(257 days)
Not Found
No
The document describes analysis of blood glucose data and trends, and calculation of insulin doses based on prescribed regimens and blood glucose values. While this involves data processing and algorithms, there is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML models (AUC, sensitivity, specificity), or complex pattern recognition beyond basic trend analysis and rule-based calculations. The "coaching messages" are described as being based on blood glucose values and trends, suggesting rule-based logic rather than AI-driven personalized learning.
Yes
The device aids in diabetes self-management by providing information, analyzing blood glucose, supporting medication adherence, and offering coaching messages. It also includes an insulin dose calculator and an Insulin Adjustment Program, all of which contribute to the treatment of type 2 diabetes.
No
The "Intended Use / Indications for Use" section explicitly states, "Digital Routines is not intended to replace the care provided by a licensed healthcare professional, including prescriptions. diagnosis, or treatment." While it analyzes and reports blood glucose data and aids in self-management, it does not perform a diagnosis itself.
Yes
The device description explicitly states that Digital Routines is a "stand-alone medical software system" and lists only software components (Patient Mobile Application, HCP Web Portal, Enterprise Director Web Portal). There is no mention of accompanying hardware or hardware components being part of the device itself.
Based on the provided text, Digital Routines is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. These tests are performed in vitro (outside the body).
- Digital Routines' Function: Digital Routines primarily focuses on:
- Securely capturing, storing, and transmitting blood glucose data (which is generated by an IVD, like a blood glucose meter, but Digital Routines doesn't perform the test itself).
- Providing information and tools for diabetes self-management (medication adherence, coaching messages, educational information).
- Calculating insulin doses based on existing data and prescribed regimens.
- Facilitating communication and data sharing between patients and HCPs.
While Digital Routines uses data generated by an IVD (blood glucose readings), it does not perform the diagnostic test itself. Its function is to manage, analyze, and provide guidance based on that data, as well as other patient-reported information.
N/A
Intended Use / Indications for Use
Digital Routines is indicated for use by healthcare providers (HCPs) and their patients - aged 21 years and older - who have type 2 diabetes. Digital Routines is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Digital Routines system analyzes and reports blood glucose test results and supports medication adherence. In addition, Digital Routines provides coaching messages (motivational, behavioral, and educational) based on blood glucose values and trends. It includes software intended for use on mobile phones (for patients) or personal computers (for HCPs) 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 following Digital Routines insulin management features are for prescription use only:
· For bolus insulin users with type 2 diabetes, Digital Routines 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. The healthcare provider must activate the insulin dose calculator for patient.
• For basal insulin users with type 2 diabetes, Digital Routines 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 knowledgeable in the care and management of diabetes. The healthcare provider must activate the IAP and configure it with patient-specific parameters.
Digital Routines 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
The Digital Routines is a stand-alone medical software system intended to be used by patients aged 21 and older who have type 2 diabetes. Digital Routines is a new kind of approach to support in helping patients manage their type 2 diabetes. Digital Routines real-time feedback and guidance fit into daily life to help patients stay on track with their diabetes care plan.
Digital Routines is accessible directly from the patient's mobile phone, but also includes the patient's HCP throughout the process. It supports the healthcare provider`s treatment plan while helping with building the patient's knowledge about diabetes and stay motivated. The device also incorporates an insulin calculator for bolus insulin users and an insulin adjustment program for basal insulin users. These features require the approval of a physician before the patient can access them.
The system comprises three core software components:
- the Patient Mobile Application (i)
- the HCP Web Portal (ii)
- the Enterprise Director Web Portal (iii)
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
aged 21 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)
Software V&V testing was performed on the device to ensure that the device meets all applicable software requirements. The cybersecurity of the device was evaluated in accordance with the FDA guidance documents on cybersecurity. Human factors testing was conducted to validate the device for use according to its labeling. The device has passed all testing.
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.
WellDoc Inc. BlueStar® Rx (K203434)
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.
Not Found
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 15, 2023
GNC Holdings, LLC Yongkai Wong Executive Vice Chairman 75 Hopper Pl Pittsburgh, PA 15222
Re: K221924
Trade/Device Name: Digital Routines Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: NDC Dated: December 14, 2022 Received: December 15, 2022
Dear Yongkai Wong:
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 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
1
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 531-542 of the Act); 21 CFR 1000-1050.
