(106 days)
DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older -who have type 2 diabetesManager® 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 DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. 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 DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager®-Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The DiabetesManager®-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 DiabetesManager®-Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the DiabetesManager®-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.
The DiabetesManager®-Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
The WellDoc BlueStar DiabetesManager® System is a stand-alone, over-the-counter (OTC) software system that has the capability of providing additional functions, if and when, the functions are prescribed by the prescribing healthcare provider. Once the additional prescription (Rx) functions are activated, the entire software system is called WellDoc BlueStar DiabetesManager-Rx® System.
Both BlueStar DiabetesManager System and DiabetesManager-Rx System are implemented through an enterprise such as a health plan or large physician group in tandem with healthcare providers (HCPs) 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 (changed under K141273), 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.
The Patient Web Portal and the Patient Mobile application have a similar feature set. Data entered into these applications is 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. Patientified by healthcare providers and an access code is provided to allow access to both the web and mobile applications. On the patient applications (Mobile and Web), the basic DiabetesManager System functions as an information repository [logbook and Personal Health Record (PHR)], diabetes education resource (learning library and health tips), educational messaging/coaching, and secure communication system (Message Center). If and when a prescription is obtained, additional functions become available to the patient as DiabetesManager-Rx System. Prescription functions include additional medication information (dose and schedule), enhanced coaching [(Blood Glucose (BG) real-time coaching feedback), messaging (Message Center Content), and workflow and decision support for healthcare providers. The patient web portal and mobile application also provide an insulin dosing 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.
With this 510(k), BlueStar will have FDA clearance 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 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. These modifications do not change the fundamental scientific technology or the indications for use of the device.
The provided document is a 510(k) summary for the WellDoc BlueStar (WellDoc DiabetesManager® System and DiabetesManager®-Rx System). It primarily addresses administrative changes and modifications to the device's connectivity, rather than a comprehensive clinical study proving efficacy against specific acceptance criteria for the core functionality.
However, based on the non-clinical performance data section, we can infer the acceptance criteria and the study that proves the device meets them, specifically for the modifications introduced with this 510(k).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a formal table with quantitative acceptance criteria and their corresponding performance metrics. Instead, it mentions that "Verification, validation and human factors testing were performed to ensure that the device meets its requirements and intended use." For the specific modifications, the performance is reported qualitatively.
| Acceptance Criterion (Inferred from Modifications) | Reported Device Performance (Qualitative) |
|---|---|
| Successful data transmission from OneTouch Verio Flex BG meter to BlueStar app | "data was transmitted successfully from the OneTouch Verio Flex BG meter" |
| Successful data transmission from BlueStar Server to OneTouch Reveal Server | "data was transmitted successfully... to the One Touch Reveal Server" |
| Compatibility of the app with specified mobile environmental operating systems (iOS 9.X+, Android 4.3+) | "the app is compatible with the mobile environmental operating systems" |
| Overall system functions as intended after modifications | "the system functions as intended" |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Verification, validation and human factors testing were performed." However, it does not specify the sample size used for these tests (e.g., number of users, number of data transmissions, number of test cases).
The data provenance is not explicitly mentioned but would typically be from laboratory testing and potentially simulated or real-world user testing during the verification and validation phases. Given the nature of a software and connectivity update, the testing would likely be prospective, conducted by the manufacturer. The country of origin for the data is not stated, but the manufacturer is based in Columbia, Maryland, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of external experts to establish ground truth for the technical performance tests described. These tests would typically involve engineers and quality assurance personnel verifying system functionality against defined specifications. If "human factors testing" involved experts, their number and qualifications are not specified.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For technical verification and validation, success or failure is usually determined by predefined criteria in test protocols, rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes modifications related to connectivity and data transmission, not a new diagnostic or interpretative algorithm that would typically warrant an MRMC study comparing human readers with and without AI assistance. The changes "do not change the fundamental scientific technology or the indications for use of the device," implying the core functionality and interpretations remain as previously cleared.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
The described tests are primarily standalone evaluations of the updated software's technical functionality, specifically its ability to connect and transmit data. The "system functions as intended" implies an assessment of the algorithm and data flow without necessarily involving a human actively interpreting its output in a clinical decision-making context during these specific tests. However, it's not a standalone study of a new algorithm's diagnostic or predictive performance.
7. The Type of Ground Truth Used
For the connectivity and compatibility tests, the ground truth would be based on:
- Technical specifications and expected operational behavior: Verifying that data packets are correctly transmitted and received, and that the application functions on specified operating systems as per its design.
- Known device outputs/inputs: For data transmission, the ground truth would be the actual blood glucose values from the OneTouch Verio Flex BG meter, verifiable against the data received by the BlueStar app and transmitted to the OneTouch Reveal Server.
8. The Sample Size for the Training Set
The document does not mention a training set because the modifications described are related to connectivity and compatibility, not the development or retraining of a machine learning algorithm. The core algorithms for "coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends" are presumed to be part of the previously cleared device (K100066) and are not being newly developed or revised in a way that would require a new training set in this submission.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for the modifications in this submission, the acquisition of ground truth for a training set is not applicable here.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).