(99 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data capture, analysis, reporting, coaching messages based on real-time data and trends, and insulin dose calculations based on prescribed regimens and configured parameters, none of which inherently require AI/ML.
Yes.
The device provides an insulin dose calculator and an Insulin Adjustment Program (IAP) to calculate and titrate insulin doses, which are direct therapeutic interventions for diabetes management.
No
The device is intended to aid in diabetes self-management, analyze and report blood glucose test results, support medication adherence, and provide coaching messages and an insulin dose calculator. It explicitly states it is "not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment." Therefore, it is not a diagnostic device.
Yes
The device is described as a "stand-alone software system" and its components are software applications for mobile phones, personal computers, and web interfaces. While it connects to external hardware (blood glucose meter, CGM server), the device itself is the software that processes and presents the data, and provides calculations and coaching. The description focuses on software features and validation.
Based on the provided text, the BlueStar® Rx device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use focuses on capturing, storing, and transmitting blood glucose data, providing self-management information, analyzing and reporting blood glucose results, supporting medication adherence, and providing coaching messages. While it uses blood glucose data, it does not perform the in vitro analysis of a biological sample itself.
- Device Description: The device is described as a software system intended for use on mobile phones or personal computers. It connects to a blood glucose meter (One Touch Verio Flex) to receive data, but the meter is the device that performs the in vitro diagnostic test (measuring glucose in a blood sample). BlueStar® Rx then processes and utilizes this data.
- Lack of IVD Characteristics: The description does not mention any components or functions that would perform an in vitro test on a biological sample. It's a software-based system that utilizes data generated by an IVD (the blood glucose meter).
In summary, BlueStar® Rx is a software-based diabetes management tool that uses data from an IVD (a blood glucose meter) but is not an IVD itself.
N/A
Intended Use / Indications for Use
BlueStar® Rx 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 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 analyzes and reports blood glucose test results and supports medication adherence. In addition, the 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 settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
For bolus insulin users with type 1 and type 2 diabetes, BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.
For basal insulin users with type 2 diabetes, BlueStar® Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider knowledgeable in the care and management of diabetes. The healthcare provider must activate the Insulin Adjustment Program and configure it for patient-specific parameters.
The BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Product codes
MRZ, NDC, LNX
Device Description
BlueStar Rx is a modified version of the primary predicate (WellDoc BlueStar Rx cleared under K190013). BlueStar Rx maintains all of the features of the primary predicate and adds the titration of long-acting basal insulin doses for qualified type 2 diabetes patients who are not using bolus insulin. This long-acting basal insulin titration feature is included as part of the Insulin Adjustment Program (IAP) in BlueStar Rx. WellDoc BlueStar® as cleared under K190013, 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. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. There are two versions of the primary predicate WellDoc BlueStar® (cleared under K190013) -BlueStar® (OTC version) and BlueStar® Rx (prescription only) applications. In this submission, Welldoc does not propose to change the OTC version of BlueStar application. Like the bolus insulin dose calculator already included in the primary predicate (BlueStar Rx), the new long-acting basal insulin titration feature is also limited to the prescription use (Rx) version. The bolus insulin calculator feature will be disabled in patients using long-acting basal insulin titration feature in the BlueStar Rx. Health care providers (HCPs) will be required to initiate and manage the basal insulin titration for their qualified type 2 diabetes patients using the following two interfaces:
- Web based HCP interface for use by the providers to prescribe long-acting basal insulin doses for the qualified type 2 diabetes patients.
- Web and mobile patient interface for use by patients to follow provider's basal insulin titration plan.
The IAP feature in BlueStar Rx provides directions to the patients based on prescription by their HCP for titrating long-acting insulin doses only.
BlueStar® Rx will also maintain the following features of the primary predicate (WellDoc BlueStar Rx cleared under K190013): (1) ability to connect to the One Touch Verio Flex Blood Glucose Meter via Bluetooth which allows users to send data from their BG meter to the BlueStar® Rx app. which will provide coaching messages (motivational, and educational) based on the real-time blood glucose values and trends. (2) 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.
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
18 years and older
Intended User / Care Setting
healthcare providers (HCPs) and their 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)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
WellDoc, Incorporated Sabyasachi Roy Vice President Regulatory and Quality Systems 10221 Wincopin Circle, Suite 150 Columbia, Maryland 21044
May 21, 2024
Re: K193654
Trade/Device Name: BlueStar® Rx - IAP Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: MRZ, NDC
Dear Sabyasachi Roy:
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 April 7, 2020. 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo 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.
April 7, 2020
WellDoc, Inc Sabyasachi Roy Vice President Regulatory and Quality Systems 10221 Wincopin Circle, Suite 150 Columbia. MA 21044
Re: K193654
Trade/Device Name: BlueStar® Rx Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRZ, NDC, LNX Dated: March 4, 2020 Received: March 4, 2020
Dear Sabyasachi Roy:
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
2
- 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 mediation-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.
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K193654
Device Name BlueStar® Rx
Indications for Use (Describe)
BlueStar® Rx 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 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 analyzes and reports blood glucose test results and supports medication adherence. In addition, the 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 settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. · For bolus insulin users with type 1 and type 2 diabetes, BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.