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,
Digitally signed by Paula Paula Caposino -S Caposino -S Date: 2023.03.15
16:39:05 -04'00'
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221924
Device Name Digital Routines
Indications for Use (Describe)
Digital Routines is indicated for use by healthcare providers (HCPs) and their patients - aged 21 years and older - who have type 2 diabetes. Digital Routines is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Digital Routines system analyzes and reports blood glucose test results and supports medication adherence. In addition, Digital Routines provides coaching messages (motivational, behavioral, and educational) based on blood glucose values and trends. It includes software intended for use on mobile phones (for patients) or personal computers (for HCPs) 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 following Digital Routines insulin management features are for prescription use only:
· For bolus insulin users with type 2 diabetes, Digital Routines 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. The healthcare provider must activate the insulin dose calculator for patient.
· For basal insulin users with type 2 diabetes, Digital Routines includes an Insulin Adjustment Program (1AP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider knowledgeable in the care and management of diabetes. The healthcare provider must activate the IAP and configure it with patient-specific parameters.
Digital Routines 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) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
Applicant Information:
| Date Prepared: | March 13, 2023 |
|---|---|
| Name: | GNC Holdings, LLC |
| Address: | 75 Hopper Pl |
| Pittsburgh PA, 15222 | |
| Contact Person: | YongKai Wong |
| Executive Vice Chairman | |
| yongkaiwong@citiccapital.com | |
| Phone: | 412-219-3879 |
Device Information:
| Trade Name: | Digital Routines |
|---|---|
| Common Names: | Personal Diabetes Management System |
| Product Code (s): | NDC |
| Regulation(s): | 21 CFR 868.1890 - Predictive pulmonary-function value calculator |
| Classification: | Class II |
Predicate Device:
- WellDoc Inc. BlueStar® Rx (K203434) ●
Device Description:
The Digital Routines is a stand-alone medical software system intended to be used by patients aged 21 and older who have type 2 diabetes. Digital Routines is a new kind of approach to support in helping patients manage their type 2 diabetes. Digital Routines real-time feedback and guidance fit into daily life to help patients stay on track with their diabetes care plan.
Digital Routines is accessible directly from the patient's mobile phone, but also includes the patient's HCP throughout the process. It supports the healthcare provider`s treatment plan while helping with building the patient's knowledge about diabetes and stay motivated. The device also incorporates an insulin calculator for bolus insulin users and an insulin adjustment program for basal insulin users. These features require the approval of a physician before the patient can access them.
4
The system comprises three core software components:
- the Patient Mobile Application (i)
- the HCP Web Portal (ii)
- the Enterprise Director Web Portal (iii)
HCPs can authorize the Insulin Calculator or initiate an Insulin Adjustment Program (Rx only). The Insulin Adjustment Program is designed to help physicians and their patients with type 2 diabetes to adjust their long-acting (basal) insulin to improve diabetes management. The program works by collecting and analyzing blood glucose readings to adjust basal insulin doses according to the physician's instructions. Physicians can view and adjust their patient's treatment plan at any time, and they receive safety notifications such as if a patient experiences hypoglycemia or takes insulin doses that substantially differ from the recommended amount.
The Insulin Calculator uses the physician authorized regimen to calculate the corresponding dose of bolus insulin to take based on a patient's carbs and blood glucose value. Patients eligible to use the Insulin Calculator have the option within Digital Routines to request access to it. The patient's physician must authorize the Insulin Calculator for it to be activated. Prior to using the Insulin Calculator, the patient will be required to complete in-app training on the use of the calculator. The Insulin Calculator may also include an optional Insulin on Board feature that must be authorized by the physician.
Indications for Use:
Digital Routines is indicated for use by healthcare providers (HCPs) and their patients – aged 21 years and older - who have type 2 diabetes. Digital Routines is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Digital Routines system analyzes and reports blood glucose test results and supports medication adherence. In addition, Digital Routines provides coaching messages (motivational, behavioral, and educational) based on blood glucose values and trends. It includes software intended for use on mobile phones (for patients) or personal computers (for HCPs) 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 following Digital Routines insulin management features are for prescription use only:
· For bolus insulin users with type 2 diabetes, Digital Routines 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. The healthcare provider must activate the insulin dose calculator for patient.
• For basal insulin users with type 2 diabetes, Digital Routines includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin
5
doses for titrating insulin levels based on configuration by a healthcare provider knowledgeable in the care and management of diabetes. The healthcare provider must activate the IAP and configure it with patient-specific parameters.
