BlueStar® Rx System)
Reference Device:	K150910 (Accu-chek Connect Diabetes Management Application)

Device Description

Enterprise Director Portal ●
. HCP Service
Patient Mobile Application ●
Patient Web Portal ●

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Indications for Use

The device has two (2) versions: over the counter and prescription.

OTC:

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

Rx:

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

Intended Use

The intended use of the subject device is unchanged from the previously cleared version (K162352), and is as follows:

The BlueStar® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes selfmanagement. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System 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. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.

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

Substantial Equivalence Discussion

Intended Use Comparison

The table below includes a comparison of the intended use between the new device and those of the predicate device:

Characteristic	Subject Device	Predicate Device
	The WellDoc BlueStar System	The WellDoc BlueStar System

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K190013	K162532
OTC: The WellDoc BlueStar® System isindicated for use by healthcare providers(HCPs) and their patients - aged 18 yearsand older - who have Type 1 or Type 2diabetes. The BlueStar® System is intendedto provide secure capture, storage, andtransmission of blood glucose data as wellas information to aid in diabetes self-management. The BlueStar® Systemanalyzes and reports blood glucose testresults and supports medication adherence.In addition, the BlueStar® System providescoaching messages (motivational,behavioral, and educational) based on real-time blood glucose values and trends. Itincludes software intended for use onmobile phones or personal computers in thehome or in professional healthcare settings.The software also allows for entry of otherdiabetes-related healthcare information andprovides educational information.	OTC: The WellDoc BlueStar® System isindicated for use by healthcare providers(HCPs) and their adult patients – aged 21years and older - who have type 2 diabetes.The BlueStar System is intended toprovide secure capture, storage, andtransmission of blood glucose data as wellas information to aid in diabetes self-management. The BlueStar® Systemanalyzes and reports blood glucose testresults and supports medication adherence.In addition, the BlueStar System providescoaching messages (motivational,behavioral, and educational) based on real-time blood glucose values and trends. Itincludes software intended for use onmobile phones or personal computers inthe home or in professional healthcaresettings. The software also allows for entryof other diabetes-related healthcareinformation and provides educationalinformation.
Indications for Use The BlueStar® System is not intended toreplace the care provided by a licensedhealthcare professional, includingprescriptions, diagnosis, or treatment.Rx: BlueStar is indicated for use byhealthcare providers (HCPs) and their adultpatients - aged 18 years and older - whohave Type 1 or Type 2 diabetes. BlueStar®Rx is intended to provide secure capture,storage, and transmission of blood glucosedata as well as information to aid in diabetesself-management. BlueStar® Rx analyzesand reports blood glucose test results andsupports medication adherence. In addition,BlueStar® Rx provides coaching messages(motivational, behavioral, and educational)based on real-time blood glucose values andtrends. It includes software intended for useon mobile phones or personal computers inthe home or in professional healthcare	The BlueStar® System is not intended toreplace the care provided by a licensedhealthcare professional, includingprescriptions, diagnosis, or treatment.Rx: BlueStar® Rx is indicated for use byhealthcare providers (HCPs) and theiradult patients – aged 21 years and older -who have type 2 diabetes. BlueStar® Rx isintended to provide secure capture,storage, and transmission of blood glucosedata as well as information to aid indiabetes self-management. BlueStar® Rxanalyzes and reports blood glucose testresults and supports medication adherence.In addition, BlueStar® Rx providescoaching messages (motivational,behavioral, and educational) based on real-time blood glucose values and trends. It
	of other diabetes-related healthcareinformation and provides educationalinformation. The prescription version ofBlueStar® Rx includes an insulin dosecalculator to allow patients to use theirprescribed regimen to calculate a dose ofinsulin for a given amount of carbohydratesand/or blood glucose value.BlueStar® Rx is not intended to replace thecare provided by a licensed healthcareprofessional, including prescriptions,diagnosis, or treatment.	mobile phones or personal computers inthe home or in professional healthcaresettings. The software also allows for entryof other diabetes-related healthcareinformation and provides educationalinformation. The prescription version ofBlueStar® Rx includes an insulin dosecalculator to allow patients to use theirprescribed regimen to calculate a dose ofinsulin for a given amount ofcarbohydrates and/or blood glucose value.BlueStar® Rx is not intended to replacethe care provided by a licensed healthcareprofessional, including prescriptions,diagnosis, or treatment.
Prescription OnlyorOver the Counter	OTC, Rx	OTC, Rx
Intended Population	Patients with Type 1 or Type 2 Diabetes;Aged 18 and older	Patients with Type 2 Diabetes;Aged 21 and older
Environment ofUse	Home or Clinic	Home or Clinic

