WellDoc BlueStar

WellDoc, Inc. • General Hospital • 11/04/2019

510(k)IEC 62304 Class B

Device Purpose

The WellDoc BlueStar System is a comprehensive software platform designed to empower adults with type 1 or type 2 diabetes in their self-management efforts through data tracking, analysis, and personalized coaching. Utilizing mobile and web applications, it integrates blood glucose data from meters and CGMs, offers educational resources, and, in its prescription version, provides an insulin dose calculator with Insulin on Board functionality to support therapeutic decisions.

Summary

The WellDoc BlueStar System is a software-based platform designed for healthcare providers and adult patients (18 years and older) managing type 1 or type 2 diabetes. Its primary purpose is to facilitate diabetes self-management by enabling secure capture, storage, and transmission of blood glucose data, alongside other relevant health information. The system analyzes blood glucose results, supports medication adherence, and delivers motivational, behavioral, and educational coaching messages tailored to real-time glucose values and trends. It is available as a mobile and web application for use in home or professional healthcare settings, offering features like a digital logbook, personal health record, educational resources, and secure communication tools. The BlueStar system has two versions: an over-the-counter (OTC) version and a prescription version (BlueStar Rx). The BlueStar Rx version uniquely includes an insulin dose calculator that assists patients in determining insulin doses based on their prescribed regimen, carbohydrate intake, and/or blood glucose levels; this calculator now incorporates an 'Insulin on Board' (IOB) feature using a linear decay model. The system integrates with external devices, connecting via Bluetooth to the OneTouch Verio Flex Blood Glucose Meter to receive real-time data for coaching, and can also access 3-hour delayed data from continuous glucose monitors (CGMs) via API for visualization purposes only. While providing decision support and workflow tools for healthcare providers, it is not intended to replace professional medical care, diagnosis, or treatment.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Diabetes ManagementBlood Glucose MonitoringSoftware SystemInsulin Dose CalculatorPatient Self-ManagementCoaching MessagesMobile Health (mHealth)Data VisualizationMedication AdherenceInsulin on Board (IOB)

Device Metadata

Submission Number

K190013

Company

WellDoc, Inc.

Panel

General Hospital

Product Code

N/A

Data Type

Signals

Clinical Function

Assessment

AI Function

Analysis

AI Subclass

quantification/feature localization

Relevant Clinical Questions

Q1. How does the 'Insulin on Board' (IOB) linear decay model account for individual variations in insulin sensitivity and duration of action across different insulin types?; What specific algorithms or logic drive the real-time coaching messages, and how are they personalized beyond just current blood glucose values and trends?; What is the typical latency and reliability of data transmission from the OneTouch Verio Flex meter and CGM APIs to the BlueStar system, and how might this impact the timeliness of coaching?; For the 3-hour delayed CGM data visualization, what specific data points are displayed, and how do clinicians and patients typically utilize this delayed information in conjunction with more current BG meter readings?; What security measures are in place for the API connection with CGMs and data transmission to the OneTouch Reveal Server to ensure patient data privacy and integrity, beyond general cybersecurity compliance?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score45/100

SBOM Evidence⚠ Not mentioned in summary

Cyber Risk Assessment✓ Detected in Summary

Postmarket Plan✓ Detected in Summary

§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials(algorithm)

✓ Detected

SaaSBOMSoftware-as-a-Service Bill of Materials(server, remote, bluetooth, platform)

✓ Detected

HBOMHardware Bill of Materials

- Not detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials

- Not detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of ML-BOM, SaaSBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Not detected in AI-generated device summary: SBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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