T:SLIM INSULIN DELIVERY SYSTEM

K141758 · Tandem Diabetes Care, Inc. · LZG · Oct 31, 2014 · General Hospital

Device Facts

• Record ID: K141758
• Device Name: T:SLIM INSULIN DELIVERY SYSTEM
• Applicant: Tandem Diabetes Care, Inc.
• Product Code: LZG · General Hospital
• Decision Date: Oct 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Programmable insulin infusion pump; delivers basal/bolus insulin via motor-driven micro-syringe in disposable 3mL cartridge; infusion set delivers insulin to subcutaneous tissue. User-operated via capacitive touch screen GUI; programs timing/quantity of delivery. Includes pressure sensor for reservoir volume estimation, occlusion detection, and cartridge removal monitoring. Used by patients for diabetes management. Powered by internal battery; rechargeable via USB. System includes pump, cartridge, infusion set, and filling accessories. Output informs patient of insulin delivery status and system function; enables precise glycemic control.

Clinical Evidence

Bench testing only. Verification and validation performed per FDA Infusion Pump guidance. Testing included software, hardware, mechanical, environmental, water ingress, simulated aging, electrical safety, and electromagnetic compatibility. Human factors formative and summative studies conducted to validate user interface.

Technological Characteristics

Software-controlled programmable infusion pump; capacitive touch screen GUI; motor-driven micro-syringe mechanism; 3mL disposable cartridge; internal rechargeable battery. Connectivity via USB for charging. Pressure sensor for volume estimation and occlusion detection. Verified per design control processes.

Indications for Use

Indicated for subcutaneous insulin delivery at set/variable rates for diabetes mellitus management in patients 12 years of age and older.

Regulatory Classification

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.

Predicate Devices

• t:slim® Insulin Delivery System (K111210, K133593)

Reference Devices

• UnoMedical Comfort™ Infusion Set (K051264)
• Becton Dickenson 3mL sterile syringe (K941562)

Submission Summary (Full Text)

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

October 31, 2014

Tandem Diabetes Care, Incorporated c/o Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 1910

Re: K141758

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: October 1, 2014 Received: October 1, 2014

Dear Ms. Hogan:

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runner DDS, MA

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

Device Name

t:slim® Insulin Delivery System

Indications for Use (Describe)

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.

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

� Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY

# 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: [phone] Facsimile: 858-362-7070

Contact Person: John Sheridan Contact Email: [e-mail]

Date Prepared: June 30, 2014

## 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, K133593)

## Purpose of the 510(k) notification

The t:slim® Insulin Delivery System is a modification to the previously cleared t:slim® Insulin Delivery System.

### Intended Use

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 510(k) is limited to a new software version and minor changes to the pump component of the t:slim System.

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

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- 1. a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump");
- 2. a dedicated, disposable 3mL (300 unit) insulin cartridge ("cartridge");
- 3. an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
- 4. accessories, including a Becton Dickenson 3mL sterile syringe (K941562) and 26 gauge sterile needle, or equivalently cleared syringe and 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. It utilizes a motor-driver 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 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 modified t:slim Insulin Delivery System 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 and DC car adapter power supply with USB. The new software version and minor changes to the pump component of the t:slim System were verified and/or validated per Tandem's design control process and shown to meet design requirements.

# Performance Data

Software verification and validation testing was performed per FDA's quidance document. 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"). Hardware changes were supported by verification testing per previously established acceptance criteria. Completed testing to support substantial equivalence determination included software, hardware, mechanical, environmental conditioning, water ingress, simulated aging testing, electrical safety and electromagnetic compatibility testing. Tandem completed verification of the t:slim System's user interface through a series of human factor formative and summative studies.

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## Substantial Equivalence

The modified t:slim System 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 510(k) is to introduce a new software version and minor hardware changes to the pump component of the System. The verification and validation testing, including human factors testing, confirms that the modified t:slim System is substantially equivalent to its predicate.