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 12 years of age and greater.

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 Special 510(k) is limited to changes to the cartridge configuration of the t:slim System.
The t:slim System with the modified cartridge, 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 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 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 capacitive 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.
  The t:slim cartridge is a single-use device, 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 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

This 510(k) submission (K133593) is for a Special 510(k) notice regarding changes to the cartridge of the t:slim™ Insulin Delivery System. The primary focus of the performance data and acceptance criteria is to ensure that the modifications to the cartridge materials do not negatively impact the device's safety and effectiveness compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance / Evaluation Method
Material Safety & Compatibility	Biocompatibility with human tissue	Confirmation of biocompatibility testing per ISO 10993-1, repeated cytotoxicity testing.
	Insulin compatibility (no degradation or interaction with insulin)	Insulin Compatibility testing.
	Extractables and Leachables within acceptable limits	Extractable and Leachables testing.
	Chemical composition of new materials matches specifications (or is acceptable)	Chemical composition comparison (FTIR).
Cartridge Structural Integrity	Patient line bond strength sufficient	Patient line bond strength testing.
	Cartridge integrity (no leaks under pressure)	Cartridge Pressure/leak testing.
	Package seal integrity maintained	Package seal integrity testing.
Functional Performance (Delivery)	Infusion flow accuracy meets specifications	Infusion flow accuracy testing.
	Fill volume accuracy meets specifications	Fill volume accuracy testing.
Manufacturing Process & Quality	Production processes validated (Installation, Operational, Performance)	Production IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification).
	Product inspection and release testing standards met	Product inspection and release testing.
Risk Mitigation	All identified risks mitigated, no new risks introduced	Evaluation of risks for the type of change involved, confirmation that all changes made to the cartridge were assessed to make sure all the risks were mitigated (e.g., infusion flow accuracy, fill volume accuracy, leakage, bond strength and tubing integrity, shelf life, biocompatibility, insulin compatibility) and that no new risks were introduced as a result of these modifications.

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

The document does not explicitly state specific sample sizes for each test mentioned (e.g., for bond strength, leak testing, flow accuracy, etc.). It refers generally to "testing" and "evaluation". Given the nature of a Special 510(k) for material and supplier changes, the testing would typically involve a statistically relevant number of units to demonstrate equivalence to the previously cleared predicate device.

The data provenance is not explicitly stated as country of origin but is implicitly domestic, as the submitter, Tandem Diabetes Care, Inc., is based in San Diego, CA, USA, and the submission is to the U.S. FDA. The data is retrospective in the sense that it's based on internal verification and qualification testing performed by the manufacturer to support the safety and effectiveness of the modified device before market introduction. It is not clinical trial data involving patients.

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

This type of submission (Special 510(k) for material changes) does not typically involve a "test set" with "ground truth" established by external experts in the same way clinical studies for diagnostic devices might. The "ground truth" here is adherence to pre-defined engineering specifications, regulatory standards (like ISO 10993-1), and the performance characteristics of the predicate device. The experts involved would be the manufacturer's internal R&D, engineering, quality, and regulatory personnel responsible for designing, testing, and verifying the changes, along with potentially external lab specialists for specific tests like biocompatibility or extractables/leachables. Their qualifications would be relevant scientific and engineering degrees and experience in medical device development and testing. The document does not specify the number or detailed qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable in the context of this Special 510(k). Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image-based diagnostic device evaluations where multiple human readers interpret data to establish a consensus ground truth. Here, the "ground truth" is defined by established engineering specifications and compliance with validated test methods.

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

Not applicable. This submission is for modifications to an insulin pump cartridge, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was performed or is relevant.

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

Not applicable. This device is an insulin pump, not an algorithm. Performance is tested for the physical device components and their functionality.

