(126 days)
InPen System (K160629)
No
The document describes data analysis, reporting, and rule-based coaching messages, but does not explicitly mention the use of AI or ML algorithms for these functions. The insulin dose calculator and adjustment program are described as being based on prescribed regimens and configured parameters, not learned models.
Yes
The device provides features like an insulin dose calculator and an Insulin Adjustment Program (IAP) to help patients manage their diabetes, which directly influences treatment.
No
The text explicitly states: "BlueStar Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment." While it collects and analyzes data that aids in diabetes self-management and provides information for healthcare providers, it does not make a diagnosis.
Yes
The device description explicitly states, "BlueStar is a Software as a Medical Device (SaMD)". While it interacts with hardware like the Tempo Smart Button and other compatible devices, the core medical device functionality described (data capture, storage, transmission, analysis, reporting, coaching, calculators, and adjustment programs) resides solely within the software applications. The hardware components are external devices that provide data to the software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
- BlueStar's Function: BlueStar is a software-based device that primarily focuses on:
- Data Management: Securely capturing, storing, and transmitting glucose and insulin data.
- Information and Education: Providing information, coaching messages, and educational content for diabetes self-management.
- Calculations: Offering an insulin dose calculator and an Insulin Adjustment Program based on existing data and prescribed regimens.
- Communication: Facilitating communication between patients and healthcare providers.
While BlueStar uses data from devices that perform in vitro diagnostics (like blood glucose meters), BlueStar itself does not perform any diagnostic testing on biological samples. It processes and presents data that is generated by other devices or manually entered by the user.
The intended use and device description clearly indicate that BlueStar is a diabetes self-management tool and information system, not a diagnostic test.
N/A
Intended Use / Indications for Use
BlueStar® 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. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar Rx automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar Rx analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
For bolus insulin users with type 2 diabetes, BlueStar Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insultin for a given amount of carbohydrates and/or 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 levels based on configuration by a healthcare provider. The healthcare provider must activate the IAP and configure it for patient-specific parameters.
BlueStar Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
BlueStar®
BlueStar® is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Product codes
NDC
Device Description
BlueStar® (subject device) combines the existing diabetes self-management features of the predicate (BlueStar® and BlueStar® Rx, K193654) with the automatic tracking of insulin delivery functionality of the reference InPen System (K160629). BlueStar maintains all of the features of the predicate and adds the capability to connect with compatible devices connected with insulin pens via Bluetooth wireless technology. In this submission, the predicate device is being modified such that it can receive insulin dose-related data when connected to a Tempo Smart Button™ (TSB). The TSB when attached to a disposable Tempo Pen (insulin pen), can transfer dose-related data (corresponding to the brand of insulin, dose amount, date, and time) via Bluetooth® Low Energy (Bluetooth) wireless technology.
BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to assist patients in managing their diabetes with guidance from their providers. BlueStar has two versions – BlueStar (Over the Counter, OTC) and BlueStar Rx (prescription use version).
BlueStar is comprised of the following software applications (app):
- iOS and Android based mobile apps for patients .
- web-based app (web-portal) for HCPs ●
BlueStar requires initial registration before the patient can access the software applications.
BlueStar is compatible with devices including Blood Glucose Meters (BGM), Blood Pressure Monitors, Continuous Glucose Monitors (CGM) , Tempo Smart Button™ 2, Weight Scales, Activity trackers. Data, including blood glucose values, blood pressure, medications, carbohydrates, physical activity, weight, and sleep are entered, stored and processed in the patient software applications. Data can be entered manually or automatically via Bluetooth for compatible devices. Additionally, the mobile application for patients is capable of automatically receiving, storing, processing, and displaying insulin data from the Tempo Smart Button via Bluetooth.
