t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater

K162080 · Tandem Diabetes Care, Inc. · LZG · Oct 25, 2016 · General Hospital

Device Facts

• Record ID: K162080
• Device Name: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
• Applicant: Tandem Diabetes Care, Inc.
• Product Code: LZG · General Hospital
• Decision Date: Oct 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 6 years of age and greater. The device is indicated for use with NovoLog® or Humalog® U-100 insulin. 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. The device is indicated for use with NovoLog® or Humalog® U-100 insulin. The Tandem® Device Updater™ System consists of software which allows for communication between a computer and a t:slim® or t:flex™ Insulin Delivery System. It allows for remote software installation and update of a Tandem Insulin Delivery System.

Device Story

t:slim and t:flex are software-controlled, programmable insulin infusion pumps for subcutaneous delivery. Systems use dedicated disposable cartridges (3.0 mL for t:slim; 4.8 mL for t:flex) and infusion sets. Tandem Device Updater System enables remote software installation/updates via PC-to-pump communication. Devices manage diabetes by delivering basal and bolus insulin. Users/caregivers operate pumps to manage insulin dosing; healthcare providers use output to adjust therapy. Hardware modifications include updated wake button and fuel gauge registers. Safety assurance case covers operational, environmental, electrical, hardware, software, mechanical, and biological hazards. Benefits include precise insulin delivery and remote update capability.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing, software verification/validation, and human factors studies. Pediatric human factors testing (ages 6-12) validated the ability of the intended user population to identify, interpret, and understand device alarms. Safety assurance case provided for hardware/software modifications.

Technological Characteristics

Software-controlled programmable infusion pump; basal/bolus delivery. Components: disposable 3.0 mL/4.8 mL cartridges, infusion sets, AC/DC power adapters. Connectivity: USB for PC communication/updates. Hardware updates: wake button, fuel gauge registers. Software: firmware-based pump control and PC-based updater application.

Indications for Use

Indicated for subcutaneous insulin delivery at set/variable rates for diabetes mellitus management. t:slim: individuals 6+ years. t:flex: individuals 12+ years. Use with NovoLog or Humalog U-100 insulin.

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 Delivery System, t:flex® Insulin Delivery System, Tandem Device Updater (K160428)
• t:slim® Insulin Delivery System (K160056)

Reference Devices

• UnoMedical's 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

October 25, 2016

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

Re: K162080

Trade/Device Name: t:slim® Insulin Delivery System, t:flex™ Insulin Delivery System, Tandem® Device Updater™ System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG, MRZ Dated: September 27, 2016 Received: September 28, 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 (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 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/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 [phone] or [phone] or at its Internet address

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

Sincerely,

Tina
Kiang-S

Tina Kiang, Ph.D. Acting 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) K162080 Device Name

t:slim® Insulin Delivery System, t:flex™ Insulin Delivery System, The Tandem® Device Updater™ 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 melliting insulin, for individuals 6 vears of age and greater. The device is indicated for use with NovoLog® or Humalog® U-100 insulin.

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. The device is indicated for use with NovoLog® or Humalog® U-100 insulin.

The Tandem® Device Updater™ System consists of software which allows for communication between a computer and a t:slim® or t:flex™ Insulin Delivery System. It allows for remote software installation and update of a Tandem Insulin Delivery System.

| Type of Use (Select <i>one</i> or <i>both</i> , as applicable) |
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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

# 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: Michael Sarrasin Contact Email: [e-mail]

Date Prepared: October 25, 2016

### Name of Device

t:slim® Insulin Delivery System t:flex™ Insulin Delivery System The Tandem® Device Updater™ System

#### Common or Usual Name

Insulin infusion pump

### Classification Name

Infusion Pump per 21 CFR 880.5725

#### Product Codes

LZG. Insulin Infusion Pump MRZ, Infusion Pump Accessories

#### Predicate Devices

Primary Predicate Device: Tandem Diabetes Care, Inc. t:slim Delivery System, t:flex® Insulin Delivery System, Tandem Device Updater (K160428)

Reference Predicate Device: Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System (K160056)

