t:flex Insulin Delivery System

K143189 · Tandem Diabetes Care, Inc. · LZG · Jan 9, 2015 · General Hospital

Device Facts

• Record ID: K143189
• Device Name: t:flex Insulin Delivery System
• Applicant: Tandem Diabetes Care, Inc.
• Product Code: LZG · General Hospital
• Decision Date: Jan 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The t:flex™ 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

t:flex Insulin Delivery System is a software-controlled, programmable, battery-operated infusion pump for subcutaneous insulin delivery. Device consists of pump, 4.8 mL disposable cartridge, infusion set, and accessories. User programs basal and bolus delivery via capacitive touch screen GUI. Motor-driven micro-syringe mechanism delivers insulin from cartridge through infusion set into subcutaneous tissue. Pump includes pressure sensor to estimate reservoir volume, detect occlusions, and monitor cartridge status. Used by patients for diabetes management; provides continuous insulin therapy. Benefits include larger cartridge capacity (4.8 mL vs 3.0 mL) for patients requiring higher daily insulin doses.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software verification and validation, aged mechanical verification, water ingress testing, battery runtime, EMC, electrical safety, and cartridge mechanical/package testing. Human factors formative and summative studies were conducted to verify the user interface.

Technological Characteristics

Software-controlled, programmable infusion pump; 4.8 mL disposable cartridge; motor-driven micro-syringe mechanism; capacitive touch screen GUI; internal battery with USB charging; pressure sensor for volume estimation and occlusion detection. Connectivity via USB for power. Sterilization provided for single-use cartridges.

Indications for Use

Indicated for subcutaneous insulin delivery at set/variable rates for diabetes mellitus management in individuals 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 (K141758)

Reference Devices

• UnoMedical Comfort™ Infusion Set (K051264)

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

January 9,2015

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

Re: K143189

Trade/Device Name: t:flex Insulin Delivery System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG Dated: November 5, 2014 Received: November 5, 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 Runno 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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510(k) Number (if known)

Device Name

t:flex™ Insulin Delivery System

Indications for Use (Describe)

The t:flex™ 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)

区 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:flex™ Insulin Delivery System

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

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

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

Date Prepared: November 5, 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 (K141758)

### Purpose of the 510(k) notification

The t:flex™ Insulin Delivery System is a modification to the previously cleared t:slim® Insulin Delivery System. Specifically, t:flex™ System includes a larger cartridge (4.8 mL vs 3.0 mL) to accommodate patients with higher needs of daily insulin intake.

#### Intended Use

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

- 1. a software-controlled, programmable insulin infusion pump ("t:flex Pump" or "Pump");
- 2. a dedicated, disposable 4.8 mL (480 unit) insulin cartridge ("cartridge");

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- 3. an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
- 4. accessories, including a 5 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:flex 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:flex Pump is a capacitive touch screen that displays information used to control the t:flex System. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge.

The t:flex cartridge is a single-use device, individually packaged and sealed, and is provided sterile. The cartridge attaches to the t:flex Pump and is designed to hold up to 4.8 mL, or 480 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:flex Insulin Delivery System has the same technological characteristics as the predicate device. The t:flex System consists of: (1) a software-controlled, programmable insulin infusion pump capable of both basal and bolus delivery of insulin ("t:flex Pump"); (2) a dedicated disposable 4.8 mL (480 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) an AC power supply and DC car adapter power supply with USB.

# Performance Data

Software verification and validation testing was performed per FDA's guidance 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 pump software, aged mechanical verification, pump aged water ingress, average current consumption testing, battery runtime verification, EMC testing and electrical safety testing. Cartridge testing includes cartridge verification testing, mechanical testing and package and distribution testing. Tandem completed verification of the t:flex System's user interface through human factor formative and summative studies.

## Substantial Equivalence

The t:flex System has the same intended use and indications for use, the same principles of operation, and same technological characteristics as the previously cleared predicate device. The purpose of this 510(k) is to introduce a pump with a larger insulin cartridge, minor software and hardware changes. The changes made to the device are those necessary to accommodate the

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larger insulin cartridge. The verification and validation testing, including human factors testing, confirms that the t:flex System is substantially equivalent to its predicate.