• For basal insulin users with type 2 diabetes, BlueStar® Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider knowledgeable in the care and management of diabetes. The healthcare provider must activate the Insulin Adjustment Program and configure it for patient-specific parameters.
The BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
| Date Prepared: | December 30, 2019 |
|---|---|
| Name of Manufacturer: | WellDoc, Inc. |
| Address: | 10221 Wincopin Circle, Suite 150 |
| Columbia, MD 21044 | |
| Contact Person: | Sabyasachi Roy, MSEE, Ph.D. |
| VP, Regulatory and Quality Systems | |
| Phone: | (443) 692-3100 |
| Fax: | (443) 692-3099 |
| Trade or Proprietary Name: | BlueStar® Rx |
| Common or Usual Name: | Medical computers and software |
| Infusion pump accessories | |
| Product Codes: | Classification: MRZ, |
| Secondary: NDC, LNX | |
| Regulation: | 21 CFR 880.5725 – Accessories, Pump, Infusion |
| 21 CFR 868.1890 – Calculator, Drug dose | |
| Regulatory Class: | II |
| Classification Panel: | General Hospital, Clinical Chemistry |
| Primary Predicate Device: | K190013 (WellDoc® BlueStar® and WellDoc® BlueStar® Rx System) |
| Secondary Predicate Device: | K171450 (Glooko Mobile Insulin Dosing System (MIDS)) |
Device Description
BlueStar Rx is a modified version of the primary predicate (WellDoc BlueStar Rx cleared under K190013). BlueStar Rx maintains all of the features of the primary predicate and adds the titration of long-acting basal insulin doses for qualified type 2 diabetes patients who are not using bolus insulin. This long-acting basal insulin titration feature is included as part of the Insulin Adjustment Program (IAP) in BlueStar Rx. WellDoc BlueStar® as cleared under K190013, 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
5
diabetes patients to self-manage their disease. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. There are two versions of the primary predicate WellDoc BlueStar® (cleared under K190013) -BlueStar® (OTC version) and BlueStar® Rx (prescription only) applications. In this submission, Welldoc does not propose to change the OTC version of BlueStar application. Like the bolus insulin dose calculator already included in the primary predicate (BlueStar Rx), the new long-acting basal insulin titration feature is also limited to the prescription use (Rx) version. The bolus insulin calculator feature will be disabled in patients using long-acting basal insulin titration feature in the BlueStar Rx. Health care providers (HCPs) will be required to initiate and manage the basal insulin titration for their qualified type 2 diabetes patients using the following two interfaces:
- Web based HCP interface for use by the providers to prescribe long-acting basal insulin doses for the qualified type 2 diabetes patients.
- Web and mobile patient interface for use by patients to follow provider's basal insulin titration plan.
The IAP feature in BlueStar Rx provides directions to the patients based on prescription by their HCP for titrating long-acting insulin doses only.
BlueStar® Rx will also maintain the following features of the primary predicate (WellDoc BlueStar Rx cleared under K190013): (1) ability to connect to the One Touch Verio Flex Blood Glucose Meter via Bluetooth which allows users to send data from their BG meter to the BlueStar® Rx app. which will provide coaching messages (motivational, and educational) based on the real-time blood glucose values and trends. (2) 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.
Indications for Use
BlueStar® Rx 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 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 analyzes and reports blood glucose test results and supports medication adherence. In addition, the 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 settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
- . For bolus insulin users with type 1 and type 2 diabetes, BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.
6
- For basal insulin users with type 2 diabetes, BlueStar Rx includes an Insulin . Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the Insulin Adjustment Program and configure it for patient-specific parameters.
The BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
| Feature | BlueStar Rx
(Subject Device) | WellDoc BlueStar Rx System
(Primary Predicate Device) | Glooko Mobile Insulin
Dosing System (MIDS)
(Secondary Predicate) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | MRZ, NDC, LNX | MRZ, NDC, LNX | NDC |
| Class | II | II | II |
| Regulation | 21 CFR 880.5725: Accessories,
Pump, Infusion
21 CFR 868.1890: Calculator,
Drug dose | 21 CFR 880.5725:
Accessories, Pump, Infusion
21 CFR 868.1890: Calculator,
Drug dose | 21 CFR 868.1890: Calculator,
Drug dose |
| 510(k)
Number | K193654 | K190013 | K171450 |
| Indications
for Use | Rx:
BlueStar® Rx 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 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 analyzes and
reports blood glucose test
results and supports
medication adherence. In
addition, the 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 | Rx:
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 | The Glooko Mobile Insulin
Dosing
System (MIDS) is indicated
for the
management of type 2
diabetes by calculating
appropriate long-acting
basal insulin doses for
titrating insulin levels based
on configuration by a
physician or healthcare
provider
knowledgeable in the care
and management of diabetes.