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Discussions of differences in Indications for Use statement

As compared to the previously cleared version, the subject device of this application proposes to make the following changes:

Change the indications for use to include Type 1 diabetic patients to the user group; ●
Change the indications for use to allow use in patients aged 18 and older (previously it was 21 years and older);
Add Insulin on Board (IOB) to its insulin dose calculator function; and ●
Add the ability to receive 3-hour delayed data from continuous glucose monitors via API for data visualization purposes only.

Discussions of differences in intended population

Change the indications for use to include Type 1 diabetic patients to the user group;
Change the indications for use to allow use in patients aged 18 and older (previously it was 21 years and older);

Discussions of differences in environment of use

The environment of use for the subject device is identical to the predicate device: home and clinic use.

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Summary

The subject and predicate devices are both insulin dose calculators intended to be used by diabetic patients. The differences between the subject and predicate devices are focused on the intended patient population being expanded to include Type 1 diabetic patients and patients aged 18 and older, in addition to updates to the user interface; these changes do not raise different questions of safety or effectiveness. Performance data provided in the submission, including human factors, design, and labeling information, demonstrate substantially equivalent performance to the predicate. The data included participants from the new intended patient population and in conjunction with implemented labeling risk mitigation measures the device is equivalent to the predicate.

Moreover, as further demonstrated in the non-clinical testing, the different technological characteristics of adding the Insulin on Board feature and ability to connect to delayed data from CGM do not affect the safety and effectiveness of WellDoc BlueStar System.

Technological Characteristics

The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:

TechnologicalCharacteristic	Subject DeviceThe WellDoc BlueStarSystemK190013	PredicateDeviceThe WellDocBlueStar SystemK162532	ReferenceDeviceThe ACCU-CHEK ConnectDiabetesManagementAppK150910	Comments
Insulin DoseCalculator	Yes (Rx-only)	Yes (Rx-only)	Yes (Rx-only)	Same
Insulin on Board	Yes (Rx-only)	No	Yes (Rx-only)	See Comment 1
Connection toBlood GlucoseMeter	One-Touch Verio Flexand CGMs(CGM for datavisualization only)	One-TouchVerio Flex	ACCU-CHEKAviva Connectblood glucosemeter	See Comment 2

Discussions of differences in technological characteristics:

Comment 1: The addition of Insulin on Board to the Insulin Dose Calculator function available by prescription-only in BlueStar® Rx.

Both the subject device and reference device use a well-understood and accepted linear decay model to model the Insulin on Board decay. There are no notable differences with regards to this technological characteristic to a previously-cleared device.

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Comment 2: The ability to receive three-hour delayed data from continuous glucose monitoring devices via API for data visualization purposes only.

The subject device does not use Bluetooth to connect to a Continuous Glucose Meter directly. There are no new questions with regards to software or cybersecurity. De Novo DEN140038 classified CGM secondary display regulation. BlueStar has complied per the special controls stated in 21 CFR 862.1350 .

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 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
Electrical Safety	N/A - This is a stand-alone software system. Electrical Safety testing was not required or completed.
EMC	N/A
Wireless Coexistence & RF Wireless testing	N/A
Accessory compatibility	N/A
Battery testing	N/A
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.
Reprocessing/Cleaning	N/A
MR Safety	N/A
Biocompatibility	N/A

Clinical Tests

Not Applicable.

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Conclusions

The differences between the predicate and the subject devices do not raise any new or different questions of safety or effectiveness. The WellDoc® BlueStar® and BlueStar® Rx System is substantially equivalent to WellDoc® BlueStar® and BlueStar® Rx System cleared under K162532 with respect to the indications for use, target populations, treatment method, and technological characteristics.

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).