The t:slim™ Insulin Delivery System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater.

Device Description

The t:slim™ Insulin Delivery System ("t:slim System") consists of the following components and accessories:

a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump").
a dedicated, disposable 3mL (300 unit) insulin cartridge ("cartridge");
an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
accessories, including a Becton Dickenson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pump's internal battery, cartridge Instructions for Use, and User's Guide.
The t:slim Pump is a battery operated infusion pump capable of both basal and bolus delivery of insulin. It utilizes a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient's subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the end user (i.e., the patient). The graphical user interface on the t:slim Pump is a capacitive touch screen that is overlaid on an organic light emitting diode ("OLED") screen that displays information used to control the t:slim System. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge.
Cartridges are individually packaged and sealed, and provided sterile. The cartridge attaches to the t:slim Pump and is designed to hold up to 3 mL, or 300 units, of insulin. The cartridge has been tested for insulin compatibility with two types of rapid-acting U-100 insulin (Humalog® and NovoLog®) and determined to be insulin compatible as demonstrated by the performance data submitted in this 510(k) application.

AI/ML Overview

The provided text describes the t:slim™ Insulin Delivery System and its path to 510(k) clearance. Here's a breakdown of the acceptance criteria and study details based on the input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria or performance metrics for each test, but it broadly claims the device "functioned as intended and testing results observed were as expected." The performance data is presented as a list of validated and verified activities.

Acceptance Criteria Category	Reported Device Performance
System Performance	The t:slim System meets its intended requirements.
User Interface (Human Factors)	Can be used without critical errors that could lead to user harm. Satisfies all functional performance, safety requirements, and meets its intended use, and is safe for the intended user population.
Pump Performance	Pump Flow Rate Accuracy, Pump Bolus Accuracy, Battery Indication Performance, Cartridge Depletion and Low Insulin Alert, Flow Rate Accuracy for Minimum Flow Rate, Flow Rate Accuracy after Change in the Infusion Rate or Bolus Dose, Minimum Bolus Accuracy, Occlusion Alarm Test, Free Fall Test and Vibration Tests – functioned as intended and testing results observed were as expected.
Cartridge Performance	Cartridge Performance Validation, Insulin Stability Study, Biocompatibility, Insulin Compatibility Testing – functioned as intended and testing results observed were as expected; determined to be insulin compatible with Humalog® and NovoLog®.
Environmental & Operational Life	Pump Environmental and Operational Life Validation – functioned as intended and testing results observed were as expected.
Software, Hardware, Mechanical, Electrical Safety, EMC	Completed validation and verification activities, functioning as intended.
Water Ingress, Simulated Aging	Completed validation and verification activities, functioning as intended.

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

Human Factors Summative Study:
- Sample Size: 53 patients
- Data Provenance: Prospective, non-randomized, multicenter study. (Country of origin is not specified, but typically for 510(k) in the US, it would be within the US.)
For other performance tests (e.g., pump flow rate, bolus accuracy, cartridge performance), the document does not specify sample sizes for individual tests. It broadly mentions "appropriate validation and verification activities."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for any of the tests. The Human Factors study involved patients, and the assessment of whether "critical errors" occurred was likely based on pre-defined criteria associated with potential harm, but expert involvement for ground truth establishment beyond this is not detailed.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or evaluating the results of the performance studies.

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

No, an MRMC comparative effectiveness study was not done. This device is an insulin pump, and the studies described are related to its functional performance, safety, and user interface, not comparative effectiveness with human readers using an AI.

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

The "standalone" concept, as typically applied to AI algorithms, doesn't directly apply here since the t:slim system is a physical device that requires human interaction for its intended use (programming insulin delivery). However, the document does describe extensive device-centric standalone testing for various components and functions of the pump and cartridge (e.g., Pump Flow Rate Accuracy, Bolus Accuracy, Cartridge Performance Validation, Occlusion Alarm Test). These tests evaluate the device's inherent performance characteristics independent of a human user's specific performance in a clinical setting, although they are part of a system intended for human use.

7. The Type of Ground Truth Used:

Human Factors Study: The ground truth for this study was established against pre-defined safety criteria and the absence of "critical errors that could lead to user harm" during patient tasks. This is essentially ground truth based on safety and functional criteria defined by experts/engineers in the context of user interaction.
Other Performance Tests (e.g., flow rate, bolus accuracy): The ground truth would have been established against engineered specifications and established physical/chemical principles. For example, a flow rate test would compare the delivered insulin volume against a precisely measured or expected volume based on pump programming. Insulin compatibility would be measured against pre-defined chemical stability parameters.

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning. The studies described are verification and validation activities for a medical device's physical and software performance. Therefore, there is no direct equivalent of a "training set" as understood in AI/ML development.

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

As there is no "training set" in the AI/ML sense, this question is not applicable. The device's design and functionality would be based on engineering principles and regulatory requirements, and its performance verified and validated through the studies described.

