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510(k) Data Aggregation
(305 days)
BlueStar has complied per the special controls stated in 21 CFR 862.1350 .
Performance Testing
The
The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.
The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their patients - aged 18 years and older - who have Type 1 or Type 2 Diabetes. The system is intended to assist Type 1 and Type 2 Diabetes patients to self-manage their disease, as cleared under K162532. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® - BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a licensed HCP with prescribing authority.
BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications:
- Enterprise Director Portal
- HCP Service
- Patient Mobile Application
- Patient Web Portal
The Enterprise Director application is used for administrative purposes. The HCP Service houses the Medication Reconciliation feature, which allows for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273).
The Patient Web Portal and the Patient Mobile application have a similar feature set. Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications are stored in the database and can be retrieved for display in either application. Both applications require the initial web- or mobile-based registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers.
In BlueStar® Rx, the patient web portal and mobile application also provide an insulin calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. This submission introduces Insulin on Board to be considered in the calculation. The insulin dose calculator is indicated for prescription-use only.
Furthermore, as cleared under K162225, BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends. The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only. These modifications do not change the fundamental scientific technology of the device.
This document describes the WellDoc BlueStar and BlueStar Rx System, a software system for diabetes self-management. This 510(k) summary (K190013) references K162532 as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of acceptance criteria with specific performance metrics (e.g., accuracy percentages, error rates). Instead, it states that the device's performance was evaluated through various non-clinical tests to demonstrate substantial equivalence to its predicate.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a "Major Level of Concern," and "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices." Implied acceptance of proper functionality and reliability of the 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”" (No specific performance metrics are given, but compliance with these guidances indicates successful V&V.) |
| Cybersecurity | Evaluation per FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2, 2014), specifically addressing Identify, Protect, Detect, Response, and Recover areas. Implied acceptance of robust cybersecurity measures. | "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" (No specific performance metrics are given, but evaluation against this guidance implies successful implementation of cybersecurity.) |
| Human Factors | Adequate validation of the user interface for use per the labeling for both patients and healthcare providers, ensuring safe and effective interaction for the intended user populations. | "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." (This indicates successful human factors testing that supports the user interface's validity for its intended use.) |
| Insulin on Board | No new questions of safety or effectiveness are raised by the addition of Insulin on Board (IOB) to the insulin dose calculator function. The linear decay model used must be "well-understood and accepted." | "Both the subject device and reference device use a well-understood and accepted linear decay model to model the Insulin on Board decay. There are no notable differences with regards to this technological characteristic to a previously-cleared device." (This confirms the successful application of the IOB feature without raising new safety/effectiveness concerns, aligning with the implied criteria.) |
| CGM Data Access | No new questions with regards to software or cybersecurity due to the ability to receive 3-hour delayed data from continuous glucose monitoring devices via API for data visualization only. Compliance with special controls stated in 21 CFR 862.1350 (related to CGM secondary display regulation). | "The subject device does not use Bluetooth to connect to a Continuous Glucose Meter directly. There are no new questions with regards to software or cybersecurity. De Novo DEN140038 classified CGM secondary display regulation. BlueStar has complied per the special controls stated in 21 CFR 862.1350." (This indicates successful integration of CGM data access without introducing new software or cybersecurity risks, and compliance with relevant regulations.) |
| Overall Equivalence | The differences between the subject and predicate devices (expanded patient population, IOB, CGM data access) do not raise different questions of safety or effectiveness, and performance data demonstrates substantially equivalent performance to the predicate. | "The differences between the predicate and the subject devices do not raise any new or different questions of safety or effectiveness. The WellDoc® BlueStar® and BlueStar® Rx System is substantially equivalent to WellDoc® BlueStar® and BlueStar® Rx System cleared under K162532 with respect to the indications for use, target populations, treatment method, and technological characteristics." "Performance data provided in the submission, including human factors, design, and labeling information, demonstrate substantially equivalent performance to the predicate." (This is the overarching conclusion of the submission, confirming the device meets the substantial equivalence criteria.) |
2. Sample Sizes used for the Test Set and Data Provenance
The document explicitly states: "Clinical Tests: Not Applicable."
