The t:slim® Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 6 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin.

Device Description

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. The scope of this Traditional 510(k) is limited to expansion of the indications for use to include individuals 6 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin. No changes have been made to the device components to accommodate the modified indications for use.

The t:slim System, like the predicate device, consists of the following components and accessories:

1. a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump");
1. a dedicated, disposable 3.0 mL (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 3 mL sterile syringe and 26 gauge sterile needle, as well as an AC power supply and DC car adapter 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. The Pump 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 user (i.e., the patient). The graphical user interface ("GUI") of the t:slim Pump is a touch 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.

Identical to the predicate device, the t:slim cartridge is a single-use device, individually packaged and sealed, and is provided sterile. The cartridge attaches to the t:slim Pump and is designed to hold up to 3.0 mL (300 units) of insulin. Both in the predicate and in the device that is the subject of this 510(k) notice, the delivery of insulin is accomplished through a micro-syringe within the head of the cartridge. The Pump has a pressure measurement sensor to estimate the volume of insulin in the insulin reservoir by measuring air pressure in the cartridge. This information is used to provide feedback to the software to determine the insulin volume, detect occlusions and cartridge removal.

AI/ML Overview

The provided text describes a 510(k) submission for the t:slim® Insulin Delivery System, focusing on expanding its indications for use to include individuals 6 years of age and greater. This is a regulatory document rather than a study report detailing specific performance criteria and a study to prove they are met in a quantitative sense as might be expected for an AI/ML medical device.

Therefore, many of the requested elements for acceptance criteria and study details are not directly applicable or available in the provided text, as this document is about establishing substantial equivalence based on existing data and human factors testing for a wider age range, rather than presenting a novel clinical performance study with specific device metrics.

However, I can extract information related to the safety assurance case and human factors testing, as these touch upon aspects of "acceptance criteria" in a broader sense for this type of regulatory submission.

Here's an attempt to answer based on the provided text, noting where information is not available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance metrics in the way one would see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are framed in terms of general safety, reliability, and substantial equivalence, particularly concerning the expanded age range.

Acceptance Criteria (Implied from Safety Assurance Case & Substantial Equivalence Claim)	Reported Device Performance (Summary)
Safety risk reduced to acceptable levels (ALARP)	A comprehensive safety assurance case was provided, addressing operational, environmental, electrical, hardware, software, mechanical, biological/chemical, and use hazards. Mitigating technologies are used, and risks are deemed substantially equivalent to the predicate device.
Adequate device reliability	Documented as part of the assurance case.
Adequate design verification and validation of device specifications	Documented as part of the assurance case.
Maintain substantially equivalent use for individuals 6 years and greater	Human Factors testing supports substantially equivalent use of the device in individuals from 6 years of age and greater. Updated labeling, warnings, and precautions provide further information regarding the risks for pediatric users. The device has identical technological characteristics to the predicate device for this expanded indication.
Supported by peer-reviewed literature for CSII in ages 6-11	A summary of peer-reviewed literature supports the use of Continuous Subcutaneous Insulin Infusion (CSII) in ages 6 through 11.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified for the human factors testing or the peer-reviewed literature summary.
Data Provenance: Not specified for human factors testing. The peer-reviewed literature would be drawn from various studies, likely international, but this is not detailed. The human factors testing is implied to be relevant to the U.S. market.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable/Not specified. This document describes a 510(k) submission for an insulin pump, not for a diagnostic device that requires expert-established ground truth for a test set in the same manner as an AI/ML imaging system. The "ground truth" here is the established safety and efficacy of CSII, and the device's equivalent performance to its predicate and suitability for a broader age range, assessed through engineering principles, human factors, and literature review.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/None specified. No adjudication method is mentioned as this is not a study involving human reader interpretations that require adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study was not done. This device is an insulin pump, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable/Not directly addressed in this framework. The device itself is a standalone insulin pump. The "performance" being evaluated is its safety and functionality for an expanded age range, not an algorithm's diagnostic accuracy in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this submission is multifaceted:
- Peer-reviewed medical literature: Supporting the general efficacy and safety of CSII in pediatric populations (ages 6-11).
- Device specifications and design verification/validation: Demonstrating the device meets its intended functional requirements.
- Human Factors testing: Confirming that the device can be used safely and effectively by the intended user population, including the expanded pediatric group, and that updated labeling is sufficient.
- Predicate device's established safety and performance: The t:slim System is shown to have identical technological characteristics and similar intended use to the predicate device, implying its "ground truth" is aligned with the predicate's proven track record.

