The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have 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 adult patients - aged 21 years and older - who have 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 adult patients – aged 21 years and older - who have Type 2 Diabetes. The system is intended to assist Type 2 Diabetes patients to self-manage their disease, as cleared under K100066. 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 HCP.

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 (unchanged since cleared under K100066). 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 (unchanged since cleared under K100066). Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications is stored in the database and can be retrieved for display in either applications require the initial web- or mobilebased 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 dosing 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 insulin dose calculator is restricted to prescription-use only.

Furthermore, as cleared under K16225 (reference device), 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. These modifications do not change the fundamental scientific technology of the device.

AI/ML Overview

The provided documentation is a 510(k) summary for the WellDoc BlueStar® and BlueStar® Rx systems. It describes the device, its indications for use, and a comparison to predicate devices, but does not appear to contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria.

Instead, the document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices (K100066 and K162225) based on intended use, design, materials, and overall performance characteristics. The "Non-Clinical Performance Data" section mentions "Software Verification, Software Validation, Human Factors Testing" as data provided to support substantial equivalence, suggesting these activities were performed. However, it does not provide the specific acceptance criteria for these tests or the detailed results that would allow for a table of acceptance criteria versus reported device performance.

Therefore, many of the requested fields cannot be filled directly from this document.

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance

Information Not Available in Document: The document does not provide a specific table of acceptance criteria or quantifiable performance metrics beyond stating that "Verification, validation and human factors testing showed that the system can be used by a layperson without HCP oversight, meets its requirements and functions as intended." It does not list target accuracy, specificity, sensitivity, or other predefined benchmarks with corresponding measured values.

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

Information Not Available in Document: The document does not specify the sample size used for the mentioned "Software Verification, Software Validation, Human Factors Testing" or the provenance of any data used in these tests.

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)

Information Not Available in Document: The document does not mention the use of experts to establish ground truth for any test set. The focus is on software functionality and human factors for a self-management diabetes system, not diagnostic accuracy requiring expert interpretation.

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

Information Not Available in Document: The document does not describe any adjudication methods, as no expert-based ground truth establishment is mentioned.

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

Information Not Available in Document: An MRMC comparative effectiveness study is not mentioned. The device, an AI-powered diabetes self-management system, isn't described in a way that suggests "human readers" or "AI assistance" in the context of image interpretation or similar diagnostic tasks. Its function is to provide coaching messages and an insulin dose calculator.

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

Information Available:
The device ("WellDoc BlueStar®" and "WellDoc BlueStar® Rx") is a "stand-alone software system" intended for use by both patients and healthcare providers. The document states that "software intended for use on mobile phones or personal computers" and that the system "provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends." BlueStar® Rx also "includes an insulin dose calculator." These descriptions imply standalone algorithm performance in generating coaching messages and calculating insulin doses based on input data. The "human factors testing" mentioned confirms that the system is designed to be used by a layperson, indicating that the core functionality operates somewhat independently, though the system is meant to support self-management with HCP oversight (for Rx version).

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

Information Not Available in Document: The document does not specify the type of ground truth used for any testing. Given the nature of the device (diabetes management, coaching, insulin calculation), "ground truth" would likely relate to the correctness of calculations or the appropriateness of coaching messages, which might be assessed against clinical guidelines or pre-defined rules rather than expert consensus on medical images or pathology.

8. The sample size for the training set

Information Not Available in Document: The document does not provide any information about a training set size or methodology. It's unclear if machine learning/AI techniques that require explicit training sets were used in a manner that necessitated reporting such a detail in this K162532 summary, as the "AI" aspect is described more generally as providing "coaching messages... based on real-time blood glucose values and trends."

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

Information Not Available in Document: As no training set is mentioned, the method for establishing its ground truth is also not provided.

Summary

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May 21, 2024

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.

WellDoc, Incorporated Danielle Dorfman Manager, Regulatory Affairs and Quality System 10221 Wincopin Circle Suite 150 Columbia, Maryland 21044

Re: K162532

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

Dear Danielle Dorfman:

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 January 12, 2017. 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 12, 2017

WellDoc, Incorporated Danielle Dorfman Manager, Regulatory Affairs and Quality System 10221 Wincopin Circle, Suite 150 Columbia, Maryland 21044

Re: K162532

Trade/Device Name: WellDoc® BlueStar®, WellDoc® BlueStar®Rx Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ, LNX, NDC Dated: January 7. 2016 Received: January 9, 2017

Dear Danielle Dorfman:

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. 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.