Digital Routines is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Summary Comparison to Predicate:
The following tables provide a summary of substantial equivalence between the subject device and the cited predicate. The subject device has the same intended use and substantially equivalent characteristics that do not raise different questions of safety or effectiveness.
Comparison to Predicate Device:
The following table provides a comparison of the detection features of the Digital Routines device and the predicate device:
| Features | GNC Holdings, LLC
Digital Routines | WellDoc Inc.
BlueStar Rx (K203434) | Comparison |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Classification | 21 CFR 868.1890 | 21 CFR 868.1890 | Equivalent |
| Product Code | NDC | NDC | Equivalent |
| Class | II | II | Equivalent |
| Indications
for Use | Digital Routines is indicated
for use by healthcare
providers (HCPs) and their
patients - aged 21 years and
older - who have type 2
diabetes. Digital Routines is
intended to provide secure
capture, storage, and
transmission of blood
glucose data as well as
information to aid in
diabetes self-management.
The Digital Routines system | 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 | Equivalent |
| Features | GNC Holdings,
LLC
Digital Routines | WellDoc Inc.
BlueStar Rx
(K203434) | Comparison |
| | analyzes and reports blood
glucose test results and
supports medication
adherence. In addition,
Digital Routines provides
coaching messages
(motivational, behavioral,
and educational) based on
blood glucose values and
trends. It includes software
intended for use on mobile
phones (for patients) or
personal computers (for
HCPs) 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 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 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. | |
| Environment
of Use | Home | Home | Equivalent |
| Target
Population | Patients with Type 2
diabetes; Aged 21 years and
older | Patients with Type 1 or
Type 2 diabetes; Aged 18
years and older | Equivalent - the predicate
device is also indicated for
patients with Type 1
diabetes, however, both
devices are indicated for
patients with Type 2
diabetes. |
| Technological Characteristics | | | |
| Software | Yes | Yes | Equivalent - both devices
contain software.
Differences in the specific
software implementation
do not raise different
questions of safety and |
| | GNC Holdings,
LLC
Digital Routines | WellDoc Inc.
BlueStar Rx
(K203434) | Comparison |
| Features | | | effectiveness. |
| HCP Portal | Yes | Yes | Equivalent – both devices
provide a web portal for
HCP users |
| Patient App | Mobile application | Mobile application, web
portal | Equivalent – both devices
include a mobile
application for patients.
The predicate device also
includes a web portal. This
difference does not raise
different questions of
safety and effectiveness as
the web portal's
functionality is largely
replicated in the mobile
application. |
| Logbook | Supports BG, carbs,
activities, weight, waistline,
blood pressure, sleep
information, | Supports BG, carbs,
activities | Equivalent – the subject
device allows for the
logging of additional
health parameters. This
difference does not raise
different questions of
safety and effectiveness. |
| Ability to Log
Medications | Yes | Yes | Equivalent |
| Supported
Mobile
Platforms | Android, iOS | Android, iOS | Equivalent |
| Support for
Bluetooth
glucose
meters | Yes | Yes | Equivalent – both devices
support specific Bluetooth
connected glucose meters |
| Features | GNC Holdings,
LLC
Digital Routines | WellDoc Inc.
BlueStar Rx
(K203434) | Comparison |
| Insulin Dose
Calculator | Insulin Calculator for bolus
insulin users
Insulin Adjustment Program
for basal insulin users | Bolus Insulin Calculation
Pre-mixed Insulin
Calculation
Basal (long-acting) Insulin
Titration | Equivalent - both devices
support insulin dose
calculation and dose
adjustment for bolus and
basal insulin users
respectively. |
| Support for
Insulin on
Board | Yes (Rx only) | Yes (Rx only) | Equivalent - both devices
incorporate the Insulin on
Board in calculation of the
recommended dose. |
6
7
8
Summary of Performance Testing
Software V&V testing was performed on the device to ensure that the device meets all applicable software requirements. The cybersecurity of the device was evaluated in accordance with the FDA guidance documents on cybersecurity. Human factors testing was conducted to validate the device for use according to its labeling. The device has passed all testing.
Software
The software in the device is a Major level of concern. Software V&V testing has demonstrated that the device meets the applicable software requirements.
Conclusion
Based upon the intended use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Digital Routines has been shown to be substantially equivalent to the legally-marketed predicate.