8. The sample size for the training set

Not applicable/Not specified. This document does not describe a machine learning model or a training set in the conventional sense. The "training" for the device's expanded indication relies on existing engineering documentation, human factors insights, and clinical literature.

9. How the ground truth for the training set was established

Not applicable. As there is no "training set" for a machine learning model described, this question is not relevant to the provided text.

Summary

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

July 25, 2016

Tandem Diabetes Care, Inc. Mr. Michael Sarrasin Senior Director of Regulatory Affairs 11045 Roselle Street San Diego, California 92121

Re: K160056

Trade/Device Name: t:slim Insulin Delivery System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: Julv 5. 2016 Received: July 6, 2016

Dear Mr. Sarrasin:

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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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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Tina Kiang
-S

for Erin I. Keith, M.S. 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

510(k) Number (if known) K160056

Device Name t:slim® Insulin Delivery System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K160056

Tandem Diabetes Care, Inc.

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

Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego, CA 92121 Phone: 858-366-6900 Facsimile: 858-362-7070

Contact Person: Michael Sarrasin Contact Email: MSarrasin@tandemdiabetes.com

Date Prepared: July 21, 2016

Name of Device

t:slim® Insulin Delivery System

Common or Usual Name

Insulin infusion pump

Classification Name

Infusion Pump per 21 CFR 880.5725

Product Code

LZG, Insulin infusion Pump

Predicate Devices

Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System (K141758)

Purpose of the 510(k) notification

The purpose of this 510(k) is to describe modified indications for use for the t:slim® Insulin Delivery System

Intended Use

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Device Description

The t:slim System, like the predicate device, consists of the following components and accessories:

1. a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump");
1. a dedicated, disposable 3.0 mL (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 3 mL sterile syringe and 26 gauge sterile needle, as well as an AC power supply and DC car adapter power supply with USB for charging the Pump's internal battery, cartridge Instructions for Use, and User's Guide,

ldentical to the predicate device, the t:slim cartridge is a single-use device, individually packaged and sealed, and is provided sterile. The cartridge attaches to the t:slim Pump and is designed to hold up to 3.0 mL (300 units) of insulin. Both in the predicate and in the device that is the subject of this 510(k) notice, the delivery of insulin is accomplished through a micro-syringe within the head of the cartridge. The Pump has a pressure measurement sensor to estimate the volume of insulin in the insulin reservoir by measuring air pressure in the cartridge. This information is used to provide feedback to the software to determine the insulin volume, detect occlusions and cartridge removal.

Technological Characteristics

The t:slim Insulin Delivery System that is the subject of the modified indication in this 510(k) submission has the same technological characteristics as the predicate device. The 510(k) device and the predicate Systems both consist 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 3.0 mL (300 units) insulin cartridge; (3) UnoMedical's Comfort™ Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories including a sterile syringe and needle (for cartridge filling) an AC power supply and DC car adapter power supply with USB.

Performance Data

A summary of peer reviewed literature supports the use of CSII in ages 6 through 11.

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A safety assurance case was provided for the t:slim Insulin Delivery Systems as recommended in the FDA's guidance document, Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions Guidance, issued on December 2, 2014.

The stated goal of the t:slim assurance case is:

The safety risk resulting from use of t:slim pump is reduced to acceptable levels and is As . Low As Reasonably Practicable (ALARP) through use of mitigating technologies and the risks are substantially equivalent to the predicate device.
The assurance case defined the device system, including the indications for use, patient types, users, use conditions, environments of use, and list of specific devices covered by the assurance case with associated design specification and labeling documentation. The supporting assurance arguments covered the following attributes:
. Demonstrate acceptability of risk mitigations
Demonstrate adequate device reliability
Demonstrate adequate design verification and validation of device specifications .

The assurance case included mitigations of risks related to the following hazards:

. Operational Hazards
. Environmental Hazards
Electrical Hazards
Hardware Hazards
Software Hazards
Mechanical Hazards
. Biological and Chemical Hazards
Use Hazards

The following evidence was included in the assurance case to support the modifications of the subject device's indications for use in comparison to the predicate:

Human Factors testing supports substantially equivalent use of the device in individual's from 6 years of age and greater. Updated labeling, warnings, and precautions provide further information regarding the risks of the device for pediatric users.

Substantial Equivalence

The current t:slim System has the same intended use and very similar indications for use compared to the predicate device. The only change is the modification of the indications to include users as young as 6 years of age. The system also has identical technological characteristics. Human factors testing confirms that the current t:slim System, when indicated for younger users, continues to perform in a substantially equivalent manner.

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).