Summary

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K111210

NOV - 9 2011

510(k) SUMMARY Tandem Diabetes Care, Inc.'s t:slim™ Insulin Delivery System

Submitter's Name, Address, Telephone Number, Contact Person, Contact Email Address and Date Prepared

Tandem Diabetes Care™, Inc. 11045 Roselle Street, Suite 200 San Diego, California 92121 Phone: (858) 366-6963 Facsimile: (858) 202-6707

Contact Person: Don Canal Contact Email Address: dcanal@tandemdiabetes.com

Date Prepared: August 3, 2011

Common or Usual Name / Classification Regulation

Insulin Pump / 21 C.F.R. 880.5725

Predicate Devices

Medtronic MiniMed's 508 Insulin Pump (K990801)

Nipro Diabetes Systems, Inc.'s Amigo Insulin Pump (K071613)

Intended Use / Indications for Use

Device Description

The t:slim™ Insulin Delivery System ("t:slim System") consists of the following components and accessories:

1. a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump").
1. a dedicated, disposable 3mL (300 unit) insulin cartridge ("cartridge");
1. an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
1. accessories, including a Becton Dickenson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pump's internal battery, cartridge Instructions for Use, and User's Guide.

The t:slim Pump is a battery operated infusion pump capable of both basal and bolus delivery of insulin. It utilizes a motor-driven mechanism to deliver insulin from within a

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disposable cartridge, through an infusion set, into a patient's subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the end user (i.e., the patient). The graphical user interface on the t:slim Pump is a capacitive touch screen that is overlaid on an organic light emitting diode ("OLED") screen that displays information used to control the t:slim System. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge.

Cartridges are individually packaged and sealed, and provided sterile. The cartridge attaches to the t:slim Pump and is designed to hold up to 3 mL, or 300 units, of insulin. The cartridge has been tested for insulin compatibility with two types of rapid-acting U-100 insulin (Humalog® and NovoLog®) and determined to be insulin compatible as demonstrated by the performance data submitted in this 510(k) application.

Technological Characteristics

The t:slim System consists of: (1) a software-controlled, programmable insulin infusion pump capable of both basal and bolus delivery of insulin ("t:slim Pump"): (2) a dedicated disposable 3mL (300 unit) insulin cartridge; (3) UnoMedical's Comfort™ Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories. The t:slim System and the cartridge materials of construction are commonly used in electromechanical medical equipment.

Performance Data

Tandem Diabetes Care™, Inc. ("Tandem") completed the appropriate validation and verification activities required by the Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump -- Premarket Notification [510(k)] Submissions Draft Guidance, issued on April 23, 2010 ("Draft Guidance"). Pump validation and verification activities included: software, hardware, mechanical, environmental conditioning, water ingress, simulated aging testing, electrical safety and electromagnetic compatibility testing. Cartridge verification activities included: mechanical testing, environmental conditioning, simulated aging, biocompatibility and insulin compatibility testing. System performance testing was conducted to ensure that the t:slim System meets its intended requirements. Tandem completed verification of the t:slim System's user interface through a series of Formative Studies. Testing was completed to relevant standards, as applicable.

The following performance and safety tests were conducted to evaluate the t:slim System:

Pump Flow Rate Accuracy, .
. Pump Bolus Accuracy.
Battery Indication Performance, .
Cartridge Depletion and Low Insulin Alert, .
t Summative Human Factors Study,
. Cartridge Performance Validation,
Pump Environmental and Operational Life Validation, .
. Flow Rate Accuracy for Minimum Flow Rate,
Flow Rate Accuracy after Change in the Infusion Rate or Bolus Dose, .
t Insulin Stability Study,

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Minimum Bolus Accuracy, .
. Occlusion Alarm Test, and
. Free Fall Test and Vibration Tests.

In all instances, the t.slim Insulin Delivery System functioned as intended and testing results observed were as expected.

Human Factors Validation

Validation of the User interface was accomplished through a prospective non-randomized, multicenter Investigational Human Factors Summative Study. In this Summative Study, a total of 53 patients ranging in age from 12-74 years old participated in representative training, then exercised all tasks critical for the safe operation of the t:slim System in the home use ambulatory environment. This Study demonstrated that the t.slim System can be used without critical errors that could lead to user harm. Through this comprehensive series of tests and system risk analysis, the Company has demonstrated that the t:slim System satisfies all functional performance, safety requirements, and user meets its intended use, and is safe for the intended user population.

Assurance Case Reports

Tandem has demonstrated the t:slim System is safe and effective as intended, through the use of Assurance Case Reports as recommended in the Draft Guidance.

Substantial Equivalence

The t:slim System is as safe and effective as Medtronic MiniMed's 508 Insulin Pump (K990801) and Nipro Medical Corporation's Amigo Insulin Pump (K071613), as demonstrated by performance data. It has the same intended use/indications for use, and similar technological characteristics and principles of operation, and the minor technological differences between the t.slim System and its predicate devices raise no new issues of safety or effectiveness. Thus, the t:slim System is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Mr. Don Canal Vice President, Quality and Regulatory Tandem Diabetes Care, Incorporated 11045 Roselle Street Suite 200 San Diego, California 92121

NOV - 9 2011

Re: K111210

Trade/Device Name: t:slim Insulin Delivery System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG Dated: November 7, 2011 Received: November 7, 2011

Dear Mr. Canal:

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.

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Page 2 - Mr. Canal

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 (OS) 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,

Antman 20. nute

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 Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K111210

Device Name: t:slim™ Insulin Delivery System

Indications for Use:

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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111210

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).