T:CONNECT DATA MANAGEMENT SYSTEM

K122361 · Tandem Diabetes Care, Inc. · OUG · Feb 22, 2013 · General Hospital

Device Facts

• Record ID: K122361
• Device Name: T:CONNECT DATA MANAGEMENT SYSTEM
• Applicant: Tandem Diabetes Care, Inc.
• Product Code: OUG · General Hospital
• Decision Date: Feb 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6310
• Device Class: Class 1
• Attributes: Software as a Medical Device

Indications for Use

The t:connect Diabetes Management Application is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their care givers, and their healthcare providers in home and clinical settings. The t connect Application supports diabetes management through the display and analysis of information downloaded from Tandem Diabetes Care insulin pumps and specified blood glucose meters.

Device Story

t:connect is a web-based software system for diabetes management; retrieves history logs, diagnostic info, and pump settings from Tandem insulin pumps and blood glucose meters via USB connection. System components include a client-side Data Uploader, Web Application, and secure database server. Users (patients, caregivers, clinicians) view tabular and graphical reports (BG, insulin delivery, logbooks) via web browser. System does not modify therapy or pump parameters; provides read-only data visualization to assist clinical decision-making and diabetes management. Used in home and clinical settings; requires user authentication for secure access. Benefits include centralized data visualization and reporting to support therapy adjustments.

Clinical Evidence

No clinical data. Performance verified through software verification and validation testing, GUI verification, and human factors evaluation. Summative human factors validation test conducted with 30 participants (15 healthcare professionals, 15 type 1 diabetics) to assess usability and task performance; no safety-related issues identified.

Technological Characteristics

Web-based software system; client-side Data Uploader (PC-based) and server-side Web Application. Connectivity via USB for data retrieval and encrypted internet connection for server communication. Supports Windows (XP, Vista, 7) and Mac OS (10.5-10.7). Compatible with standard web browsers (IE, Safari, Firefox, Chrome).

Indications for Use

Indicated for individuals with diabetes mellitus using Tandem Diabetes Care insulin pumps, their caregivers, and healthcare providers in home and clinical settings to display and analyze data from insulin pumps and specified blood glucose meters.

Regulatory Classification

Identification

(1) A medical device data system (MDDS) is a hardware device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:(i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) The electronic display of medical device data. (2) An MDDS may include electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, and interfaces. This identification does not include hardware devices intended to be used in connection with active patient monitoring. Hardware devices for active patient monitoring are classified under other regulations and are not included in this regulation.

Predicate Devices

• Medtronic MiniMed Diabetes Data Management System (K032164)
• Aidera Diasend System (K101806)

Submission Summary (Full Text)

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K122361

# FEB 2 2 2013

## 510(k) SUMMARY

# Tandem Diabetes Care, Inc.'s t:connect Data Management System

Tandem Diabetes Care, Inc. Submitter's Name: 11045 Roselle Street, Suite 200 Address: San Diego, California 92121 Phone: [phone] Facsimile: [phone]

Contact Person: Nora C.R. York Contact Email Address: [e-mail]

July 31, 2012 Date Prepared:

# Common or Usual Name / Classification Regulation

The t:connect Data Management System is an accessory to the Tandem t:slim Insulin Pump system which is classified under 21 C.F.R. 880.5725, Pump, Infusion, Insulin, Class II, Product Code, LZG.

#### Predicate Devices

Medtronic MiniMed Diabetes Data Management System (K032164)

Aidera Diasend System (K101806)

#### Intended Use / Indications for Use

The t:connect Diabetes Management Application is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their care givers, and their healthcare providers in home and clinical settings. The t connect Application supports diabetes management through the display and analysis of information downloaded from Tandem Diabetes Care insulin pumps and specified blood glucose meters.

#### Device Description

The Tandem t:connect is a web based software system which allows pump users, care rhe Tunders troomfoot rofessionals to view data retrieved from a Tandem Ambulatory Insulin Pump and Blood Glucose meters. t:connect is comprised of a Data Uploader, a Web Application, a Secure Web and Database Server, and an Admin Web Application.

The t:connect Data Uploader is a client based software application installed on the pump user's personal computer. Using a USB cable connecting the pump to a personal computer, the application uploads pump data to a secure online database server through a secure, encrypted, internet connection. The t.connect Data Uploader also uploads data from a limited set of Blood Glucose meters.

The t:connect Web Application is a reporting application that provides users with the ability to view and print (to PDF) both tabular and graphical reports representing the data uploaded to the online database. The f:connect Web Application is the "t:connect Website" shown in Figure 1.

The tconnect Web and Database Server is an application that runs on the secure server. Data displayed on the t:connect Web Application is retrieved from the secure Database

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"intermediary" providing an extra layer of security and restricted access to the Database Server.

For both the Data Uploader and the Web Application, users are authenticated against a "or both the extir oploads to insure maximum security and secure access to only their data.

The Admin Web Application is an application used to manage accounts. It also allows holders of certain types of accounts to Logon As User to the t.connect Web Application as other users.

t:connect does not have the ability to modify any therapy provided by or parameters internal to the devices it communicates with. t:connect only reads data from these devices.

The major functions of the device include:

- Retrieve History Log data from the pump and transmit to the database server .
- Retrieve History Log data from various BG meters and transmit to the database server .
- Retrieve Diagnostic information from the pump and transmit to the database server .
- Provide a means to view the pump's complete history log �
- Retrieve Pump Settings from the pump for easy viewing by the user o
- Display Therapy Data textually and graphically .
- Manage User Accounts for retrieving and viewing pump data .
- Generate Notifications for the user の
- Print reports to PDF .
- Export data for use in generating customer reports using other software applications o
- Provision of user help .
- Administrator functionality related to creation and managing user accounts

## Performance Data

Tandem has completed the necessary performance testing to verify that the design input requirements have been met. Software verification and validation testing was completed to demontrate the t:connect Data Management System meets the established design inputs and its intended use.

