DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1

K100066 · Welldoc, Inc. · MRZ · Jul 15, 2010 · General Hospital

Device Facts

• Record ID: K100066
• Device Name: DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
• Applicant: Welldoc, Inc.
• Product Code: MRZ · General Hospital
• Decision Date: Jul 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 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.

Device Story

System captures, stores, and transmits blood glucose data; provides diabetes self-management information; analyzes test results; supports medication adherence. Rx version adds real-time coaching messages based on blood glucose values/trends. Used in home or clinical settings via mobile/web applications. Patients enter data; HCPs review data and activate Rx features. System acts as information repository, educational resource, and communication tool. Benefits include improved self-management and adherence through data-driven feedback and educational content.

Clinical Evidence

Bench testing only. Provided software verification and validation per FDA guidance and human factors study results to support substantial equivalence.

Technological Characteristics

Standalone software system; mobile and web-based applications. Functions include data capture, storage, transmission, analysis, and reporting. Provides BG trends, statistics, and educational content. Rx version includes automated coaching messages based on real-time BG values.

Indications for Use

Indicated for adult patients aged 21+ with type 2 diabetes. Used by patients and healthcare providers for blood glucose data capture, storage, transmission, analysis, and diabetes self-management support.

Regulatory Classification

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.

Predicate Devices

• ACCU-CHEK®-Advisor Insulin Guidance Software (K043529)
• ACCU-CHEK®-360° Diabetes Management System (K080227)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logos are displayed against a white background.

May 17, 2024

WellDoc, Incorporated Ryan Sysko Chief Executive Officer 1501 Saint Paul Street, Suite 118 Baltimore, Maryland 21202

Re: K100066

Trade/Device Name: WellDoc DiabetesManager® System and DiabetesManager® Rx System Model Version 1.1 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: MRZ

Dear Ryan Sysko:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 15, 2010. Specifically, FDA is updating this SE Letter as an administrative correction. A second product code was inadvertently included.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Juliane Lessard, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6126, Juliane.Lessard(@fda.hhs.gov.

Sincerelv.

Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery, General Hospital and Human Factors Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{1}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Mr. Ryan Sysko Chief Executive Officer WellDoc, Incorporated 1501 Saint Paul Street, Suite 118 Baltimore, Marvland 21202

JUL 1 5 2010

Re: K100066

Trade/Device Name: WellDoc DiabetesManager® System and DiabetesManager® Rx System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ . LNX Dated: June 14, 2010 Received: June 15, 2010

Dear Mr. Sysko:

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. 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.

1

{2}------------------------------------------------

## Page 2- Ms. Peeples

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

2

Radiological Health

Enclosure

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the WellDoc logo. The logo consists of a symbol on the left and the word "WellDoc" on the right. The symbol appears to be two hands clasped together in a circular shape. The word "WellDoc" is written in a serif font, with a registered trademark symbol next to the "C".

7/9/2010

# Attachment A: Revised Indications for Use

## Indications for Use

510(k) Number (if known):

Device Name: WellDoc DiabetesManager " System and DiabetesManager " -Rx System

Indications for Use:

#### DiabetesManager (OTC Use):

DiabetesManager ______________________________________________________________________________________________________________________________________________________________ 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 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.

Prescription Use X Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Device Evaluation (ODE)

Al C. Ch

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K100066 510(k) Number:

3

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

| | TITLE: Response to FDA Feedback on 510 (K) K100066 |
|-----------------------------------|-----------------------------------------------------------------------------------------|
| | 7/9/2010 |
| 510(k) Summary | |
| General Information: | JUL 1 5 2010 |
| Date of Summary Preparation: | June 10, 2010 |
| Name and Address of Manufacturer: | WellDoc, Inc.<br>1501 St Paul Street, Suite 118<br>Baltimore, MD 21217 |
| Contact Person: | Ryan Sysko<br>Chief Executive Officer<br>Telephone [phone]<br>Fax [phone] |
| Trade Names: | DiabetesManager® System<br>DiabetesManager®-Rx System |
| Common Names: | Medical computers and software<br>Infusion pump accessories |
| Regulation Numbers: | LNX is unclassified and therefore has no regulation number |
| | 21 CFR 880.5725 (Infusion Pump) |
| Classification Names: | Medical computers and software |
| | Infusion pump |
| Regulatory Class: | II |
| Classification Panel: | General Hospital |
| Product Codes: | LNX<br>MRZ |
| Predicate Devices: | K043529 ACCU-CHEK®-Advisor<br>Insulin Guidance Software |
| | K080227 ACCU-CHEK®-360° Diabetes<br>Management System |

:

.. 10

/ 1

{5}------------------------------------------------

| <div> <img alt="WellDoc Logo" src="logo.png"/> <span>WellDoc^®</span> </div> | <table><tr><th>TITLE:</th><td>Response to FDA Feedback on 510 (K) K100066</td></tr><tr><th></th><td>7/9/2010</td></tr></table> | TITLE: | Response to FDA Feedback on 510 (K) K100066 | | 7/9/2010 |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------|---------------------------------------------|--|----------|
| TITLE: | Response to FDA Feedback on 510 (K) K100066 | | | | |
| | 7/9/2010 | | | | |

# Indications for Use:

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.

## Device Description:

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 ●

{6}------------------------------------------------

| <img alt="WellDoc Logo" src="logo.jpg"/> WellDoc ^® | TITLE: Response to FDA Feedback on 510 (K) K100066 | |
|---------------------------------------------------------------|----------------------------------------------------|--|
| | 7/9/2010 | |

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.

## Performance Data:

Human factors study results and software verification and validation (documented in accordance with FDA's "Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") were provided and supported substantial equivalence.

### Substantial Equivalence:

The DiabetesManager and DiabetesManager-Rx include indications for use that are similar to and consistent with those of the predicate devices, do not impact safety or effectiveness, and have the same intended uses as the predicate devices. Additionally, the DiabetesManager and DiabetesManager-Rx's technological characteristics are similar to and consistent with those of the predicate devices, e.g., all include software applications that provide data capture, storage, transmission, analysis and reporting of blood glucose (BG) values; all have data analysis and review features that provide BG trends and statistics; the DiabetesManager, DiabetesManager-Rx and ACCU-CHEK® 360° identify, analyze and display in- and out-of- target BG and historical lab values. Additionally, the ACCU-CHEK® Advisor provides directions which are similar to directions that physicians provide to patients as part of routine clinical practice. Likewise, the self management messages in the DiabetesManager and the blood glucose feedback and trend messages in the DiabetesManager-Rx are similar to directions that physicians provide to patients as part of routine clinical practice and are based on evidence-based standards of care. Minor technological differences do not impact safety or effectiveness as compared to the predicate devices. Therefore, DiabetesManager and DiabetesManager-Rx are substantially equivalent.

38