The physician or healthcare
provider must activate the
MIDS dose calculator and
configure the patient-specific
parameters. The system is not
intended to provide treatment
decisions or to be used as a
substitute for professional
healthcare advice. |
| Feature | BlueStar Rx
(Subject Device) | BlueStar Rx System
(Primary Predicate Device) | Glooko Mobile Insulin
Dosing System (MIDS)
(Secondary Predicate) |
| | in the home or in professional
healthcare settings. The
software also allows for entry
of other diabetes-related
healthcare information and
provides educational
information.
For bolus insulin users
with type 1 and type 2
diabetes, BlueStar® Rx
includes an insulin
dose calculator to
allow patients to use
their prescribed
regimen to calculate a
dose of bolus insulin
for a given amount of
carbohydrates and/or
blood glucose value. For basal insulin users
with type 2 diabetes,
BlueStar Rx includes
an Insulin Adjustment
Program (IAP) which
calculates appropriate
long-acting basal
insulin doses for
titrating insulin levels
based on configuration
by a healthcare
provider. The
healthcare provider
must activate the
Insulin Adjustment
Program and configure
it for patient-specific
parameters. The BlueStar® Rx is not
intended to replace the care
provided by a licensed
healthcare professional,
including prescriptions,
diagnosis, or treatment. | 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. | |
| Environment
of Use | Home or Clinic | Home or Clinic | Home or Clinic |
| Feature | BlueStar Rx
(Subject Device) | WellDoc BlueStar Rx System
(Primary Predicate Device) | Glooko Mobile Insulin Dosing System (MIDS)
(Secondary Predicate) |
| Type of
Insulin
Adjustment | Bolus Insulin Calculation and
Basal (long-acting) Insulin
Titration | Bolus Insulin Calculation | Basal (long-acting) Insulin
Titration |
| Titration
Plan | HCP determined | N/A | HCP determined |
| Basal
Titration
Safety
Features | - Suspends titration on
hypoglycemia
- Suspends titration on
unsafe dose - Maximum dose set by HCP
(system limits to 100-units) - Fasting BG reminder
- Insulin injection reminder
- Report to HCP | N/A as Basal Titration not
included | - Suspends titration on
hypoglycemia - Suspends titration on
unsafe dose - Maximum dose set by
HCP - Fasting BG reminder
- Insulin injection reminder
- Report to HCP |
| Safety
Notifications | Yes (Hyper notification with
instructions;
Hypo notification with
instructions;
Unsafe dose;
Maximum dose) | N/A for Basal Titration | Yes (Hyper notification with
instructions;
Hypo notification with
instructions;
Unsafe dose;
Maximum dose) |
| Basal
Titration
Status | Active
Suspended
Ended | N/A for Basal Titration | Active
Inactive
Alert
Adherence
Ended |
| Logbook | Yes | Yes | Yes |
| Technological Characteristics | | | |
| Interface | Patient interface - web and
mobile application
HCP interface - web | Patient interface - web and
mobile application
HCP interface - web. | Patient interface - web and
mobile application
HCP interface - web |
| | Includes support for iOS,
Android and web browsers
such as Internet Explorer,
Chrome, Firefox, Safari. | Includes support for iOS,
Android and web browsers
such as Internet Explorer,
Chrome, Firefox, Safari and
others. | Includes support for iOS,
Android and web browsers
such as Internet Explorer,
Chrome, Firefox, Safari. |
| Reports &
Statistics | Yes | Yes | Yes |
| Secure
Database | Yes | Yes | Yes |
| Data
Transfer
Mode | Internet | Internet | Internet |
Comparison to Predicates
7
8
Discussions of differences in Indications for Use statement:
As compared to the previously cleared version of the BlueStar® Rx, the subject device of this
9
application proposes to make the following changes:
- Requires HCPs to initiate and manage long-acting basal insulin titration for their patients with type 2 diabetes
The indications for use of the subject device clearly reflects this new basal insulin titration capability in the statement included:
"For basal insulin users with type 2 diabetes, BlueStar Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the Insulin Adjustment Program and configure it for patient-specific parameters."
This statement is equivalent to the secondary predicate's (Glooko MIDS) indications for use as noted in the table above.
Discussions of differences in technological characteristics:
The subject device includes all of the features of the WellDoc BlueStar® Rx system cleared under K190013 and is technologically similar to the secondary predicate - Glooko MIDS. The subject device maintains all of the technological capabilities of the primary predicate (BlueStar® and BlueStar® Rx) including:
- the ability to connect to the One Touch Verio Flex Blood Glucose Meter via Bluetooth. ● This will allow users to send data from their meter to the BlueStar® and 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 also has 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.
The inclusion of the basal insulin titration under the Insulin Adjustment (IAP) feature in the subject device does not interfere with the existing functionality cleared in the WellDoc BlueStar® and WellDoc BlueStar® Rx app under K190013.
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” |
| ---------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
10
| 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 |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
Clinical Tests
Not Applicable.
Conclusions
The subject device in this premarket notification - BlueStar® Rx with the Insulin Adjustment Program (IAP) feature has similar indications for use and technological characteristics as those of the predicate devices (WellDoc BlueStar® Rx cleared under K190013 and Glooko MIDS cleared under K171450).
Performance testing demonstrated that the BlueStar® Rx performed as intended. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The BlueStar Rx is substantially equivalent to the predicates cited.