(203 days)
Not Found
No
The description focuses on data retrieval, display, analysis (in terms of reporting), and account management. There is no mention of AI or ML algorithms being used for prediction, pattern recognition beyond simple reporting, or any form of learning from the data. The analysis is limited to displaying and summarizing existing data.
No
The device is described as a web-based software system that displays and analyzes information from insulin pumps and blood glucose meters. It does not actively modify therapy or parameters of the devices it communicates with; it only reads data. Therefore, it is a data management and display tool, not a therapeutic device.
Yes
The device aids in diabetes management by displaying and analyzing information from insulin pumps and blood glucose meters, which can contribute to the diagnosis and monitoring of diabetes. It specifically states its purpose is for "display and analysis of information downloaded from Tandem Diabetes Care insulin pumps and specified blood glucose meters."
Yes
The device is described as a "web based software system" comprised of various software components (Data Uploader, Web Application, Server, Admin Application) that interact with external hardware (insulin pumps, blood glucose meters) but does not include or modify the hardware itself. The testing described focuses on software verification and validation, GUI, and human factors related to the software interface.
Based on the provided information, the t:connect Diabetes Management Application is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the application is for "display and analysis of information downloaded from Tandem Diabetes Care insulin pumps and specified blood glucose meters." It supports diabetes management by providing insights from existing data, not by performing a test on a biological sample to diagnose or monitor a condition.
- Device Description: The description details a software system that retrieves, stores, and displays data from external devices (insulin pumps and blood glucose meters). It explicitly states that it "only reads data from these devices" and "does not have the ability to modify any therapy provided by or parameters internal to the devices it communicates with." This is characteristic of a data management system, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes that would be involved in an in vitro diagnostic test, such as reagents, sample handling, or analysis of biological specimens.
In summary, the t:connect Diabetes Management Application functions as a data management and reporting tool for diabetes-related information collected by other devices. It does not perform any diagnostic testing itself, which is the core function of an IVD.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
LZG
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
"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
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
Not Found
Intended User / Care Setting
individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their care givers, and their healthcare providers in home and clinical 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
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
-
- Software Validation Report
-
- Software Verification Report
-
- GUI Verification Test Report
-
- Human Factors Research Validation Report
- Software V&V Report 5.
- Labeling Verification Test report ®.
-
- Final Traceability Report
-
- Risk Management Summary
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.
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.
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
§ 880.6310 Medical device data system.
(a)
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.
(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
0
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: (858) 366-6963 Facsimile: (858) 202-6707
Contact Person: Nora C.R. York Contact Email Address: nyork@tandemdiabetes.com
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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|---|---|
| Tandem Diabetes Care - t:connect 510(k) Notification | |
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1
"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.
-
- Software Validation Report
-
- Software Verification Report
-
- GUI Verification Test Report
-
- Human Factors Research Validation Report
- Software V&V Report 5.
- Labeling Verification Test report ర్.
-
- Final Traceability Report
-
- 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
| Title: | r auch Number. |
|---|---|
| 19 of 66 | |
| Tandem Diabetes Care - t:connect 510(k) Notification | |
| The first to the first the first and the are a minute a firm a fine a firm a fine a firm a fine a fire | |
| Property of Children Compression a consideration of CLE LE STANLINE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE L | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
2
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
Diabetes
t:connect | Medtronic
DMS
(K032164) | Aiedera
Diasend
(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
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
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Company of the commend on a frequent of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of th
For a manager of the commended to the comments of the comments of the comments of the comments of the country of
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| Title: | |
| 20 of 66 | |
| Care - I connect 510(k) Notification | |
| soloholos | |
| andam | |
| and the county of the production of the count of the complete of the comments of course of the comments of coursely | |
| A . L . L . B . B |
3
| Element of Comparison | Tandem
Diabetes
t:connect | Medtronic
DMS
(K032164) | Aiedera
Diasend
(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
OSX 10.6
OSX 10.7 | OSX 10.5
OSX 10.6
OSX 10.7 | OSX 10.5
OSX 10.6
OSX 10.7 |
| | Supported Browsers | IE
Safari
Firefox
Chrome | IE
Safari
Firefox |
. . . . .
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|---|---|---|---|
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4
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.
5
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 (800) 638-2041 or (301) 796-7100 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
6
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:
Draket : 000 1 million in 19, 1
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