The BlueStar apps for patients function as an information repository (logbook and Personal Health Record) and diabetes education resource (curriculum, articles, videos). Patients also receive in-the-moment coaching (Real Time Feedback messages), Pattern Reports and SMART Visit Reports that can be shared with their providers. Coaching messages are motivational, behavioral, and educational in nature and are based on data (and trends) including real-time blood glucose, blood pressure, and weight. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. Patients also receive insights based on data entered and trends detected by the app. BlueStar patient apps include a secure communication system (Message Center) as well as a medication information repository (dose and schedule). Qualified type 1 and type 2 diabetes patients have access to a bolus insulin calculator (cleared under K190013). Qualified type 2 diabetes patients have access to the Insulin Adjustment Program (IAP) to titrate long-acting basal insulin (cleared under K193654). Patients use their mobile software applications to follow their HCP's bolus insulin prescription or basal insulin titration plan. The bolus insulin calculator and basal insulin titration features are only available in BlueStar Rx for use under the direction of their HCP.
The provider can review patient information, workflows and decision support information using the web-based software application for HCP. The HCP can initiate and manage basal insulin titration (IAP) and the bolus insulin calculator prescription / parameters through the web-based software application for HCP.
The SMART Visit Report includes data summary, analysis, and decision support for treatment as well as psychosocial issues identified by patient survey responses within the app. The SMART Visit Report can be sent by the patient to his/her HCP from the mobile app. The HCP can also generate SMART Visit Reports from their web portal.
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, Home under direction of HCP and Clinic
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 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 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).
Human factors evaluation was conducted with the intended user populations of patients and healthcare providers. The human factors information provided in the submission confirms that the user interface has been adequately validated for use per the labeling.
Performance testing demonstrated that the BlueStar Rx performed as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BlueStar® Rx (K193654)
Reference Device(s)
InPen System (K160629)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(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). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 28, 2023
Welldoc, Inc. David Boser Director, Regulatory Affairs 10221 Wincopin Circle, Ste #150 Columbia, Maryland 21044
Re: K230813
Trade/Device Name: BlueStar® and BlueStar® Rx Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: March 23, 2023 Received: March 24, 2023
Dear David Boser:
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.
1
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 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.
Joshua Balsam -S
Joshua Balsam, PhD Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230813
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. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar Rx automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar Rx analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
• For bolus insulin users with type 2 diabetes, BlueStar Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insultin for a given amount of carbohydrates and/or 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 levels based on configuration by a healthcare provider. The healthcare provider must activate the IAP and configure it for patient-specific parameters.
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) | |
|---|---|
| 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."
3
Indications for Use
510(k) Number (if known) K230813
Device Name BlueStar®
Indications for Use (Describe)
BlueStar® is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
BlueStar 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."
4
510(k) Summary: K230813
| Date Prepared: | March 23, 2023 |
|---|---|
| Name of Manufacturer: | WellDoc, Inc. |
| Address: | 10221 Wincopin Circle, Suite 150 |
| Columbia, MD 21044 | |
| Contact Person: | David Boser |
| Director, Regulatory Affairs | |
| Phone: | (248) 249-5243 |
| Fax: | (443) 692-3099 |
| Trade or Proprietary Name: | BlueStar®, BlueStar® Rx |
| Common or Usual Name: | Calculator, Drug Dose |
| Product Codes: | Classification: NDC |
| Regulation: | 21 CFR 868.1890 - Calculator, Drug Dose |
| Regulatory Class: | II |
| Classification Panel: | Clinical Chemistry |
| Predicate Device: | BlueStar® Rx (K193654) |
5
Device Description
BlueStar® (subject device) combines the existing diabetes self-management features of the predicate (BlueStar® and BlueStar® Rx, K193654) with the automatic tracking of insulin delivery functionality of the reference InPen System (K160629). BlueStar maintains all of the features of the predicate and adds the capability to connect with compatible devices connected with insulin pens via Bluetooth wireless technology. In this submission, the predicate device is being modified such that it can receive insulin dose-related data when connected to a Tempo Smart Button™ (TSB). The TSB when attached to a disposable Tempo Pen (insulin pen), can transfer dose-related data (corresponding to the brand of insulin, dose amount, date, and time) via Bluetooth® Low Energy (Bluetooth) wireless technology.
BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to assist patients in managing their diabetes with guidance from their providers. BlueStar has two versions – BlueStar (Over the Counter, OTC) and BlueStar Rx (prescription use version).
