(125 days)
No
The description focuses on data analysis, reporting, and rule-based coaching messages based on real-time data and trends, which does not explicitly indicate the use of AI/ML. The document also explicitly states that "These modifications do not change the fundamental scientific technology of the device," implying no significant technological shift like the introduction of AI/ML.
No
Explanation: The device provides information, coaching messages, and an insulin dose calculator to aid in diabetes self-management but explicitly states it is "not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment." This indicates it's a supportive tool, not a therapeutic device directly treating a condition.
No
The Intended Use / Indications for Use section explicitly states: "The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment."
Yes
The device description explicitly states that WellDoc® BlueStar® is a "stand-alone software system" and details its implementation through various software applications (portals, services, mobile app). While it can connect to a blood glucose meter, the core device being cleared is the software system itself, which performs data analysis, provides coaching, and includes an insulin dose calculator in the Rx version. The performance studies listed are software verification, software validation, and human factors testing, further supporting its classification as a software-only medical device.
Based on the provided text, the WellDoc BlueStar® System and WellDoc BlueStar® Rx System are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- WellDoc BlueStar's Function: The description clearly states the system's purpose is to:
- Securely capture, store, and transmit blood glucose data.
- Provide information to aid in diabetes self-management.
- Analyze and report blood glucose test results (which are input to the system, not generated by it).
- Support medication adherence.
- Provide coaching messages based on blood glucose values and trends.
- Allow entry of other diabetes-related healthcare information.
- Provide educational information.
- (For BlueStar Rx) Calculate insulin doses based on prescribed regimens and input data.
- No Specimen Examination: The system does not perform any tests on biological specimens itself. It receives blood glucose data, which is presumably generated by a separate blood glucose meter (like the One Touch Verio Flex mentioned as a reference device).
- Focus on Self-Management and Information: The primary function is to help patients manage their diabetes through data analysis, reporting, coaching, and information provision, not to diagnose or test specimens.
Therefore, the WellDoc BlueStar® System and WellDoc BlueStar® Rx System are considered software medical devices that aid in diabetes management, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MRZ, LNX, NDC
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.
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: Software Verification, Software Validation, Human Factors Testing.
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.
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).
0
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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
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.
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 (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,
Image /page/2/Picture/8 description: The image contains a signature and name. The name reads "Tina Kiang-S". The signature is to the left of the name and is illegible. The background is white.
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) K162532
Device Name WellDoc® BlueStar®
Indications for Use (Describe)
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.
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."
4
Indications for Use
510(k) Number (if known) K162532
Device Name WellDoc® BlueStar® Rx
Indications for Use (Describe)
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.
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.
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."
5
Image /page/5/Picture/0 description: The image contains the WellDoc logo. The logo features a stylized graphic of two hands intertwined in a circular shape, colored in shades of blue and teal. To the right of the graphic is the word "WellDoc" in a bold, blue font. A small registration mark is present next to the word.
510(k) Summary
General Information
Date of Summary Preparation: December 19, 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®."Y gmF qeÌ BlueStar® Rx |
| Common or Usual Name: | Medical computers and software |
| Infusion pump accessories | |
| Product Codes: | MRZ, LNX, NDC |
| Classification Name: | Infusion Pump |
| 21 CFR 880.5725 (Infusion Pump) | |
| Regulatory Class: | II |
| Classification Panel: | General Hospital |
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Image /page/6/Picture/0 description: The image contains the logo for WellDoc. The logo consists of a blue and light blue graphic on the left, resembling intertwined hands or a circular shape. To the right of the graphic is the text "WellDoc" in a blue, sans-serif font. A small registration mark is present to the upper right of the word "WellDoc".
| Predicate Device: | K100066 (WellDoc DiabetesManager® System and Diabetes
Manager®-Rx System) |
|-------------------|-----------------------------------------------------------------------------------------|
| Reference Device: | K162225 (WellDoc BlueStar®/ DiabetesManager® System and
Diabetes Manager®-Rx System) |
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
7
Image /page/7/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.
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
8
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
9
Image /page/9/Picture/0 description: The image contains the logo for WellDoc. The logo features a blue and teal intertwined circular design on the left. To the right of the design is the name "WellDoc" in blue font with a registered trademark symbol.
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
10
Image /page/10/Picture/0 description: The image shows the WellDoc logo. The logo features a blue and teal circular design on the left, resembling intertwined hands. To the right of the design is the word "WellDoc" in a blue, sans-serif font. The logo appears to be for a healthcare or wellness-related company.
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 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 | 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 | 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
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
Diabetes Manager® 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 Diabetes Manager®
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 |
| | | | |
| | 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. | 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. | 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 | 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 to
Support
Substantial
Equivalence
(Performance
Data) | Software Verification,
Software Validation, Human
Factors Testing | Software Verification, Software
Validation, Human Factors
Testing | Software Verification,
Software Validation, Human
Factors Testing |
| Manual Data
Entry | Yes | Yes | Yes |
| Logbook (BG
values, Carbs,
Activity) | Yes | Yes | Yes |
| Real-time
Feedback on BG
values (coaching
messages) | Yes | Yes | Yes |
| Pattern Detection.
Graphs, Charts | Yes | Yes | Yes |
| Ability to Log
Medications | Yes | Yes | Yes |
| Medication
Management
(reminders,
integration with
drug database) | Yes | Yes | Yes |
| Ability to Share
Data and Reports | Yes | Yes | Yes |
| Supported Mobile
Platforms | iPhone, Android | iPhone, Android | iPhone, Android |
| Insulin Dose
Calculator | Yes (Rx-only) | Yes | Yes (Rx-only) |
| Connection to BT
meter | Yes | No | Yes |
| Data transmission
to OneTouch
Reveal Server | Yes | No | Yes |
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Image /page/11/Picture/0 description: The image shows the WellDoc logo. The logo consists of a blue symbol on the left and the word "WellDoc" in blue on the right. The symbol appears to be two hands intertwined in a circular shape.
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Image /page/12/Picture/0 description: The image shows the WellDoc logo. The logo consists of a blue and teal circular design on the left, resembling intertwined hands. To the right of the design is the word "WellDoc" in blue, with a registered trademark symbol next to it.
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.