Therefore, there is no test set or information regarding sample sizes, country of origin, or retrospective/prospective nature of data for clinical validation of device performance. The performance claim is based on non-clinical testing and substantial equivalence to a predicate device.
For the Human Factors testing, it mentions: "Human factors testing was conducted with the intended user populations of patients and healthcare providers." However, specific sample sizes for these user populations are not provided. The data provenance is not stated (e.g., country of origin, prospective or retrospective).
3. Number of Experts used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
As there were no clinical tests and no explicit "test set" in the context of clinical performance evaluation (only non-clinical V&V and human factors), there is no information provided about experts establishing ground truth for a test set.
For the human factors study, "healthcare providers" were part of the intended user population, implying experts were involved as participants, but not in establishing ground truth in the traditional sense of diagnostic accuracy. Their qualifications beyond being "healthcare providers" are not detailed.
4. Adjudication Method for the Test Set
Since there was no clinical "test set" requiring ground truth establishment, no adjudication method (e.g., 2+1, 3+1, none) is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document states "Clinical Tests: Not Applicable."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document primarily focuses on the software system's functionality and its ability to process data, provide coaching messages, and calculate insulin doses. The "Software verification and validation" would assess the algorithm's standalone performance in terms of its intended functions. However, there isn't a separate, explicit study titled "standalone performance study" with specific metrics beyond the general software V&V. The human factors testing then evaluates it with human interaction. The insulin dose calculator performs its calculations algorithmically, and its "performance" is implicitly evaluated through software V&V and comparison to a well-understood linear decay model.
7. The type of ground truth used
For the software validation, the "ground truth" would be the expected output of the algorithms and software logic based on design specifications and established clinical models (e.g., for the insulin dose calculator, the "ground truth" is a correct calculation based on inputted parameters and a 'well-understood and accepted linear decay model'). For cybersecurity, the ground truth is adherence to security best practices and robustness against known vulnerabilities. For human factors, the ground truth is the usability and safety of the interface as determined by user interaction and expert review. No pathology or outcomes data is mentioned as ground truth.
8. The sample size for the training set
The document does not mention a training set or its sample size. This is a software medical device, and the evaluation is primarily focused on verification and validation of its deterministic functions, safety, cybersecurity, and human factors, rather than a machine learning model that would require a distinct training set.
9. How the ground truth for the training set was established
Since no training set is mentioned, the method for establishing its ground truth is not applicable.
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(8 days)
, CA 91325
May 19, 2015
Re: K151236
Trade/Device Name: MiniMed Connect Regulation Number: 21 CFR 862.1350
| 510(k) Exempt |
| Regulation Number: | 862.1350
MiniMed Connect is intended to provide a secondary display of continuous glucose monitoring and/or insulin pump data on a suitable consumer electronic device to care partners and users of a MiniMed 530G system or Paradigm REAL-Time Revel system for the purpose of passive monitoring.
MiniMed Connect system is not intended to replace the real-time display of continuous glucose monitoring and/or insulin pump data on the primary display device (i.e. the sensor-augmented pump). All therapy decisions should be based on blood glucose measurements obtained from a blood glucose meter.
The MiniMed Connect is not intended to analyze or modify the continuous glucose monitor data and/or insulin pump data that it receives. Nor is it intended to control any function of the connecting continuous glucose monitor system and/or insulin pump. The MiniMed Connect is not intended to serve as a replacement for a primary display device for the continuous glucose monitoring system and/or insulin pump data. The MiniMed Connect is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.
MiniMed® Connect is a secondary display of continuous glucose monitor and/or insulin pump data on a suitable consumer electronic device for insulin pump patients and their care partners. This system is designed as an optional accessory to compatible sensor-augmented pump systems.