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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162532

Device Name WellDoc® BlueStar®

Indications for Use (Describe)

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)

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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Indications for Use

510(k) Number (if known) K162532

Device Name WellDoc® BlueStar® Rx

Indications for Use (Describe)

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)

	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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510(k) Summary

General Information

Date of Summary Preparation: December 19, 2016

Name of Manufacturer:	WellDoc, Inc.
Address:	10221 Wincopin Circle Suite 150Columbia, MD 21044
Contact Person:	Kevin McRaithChief Executive Officer
Phone:	(443) 692-3100
Fax:	(443) 692-3099
Trade or Proprietary Name:	WellDoc® BlueStar®."Y gmF qeÌ BlueStar® Rx
Common or Usual Name:	Medical computers and softwareInfusion pump accessories
Product Codes:	MRZ, LNX, NDC
Classification Name:	Infusion Pump21 CFR 880.5725 (Infusion Pump)
Regulatory Class:	II
Classification Panel:	General Hospital

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Predicate Device:	K100066 (WellDoc DiabetesManager® System and DiabetesManager®-Rx System)
Reference Device:	K162225 (WellDoc BlueStar®/ DiabetesManager® System andDiabetes Manager®-Rx System)

Device Description

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

The Enterprise Director application is used for administrative purposes (unchanged since cleared under K100066). The HCP Service houses the Medication Reconciliation feature, which allows

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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).

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Image /page/8/Picture/0 description: The image shows the WellDoc logo. The logo features a stylized graphic of two hands intertwined in a circular shape, with a gradient of blue and teal colors. To the right of the graphic is the word "WellDoc" in a bold, blue font. The logo is clean and professional, suggesting a focus on health and well-being.

to transmit data to the OneTouch Reveal Server. These modifications do not change the fundamental scientific technology of the device.

Indications for Use

OTC: The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their adult patients – aged 21 years and older - who have 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.

Rx: The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their adult patients – aged 21 years and older - who have 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, 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

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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.

Summary of Technological Characteristics (compared to the predicate)

Intended use, design, materials, and performance are substantially equivalent to the predicate device referenced. The differences between the subject and predicate devices are: (1) the ability to connect to the OneTouch Verio Flex Blood Glucose Meter via Bluetooth (to transmit BG values taken by the meter) and the ability to transmit data from the BlueStar Server to the OneTouch Reveal Server (as cleared under K162225); (2) change in indications for use to specify the insulin dose calculator as prescription-only (in BlueStar® Rx); and (3) change in indications for use to allow the coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends to be accessed over-the-counter (in both BlueStar® and BlueStar® Rx).

The modifications herein do not change the fundamental scientific technology of the BlueStar application and do not change the subject device's substantial equivalence to the predicate device.

Please refer to the table below for a comparison of the subject and predicate devices. Note that while both the predicate and subject device contain an insulin dose calculator with substantially

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equivalent functionality, the predicate device was not identified with the NDC product code at

the time of clearance.

Feature	Subject Device	Predicate Device, K100066	Reference Device, K162225
Indications for Use	OTC: The WellDocBlueStar® System is indicatedfor use by healthcare providers(HCPs) and their adult patients- aged 21 years and older -who have type 2 diabetes. TheBlueStar System is intended toprovide secure capture,storage, and transmission ofblood glucose data as well asinformation to aid in diabetesself-management. TheBlueStar® System analyzesand reports blood glucose testresults and supportsmedication adherence. Inaddition, the BlueStar Systemprovides coaching messages(motivational, behavioral, andeducational) based on real-time blood glucose values andtrends. It includes softwareintended for use on mobilephones or personal computersin the home or in professionalhealthcare settings. Thesoftware also allows for entryof other diabetes-relatedhealthcare information andprovides educationalinformation.The BlueStar® System is notintended to replace the careprovided by a licensedhealthcare professional,including prescriptions,diagnosis, or treatment.Rx: The WellDoc BlueStar®Rx System is indicated for useby healthcare providers(HCPs) and their adult patients- aged 21 years and older -who have type 2 diabetes. TheBlueStar Rx System isintended to provide securecapture, storage, andtransmission of blood glucose	DiabetesManager (OTC Use):The WellDoc DiabetesManager® System is indicated for use byhealthcare providers (HCPs) andtheir adult patients - aged 21years and older - who have type2 diabetes. The DiabetesManagerSystem is intended to providesecure capture, storage, andtransmission of blood glucosedata as well as information to aidin diabetes self-management.The DiabetesManager Systemanalyzes and reports bloodglucose test results and supportsmedication adherence. Itincludes software intended foruse on mobile phones orpersonal computers in the homeor in professional healthcaresettings. The software alsoallows for entry of otherdiabetes-related healthcareinformation and provideseducational information.The DiabetesManager System isnot intended to replace the careprovided by a licensed healthcareprofessional, includingprescriptions, diagnosis, ortreatment.DiabetesManager-Rx(Prescription Use):The WellDoc DiabetesManager -Rx System is indicated for useby healthcare providers (HCPs)and their adult patients - aged 21years and older - who have type2 diabetes. TheDiabetesManager-Rx System isintended to provide securecapture, storage, andtransmission of blood glucosedata as well as information to aidin diabetes self-management.The DiabetesManager -RxSystem analyzes and reports	DiabetesManager® (OTCUse): The WellDocDiabetesManager® System isindicated for use byhealthcare providers (HCPs)and their adult patients - aged21 years and older -who havetype 2 diabetes. TheDiabetes Manager® System isintended to provide securecapture, storage, andtransmission of bloodglucose data as well asinformation to aid in diabetesself-management. TheDiabetes Manager® Systemanalyzes and reports bloodglucose test results andsupports medicationadherence. It includessoftware intended for use onmobile phones or personalcomputers in the home or inprofessional healthcaresettings. The software alsoallows for entry of otherdiabetes-related healthcareinformation and provideseducational information.The Diabetes Manager®System is not intended toreplace the care provided bya licensed healthcareprofessional, includingprescriptions, diagnosis, ortreatment.DiabetesManager®-Rx(Prescription Use): TheWellDocDiabetesManager®-RxSystem is indicated for useby healthcare providers(HCPs) and their adultpatients - aged 21 years andolder - who have type 2diabetes. TheDiabetesManager®-RxSystem is intended to providesecure capture, storage, and

