DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older -who have type 2 diabetesManager® 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 DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. 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 DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager®-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 DiabetesManager®-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 DiabetesManager®-Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the DiabetesManager®-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.

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

Device Description

The WellDoc BlueStar DiabetesManager® System is a stand-alone, over-the-counter (OTC) software system that has the capability of providing additional functions, if and when, the functions are prescribed by the prescribing healthcare provider. Once the additional prescription (Rx) functions are activated, the entire software system is called WellDoc BlueStar DiabetesManager-Rx® System.

Both BlueStar DiabetesManager System and DiabetesManager-Rx System are implemented through an enterprise such as a health plan or large physician group in tandem with healthcare providers (HCPs) 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 (changed under K141273), 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.

The Patient Web Portal and the Patient Mobile application have a similar feature set. Data entered into these applications is 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. Patientified by healthcare providers and an access code is provided to allow access to both the web and mobile applications. On the patient applications (Mobile and Web), the basic DiabetesManager System functions as an information repository [logbook and Personal Health Record (PHR)], diabetes education resource (learning library and health tips), educational messaging/coaching, and secure communication system (Message Center). If and when a prescription is obtained, additional functions become available to the patient as DiabetesManager-Rx System. Prescription functions include additional medication information (dose and schedule), enhanced coaching [(Blood Glucose (BG) real-time coaching feedback), messaging (Message Center Content), and workflow and decision support for healthcare providers. 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.

With this 510(k), BlueStar will have FDA clearance 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 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 or the indications for use of the device.

AI/ML Overview

The provided document is a 510(k) summary for the WellDoc BlueStar (WellDoc DiabetesManager® System and DiabetesManager®-Rx System). It primarily addresses administrative changes and modifications to the device's connectivity, rather than a comprehensive clinical study proving efficacy against specific acceptance criteria for the core functionality.

However, based on the non-clinical performance data section, we can infer the acceptance criteria and the study that proves the device meets them, specifically for the modifications introduced with this 510(k).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a formal table with quantitative acceptance criteria and their corresponding performance metrics. Instead, it mentions that "Verification, validation and human factors testing were performed to ensure that the device meets its requirements and intended use." For the specific modifications, the performance is reported qualitatively.

Acceptance Criterion (Inferred from Modifications)	Reported Device Performance (Qualitative)
Successful data transmission from OneTouch Verio Flex BG meter to BlueStar app	"data was transmitted successfully from the OneTouch Verio Flex BG meter"
Successful data transmission from BlueStar Server to OneTouch Reveal Server	"data was transmitted successfully... to the One Touch Reveal Server"
Compatibility of the app with specified mobile environmental operating systems (iOS 9.X+, Android 4.3+)	"the app is compatible with the mobile environmental operating systems"
Overall system functions as intended after modifications	"the system functions as intended"

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Verification, validation and human factors testing were performed." However, it does not specify the sample size used for these tests (e.g., number of users, number of data transmissions, number of test cases).

The data provenance is not explicitly mentioned but would typically be from laboratory testing and potentially simulated or real-world user testing during the verification and validation phases. Given the nature of a software and connectivity update, the testing would likely be prospective, conducted by the manufacturer. The country of origin for the data is not stated, but the manufacturer is based in Columbia, Maryland, USA.

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

The document does not mention the use of external experts to establish ground truth for the technical performance tests described. These tests would typically involve engineers and quality assurance personnel verifying system functionality against defined specifications. If "human factors testing" involved experts, their number and qualifications are not specified.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For technical verification and validation, success or failure is usually determined by predefined criteria in test protocols, rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes modifications related to connectivity and data transmission, not a new diagnostic or interpretative algorithm that would typically warrant an MRMC study comparing human readers with and without AI assistance. The changes "do not change the fundamental scientific technology or the indications for use of the device," implying the core functionality and interpretations remain as previously cleared.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

The described tests are primarily standalone evaluations of the updated software's technical functionality, specifically its ability to connect and transmit data. The "system functions as intended" implies an assessment of the algorithm and data flow without necessarily involving a human actively interpreting its output in a clinical decision-making context during these specific tests. However, it's not a standalone study of a new algorithm's diagnostic or predictive performance.

