(289 days)
No
The description focuses on rule-based algorithms for insulin dose calculation and adjustment based on healthcare provider configuration, not on learning from data.
Yes
The device is a therapeutic device because its IAP calculates appropriate insulin doses and dose adjustments for patients with type 1 or type 2 diabetes based on configurations by a healthcare provider.
No
Explanation: The device "analyzes, and reports blood glucose test results and supports medication adherence," and provides "an insulin dose calculator" and "Insulin Adjustment Program," which are all related to managing a pre-existing condition (diabetes) rather than diagnosing it. The text explicitly states, "BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment."
Yes
The device description explicitly states that the subject device is a "standalone software system" and describes its interfaces as "Web based HCP interface" and "Web and mobile patient interface," indicating it is solely software running on existing hardware (mobile phones, personal computers).
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- BlueStar® Rx Functionality: BlueStar® Rx primarily focuses on:
- Analyzing and reporting blood glucose test results: While it uses blood glucose data, it doesn't perform the in vitro test itself. It receives the results from a separate blood glucose meter.
- Supporting medication adherence: This is a management and behavioral support function.
- Providing coaching messages: This is educational and motivational support.
- Calculating insulin doses: This is a therapeutic calculation based on patient data and healthcare provider prescriptions.
- Allowing entry of other diabetes-related information: This is data management.
- Providing educational information: This is self-management support.
The core function of BlueStar® Rx is to process, analyze, and provide guidance based on data, including blood glucose data obtained from an external source. It does not perform the diagnostic test on a specimen from the body.
Therefore, while it is a medical device used in the management of diabetes, it does not fit the definition of an In Vitro Diagnostic device.
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. BlueStar® Rx analyzes, and reports blood glucose test results and supports medication adherence. In addition, BlueStar® Rx provides coaching messages (motivational, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information to aid in diabetes self-management.
• 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.
• For bolus insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen.
• For premixed insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin.
The algorithms for the IAP are not designed for the titration of NPH, regular human premixed insulins. The healthcare provider must activate the IAP and configure it with patient-specific parameters.
BlueStar® Rx 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)
NDC
Device Description
Subject device (BlueStar® Rx) is a modified version of the predicate (BlueStar® Rx cleared under K193654). BlueStar® Rx maintains the basic features / functionality of the predicate and adds the titration of fast-acting bolus insulin doses and premixed insulins for qualified type 2 diabetes patients. Qualified patients are those with type 2 diabetes whose blood glucose is not adequately managed on current insulin therapies (e.g., using basal insulin) and/or non-insulin therapies.
This bolus insulin and premixed titration feature is included as part of the expanded Insulin Adjustment Program (IAP) in BlueStar® Rx. The predicate (BlueStar® Rx, K193654) is a standalone 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. Like the predicate, the subject device (BlueStar® Rx) is intended to provide secure capture, storage, and transmission of blood glucose data as well as other information to aid in diabetes self-management. Patients receive guidance on diabetes self-management, are encouraged to reach out to their healthcare team when needed and have access to a bolus insulin calculator'. The insulin adjustment program (IAP) of the predicate (BlueStar® Rx, K193654) already includes the ability to titrate long-acting basal insulin for patients with type 2 diabetes. In this submission, fast-acting bolus insulin and premixed insulin titration features are added to the subject device's (BlueStar® Rx) IAP for patients with type 2 diabetes.
Health care providers (HCPs) will be required to initiate and manage the titration of basal, bolus and premixed 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 insulin doses for the qualified type 2 diabetes patients.
- . Web and mobile patient interface for use by patients to follow provider's insulin titration plan.
The IAP feature in subject device (BlueStar® Rx) provides directions to the patients based on prescription by their HCP for titrating basal, bolus and premixed insulin doses.
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)
The following bench testing was performed and reviewed to support the substantial equivalence ofthe 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
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.
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.
BlueStar® Rx (K193654)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 & Human Services logo. To the right of that is the FDA logo, which 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.
September 8, 2021
WellDoc. Inc. Sabyasachi Roy Vice President, Regulatory Affairs and Quality Systems 10221 Wincopin Circle, Suite 150 Columbia, Maryland 21044
Re: K203434
Trade/Device Name: BlueStar® Rx Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: November 20, 2020 Received: November 23, 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
1
542 of the Act); 21 CFR 1000-1050.