MiniMed® Connect consists of a MiniMed® Connect app (for a local secondary display), the CareLink® Connect module of CareLink® Personal (for a remote secondary display), and the MiniMed® Connect uploader (for data transmission to the local app).
The MiniMed® Connect uploader is a small, battery-powered, ambulatory device that is carried with the patient in near proximity to the insulin pump. Its rechargeable battery is charged as needed (approximately once a day) using a USB Charger that accompanies the device.
The MiniMed® Connect uploader receives continuous glucose monitor and/or insulin pump data from the sensor-augmented insulin pump using a proprietary 916.5 MHz RF, and then converts it into a 2.4 GHz Bluetooth Low Energy (BLE) format. This BLE formatted data can then be read by the MiniMed® Connect app installed on a compatible consumer electronics device with BLE capabilities.
The MiniMed® Connect app reads the BLE data transmission and displays it on the patient's compatible consumer electronic device. The MiniMed® Connect app then uploads the continuous glucose monitor and/or insulin pump data to CareLink® Connect, the remote monitoring module of CareLink® Personal. Authorized care partners can access CareLink® Connect to view the patient's continuous glucose monitor and/or insulin pump data through an Internet-enabled consumer electronic device for the purpose of passive monitoring.
Accessories associated with this system include:
- USB Charger (for charging the MiniMed® Connect uploader) .
I am sorry, but the provided text does not contain the specific information required to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary for the MiniMed Connect device, which primarily focuses on establishing substantial equivalence to a predicate device.
Specifically, the text states under "PERFORMANCE DATA [807.92(b)] VII.":
"Results of the verification and validation testing indicate that the product meets established performance requirements, and is safe and effective for its intended use."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Details about the sample size, data provenance, number of experts, their qualifications, or adjudication methods for a test set.
- Information about MRMC comparative effectiveness studies, effect sizes, or standalone algorithm performance.
- The type of ground truth used, training set sample size, or how ground truth for the training set was established.
The document confirms that verification and validation testing was done and that the device met performance requirements, but it does not elaborate on what those requirements were or present the results of such testing.
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(39 days)
Regulation: 21 CFR 862.1350, Continuous glucose monitor secondary display device
- 2.
this de novo submission is sufficient to classify this device into class II under regulation 21 CFR 862.1350
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| Class: | II (special controls) |
| Regulation: | 21 CFR 862.1350
The purpose of Dexcom Share Direct Secondary Displays is to notify another person, the Follower, of the patient's Dexcom G4 PLATINUM Continuous Glucose Monitoring System sensor glucose information. The Secondary Displays is intended for providing secondary notification of a continuous glucose monitoring system and does not replace real time continuous glucose monitoring (G4 PLATINUM System) or standard home blood glucose monitoring.
The Dexcom Share Direct Secondary Displays is not intended to modify or analyze data received from the continuous glucose monitor system. Nor is it intended to instruct, or to transmit information to the continuous glucose monitor system. The Dexcom Share Direct Secondary Displays is not intended to serve as a replacement for a primary display device for a continuous glucose monitoring system. The Dexcom Share Direct Secondary Displays is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.
The Dexcom Share Direct Secondary Displays is a family of mobile applications (apps) that allows for the real-time monitoring of data from the Bluetooth enabled "Dexcom G4 PLATINUM Receiver with Share" by a third party by means of display on a compatible third party device with an internet connection. The system consists of two apps: one installed on the Continuous Glucose Monitor (CGM) patient's phone (the "Share2" app) and one installed on the phone of another person (the "Follow" app). Using the Share2 app, the patient can designate people ("Followers") with which to share their CGM data. The Share2 app receives real-time CGM data directly from the CGM receiver and transmits it to the Dexcom Cloud server (a web-based storage location). The Follow app. installed on a Follower's phone, can then download the CGM data and display it in real time.
