(305 days)
K162532 (WellDoc® BlueStar® and BlueStar® Rx System)
K150910 (Accu-chek Connect Diabetes Management Application)
No
The summary describes data analysis and rule-based coaching messages based on real-time data and trends, but does not mention AI or ML. The performance studies focus on software validation, cybersecurity, and human factors, not AI/ML model performance.
No
The device is intended to aid in diabetes self-management, provide information, coaching messages, and an insulin dose calculator, but it explicitly states that it is "not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment." Therefore, it is a management and information tool, not a therapeutic device.
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." This indicates it does not perform diagnostic functions.
Yes
The device description explicitly states that WellDoc® BlueStar® is a "stand-alone software system" and details its implementation through various software applications (portals and mobile apps). While it can connect to a blood glucose meter, the core functionality and regulatory submission focus on the software's features and validation.
Based on the provided text, the WellDoc BlueStar® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or treatment.
- WellDoc BlueStar® System's Function: The description clearly states that the system's primary functions are:
- Secure capture, storage, and transmission of blood glucose data.
- Providing information to aid in diabetes self-management.
- Analyzing and reporting blood glucose test results (which are generated by a separate device, the blood glucose meter).
- Supporting medication adherence.
- Providing coaching messages based on blood glucose values and trends.
- Allowing entry of other diabetes-related healthcare information and providing educational information.
- In the Rx version, calculating insulin doses based on prescribed regimens and blood glucose values.
- No Specimen Examination: The system itself does not perform any tests on biological specimens. It receives data from a blood glucose meter (an IVD device) and uses that data for analysis, reporting, and providing guidance.
- Intended Use: The intended use is for diabetes self-management and providing information and support to patients and healthcare providers, not for performing diagnostic tests on specimens.
While the system utilizes data generated by an IVD device (the blood glucose meter), it is a software system that aids in managing the condition based on that data, rather than performing the diagnostic test itself.
N/A
Intended Use / Indications for Use
The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes seff-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.
The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Product codes (comma separated list FDA assigned to the subject device)
MRZ, NDC
Device Description
WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their patients - aged 18 years and older - who have Type 1 or Type 2 Diabetes. The system is intended to assist Type 1 and Type 2 Diabetes patients to self-manage their disease, as cleared under K162532. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® - BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a licensed HCP with prescribing authority.
BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications:
- Enterprise Director Portal
- HCP Service
- Patient Mobile Application
- Patient Web Portal
The Enterprise Director application is used for administrative purposes. The HCP Service houses the Medication Reconciliation feature, which allows for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273).
The Patient Web Portal and the Patient Mobile application have a similar feature set. Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications are stored in the database and can be retrieved for display in either application. Both applications require the initial web- or mobile-based registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers.
In BlueStar® Rx, the patient web portal and mobile application also provide an insulin calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. This submission introduces Insulin on Board to be considered in the calculation. The insulin dose calculator is indicated for prescription-use only.
Furthermore, as cleared under K162225, BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends. The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only. These modifications do not change the fundamental scientific technology of the device.
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
aged 18 years and older
Intended User / Care Setting
healthcare providers (HCPs) and their patients, 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)
The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:
Software: Software verification and validation per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a Major Level of Concern FDA Guidance “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices”
Cybersecurity: Cybersecurity was evaluated per the FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff, (October 2, 2014). Specifically, addressing the following areas: Identify and Protect, Detect, Response and Recover
Electrical Safety: N/A - This is a stand-alone software system. Electrical Safety testing was not required or completed.
EMC: N/A
Wireless Coexistence & RF Wireless testing: N/A
Accessory compatibility: N/A
Battery testing: N/A
Human Factors: Human factors testing was conducted with the intended user populations of patients and healthcare providers. The human factors, design, and labeling information provided in the submission confirm that the user interface has been adequately validated for use per the labeling.
Reprocessing/Cleaning: N/A
MR Safety: N/A
Biocompatibility: N/A
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.
K162532 (WellDoc® BlueStar® and BlueStar® Rx System)
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.
K150910 (Accu-chek Connect Diabetes Management Application)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.
November 4, 2019
WellDoc. Inc. Caroline York Senior Vice President, Operations 10221 Wincopin Circle, Suite 150 Columbia, Maryland 21044
Re: K190013
Trade/Device Name: WellDoc BlueStar Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRZ, NDC Dated: October 25, 2019 Received: October 28, 2019
Dear Caroline York:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190013
Device Name WellDoc® BlueStar®
Indications for Use (Describe)
The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes seff-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
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3
Indications for Use
510(k) Number (if known) K190013
Device Name WellDoc® BlueStar®
Indications for Use (Describe)
The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System provides coaching messages (motivational, behavioral) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.