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-
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,
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K203434
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 analyzes, and reports blood glucose test results and supports medication adherence. In addition, BlueStar® Rx provides coaching messages (motivational, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information to aid in diabetes self-management.
· 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.
• For bolus insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen.
· For premixed insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of
premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin.
The algorithms for the IAP are not designed for the titration of NPH, regular human premixed insulins. The healthcare provider must activate the IAP and configure it with 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(k) Number: K203434
510(k) Summary
| Date Prepared: | September 03, 2021 |
|---|---|
| Name of Manufacturer: | WellDoc, Inc. |
| Address: | 10221 Wincopin Circle, Suite 150 |
| Columbia, MD 21044 | |
| Contact Person: | Sabyasachi Roy, MSEE, Ph.D. |
| Vice President, Regulatory Affairs | |
| Phone: | (443) 692-3100 |
| Fax: | (443) 692-3099 |
| Trade or Proprietary Name: | BlueStar® Rx |
| Common or Usual Name: | Calculator, Drug Dose |
| Product Codes: | NDC |
| Regulation: | 21 CFR 868.1890 - Calculator, Drug dose |
| Regulatory Class: | II |
| Classification Panel: | Clinical Chemistry |
| Predicate Device: | BlueStar® Rx (K193654) |
4
Device Description
Subject device (BlueStar® Rx) is a modified version of the predicate (BlueStar® Rx cleared under K193654). BlueStar® Rx maintains the basic features / functionality of the predicate and adds the titration of fast-acting bolus insulin doses and premixed insulins for qualified type 2 diabetes patients. Qualified patients are those with type 2 diabetes whose blood glucose is not adequately managed on current insulin therapies (e.g., using basal insulin) and/or non-insulin therapies.
This bolus insulin and premixed titration feature is included as part of the expanded Insulin Adjustment Program (IAP) in BlueStar® Rx. The predicate (BlueStar® Rx, K193654) is a standalone 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. Like the predicate, the subject device (BlueStar® Rx) is intended to provide secure capture, storage, and transmission of blood glucose data as well as other information to aid in diabetes self-management. Patients receive guidance on diabetes self-management, are encouraged to reach out to their healthcare team when needed and have access to a bolus insulin calculator'. The insulin adjustment program (IAP) of the predicate (BlueStar® Rx, K193654) already includes the ability to titrate long-acting basal insulin for patients with type 2 diabetes. In this submission, fast-acting bolus insulin and premixed insulin titration features are added to the subject device's (BlueStar® Rx) IAP for patients with type 2 diabetes.
Health care providers (HCPs) will be required to initiate and manage the titration of basal, bolus and premixed 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 insulin doses for the qualified type 2 diabetes patients.
- . Web and mobile patient interface for use by patients to follow provider's insulin titration plan.
The IAP feature in subject device (BlueStar® Rx) provides directions to the patients based on prescription by their HCP for titrating basal, bolus and premixed insulin doses.
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. 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 to aid in diabetes self-management.
- For bolus insulin users with type 1 or type 2 diabetes, BlueStar® Rx includes an insulin ●
1 Bolus insulin calculator was previously cleared for Welldoc BlueStar® Rx under K190013.
5
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.
- For bolus insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate . dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen.
- For premixed insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates . appropriate dose adjustments of premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin.
The algorithms for the IAP are not designed for the titration of NPH, regular human insulin, or human premixed insulins. The healthcare provider must activate the IAP and configure it with 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® Rx
(Subject Device) | BlueStar® Rx
(Predicate Device) |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | K203434 | K193654 |
| Target
Population for
insulin
titration | Qualified Type 2 diabetes patients ≥18 years
requiring intensification of insulin; and their
provider | Qualified Type 2 diabetes patients ≥18 years
requiring intensification of insulin; and their
provider |
| Environment
of Use | Home under direction of HCP and Clinic | Home under direction of HCP and Clinic |
| 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. 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 | The WellDoc 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 |
| Feature | BlueStar® Rx
(Subject Device) | BlueStar® Rx
(Predicate Device) |
| | diabetes-related healthcare information and provides educational information to aid in diabetes self-management.