#### Purpose of the 510(k) notification

The purpose of this 510(k) is to describe modified indications for use of the t:slim® Insulin Delivery System. The indications for use of the t:slim Insulin Delivery System under this 510(k) combines the indications for use of the t:slim Insulin Delivery System cleared under K160056 with the updated software and accessories cleared for the t:slim Insulin Delivery System cleared under K160482. The t:slim Insulin Delivery System was cleared under K160482 with updated software and with the Tandem Device Updater System accessory for ages 12 years and older. The t:slim Insulin Delivery System was cleared under K160056 for ages 6 years and older without the software update or Tandem Device Updater System accessory of K160482. This 510(k) combines the updated

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software, Tandem Device Updater System accessory, and indication for 6 years and older for the t:slim Insulin Delivery System

Minor device hardware modifications were also included for the t:slim Insulin Delivery System and t:flex Insulin Delivery System in this 510(k).

# Device Description

The t:slim® and t:flex™ Insulin Delivery Systems facilitate the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The accessory Tandem Device Updater™ System is comprised of a personal computer application. a web server, an embedded firmware application, and a Tandem pump (t:slim or t:flex). The goal of the Tandem Device Updater System is to provide a secure process for software installation and update.

### 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 6 years of age and greater. The device is indicated for use with NovoLog® or Humalog® U-100 insulin.

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. The device is indicated for use with NovoLog® or Humalog® U-100 insulin.

The Tandem® Device Updater™ System consists of software which allows for communication between a computer and a t:slim or t:flex™ Insulin Delivery System. It allows for remote software installation and update of a Tandem Insulin Delivery System.

# Technological Characteristics

The t:slim and t:flex Insulin Delivery Systems have the same technological characteristics as the respective predicate devices. Both Systems, like the predicates, consist of: (1) a software-controlled, programmable insulin infusion pump capable of both basal and bolus delivery of insulin ("t:slim and t:flex Pump"); (2) a dedicated disposable 3.0 mL (300 units) and 4.8 mL (480 units) insulin cartridge, respectively: (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.

Minor technological differences when compared to the primary predicate device include minor modifications to the wake button and updates to the fuel gauge registers. There are no software changes when compared to the primary predicate device.

The Tandem Device Updater ™ System is identical to the previously cleared Tandem Device Updater System. The products both allow for communications between a computer and an infusion pump. The software programs provide software installation and updates.

#### Performance Data

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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 Guidance, issued on December 2, 2014.

Hardware changes were supported by verification testing per previously established acceptance criteria. Testing includes tactile feedback, fluid ingress, performance testing, and simulated use.

Previously completed testing to support substantial equivalence determination included pump software, hardware, EMC testing and electrical safety testing. Software testing was previously performed on the version of software which is the subject of this 510(k). Tandem previously completed validation of the Tandem Device Updater System's user interface through human factor formative and summative studies. Pediatric Human Factors testing was completed for the t:slim Insulin Delivery System to support the use of the device in individuals 6 years of age and greater. Human Factors testing included a validation study for children between ages 6-12 in order to assess the intended user population's ability to identify, interpret, and understand the t:slim Insulin Delivery System's alarms. Labeling, warnings and precautions provide further information regarding the risks of the device for pediatric users.

An updated safety assurance case was provided for the t:slim and t:flex Insulin Delivery System 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 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 arquments 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 ●

Additions to the safety assurance case from the predicate devices' cases included the LCD screen reports, Tandem Device Updater for use with the t:slim pump, updated wake button, updated fuel qauge register, and the updated t:slim indications for use.

#### Substantial Equivalence

Tandem t:slim and t:flex™ Insulin Delivery Systems have the same intended use, the same principles of operation, and the same technological characteristics as the previously cleared predicate devices. The purpose of this 510(k) is to introduce minor hardware changes to t:slim and t:flex Systems and to include individuals 6 vears of age and greater in the indications for use for the t:slim Insulin Delivery System. The t:slim Insulin Delivery System was cleared under K160056 with indications for 6 years and greater, but was cleared separately under K150482 with an updated

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version of software and the Tandem Device Updater System accessory. This 510(k) merges the indications for use of 6 years and greater with the updated software and Tandem Device Updater accessory for the t:slim Insulin Delivery System. The verification and validation testing, including human factors testing, confirms that the t:slim® and t:flex™ Insulin Delivery Systems and Accessories are substantially equivalent to the predicates.