BlueStar is comprised of the following software applications (app):
- iOS and Android based mobile apps for patients .
- web-based app (web-portal) for HCPs ●
BlueStar requires initial registration before the patient can access the software applications.
BlueStar is compatible with devices including Blood Glucose Meters (BGM), Blood Pressure Monitors, Continuous Glucose Monitors (CGM) , Tempo Smart Button™ 2, Weight Scales, Activity Trackers. Data, including blood glucose values, blood pressure, medications, carbohydrates, physical activity, weight, and sleep are entered, stored and processed in the patient software applications. Data can be entered manually or automatically via Bluetooth for compatible devices. Additionally, the mobile application for patients is capable of automatically receiving, storing, processing, and displaying insulin data from the Tempo Smart Button via Bluetooth.
The BlueStar apps for patients function as an information repository (logbook and Personal Health Record) and diabetes education resource (curriculum, articles, videos). Patients also receive in-the-moment coaching (Real Time Feedback messages), Pattern Reports and SMART Visit Reports that can be shared with their providers. Coaching messages are motivational, behavioral, and educational in nature and are based on data (and trends) including real-time blood glucose, blood pressure, and weight. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. Patients
1 BlueStar receives 3-hour delayed CGM data via manufacturer's API.
2 Tempo Smart Button (module), manufactured by Eli Lilly and Company, is a reusable data transmitter that detects and stores insulin dose-related data when attached to a disposable Tempo Pen, and then transfers this information to a compatible mobile application via Bluetooth® Low Energy (Bluetooth) wireless technology. The dose-related data corresponds to the brand of insulin, dose amount, date, and time. In this submission, the predicate (BlueStar, and BlueStar Rx, K193654) was modified to be compatible with the Tempo Smart Button manufactured by Eit Lilly and Company. Refer to K212217 for premarket notification for Tempo Smart Button.
6
also receive insights based on data entered and trends detected by the app. BlueStar patient apps include a secure communication system (Message Center) as well as a medication information repository (dose and schedule). Qualified type 1 and type 2 diabetes patients have access to a bolus insulin calculator (cleared under K190013). Qualified type 2 diabetes patients have access to the Insulin Adjustment Program (IAP) to titrate long-acting basal insulin (cleared under K193654). Patients use their mobile software applications to follow their HCP's bolus insulin prescription or basal insulin titration plan. The bolus insulin calculator and basal insulin titration features are only available in BlueStar Rx for use under the direction of their HCP.
The provider can review patient information, workflows and decision support information using the web-based software application for HCP. The HCP can initiate and manage basal insulin titration (IAP) and the bolus insulin calculator prescription / parameters through the web-based software application for HCP.
The SMART Visit Report includes data summary, analysis, and decision support for treatment as well as psychosocial issues identified by patient survey responses within the app. The SMART Visit Report can be sent by the patient to his/her HCP from the mobile app. The HCP can also generate SMART Visit Reports from their web portal.
Indications for Use
BlueStar® (OTC):
BlueStar® is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes selfmanagement. BlueStar automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar provides coaching messages (motivational, behavioral, and educational) based on realtime glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
BlueStar® 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. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes selfmanagement. BlueStar Rx automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar Rx analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, and educational) based on
7
real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. 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 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 IAP and configure it for patient-specific parameters.
BlueStar Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Comparison to Predicates
Note-1: BlueStar Rx includes features of BlueStar (OTC version). The bolus insulin calculator and basal insulin titration under (Insulin Adjustment Program – IAP) are only available in BlueStar Rx.
| Feature | BlueStar
(Subject Device) | BlueStar Rx
(Predicate - K193654) |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | NDC | MRZ, NDC, LNX |
| Class | II | II |
| Regulation | 21 CFR 868.1890: Calculator, Drug dose | 21 CFR 880.5725: Accessories, Pump, Infusion
21 CFR 868.1890: Calculator, Drug dose |
| 510(k) Number | K230813 | K193654 |
| Intended patient population | For patients aged 18 years and older who have type 1 or type 2 diabetes.
Basal insulin titration is for type 2 diabetes patients only. | For patients aged 18 years and older who have type 1 or type 2 diabetes.