• 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.
• For bolus insulin users with type 2 diabetes, BlueStar® Rx 's IAP calculates appropriate dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen.
• For premixed insulin users with type 2 diabetes, BlueStar® Rx 's IAP calculates appropriate dose adjustments of premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin.
The algorithms for the IAP are not designed for the titration of NPH, regular human insulin, or human premixed insulins. The healthcare provider must activate the IAP and configure it with patient-specific parameters.
BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. | 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. 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. |
| Software
Based | Yes | Yes |
| Platform | Patient interface – web and mobile application
HCP interface - web
Includes support for iOS, Android and web browsers such as Internet Explorer, Chrome, Firefox, Safari and Edge. | Patient interface – web and mobile application
HCP interface - web
Includes support for iOS, Android and web browsers such as Internet Explorer, Chrome, Firefox, Safari and Edge. |
| Basal Insulin
Titrated | Basal (long-acting) Insulins:
- glargine - U100 (Lantus, Basaglar)
- glargine - U300 (Toujeo)
- detemir (Levemir)
- degludec (Tresiba) | Basal (long-acting) Insulins:
- glargine - U100 (Lantus, Basaglar)
- glargine - U300 (Toujeo)
- detemir (Levemir)
- degludec (Tresiba) |
| Feature | BlueStar® Rx
(Subject Device) | BlueStar® Rx
(Predicate Device) |
| | Basal Insulin + GLP-1 agonist - glargine/Lixisenatide (Soliqua)
- degludec/liraglutide (Xultophy) | Basal Insulin + GLP-1 agonist
- glargine/Lixisenatide (Soliqua)
- degludec/liraglutide (Xultophy) |
| Bolus insulin
titrated | Admelog U-100 Apidra U-100 Fiasp U-100 Humalog U-100 Humalog U-200 Novolog U-100 See Note-3 | None |
| Premixed
insulin titrated | Humalog Mix 75-25(U-100) Insulin Novolog Mix 70-30 FlexPen U-100 Novolog Mix 70-30 U-100 Insulin Humalog Mix 75-25 KwikPen See Note-3 | None |
| HCP
Involvement | HCP inputs are entered and confirmed using
the HCP web portal. HCP can monitor and
adjust treatment plan. | HCP inputs are entered and confirmed using
the HCP web portal. HCP can monitor and
adjust treatment plan. |
| Patient
Involvement | Patient can record actual dose taken | Patient can record actual dose taken. |
| Primary HCP
Inputs
(titration) | Insulin type
Titration parameters & rules - Initial insulin dose
- Maximum dose
- Optional (correction factor and IOB)
- Algorithm
Titration parameters (e.g., insulin increment,
interval, BG target) are set based on evidence
based titration algorithms. | Insulin type
Titration parameters & rules - Initial insulin dose
- Interval of titration
- Increment of insulin
- Maximum dose
- Fasting BG target range
- Below / above BG target &
- corresponding insulin adjustment
Titration parameters may be selected from
evidence-based titration algorithms or HCP's
custom prescription for basal insulin. |
| Patient inputs | Glucose: Fasting, Current (e.g., Pre-Meal, Bedtime) Dose: record insulin dose to reflect actual dose taken Event Type for current glucose reading (e.g., Breakfast) Carbs for Basal-bolus with Carb counting (in app support for carb counting) | Glucose: Fasting, Current (e.g., Pre-Meal, Bedtime) Dose: record insulin dose to reflect actual dose taken Event Type for current glucose reading (e.g., Breakfast) Carbs for Basal-bolus with Carb counting (in app support for carb counting) No support for bolus and premixed insulin
titration / IAP. |
| Primary
Output for
Diabetes | To Patient- Provides warnings and coaching /
RTFB when blood glucose values exceed
hypoglycemic or hyperglycemic limits; | Basal algorithms see K193654 510(k)
Summary |
| Feature | BlueStar® Rx
(Subject Device) | BlueStar® Rx
(Predicate Device) |
| Management | provides recommended adjustments to the prescribed
insulin dose; tracks blood glucose and insulin
data; send SMART visit report to HCP.
