(106 days)
No
The summary describes data analysis and reporting, and rule-based coaching messages based on real-time data and trends, but does not explicitly mention or imply the use of AI or ML algorithms for these functions. The analysis and coaching appear to be based on predefined rules and thresholds rather than learned patterns.
No
The device aids in diabetes self-management by providing information, analyzing blood glucose data, supporting medication adherence, and offering coaching messages. However, the description explicitly states that it is "not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment," which are hallmarks of therapeutic devices.
No
The "Intended Use / Indications for Use" section explicitly states: "The DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment." This indicates it is not a diagnostic device.
Yes
The device is described as a "stand-alone, over-the-counter (OTC) software system" and its components are listed as various software applications (portals and mobile app). While it connects to a blood glucose meter, the device itself is the software system that processes and presents the data.
Based on the provided text, the WellDoc DiabetesManager® System and DiabetesManager®-Rx System are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Definition of IVD: In vitro diagnostic devices are used to examine specimens, such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections. They perform tests on these biological samples.
- Function of the DiabetesManager System: The description clearly states that the system's primary functions are:
- Secure capture, storage, and transmission of blood glucose data (which is generated by a separate device, the blood glucose meter).
- Providing information and tools for diabetes self-management (logbook, education, messaging, medication adherence support, insulin dosing calculator).
- Analyzing and reporting blood glucose test results (but not performing the test itself).
- Providing coaching messages based on blood glucose values and trends.
- No mention of testing biological samples: The text does not describe the system as performing any tests on biological specimens. It receives data from a blood glucose meter (an IVD device) and uses that data for management and informational purposes.
Therefore, the WellDoc DiabetesManager® System and DiabetesManager®-Rx System are software systems that aid in diabetes management by utilizing data from an IVD device (the blood glucose meter), but they are not IVD devices themselves.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MRZ, NDC, LNX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients - aged 21 years and older
Intended User / Care Setting
healthcare providers (HCPs) and their adult patients; in the home or in professional healthcare settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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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.
2
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
3
Indications for Use
510(k) Number (if known) K162225
Device Name
WellDoc Bluestar (WellDoc DiabetesManager® System and DiabetesManager®-Rx System)
Indications for Use (Describe)
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.
| 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 |
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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 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 (DiabetesManager® System and Diabetes |
| Manager®-Rx System) | |
| Common or Usual Name: | Medical computers and software |
| Infusion pump accessories | |
| Product Codes: | LNX, MRZ, NDC |
| Classification Name: | LNX is unclassified and therefore has no regulation number |
| 21 CFR 880.5725 (Infusion Pump) | |
| Regulatory Class: | II |
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Image /page/5/Picture/0 description: The image contains the logo for WellDoc. The logo consists of a blue and teal intertwined hands graphic on the left, followed by the word "WellDoc" in blue, with a registered trademark symbol to the right of the word.
General Hospital Classification Panel: Predicate Device: K 100066 (WellDoc DiabetesManager® System and Diabetes Manager®-Rx System)
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.
6
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".
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.
7
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.
8
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 is
indicated for use by healthcare providers
(HCPs) and their adult patients - aged 21
years and older - who have type 2 diabetes.
The Diabetes Manager 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.
Diabetes Manager-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) | 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 to
OneTouch Reveal Server | Yes | No |
| Manual Data Entry | Yes | Yes |
| Logbook | Yes | Yes |
| Coaching Messages
(Motivational, Behavioral, and Educational) based on
real-time blood glucose
values and trends | Yes | Yes |
| Supported Mobile
Platforms | iPhone, Android | Same |
| Mobile Form Factors | Candy Bar, Touch Screen | Same |
| Mobile Environmental
Operating Systems | iOS 9.X and above
Android 4.3 and above | iOS 7.X and 8.X
Android 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.