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 professionals 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 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
Display Therapy Data textually and graphically .
Manage User Accounts for retrieving and viewing pump data .
Generate Notifications for the user
Print reports to PDF .
Export data for use in generating customer reports using other software applications
Provision of user help .
Administrator functionality related to creation and managing user accounts

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Tandem t:connect Data Management System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and verifying that design inputs have been met through software testing. It doesn't explicitly state quantitative performance acceptance criteria in terms of clinical metrics (e.g., accuracy, sensitivity, specificity) for a device that makes a diagnosis or has a specific clinical outcome. Instead, the "performance" here refers to the software's functional correctness and usability.

However, we can infer some "acceptance criteria" related to functionality and usability from the description and outline the reported performance based on the provided text.

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Correctness:
Ability to retrieve and transmit pump data.	"Retrieve History Log data from the pump and transmit to the database server."
Ability to retrieve and transmit blood glucose (BG) meter data.	"Retrieve History Log data from various BG meters and transmit to the database server."
Ability to retrieve and transmit diagnostic information from the pump.	"Retrieve Diagnostic information from the pump and transmit to the database server."
Ability to view pump's complete history log.	"Provide a means to view the pump's complete history log."
Ability to retrieve and display pump settings.	"Retrieve Pump Settings from the pump for easy viewing by the user."
Ability to display therapy data textually and graphically.	"Display Therapy Data textually and graphically." (Comparison table also lists "Pie Charts of BG & Insulin," "Modal Day BG Charts," "Charts of Basal & Bolus Delivery" as "Yes").
Ability to manage user accounts.	"Manage User Accounts for retrieving and viewing pump data."
Ability to generate notifications.	"Generate Notifications for the user." (Comparison table lists "Notifications" as "Yes").
Ability to print reports to PDF.	"Print reports to PDF." (Comparison table lists "Print Report" Option as "Yes").
Ability to export data to compatible files.	"Export data for use in generating customer reports using other software applications." (Comparison table lists "Exports to Excel Compatible Files" as "Yes").
Provision of user help.	"Provision of user help."
Administrator functionality for account management.	"Administrator functionality related to creation and managing user accounts."
Safety and Effectiveness:
No modification of therapy or internal parameters of connected devices.	"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."
Ensures secure access to user data.	"users are authenticated... to insure maximum security and secure access to only their data."
Usability:
Usable by intended users (individuals with diabetes, caregivers, healthcare providers).	"Human Factors Research Validation Report" and Summative Human Factors Validation Test completed with 30 participants (15 healthcare professionals, 15 type 1 diabetics) demonstrating feedback on usability and workflow. "Formative study did not reveal any safety related issues." (This implies the system was found usable and safe during the test).
Compatibility:
Support for specified blood glucose meters (J&J/LifeScan, Abbott, Roche).	"Supports J&J/LifeScan BG Meters: Yes," "Supports Abbott BG Meters: Yes," "Supports Roche BG Meters: Yes."
Support for various operating systems (Windows XP/Vista/7, Mac OS X 10.5-10.7) and browsers (IE, Safari, Firefox, Chrome).	"Supports Microsoft OS: Win XP, Win Vista, Win 7." "Supports Apple Mac OS: OSX 10.5, OSX 10.6, OSX 10.7." "Supported Browsers: IE, Safari, Firefox, Chrome."

2. Sample Size Used for the Test Set and Data Provenance

The document describes several types of testing rather than a single "test set" for performance evaluation:

Software Verification and Validation Testing: This broad category of testing "demonstrates the t:connect Data Management System meets the established design inputs and its intended use." No specific sample size for data used in this testing is given.
Human Factors Validation Test:
- Sample Size: 30 participants.
- Data Provenance: Prospective (participants interacted with the system in a controlled setting). The country of origin is not explicitly stated, but given the company location (San Diego, California), it is likely the US.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

For the human factors study:

The "ground truth" here isn't a complex medical diagnosis, but rather the usability and safety of the device's interface and workflow.
Experts involved in the study:
- Moderator: Seated in an observation room (no specific qualifications mentioned, but implied to be trained in human factors observation).
- Certified Diabetes Educator: Provided 30 minutes of training to participants. This individual would be considered an expert in diabetes care and educating patients, which is relevant to the usability of a diabetes management system.
The 30 participants themselves, divided into 15 healthcare professionals and 15 type 1 diabetics, represent the target users whose feedback and performance define the "ground truth" of usability for this device. Their specific qualifications (e.g., years of experience for healthcare professionals) are not detailed beyond "healthcare professionals."

4. Adjudication Method for the Test Set

Human Factors Validation Test: The description mentions "The participant's interaction with the system was observed by the moderator... and were added new room so and well as system interaction and which afterou partionmative study did not reveal any safety related issues." This suggests a qualitative observation and assessment approach. There is no mention of a formal adjudicated consensus process (like 2+1 or 3+1) for evaluating interaction, as this is typically used for diagnostic image interpretation. The "ground truth" for human factors is generally established through direct observation of user performance and user feedback, potentially with the moderator or a team synthesizing findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done.
- The provided text describes software verification/validation, human factors testing, and a comparison to predicate devices for substantial equivalence. It does not mention a study evaluating human readers' performance with and without AI assistance for tasks that would require such an analysis (e.g., diagnostic accuracy).
- The t:connect system is a data management and display tool, not a diagnostic AI system that "assists" human readers in interpreting clinical data to improve their diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This concept does not directly apply to the t:connect system in the context of this 510(k).
- The t:connect is a data management application designed to be used by humans (patients, caregivers, healthcare providers) to view and analyze downloaded data. It does not perform autonomous diagnostic or decision-making functions that would typically be evaluated in a "standalone" fashion for an AI algorithm.
- The software verification and validation tests cover the "algorithm only" aspect in terms of its ability to correctly process, store, and display data according to its design specifications.

7. The Type of Ground Truth Used

For functional correctness (software V&V): The ground truth is the design input requirements and the intended use of the software. The tests verified that the software performed as designed and met these specifications.
For usability (human factors): The ground truth is established by user performance and feedback during controlled task scenarios. The absence of safety-related issues in formative studies and successful completion of tasks by representative users served as evidence of acceptable usability.

8. The Sample Size for the Training Set

The document does not report a "training set" in the context of machine learning or AI algorithm development.
The t:connect system, as described, is a data management application with defined functionalities rather than a machine learning model that requires a large dataset for training. Its functionality is based on programmed logic and rules, not learned patterns from a training set.

9. How the Ground Truth for the Training Set Was Established

As no "training set" for a machine learning model is mentioned, this question is not applicable to the information provided for the t:connect Data Management System.

Summary

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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: (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 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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	18 of 66

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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
1. Software Verification Report
1. GUI Verification Test Report
1. Human Factors Research Validation Report
Software V&V Report 5.
Labeling Verification Test report ర్.
1. Final Traceability Report
1. 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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Tandem Diabetes Care - t:connect 510(k) Notification
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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	TandemDiabetest:connect	MedtronicDMS(K032164)	AiederaDiasend(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 TherapyData	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	TandemDiabetest:connect	MedtronicDMS(K032164)	AiederaDiasend(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 10.5OSX 10.6OSX 10.7	OSX 10.5OSX 10.6OSX 10.7	OSX 10.5OSX 10.6OSX 10.7
	Supported Browsers	IESafariFirefoxChrome	IESafariFirefox

. . . . .

Title:	Tandem Diabetes Care - t:connect 510(k) Notification	Page Number:	21 of 66
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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 (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

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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:

Draket : 000 1 million in 19, 1

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Regulation Number and Section

§ 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.