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.

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)

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for "Digital Routines":

The provided document (a 510(k) summary) does not contain specific acceptance criteria, nor does it detail a study that directly proves the device meets such criteria in a quantitative sense (e.g., performance metrics, statistical results from a clinical trial). Instead, it focuses on demonstrating substantial equivalence to a predicate device, which is the primary mechanism for FDA clearance in this pathway.

The type of studies mentioned are Software Validation & Verification (V&V), cybersecurity evaluation, and human factors testing. These are general categories of testing required for software-based medical devices, not specific performance studies with quantitative acceptance criteria for the core functionality as one might expect for an AI/ML diagnostic or predictive algorithm.

Therefore, many of the requested sections will be answered as "Not provided" or "Not applicable" based on the content.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Software V&V	To ensure the device meets all applicable software requirements.	"Software V&V testing has demonstrated that the device meets the applicable software requirements." (Qualitative statement, no specific metrics provided.)
Cybersecurity	Evaluated in accordance with FDA guidance documents on cybersecurity.	"The cybersecurity of the device was evaluated in accordance with the FDA guidance documents on cybersecurity." (Qualitative statement, no specific metrics or outcomes provided.)
Human Factors	To validate the device for use according to its labeling.	"Human factors testing was conducted to validate the device for use according to its labeling." (Qualitative statement, no specific metrics or outcomes provided.)
Overall Performance	Device passed all testing. (Implicitly, the device is considered safe and effective by demonstrating substantial equivalence to the predicate.)	"The device has passed all testing." "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." (Overall conclusion of sufficiency, no specific performance metrics like accuracy, sensitivity, or specificity are presented for the core functions).

Additional Study Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states "Software V&V testing was performed" and "Human factors testing was conducted," but does not detail the sample sizes for these tests, the type of data used (beyond "blood glucose data"), or its provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. Ground truth establishment, in the context of expert review for performance evaluation, is not mentioned in this summary. The device's primary function involves calculations based on patient-entered data and HCP-configured parameters, and coaching messages derived from trends, rather than interpreting complex medical images or signals requiring a panel of expert human reviewers for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. The summary does not describe any test sets or adjudication processes that would involve expert review for ground truth consensus.
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 study is not mentioned. The device, "Digital Routines," is a diabetes self-management system with insulin dose calculation/adjustment features. Its purpose is to assist patients and HCPs with managing diabetes, not to improve human reading of diagnostic images/cases. The summary does not provide any information about human reader performance improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable. The device includes an "Insulin Calculator" and an "Insulin Adjustment Program (IAP)." While these are "Rx only" features requiring HCP activation and configuration, the calculations themselves are performed by the algorithm. The software V&V would, in principle, test the accuracy and correctness of these algorithmic calculations. However, the summary does not provide specific performance metrics for these algorithms (e.g., accuracy of insulin dose calculations against a gold standard). It merely states that "Software V&V testing has demonstrated that the device meets the applicable software requirements."
The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- Not explicitly stated for performance evaluation. For the Insulin Calculator and IAP, the "ground truth" would implicitly be the mathematically correct calculation based on the prescribed regimen and patient parameters set by the HCP. For coaching messages, the ground truth would be adherence to predefined rules for generating messages based on blood glucose values and trends. The summary does not elaborate on how this ground truth was formally established or used in testing.
The sample size for the training set:
- Not applicable / Not provided. The description of "Digital Routines" suggests a rules-based system or an application directly implementing medical guidelines (for insulin calculations and adjustments) rather than a machine learning model that requires a training set in the typical sense. It analyzes blood glucose data and provides coaching "based on blood glucose values and trends," which could be rule-based. No mention of machine learning model training is made, nor are training sets discussed.
How the ground truth for the training set was established:
- Not applicable / Not provided. As no training set is described, the method for establishing its ground truth is also not provided.

In summary: The provided 510(k) summary focuses on establishing substantial equivalence by comparing the device's features, intended use, and technological characteristics to a predicate device, and by confirming general software, cybersecurity, and human factors compliance. It lacks specific quantitative acceptance criteria and detailed performance study results that would typically be associated with direct clinical performance claims or advanced AI/ML algorithms requiring extensive training and test sets with defined ground truth.