7. The Type of Ground Truth Used

For the connectivity and compatibility tests, the ground truth would be based on:

Technical specifications and expected operational behavior: Verifying that data packets are correctly transmitted and received, and that the application functions on specified operating systems as per its design.
Known device outputs/inputs: For data transmission, the ground truth would be the actual blood glucose values from the OneTouch Verio Flex BG meter, verifiable against the data received by the BlueStar app and transmitted to the OneTouch Reveal Server.

8. The Sample Size for the Training Set

The document does not mention a training set because the modifications described are related to connectivity and compatibility, not the development or retraining of a machine learning algorithm. The core algorithms for "coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends" are presumed to be part of the previously cleared device (K100066) and are not being newly developed or revised in a way that would require a new training set in this submission.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for the modifications in this submission, the acquisition of ground truth for a training set is not applicable here.

Summary

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May 17, 2024

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

Re: K162225

Trade/Device Name: WellDoc BlueStar (WellDoc DiabetesManager® System and DiabetesManager®-Rx System) 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 November 22, 2016. 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 Juliane Lessard, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6126, Juliane.Lessard(@fda.hhs.gov.

Sincerelv.

Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery, General Hospital and Human Factors Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, with the top profile being the largest and the bottom profile being the the smallest.

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

November 22, 2016

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

Re: K162225

Trade/Device Name: WellDoc Bluestar (WellDoc DiabetesManager® System and DiabetesManager®-Rx System) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ, LNX, NDC Dated: October 26, 2016 Received: October 27, 2016

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 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, Tina Kiang -5

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) K162225

Device Name

WellDoc Bluestar (WellDoc DiabetesManager® System and DiabetesManager®-Rx System)

Indications for Use (Describe)

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

The DiabetesManager®-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)
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Image /page/4/Picture/0 description: The image shows the logo for WellDoc. The logo consists of a blue and teal intertwined symbol on the left, resembling two hands coming together. To the right of the symbol is the word "WellDoc" in a dark blue, sans-serif font. A small registration mark is present in the upper right corner of the word "WellDoc".

510(k) Summary

General Information

Date of Summary Preparation: November 18, 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 (DiabetesManager® System and DiabetesManager®-Rx System)
Common or Usual Name:	Medical computers and softwareInfusion pump accessories
Product Codes:	LNX, MRZ, NDC
Classification Name:	LNX is unclassified and therefore has no regulation number21 CFR 880.5725 (Infusion Pump)
Regulatory Class:	II

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General Hospital Classification Panel: Predicate Device: K 100066 (WellDoc DiabetesManager® System and Diabetes Manager®-Rx System)

Device Description

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

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Image /page/6/Picture/0 description: The image shows the WellDoc logo. The logo features a stylized symbol on the left, resembling two hands intertwined in a circular shape, rendered in shades of blue. To the right of the symbol is the word "WellDoc" in a bold, blue font. A small trademark symbol appears next to the word "Doc".

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Image /page/7/Picture/0 description: The image shows the WellDoc logo. The logo consists of a blue and teal intertwined symbol on the left, followed by the word "WellDoc" in blue. The symbol appears to be two hands intertwined. The logo is simple and modern.

Indications for Use

DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older -who have type 2 diabetes. The DiabetesManager® 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 DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. 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 DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager®-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 DiabetesManager®-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 DiabetesManager®-Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the DiabetesManager®-Rx System provides coaching messages (motivational, behavioral, and educational) based on realtime 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.

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Image /page/8/Picture/0 description: The image contains the logo for WellDoc. The logo consists of a blue and light blue intertwined symbol on the left, followed by the word "WellDoc" in blue font. The logo is simple and professional, and it is likely used to represent the company's brand.