Basal insulin titration is for type 2 diabetes patients only. |
| Environment of Use | Home under direction of HCP and Clinic | Home under direction of HCP and Clinic |
| 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. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar 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. BlueStar Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes |
| Feature | BlueStar
(Subject Device) | BlueStar Rx
(Predicate - K193654) |
| | automatically receives insulin dose
related data when connected to a
compatible Tempo Smart Button device
via wireless Bluetooth technology and has
the ability to detect which doses are prime
and which are injected insulin. BlueStar
Rx analyzes, and reports glucose test
results and supports medication
adherence. In addition, BlueStar Rx
provides coaching messages
(motivational, behavioral, and
educational) based on real-time glucose
values and trends. It includes software
intended for patient use on mobile phones
and software intended for healthcare
provider use through computer web
browsers. The software also allows for
entry of other diabetes-related healthcare
information and provides educational
information.
For bolus insulin users with type
1 or 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
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 IAP and configure it for
patient-specific parameters. BlueStar Rx is not intended to replace the
care provided by a licensed healthcare
professional, including prescriptions, | 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
settings. The software also allows for
entry of other diabetes-related
healthcare information and provides
educational information.
For bolus insulin users with
type 1 or 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
IAP and configure it for patient-
specific parameters. BlueStar Rx is not intended to
replace the care provided by a
licensed healthcare professional,
including prescriptions, diagnosis, or
treatment. |
| Feature | BlueStar | BlueStar Rx |
| | (Subject Device) | (Predicate - K193654) |
| Indications for Use
(OTC) | BlueStar® is indicated for use by
healthcare providers (HCPs) and their
patients – aged 18 years and older - who
have type 1 or type 2 diabetes. BlueStar is
intended to provide secure capture,
storage, and transmission of glucose data
as well as information to aid in diabetes
self-management. BlueStar automatically
receives insulin dose related data when
connected to a compatible Tempo Smart
Button device via wireless Bluetooth
technology and has the ability to detect
which doses are prime and which are
injected insulin. BlueStar analyzes, and
reports glucose test results and supports
medication adherence. In addition,
BlueStar provides coaching messages
(motivational, behavioral, and
educational) based on real-time glucose
values and trends. It includes software
intended for patient use on mobile phones
and software intended for healthcare
provider use through computer web
browsers. The software also allows for
entry of other diabetes-related healthcare
information and provides educational
information.
BlueStar is not intended to replace the
care provided by a licensed healthcare
professional, including prescriptions,
diagnosis, or treatment. | 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 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. |
| Software Level of Concern | Major | Major |
| Feature | BlueStar
(Subject Device) | BlueStar Rx
(Predicate - K193654) |
| Operating Platform | iOS and Android patient software
applications.
Web-based HCP software application
(browsers such as Internet Explorer,
Chrome, Firefox, Safari and Edge.) | iOS, Android, and web-based patient
software applications.
Web-based HCP software application
(browsers such as Internet Explorer,
Chrome, Firefox, Safari and Edge.) |
| Basal Insulin Titration &
Support | Yes
Applies to BlueStar Rx only (see Note-1). | Yes
Applies to BlueStar Rx only (see
Note-1). |
| HCP supervision | Yes
Initiate, manage the bolus insulin
calculator and basal insulin titration
parameters | Yes
Initiate, manage the bolus insulin
calculator and basal insulin titration
parameters |
| Prescription Use | Yes
Applies to BlueStar Rx only (see Note-1). | Yes
Applies to BlueStar Rx only (see
Note-1). |
| Bolus Insulin Calculator | Yes
Applies to BlueStar Rx only (see Note-1). | Yes
Applies to BlueStar Rx only (see
Note-1). |
| Tracks residual bolus
insulin to mitigate stacking | Yes | Yes |
| Accounts for insulin on
board (IOB) | Yes | Yes |
| Carbohydrate tracking | Yes | Yes |
| Blood Glucose Tracking | Yes | Yes |
| Logbook
Reports, graphs | Yes | Yes |
| Reminders | Yes | Yes |
| Compatible with Insulin
Pens | Yes
(via Tempo Smart Button) | No |
| Prime vs. dose
identification | Auto prompt with manual edit | No |
| Compatible with BGMs | Yes | Yes |
| Compatible with CGMs | Yes
through API | Yes
through API |
| Feature | BlueStar
(Subject Device) | BlueStar Rx
(Predicate - K193654) |
| connectivity with other
devices | | |
| Dosing Related Safety
Notifications | Yes | Yes |
8
9
10
11
Discussions of similarities and differences in Indications for Use statements:
The subject device (BlueStar Rx) and predicate (BlueStar Rx, K193654) have the following similarities:
- Devices use glucose value to calculate a recommended insulin dose in order to aid in optimal insulin management.
