(185 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 diabetes. The 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 diabetesrelated 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 DiabetesManager System (Version 1.1) 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 DiabetesManager-Rx® System (Version 1.1).
Both 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 a Mobile application (patient only) and Web-based applications for the patient, account director (AD), and healthcare provider(s). The applications are called:
- Account Director Web-Based Application
- Patient Mobile Based Application
- Patient Web-Based Application
- HCP Web-based Application
The Account Director application is used for administrative purposes. The HCP application is used by healthcare providers to review patient entered data and the prescribing healthcare provider can activate the Rx system for the patient.
Patient Applications
The Patient Web-based application 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 applications require the initial web-based registration before the patient can access them. Patients are identified by healthcare providers and invitations to register are sent by Account Directors.
On the patient applications (Mobile and Web-based), the basic DiabetesManager System functions as an information repository (logbook and Personal Health Record-PHR), diabetes education resource (learning library and health tips), 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), coaching (BG real-time coaching feedback), messaging (Message Center Content), and workflow and decision support for healthcare providers.
The provided text describes a 510(k) premarket notification for the WellDoc DiabetesManager® System and DiabetesManager® Rx System. However, it does not contain specific acceptance criteria or a detailed study section with quantitative performance data for the device. The "Performance Data" section merely states that "Human factors study results and software verification and validation... were provided and supported substantial equivalence." It does not present the results of these studies in a way that would allow for a table of acceptance criteria and reported device performance.
Therefore, I cannot directly provide the requested information based on the given text.
However, I can infer what might be expected in such a study based on general FDA guidance for medical device software and the nature of the device (a diabetes self-management system). If this was a more complete submission, we would typically look for performance data related to:
- Accuracy of data capture and transmission: Ensuring blood glucose readings are accurately recorded and transferred.
- Reliability of analysis and reporting: Verifying that trends and statistics derived from blood glucose data are correct.
- Clinical effectiveness (for Rx version): If the coaching messages lead to improved diabetes management outcomes.
- Usability and Human Factors: How easily and effectively users (patients and HCPs) can interact with the system.
Without the specific study details in the provided document, I cannot fill out the table or answer the specific questions. The document focuses on regulatory approval and establishing substantial equivalence, not on the detailed technical performance data.
§ 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).