To HCP - alerts when blood glucose values
exceed hypoglycemic or hyperglycemic limits
or patient deviates from prescribed regimen;
and view titration progress and summary
report.
See Note-3 | No bolus or premixed titration algorithms. |
| Limits for
Safety | The system provides hypoglycemia coaching
instructions; bolus insulin algorithm is
constrained to a 4 unit dosage increase over a 3
day period (Q3D); maximum insulin dose is 30
units per dose for both bolus (Insulin-to-
Carbohydrate Ratio) and 70 units premix
insulin (see Note-1).
See Note-3 | Basal algorithms see K193654 510(k)
Summary
No bolus or premixed algorithms. |
| Warnings | Hypoglycemia and Hyperglycemia coaching
instructions; patient deviates from prescribed
regimen; Alerts sent to HCPs.
See Note-3 | Basal algorithms see K193654 510(k)
Summary
No bolus or premixed algorithms. |
| Logbook | Yes | Yes |
| Reports &
Statistics | Yes | Yes |
| Secure
Database | Yes | Yes |
| Data Transfer
Mode | Internet | Internet |
| Algorithm
Used | Bolus Insulins
Humalog, Apidra, Novolog - AUTONOMY
ICR
Apidra - Adjust to TargetPremixed Insulin
INITIATEReal-World Approach (Hirsch et al. 2005)
See Note-2 and Note-3 | Basal algorithms see K193654 510(k)
Summary
No bolus or premixed titration algorithms. |
| Glucose
Target | Q1D or Q3D - BG Target Range (not-editable)
85 - 114 mg/dL
Q7D-ICR - BG Target Range (not-editable) 80
- 130 mg/dL | Basal algorithms see K193654 510(k)
Summary
No bolus or premixed titration algorithms. |
| Magnitude of
insulin
adjustment as
a
function of
target | The incremental dose adjustment does not
change as a function of target; the dose
adjustment is based on the algorithm used in
clinical studies. | Basal algorithms see K193654 510(k)
Summary
No bolus or premixed titration algorithms. |
| Feature | BlueStar® Rx
(Subject Device) | BlueStar® Rx
(Predicate Device) |
| insulin
adjustment | Bolus insulin algorithm is constrained to a
4unit dosage increase per 3-day period (Q3D);
maximum insulin dose is 30 units per dose for
bolus (Insulin-to-Carbohydrate Ratio) and 70
units for premix insulin. | Summary
No bolus or premixed titration algorithms. |
| Frequency of
insulin
adjustment
(increase) | No more than once daily. | Basal algorithms see K193654 510(k)
Summary
No bolus or premixed titration algorithms. |
| Frequency of
insulin
adjustment
(decrease) | Daily decrease allowed. | Basal algorithms see K193654 510(k)
Summary
No bolus or premixed titration algorithms. |
Comparison to Predicates
6
7
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Note-1: Premixed insulin is a combination of long-acting (bolus) insulin in one injection. In a 70/30 premix, only 30% of the insulin is bolus. The total max dose for premix can be higher than the max dose for bolus.
Note-2: Edelman et al. 2014 (AUTONOMY study / algorithm); Raskin et al 2005 (INITIATE study / algorithm); Bergenstal et al. 2008 (Adjust to Target in Type 2 Diabetes); Hirsch et al. 2005 (Real-World Approach).
Note-3: Similar to other devices such as Go Dose System (K160949) and d-Nav System (K181916).
Discussions of similarities and differences in Indications for Use statement:
The subject device (BlueStar® Rx), and predicate (BlueStar® Rx, K193654) share the following similarities:
- . Devices use blood glucose value to calculate a recommended insulin dose in order to aid in optimal insulin management.
- Devices are used by similar target population. With regards to insulin titration feature, ● both devices are intended for patients with type 2 diabetes.
- Devices are prescription use and used in home and clinical settings. ●
- Device software operate on the basic setup where an HCP configures, initiates and then ● oversees the insulin titration process.
- Information for diabetes management is provided in both devices.
- None of the devices are intended to be a substitute for professional clinical advice.