The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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
K190013 510(k) Summary
| Date of Summary Preparation: | November 1, 2019 |
|---|---|
| Name of Manufacturer: | WellDoc, Inc. |
| Address: | 10221 Wincopin Circle, Suite 150 |
| Columbia, MD 21044 | |
| Contact Person: | Kevin McRaith |
| Chief Executive Officer | |
| Phone: | (443) 692-3100 |
| Fax: | (443) 692-3099 |
| Trade or Proprietary Name: | WellDoc® BlueStar® |
| Common or Usual Name: | Medical computers and software |
| Infusion pump accessories | |
| Product Codes: | MRZ, NDC |
| Regulation: | 21 CFR 880.5725 - Accessories, Pump, Infusion |
| 21 CFR 868.1890 - Calculator, Drug dose | |
| Regulatory Class: | II |
| Classification Panel: | General Hospital |
| Predicate Device: | K162532 (WellDoc® BlueStar® and BlueStar® Rx System) |
| Reference Device: | K150910 (Accu-chek Connect Diabetes Management Application) |
Device Description
WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their patients - aged 18 years and older - who have Type 1 or Type 2 Diabetes. The system is intended to assist Type 1 and Type 2 Diabetes patients to self-manage their disease, as cleared under K162532. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® - BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a licensed HCP with prescribing authority.
BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications:
- Enterprise Director Portal ●
- . HCP Service
- Patient Mobile Application ●
- Patient Web Portal ●
The Enterprise Director application is used for administrative purposes. The HCP Service houses the Medication Reconciliation feature, which allows for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273).
5
The Patient Web Portal and the Patient Mobile application have a similar feature set. Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications are stored in the database and can be retrieved for display in either application. Both applications require the initial web- or mobile-based registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers.
In BlueStar® Rx, the patient web portal and mobile application also provide an insulin calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. This submission introduces Insulin on Board to be considered in the calculation. The insulin dose calculator is indicated for prescription-use only.
Furthermore, as cleared under K162225, BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends. The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only. These modifications do not change the fundamental scientific technology of the device.
Indications for Use
The device has two (2) versions: over the counter and prescription.
OTC:
The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Rx:
6
The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.
The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Intended Use
The intended use of the subject device is unchanged from the previously cleared version (K162352), and is as follows:
The BlueStar® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes selfmanagement. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.
The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Substantial Equivalence Discussion
Intended Use Comparison
The table below includes a comparison of the intended use between the new device and those of the predicate device:
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| The WellDoc BlueStar System | The WellDoc BlueStar System |
7
| K190013 | K162532 | |
|---|---|---|
| OTC: The WellDoc BlueStar® System is | ||
| indicated for use by healthcare providers | ||
| (HCPs) and their patients - aged 18 years | ||
| and older - who have Type 1 or Type 2 | ||
| diabetes. The BlueStar® System is intended | ||
| to provide secure capture, storage, and | ||
| transmission of blood glucose data as well | ||
| as information to aid in diabetes self- | ||
| management. The BlueStar® System | ||
| analyzes and reports blood glucose test | ||
| results and supports medication adherence. | ||
| In addition, the BlueStar® System provides | ||
| coaching messages (motivational, | ||
| behavioral, and educational) based on real- | ||
| time blood glucose values and trends. It | ||
| includes software intended for use on | ||
| mobile phones or personal computers in the | ||
| home or in professional healthcare settings. | ||
| The software also allows for entry of other | ||
| diabetes-related healthcare information and | ||
| provides educational information. | 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. | ||
| Indications for Use The BlueStar® System is not intended to | ||
| replace the care provided by a licensed | ||
| healthcare professional, including | ||
| prescriptions, diagnosis, or treatment. |
Rx: BlueStar is indicated for use by
healthcare providers (HCPs) and their adult
patients - aged 18 years and older - who
have Type 1 or Type 2 diabetes. BlueStar®
Rx is intended to provide secure capture,
storage, and transmission of blood glucose
data as well as information to aid in diabetes
self-management. BlueStar® Rx analyzes
and reports blood glucose test results and
supports medication adherence. In addition,
BlueStar® Rx 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 | The BlueStar® System is not intended to
replace the care provided by a licensed
healthcare professional, including
prescriptions, diagnosis, or treatment.
Rx: BlueStar® Rx is indicated for use by
healthcare providers (HCPs) and their
adult patients – aged 21 years and older -
who have type 2 diabetes. BlueStar® Rx is
intended to provide secure capture,
storage, and transmission of blood glucose
data as well as information to aid in
diabetes self-management. BlueStar® Rx
analyzes and reports blood glucose test
results and supports medication adherence.
In addition, BlueStar® Rx provides
coaching messages (motivational,
behavioral, and educational) based on real-
time blood glucose values and trends. It | |
| | of other diabetes-related healthcare
information and provides educational
information. The prescription version of
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.