- 1. Software Validation Report
- 2. Software Verification Report
- 3. GUI Verification Test Report
- 4. Human Factors Research Validation Report
- Software V&V Report 5.
- Labeling Verification Test report ర్.
- 7. Final Traceability Report
- 8. Risk Management Summary

#### Clinical and Human Factors Evaluation

Tandem completed three formative human factors studies and a summative human factors validation test using 30 participants. Data from these formative studies were used to refine the graphical user interface of the t:connect Data Management System. A summative human factors validation test was completed with 30 participants.

A total of 30 representative adult users stratified into two population segments: (15) healthcare professionals and (15) type 1 diabetics. The participants completed a set of representative task scenarios presented to them in as efficient and timely a manner as

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possible. They were asked to provide feedback regarding the usability and arrists the possible. They were actived to provicipants received 30 minutes of training prior to the session from a Certified Diabetes Educator.

The participant's interaction with the system was observed by the moderator seated in an The participant 3 interdollor than the System of the Morae usability software suite, observation room and were addior nous room so and well as system interaction and which oapterou partionmative study did not reveal any safety related issues.

#### Assurance Case Reports

Tandem has demonstrated the t:connect Data Management System is safe and effective as intended, through the use of Assurance Case Reports.

## Substantial Equivalence

The t:connect Data Management System is as safe and effective is the Medtronic MiniMed The Coomeor Data Management System (K032164) and the Aidera Diasend System (K101806), Diabetes Data Managomont Oyken (Nota For) and equivalence analysis. It has the same intended as oefnonstrated by performance outd and ogentions and principles of operation,
use/indications for use, and similar technological characteristics and principles of created disemindications for use, and similar toonhological one it Data Management System and the minor technological annoversons of safety or effectiveness. Thus, the t.connect and its prodicate actions faller no the necessaritially equivalent to the predicate devices.

| Element of Comparison | Tandem<br>Diabetes<br>t:connect | Medtronic<br>DMS<br>(K032164) | Aiedera<br>Diasend<br>(K101806) |
|-----------------------------------------|---------------------------------|-------------------------------|---------------------------------|
| Application Type | Web App | Web App | Web App |
| Pie Charts of BG & Insulin | Yes | Yes | Yes |
| Modal Day BG Charts | Yes | Yes | Yes |
| Charts of Basal & Bolus Delivery | Yes | Yes | Yes |
| User Selectable Date Ranges | Yes | Yes | Yes |
| Logbook | Yes | Yes | Yes |
| Displays Device Settings | Yes | Yes | Yes |
| "Print Report" Option | Yes | Yes | Yes |
| Allows User to Annotate Therapy<br>Data | Yes | Yes | Yes |
| Dashboard Summary | Yes | No | No |
| Notifications | Yes | No | No |
| Exports to Excel Compatible Files | Yes | Yes | Yes |
| Supported Insulin Pumps | Tandem | Medtronic | Multiple |

# Comparison of Technological Characteristics

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| Element of Comparison | Tandem<br>Diabetes<br>t:connect | Medtronic<br>DMS<br>(K032164) | Aiedera<br>Diasend<br>(K101806) |
|---------------------------------|----------------------------------|-----------------------------------|----------------------------------|
| Supports J&J/LifeScan BG Meters | Yes | Yes | Yes |
| Supports Abbott BG Meters | Yes | Yes | Yes |
| Supports Roche BG Meters | Yes | Yes | Yes |
| Supports Additional BG Meters | No | Yes | Yes |
| Supports Microsoft OS | Win XP | Win XP | Win XP |
| | Win Vista | Win Vista | Win Vista |
| | Win 7 | Win 7 | Win 7 |
| Supports Apple Mac OS | OSX 10.5<br>OSX 10.6<br>OSX 10.7 | OSX 10.5<br>OSX 10.6<br>OSX 10.7 | OSX 10.5<br>OSX 10.6<br>OSX 10.7 |
| | Supported Browsers | IE<br>Safari<br>Firefox<br>Chrome | IE<br>Safari<br>Firefox |

. . . . .

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

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

February 22, 2013

Ms. Nora C.R. York Tandem Diabetes Care, Incorporated 11045 Roselle Street Suite 200 SAN DIEGO CA 92121

Re: K122361

Trade/Device Name: Tandem t: connect Data Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: February 12, 2013 Received: February 13, 2013

Dear Ms. Nora C.R. York:

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.

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# Page 2 - Ms. Nora C.R. York

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/5/Picture/8 description: The image shows a stylized signature or logo. The text "For" is at the top left, and the text "with" is in the middle. The text "wrouts" is at the bottom. The signature is enclosed in an oval shape.

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

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

Enclosure

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#### Indications for Use Statement

510(k) Number (if known): K122361

#### Device Name: Tandem t:connect Data Management System

Indications for Use:

The t.connect Diabetes Management Application is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their caregivers, and their healthcare providers in home and clinical settings. The t:connect Application supports diabetes management through the display and analysis of information downloaded from Tandem Diabetes Care insulin pumps and specified blood glucose meters.

| Prescription Use |
|------------------|
|------------------|

X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(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)

Richard C. Chapman 2013.02.21 11:58:51 -05'00'

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

510(k) Number:

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