- Devices are used by similar patient population.
- With the exceptions of receiving additional information from the TSB, ● identification of prime vs. injected insulin dose, limiting patient use to mobile devices, and removal of the term "blood" to account for usage with BGM and CGM devices, the subject device and predicate have identical indications for use.
- Subject device's intended use population is a sub-set of the predicate's intended . use population.
- BlueStar Rx in the subject device and predicate device are prescription use and for use ● under direction of HCP.
- . Both devices include a bolus insulin calculator. HCP provides patient specific parameters prior to use of calculator. Insulin dose is calculated for meals and corrections while accounting for insulin on board (IOB).
- BlueStar Rx in subject device and predicate also includes identical basal insulin titration algorithms. HCP configures, initiates, and then oversees the insulin titration process.
- Information for diabetes management is provided in both devices. ●
- Neither of the devices are intended to be a substitute for professional clinical advice. .
The subject device and predicate have the same intended use and similar indications for use. The minor difference in indications for use do not raise any new or different questions of safety or effectiveness.
Discussions of similarities and differences in technological characteristics:
The technological characteristics between the subject device (BlueStar Rx) and the predicate (BlueStar Rx, K193654) are similar.
The similarities between the subject device and the predicate device are outlined as follows:
- . Subject device and predicate device use similar mobile operating platforms (iOS. Android)
- Subject device and predicate device have logbook functionality with manual dose logging, ●
12
reports, graphs, reminders, carbohydrate tracking, and blood glucose tracking
- . Subject device and predicate device are compatible with other devices such as BGMs, CGMs
The differences between the subject device and predicate are as follows:
Following modifications were made to the predicate to enable integration with Tempo Smart Button™:
- . TSB integration in software user interface flow including - Registration and Onboarding, TSB pairing and connections
- Logbook function including display synced doses, prime detection ●
- Bolus insulin calculator ●
- Allow HCP authorization of calculator within patient app (using a code) o
- Includes LyumjevTM (insulin lispro-aabc) o
- Basal insulin titration ●
- o Alert patient if a bolus insulin dose is synced (recorded) and Suspend Insulin Adjustment Program (IAP).
- The predicate device's patient software application supports a web-based operating . platform.
- Other modifications
- o Dosing, duplicate data, Bluetooth, and Jailbroken device related notifications
When evaluating the similarities and differences in technological characteristics, the reference device, InPen System (K160629), was also considered.
The similarities between the subject device and the reference device are outlined as follows:
- . Subject device and reference device have automated dose transfer using Bluetooth wireless technology
- Subject device and reference device have prime (vs. dose) identification using algorithm ● that allows manual editing (or override)
The differences between the subject device and the reference device are outlined as follows:
- . Reference device does not support basal insulins
In terms of technological characteristics, the subject device (BlueStar Rx), predicate device and reference device differ in certain minor details. However, those differences do not raise new or different questions of safety or effectiveness.
Performance Testing
The following bench testing was performed and reviewed to support the substantial equivalence ofthe subject device:
13
| 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). |
| Human Factors | Human factors evaluation was conducted with the intended user populations of patients and healthcare providers. The human factors information provided in the submission confirms 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 and BlueStar Rx) has same intended use, similar indications for use and technological characteristics as those of the predicate device (BlueStar Rx, K193654) and reference device (InPen System, K160629).
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. BlueStar is substantially equivalent to the predicate cited.