The DiabetesManager®-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 devices referenced. The only major differences between the subject and predicate devices are the ability to connect to the OneTouch Verio Flex Blood Glucose Meter via Bluetooth and the ability to transmit data from the BlueStar Server to the OneTouch Reveal Server. This modification does not change the fundamental scientific technology of the BlueStar application, as outlined in the Indications for Use:

. Provides secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management
Analyzes and reports blood glucose test results and supports medication . adherence
. Provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends

The subject change simply provides an alternative means of blood glucose inputs but processes the inputs in the same way as the predicate device. It should be noted that the user can continue to enter blood glucose values manually (as cleared under K100066); the subject modification allows for another means of BG inputs and is not necessary to use the app and receive feedback.

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Image /page/9/Picture/0 description: The image shows the WellDoc logo. The logo features a stylized symbol of two hands intertwined in a circular shape on the left. To the right of the symbol is the word "WellDoc" in a bold, blue font. The logo appears to be for a healthcare or wellness-related company.

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 equivalent functionality, the predicate device was not identified with the NDC product code at the time of clearance.

Feature	Subject Device	Predicate Device,K100066
Indications for Use	Diabetes Manager (OTC Use):The WellDoc DiabetesManager® System isindicated for use by healthcare providers(HCPs) and their adult patients - aged 21years and older - who have type 2 diabetes.The Diabetes Manager System is intended toprovide secure capture, storage, andtransmission of blood glucose data as well asinformation to aid in diabetes self-management. The DiabetesManager Systemanalyzes and reports blood glucose testresults and supports medication adherence. Itincludes software intended for use on mobilephones or personal computers in the home orin professional healthcare settings. Thesoftware also allows for entry of otherdiabetes-related healthcare information andprovides educational information.The DiabetesManager System is not intendedto replace the care provided by a licensedhealthcare professional, includingprescriptions, diagnosis, or treatment.Diabetes Manager-Rx (Prescription Use):The WellDoc DiabetesManager -Rx Systemis indicated for use by healthcare providers(HCPs) and their adult patients - aged 21years and older - who have type 2 diabetes.The DiabetesManager-Rx System is intendedto provide secure capture, storage, andtransmission of blood glucose data as well asinformation to aid in diabetes self-management. The DiabetesManager -RxSystem analyzes and reports blood glucosetest results and supports medicationadherence. In addition, the DiabetesManager-Rx System provides coaching messages(motivational, behavioral, and educational)	Identical

OTC or Rx	Both	Both
Product Code	LNX, MRZ, NDC	LNX, MRZ
Classification	21 CFR 880.5725	Same
Class	II	II
Connection to BT meter	Yes	No
Data transmission toOneTouch Reveal Server	Yes	No
Manual Data Entry	Yes	Yes
Logbook	Yes	Yes
Coaching Messages(Motivational, Behavioral, and Educational) based onreal-time blood glucosevalues and trends	Yes	Yes
Supported MobilePlatforms	iPhone, Android	Same
Mobile Form Factors	Candy Bar, Touch Screen	Same
Mobile EnvironmentalOperating Systems	iOS 9.X and aboveAndroid 4.3 and above	iOS 7.X and 8.XAndroid 4.X
Insulin dose calculator	Yes	Yes

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Image /page/10/Picture/0 description: The image contains the logo for WellDoc. The logo consists of a blue and teal graphic on the left, resembling two hands intertwined to form a circle. To the right of the graphic is the text "WellDoc" in blue, with a trademark symbol next to the "c".

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 were performed to ensure that the device meets its requirements and intended use. Testing showed that data was transmitted successfully from the OneTouch Verio Flex BG meter and to

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Image /page/11/Picture/0 description: The image shows the WellDoc logo. The logo features a stylized image of two hands cradling each other in a circular shape on the left side. To the right of the hands is the text "WellDoc" in a blue, sans-serif font. The logo is clean and professional, suggesting a focus on care and support.

the One Touch Reveal Server, that the app is compatible with the mobile environmental operating systems, and that the system functions as intended.

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 indications for 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).