BlueStar® Rx is not intended to replace the
care provided by a licensed healthcare
professional, including prescriptions,
diagnosis, or treatment. | 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 prescription version of
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.
BlueStar® Rx is not intended to replace
the care provided by a licensed healthcare
professional, including prescriptions,
diagnosis, or treatment. |
| Prescription Only
or
Over the Counter | OTC, Rx | OTC, Rx |
| Intended Population | Patients with Type 1 or Type 2 Diabetes;
Aged 18 and older | Patients with Type 2 Diabetes;
Aged 21 and older |
| Environment of
Use | Home or Clinic | Home or Clinic |
8
Discussions of differences in Indications for Use statement
As compared to the previously cleared version, the subject device of this application proposes to make the following changes:
- Change the indications for use to include Type 1 diabetic patients to the user group; ●
- Change the indications for use to allow use in patients aged 18 and older (previously it was 21 years and older);
- Add Insulin on Board (IOB) to its insulin dose calculator function; and ●
- Add the ability to receive 3-hour delayed data from continuous glucose monitors via API for data visualization purposes only.
Discussions of differences in intended population
- Change the indications for use to include Type 1 diabetic patients to the user group;
- Change the indications for use to allow use in patients aged 18 and older (previously it was 21 years and older);
Discussions of differences in environment of use
The environment of use for the subject device is identical to the predicate device: home and clinic use.
9
Summary
The subject and predicate devices are both insulin dose calculators intended to be used by diabetic patients. The differences between the subject and predicate devices are focused on the intended patient population being expanded to include Type 1 diabetic patients and patients aged 18 and older, in addition to updates to the user interface; these changes do not raise different questions of safety or effectiveness. Performance data provided in the submission, including human factors, design, and labeling information, demonstrate substantially equivalent performance to the predicate. The data included participants from the new intended patient population and in conjunction with implemented labeling risk mitigation measures the device is equivalent to the predicate.
Moreover, as further demonstrated in the non-clinical testing, the different technological characteristics of adding the Insulin on Board feature and ability to connect to delayed data from CGM do not affect the safety and effectiveness of WellDoc BlueStar System.
Technological Characteristics
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
| Technological
Characteristic | Subject Device
The WellDoc BlueStar
System
K190013 | Predicate
Device
The WellDoc
BlueStar System
K162532 | Reference
Device
The ACCU-
CHEK Connect
Diabetes
Management
App
K150910 | Comments |
|-----------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------|
| Insulin Dose
Calculator | Yes (Rx-only) | Yes (Rx-only) | Yes (Rx-only) | Same |
| Insulin on Board | Yes (Rx-only) | No | Yes (Rx-only) | See Comment 1 |
| Connection to
Blood Glucose
Meter | One-Touch Verio Flex
and CGMs
(CGM for data
visualization only) | One-Touch
Verio Flex | ACCU-CHEK
Aviva Connect
blood glucose
meter | See Comment 2 |
Discussions of differences in technological characteristics:
Comment 1: The addition of Insulin on Board to the Insulin Dose Calculator function available by prescription-only in BlueStar® Rx.
Both the subject device and reference device use a well-understood and accepted linear decay model to model the Insulin on Board decay. There are no notable differences with regards to this technological characteristic to a previously-cleared device.
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Comment 2: The ability to receive three-hour delayed data from continuous glucose monitoring devices via API for data visualization purposes only.
The subject device does not use Bluetooth to connect to a Continuous Glucose Meter directly. There are no new questions with regards to software or cybersecurity. De Novo DEN140038 classified CGM secondary display regulation. BlueStar has complied per the special controls stated in 21 CFR 862.1350 .
Performance Testing
The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:
| Software | Software verification and validation per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a Major Level of Concern FDA Guidance “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices” |
|---|---|
| Cybersecurity | Cybersecurity was evaluated per the FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff, (October 2, 2014). Specifically, addressing the following areas: Identify and Protect, Detect, Response and Recover |
| Electrical Safety | N/A - This is a stand-alone software system. Electrical Safety testing was not required or completed. |
| EMC | N/A |
| Wireless Coexistence & RF Wireless testing | N/A |
| Accessory compatibility | N/A |
| Battery testing | N/A |
| Human Factors | Human factors testing was conducted with the intended user populations of patients and healthcare providers. The human factors, design, and labeling information provided in the submission confirm that the user interface has been adequately validated for use per the labeling. |
| Reprocessing/Cleaning | N/A |
| MR Safety | N/A |
| Biocompatibility | N/A |
Clinical Tests
Not Applicable.
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Conclusions
The differences between the predicate and the subject devices do not raise any new or different questions of safety or effectiveness. The WellDoc® BlueStar® and BlueStar® Rx System is substantially equivalent to WellDoc® BlueStar® and BlueStar® Rx System cleared under K162532 with respect to the indications for use, target populations, treatment method, and technological characteristics.