	aid 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. Itincludes 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 regimen tocalculate a dose of insulin fora 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.	blood glucose test results andsupports medication adherence.In addition, the DiabetesManager-Rx System provides coachingmessages (motivational,behavioral, and educational)based on real-time blood glucosevalues and trends. It includessoftware intended for use onmobile phones or personalcomputers in the home or inprofessional healthcare settings.The software also allows forentry of other diabetes-relatedhealthcare information andprovides educationalinformation.The DiabetesManager-RxSystem is not intended to replacethe care provided by a licensedhealthcare professional,including prescriptions,diagnosis, or treatment.	transmission of bloodglucose data as well asinformation to aid in diabetesself-management. TheDiabetesManager®-RxSystem analyzes and reportsblood glucose test results andsupports medicationadherence. In addition, theDiabetesManager®-RxSystem provides coachingmessages (motivational,behavioral, and educational)based on real-time bloodglucose values and trends. Itincludes software intendedfor use on mobile phones orpersonal computers in thehome or in professionalhealthcare settings. Thesoftware also allows for entryof other diabetes-relatedhealthcare information andprovides educationalinformation.The DiabetesManager®-RxSystem is not intended toreplace the care provided bya licensed healthcareprofessional, includingprescriptions, diagnosis, ortreatment.
Type of Use	OTC, Rx	OTC, Rx	OTC. Rx
Product Code	LNX, MRZ, NDC	LNX, MRZ	LNX, MRZ, NDC
Classification	21 CFR 880.5725	21 CFR 880.5725	21 CFR 880.5725
Class
Data Provided toSupportSubstantialEquivalence(PerformanceData)	Software Verification,Software Validation, HumanFactors Testing	Software Verification, SoftwareValidation, Human FactorsTesting	Software Verification,Software Validation, HumanFactors Testing
Manual DataEntry	Yes	Yes	Yes
Logbook (BGvalues, Carbs,Activity)	Yes	Yes	Yes
Real-timeFeedback on BGvalues (coachingmessages)	Yes	Yes	Yes
Pattern Detection.Graphs, Charts	Yes	Yes	Yes
Ability to LogMedications	Yes	Yes	Yes
MedicationManagement(reminders,integration withdrug database)	Yes	Yes	Yes
Ability to ShareData and Reports	Yes	Yes	Yes
Supported MobilePlatforms	iPhone, Android	iPhone, Android	iPhone, Android
Insulin DoseCalculator	Yes (Rx-only)	Yes	Yes (Rx-only)
Connection to BTmeter	Yes	No	Yes
Data transmissionto OneTouchReveal Server	Yes	No	Yes

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Non-Clinical Performance Data

Documentation according to FDA's Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and Guidance for Industry and FDA Staff: Content of Premarket Submissions for the Management of Cybersecurity in Medical Devices was provided. Verification, validation and human factors testing showed that the system can be used by a layperson without HCP oversight, meets its requirements and functions as intended. Note that the insulin dose calculator can only be used under the oversight of a HCP.

Conclusions Drawn from Non-Clinical Tests

The non-clinical testing demonstrated that the product is substantially equivalent to the predicate and continues to meet the cleared intended use.

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).