The Dexcom Share Direct Secondary Displays was preceded by the Dexcom Share System. In the Dexcom Share Direct Secondary Displays, the CGM receiver is Bluetooth enabled and can communicate directly with the Share2 app on a patient's smart phone. In the predecessor, the Dexcom Share System, the CGM receiver must be placed in a Bluetooth enabled docking station which in turn transmits real-time CGM data to the Dexcom Share app on the CGM patient's mobile device. The Share app then transmits the internet to the Dexcom Share Cloud, from which the Follow app installed on a follower's phone can retrieve the data. The Dexcom Share Direct Secondary Displays eliminates the need for a docking station: the CGM receiver transmits information directly to the Share2 app on the CGM patient's phone. The Share2 app functions identically to the Share app, with the exception that it cannot communicate with the docking station. The same Follow app is used in both cases, as its function has not changed.
The Dexcom Share Direct Secondary Displays device performs the following functions:
- . Share2 App:
- o Transmit real-time glucose values and ancillary information (e.g. trends, alarms and notifications) to a third-party device/display/data storage system.
- Follow App:
- o Receive and display real-time glucose values.
- o Receive and display glucose trend information.
- o Receive and deliver notifications and alarms.
The Dexcom Share Direct Secondary Displays is used for secondary real-time monitoring of a patient's continuous glucose monitoring system. It is not intended to be the primary method of patient monitoring and it does not make treatment recommendations. It does not receive information directly from the sensor or primary transmitter of the CGM system; it receives information from the primary display device (in this case, the CGM receiver). It does not serve as a replacement for a primary display device. It does not make treatment recommendations, calculate insulin doses, or control any other medical devices.
The Dexcom Share Direct Secondary Displays device is a software-based device and its primary function is to transmit and display real-time glucose values and related information from a Dexcom G4 PLATINUM Continuous Glucose Monitoring System to a third-party device. As such, the acceptance criteria and performance evaluation focused on usability, data transmission accuracy, and compliance with regulatory requirements rather than traditional analytical or clinical performance metrics associated with glucose measurement.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Usability) | The Dexcom Share System (predecessor) was found to be adequately safe and effective for the intended users, its intended use, and use environment based on usability testing involving task-based scenarios. This was deemed applicable to the Dexcom Share Direct Secondary Displays because the interface and functionality of the Share and Follower apps remained unchanged. |
| Accuracy of Data Transmission | Bench testing demonstrated that data is transmitted accurately. Data from thirty (30) G4 PLATINUM Receivers with Share were uploaded from the Receivers to compatible Apple devices using the Share2 app and Follow app. Data on the Follow app were shown to be identical to the data on the receiver. |
| Software Development & Risk Mitigation | FDA reviewed and found acceptable the applicant's Hazard Analysis and software development processes, including level of concern, software description, device hazard analysis, software requirements specifications, architecture design chart, software design specification, traceability analysis, software development environment description, verification and validation testing, and revision level history for the Follow App. |
| Cybersecurity | Devices must include appropriate measures to protect against unauthorized access to data and unauthorized modification of data (Special control 1). This risk is mitigated by verification and validation, and design control activities. |
| Labeling - Treatment Decisions | Labeling must prominently and conspicuously display a warning: "Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system." (Special control 2). This mitigates the risk of incorrect treatment decisions. |
| Labeling - Self-Monitoring | Labeling must include a limitation: "This device is not intended to replace self-monitoring practices advised by a physician." (Special control 3). This mitigates the risk of over-reliance on followers. |
| Compliance with General Controls | The device must comply with general controls, including design controls. This ensures factors like safe design, manufacturing, and labeling practices. |
| No Modification/Analysis of Data | The device is not intended to modify or analyze data received from the continuous glucose monitor system, nor to instruct or transmit information to the continuous glucose monitor system. The device met this as it receives and displays data, not analyzes or modifies. |
| Not a Primary Display/Treatment Device | The device is not intended to serve as a primary display, receive information directly from sensor/transmitter, or control medical devices/calculate insulin doses. The device description confirms it receives data from the primary display device (CGM receiver) and its intended use explicitly states it does not make treatment recommendations or replace primary display. |
2. Sample Size Used for the Test Set and Data Provenance
- Usability Study (Clinical Study):
- Sample Size: 20 participant pairs (Sharer + Follower).