Summary

{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 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)
--------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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 PlPittsburgh PA, 15222
Contact Person:	YongKai WongExecutive Vice Chairmanyongkaiwong@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:

{4}------------------------------------------------

The system comprises three core software components:

the Patient Mobile Application (i)
the HCP Web Portal (ii)
the Enterprise Director Web Portal (iii)

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 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, LLCDigital 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
Indicationsfor Use	Digital Routines is indicatedfor use by healthcareproviders (HCPs) and theirpatients - aged 21 years andolder - who have type 2diabetes. Digital Routines isintended to provide securecapture, storage, andtransmission of bloodglucose data as well asinformation to aid indiabetes self-management.The Digital Routines system	BlueStar® Rx is indicatedfor use by healthcareproviders (HCPs) and theirpatients - aged 18 yearsand older - who have type1 or type 2 diabetes. TheBlueStar® Rx is intendedto provide secure capture,storage, and transmissionof blood glucose data aswell as information to aidin diabetesself-management The	Equivalent
Features	GNC Holdings,LLCDigital Routines	WellDoc Inc.BlueStar Rx(K203434)	Comparison
	analyzes and reports bloodglucose test results andsupports medicationadherence. In addition,Digital Routines providescoaching messages(motivational, behavioral,and educational) based onblood glucose values andtrends. It includes softwareintended for use on mobilephones (for patients) orpersonal computers (forHCPs) in the home or inprofessional healthcaresettings. The software alsoallows for entry of otherdiabetes-related healthcareinformation and provideseducational information.	BlueStar® Rx analyzesand reports blood glucosetest results and supportsmedication adherence. Inaddition, the BlueStar®Rx provides coachingmessages (motivational,behavioral, andeducational) based onreal-time blood glucosevalues and trends. Itincludes software intendedfor use on mobile phonesor personal computers inthe home or inprofessional healthcaresettings. The software alsoallows for entry of otherdiabetes-related healthcareinformation and provideseducational information.
Environmentof Use	Home	Home	Equivalent
TargetPopulation	Patients with Type 2diabetes; Aged 21 years andolder	Patients with Type 1 orType 2 diabetes; Aged 18years and older	Equivalent - the predicatedevice is also indicated forpatients with Type 1diabetes, however, bothdevices are indicated forpatients with Type 2diabetes.
Technological Characteristics
Software	Yes	Yes	Equivalent - both devicescontain software.Differences in the specificsoftware implementationdo not raise differentquestions of safety and
	GNC Holdings,LLCDigital Routines	WellDoc Inc.BlueStar Rx(K203434)	Comparison
Features			effectiveness.
HCP Portal	Yes	Yes	Equivalent – both devicesprovide a web portal forHCP users
Patient App	Mobile application	Mobile application, webportal	Equivalent – both devicesinclude a mobileapplication for patients.The predicate device alsoincludes a web portal. Thisdifference does not raisedifferent questions ofsafety and effectiveness asthe web portal'sfunctionality is largelyreplicated in the mobileapplication.
Logbook	Supports BG, carbs,activities, weight, waistline,blood pressure, sleepinformation,	Supports BG, carbs,activities	Equivalent – the subjectdevice allows for thelogging of additionalhealth parameters. Thisdifference does not raisedifferent questions ofsafety and effectiveness.
Ability to LogMedications	Yes	Yes	Equivalent
SupportedMobilePlatforms	Android, iOS	Android, iOS	Equivalent
Support forBluetoothglucosemeters	Yes	Yes	Equivalent – both devicessupport specific Bluetoothconnected glucose meters
Features	GNC Holdings,LLCDigital Routines	WellDoc Inc.BlueStar Rx(K203434)	Comparison
Insulin DoseCalculator	Insulin Calculator for bolusinsulin usersInsulin Adjustment Programfor basal insulin users	Bolus Insulin CalculationPre-mixed InsulinCalculationBasal (long-acting) InsulinTitration	Equivalent - both devicessupport insulin dosecalculation and doseadjustment for bolus andbasal insulin usersrespectively.
Support forInsulin onBoard	Yes (Rx only)	Yes (Rx only)	Equivalent - both devicesincorporate the Insulin onBoard in calculation of therecommended 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.

Regulation Number and Section

§ 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).