Compared to the predicate (BlueStar® Rx, K193654), the subject device proposes to make the following changes:
- -Expand the Insulin Adjustment Program (IAP) to include fast-acting bolus insulin and premixed insulin titration for qualified type 2 diabetes patients
The indications for use of the subject device (BlueStar® Rx) clearly reflects this expansion of the IAP capability in the two additional statement included:
"For bolus insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen.
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For premixed insulin users with type 2 diabetes, BlueStar® Rx 's IAP calculates appropriate dose adjustments of premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin."
These statements are equivalent to the indications of the predicate (BlueStar® Rx, K193654) and other devices such as (Go Dose System, K160949: d-Nav System, K181916),
The difference in indications for use do not raise any new questions of safety or effectiveness. The subject device and predicate have similar intended population and intended use.
Discussions of similarities and differences in technological characteristics:
The core technological characteristics between the subject device (BlueStar® Rx) and predicate (BlueStar® Rx) cleared under K193654 remain the same. The subject device (BlueStar® Rx) is built upon the predicate's software application platform. The subject device (BlueStar® Rx) incorporates the bolus and premixed insulin titrations features to the existing capabilities of the predicate without requiring any software architecture or fundamental design change. The bolus and premixed insulin titration features utilized the basic building blocks of adjusting patient's insulin under the supervision of an HCP as cleared under K193654. The bolus insulin titration features in the subject device (BlueStar® Rx) are similar to other devices such as Go Dose System cleared under K160949. The premixed insulin titration features in the subject device (BlueStar® Rx) are similar to other devices such as d-Nav System cleared under K181916. A thorough comparison of the subject device with its predicate is outlined in the table above.
The similarities between the subject device and predicate are outline as follows:
- . All are insulin dose calculator software systems
- Include separate software components for use by HCP and patient ●
- . Enable HCP to initiate and adjust insulin dosage based on individual patient's treatment plan
- Support a variety of insulin drugs, including basal, premixed and bolus insulins.
- . Subject device (BlueStar® Rx) uses the identical algorithm (AUTONOMY study2) for bolus insulin titration as that used in device such as Go Dose System (K160949). The eligible insulins for bolus titration in the subject device are those that are fast-acting insulin analogs which is the type of insulin used in devices such as Go Dose System.
- . Provide a history of responses (e.g., glucose reading) and insulin doses to both HCP and patients
- Incorporate safety features (e.g., limit max change in next dose) and warnings (e.g., ● hyperglycemia, hypoglycemia).
The implementation of the bolus and premixed insulin titration in the subject device (BlueStar® Rx) did not require significant changes to existing design of the predicate (BlueStar® Rx, K193654) application except:
2 Edelman SV, Liu R, Johnson J, Glass LC. AUTONOMY: the first randomized trial comparing two patient-driven approaches to initiate and titrate prandial insulin lispro in type 2 diabetes Care. 2014 Aug;37(8): 2132-40. doi: 10.2337/dc13-2664. Epub 2014 Apr 17. PMID: 24742662.
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- . There are now RTFB / coaching messages specific to bolus titration or premixed titration; standard RTFB / coaching is turned off for users in the IAP.
- Weekly insights, trends, weekly challenge, rewards, and CGM connection are disabled . (off) for users in the IAP.
- Users cannot change their diabetes type. ●
- . Users undergoing titration cannot add other insulin (basal, bolus, or premixed) to their med list and cannot edit the insulins prescribed in their titration program.
- Users cannot undergo basal titration while in bolus or premixed titration. ●
- . The design and function of the insulin calculator is unchanged other than a banner alerting user to an updated dosing regimen while in titration.
- The UI of the home screen and some sub-menus were updated but is not expected to . significantly impact device function including usability.
The inclusion of the bolus and premixed insulin titration under the Insulin Adjustment Program (IAP) in the subject device did not interfere with the existing functionality cleared in the BlueStar® Rx app under K193654.
In terms of technological characteristics, the subject device (BlueStar® Rx) and the predicate device differ in certain minor details. However, those difference do NOT raise new questions of safety or effectiveness.
Performance Testing
The following bench testing was performed and reviewed to support the substantial equivalence ofthe 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 |
| 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. |
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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 device (BlueStar® Rx, K193654).
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 predicate cited.