7. The Type of Ground Truth Used

The ground truth used in this context is primarily:

Engineering Specifications and Design Requirements: The performance of the modified cartridge must meet or exceed the original design specifications for the predicate device.
Regulatory Standards: Compliance with relevant international standards, e.g., ISO 10993-1 for biocompatibility.
Predicate Device Performance: The modified device must demonstrate substantial equivalence to the predicate device, meaning its performance, safety, and effectiveness are comparable.
Validated Test Methods: The results are derived from validated test methods and protocols.

8. The Sample Size for the Training Set

Not applicable. This device does not have an "algorithm" in the sense of a machine learning model that requires a training set. The "training" here refers to the development and manufacturing processes which are subject to qualification (IQ/OQ/PQ) and ongoing quality control.

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

Not applicable for the reasons stated in point 8.

Summary

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510(k) SUMMARY K133593

Tandem Diabetes Care, Inc. t:slim™ Insulin Delivery System

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

Tandem Diabetes Care, Inc. 11045 Roselle Street, Suite 200 San Diego, CA 92121 Phone: 858-255-6331 Facsimile: 858-362-7070

Contact Person: John Sheridan, COO Contact Email: Jsheridan@tandemdiabetes.com

Date Prepared: November 22, 2013

Common or Usual Name

Insulin infusion pump

Classification Name

Infusion Pump per 21 CFR 880.5725

Predicate Devices

Tandem Diabetes Care, Inc. t:slim™ Insulin Delivery System (K111210)

Purpose of the Special 510(k) notice.

The purpose of this Special 510(k) is to provide an update on the changes made to the cartridge of the t.slim™ Insulin Delivery System. Specifically, the modifications include material/supplier changes to the insulin reservoir, luer, patient line tubing, UV adhesive and the outer pouch of the cartridge.

Intended Use

Device Description

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The t:slim System with the modified cartridge, 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 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 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 capacitive 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.

The t:slim cartridge is a single-use device, 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 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 with modified cartridge has the same technological characteristics as the predicate device. 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 including a sterile syringe and needle (for cartridge filling) and AC power supply with USB. The material changes were qualified per original device specifications and were shown to meet design requirements.

Performance Data

Verification and qualification testing was performed based on an evaluation of risks for the type of change involved. All the changes made to the cartridge were assessed to make sure all the risks were mitigated (e.g., the infusion flow accuracy, fill volume accuracy, leakage, bond strength and tubing integrity, shelf life, biocompatibility, insulin compatibility etc.,) and that no new risks were introduced as a result of these modifications. Material changes were supported by selection of medical grade materials, confirmation of biocompatibility testing per ISO 10993-1, repeated cytotoxicity testing, and leachables evaluation. Cartridge material changes were also evaluated by specific performance tests to confirm suitability of the material in the production

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process through various installation, operational and performance qualification tests (IQ/OQ/PQ), and product inspection and release testing. Completed testing to support substantial equivalence determination include:

Extractable and Leachables testing .
Chemical composition comparison (FTIR) .
Patient line bond strength testing .
Cartridge Pressure/leak testing �
Package seal integrity testing ◆
. Production IQ/OQ/PQ
Infusion flow accuracy .
Fill volume accuracy .
Biocompatibility tests .
Insulin Compatibility .

Substantial Equivalence

The t:slim System with modified cartridge has the same intended use and indications for use, the same principles of operation, and same technological characteristics as the previously cleared predicate t:slim System. The purpose of this Special 510(k) is to update the materials used in the construction of the disposable cartridge and storage pouch. The verification and process qualification testing confirms that these changes meet the original product specifications. Thus, the proposed t:slim System is substantially equivalent to its predicate.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

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

March 24, 2014

John Sheridan Chief Operating Officer Tandem Diabetes Care, Inc. 11045 Roselle Street, #200 San Diego, California 92121

Re: K133593

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: February 27, 2014 Received: February 28, 2014

Dear Mr. Sheridan:

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.

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

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Page 2 - Mr. Sheridan

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O.Ulmer -S

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

for

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K 133593

Device Name

t:slim™ Insulin Delivery System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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).