- Data Provenance: The document does not specify the country of origin. It was a usability study with simulated use, making it prospective in its design for evaluation, though the data itself is on user interactions rather than patient outcomes.
- Bench Testing (Data Transmission Accuracy):
- Sample Size: Data from thirty (30) G4 PLATINUM Receivers with Share.
- Data Provenance: Not specified, but likely laboratory-based bench testing. Retrospective in the sense of comparing data already generated by the receiver with data displayed by the app.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Usability Study (Clinical Study): The document does not explicitly state the number or qualifications of "experts" used to establish ground truth for this usability study. The "ground truth" here would likely be defined by the successful completion of predetermined task-based scenarios by the participants and assessment of their responses by study investigators or researchers, rather than clinical experts establishing a medical diagnosis or outcome.
- Bench Testing (Data Transmission Accuracy): The ground truth was the data directly from the G4 PLATINUM Receivers. This implies a comparison against the source data, without the need for independent expert review to establish truth.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for either the usability study or the bench testing.
- Usability Study: Participants' responses to task-based scenarios were "scored," suggesting an objective measure against predefined correct actions or satisfactory outcomes.
- Bench Testing: Data on the Follow app was simply "shown to be identical" to the data on the receiver. This is a direct comparison, not requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is a data management software, not an AI-assisted diagnostic or interpretive tool that would involve human "readers" interpreting cases. Its function is to display glucose data, not to interpret or provide diagnostic information.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the device's core function is largely standalone in terms of its data transmission and display capabilities. The "Bench testing" that showed data on the Follow app was identical to the data on the receiver demonstrates the standalone performance of the software in accurately replicating the glucose data without human intervention in the data processing itself. The usability study evaluated human interaction with the system, but the data transmission component itself is algorithmic.
7. The Type of Ground Truth Used
- Usability Study: The ground truth for the usability study was the successful completion of pre-defined task-based scenarios by participants, representing effective and safe interaction with the system's interface and functionality.
- Bench Testing: The ground truth for data transmission accuracy was the glucose data directly displayed on the primary Dexcom G4 PLATINUM Receiver itself.
8. The Sample Size for the Training Set
The document explicitly states: "The interface and functionality of the Share and Follower apps remains unchanged between these two systems, so it was determined that a new clinical study was not required for the Dexcom Share Direct Secondary Displays." This implies that the usability study performed for the predecessor device (Dexcom Share System) served as the primary clinical evaluation.
- Given it's a software device managing data display, the "training set" doesn't typically apply in the same way it would for an AI/ML algorithm that learns from data.
- If we consider the development and testing cycle of the software to be analogous to "training," then the software was developed and tested internally by Dexcom (as indicated by the acceptable software development processes) using an unspecified amount of internal data and testing environments. The provided document does not specify a distinct "training set" size for the software development.
9. How the Ground Truth for the Training Set Was Established
As noted above, a traditional "training set" with ground truth in the context of machine learning isn't applicable here. The software's "ground truth" during its development and internal testing phases would be derived from:
- Functional Requirements: The software was developed to meet specific functional requirements (e.g., transmit real-time glucose values, display trends, deliver notifications) as defined by engineering specifications.
- Verification and Validation Data: Internal testing (bench testing, unit testing, integration testing) would compare the software's output against expected outcomes based on the input data, with the "ground truth" being the correct data or system behavior as defined by the product's design and intent. The bench testing performed for accuracy (comparing app data to receiver data) would be a part of this validation.
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