t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

K203234 · Tandem Diabetes Care, Inc. · QFG · Feb 15, 2022 · Clinical Chemistry

Device Facts

• Record ID: K203234
• Device Name: t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
• Applicant: Tandem Diabetes Care, Inc.
• Product Code: QFG · Clinical Chemistry
• Decision Date: Feb 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5730
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

Indications for Use

The t:slim X2 insulin pump with interoperable technology (the Pump) is intended for the subcutaneous delivery of insulin. at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.

Device Story

t:slim X2 insulin pump modification adds t:connect mobile app for remote pump interaction. App pairs with pump via Bluetooth using unique pairing codes. Users view therapy data, real-time glucose values (from Dexcom G6), and trends on smartphone GUI. App allows remote bolus requests, bolus cancellation, and receipt of pump alerts/alarms via push notifications. Device intended for home use by patients or caregivers. Output informs patient insulin dosing decisions; app does not replace pump display. Benefits include improved convenience for therapy management and data visualization. Security PIN and Quick Bolus disablement features provided for safety in caregiver-managed scenarios.

Clinical Evidence

No clinical trials performed. Evidence consists of human factors validation study with 70 participants across four age-based user groups (ages 6-19+). Study evaluated usability and safety of critical tasks in simulated use environment. Results demonstrated safe use by intended populations. Bench testing included software verification, interoperability validation (RF range, battery life), and cybersecurity penetration testing.

Technological Characteristics

Subcutaneous insulin infusion pump; Bluetooth wireless connectivity; smartphone-based GUI (Android/iOS). Materials and core pump mechanics unchanged from predicate. Software-based interoperability with mobile app; utilizes encrypted communication. Complies with ISO 14971, IEC 62304, HE 75, and IEC 62366-1 standards.

Indications for Use

Indicated for management of diabetes mellitus in individuals 6 years of age and older requiring subcutaneous insulin delivery. Contraindicated for use during MRI, CT scans, or high-frequency electrical heat (diathermy) treatment.

Regulatory Classification

Identification

An alternate controller enabled infusion pump (ACE pump) is a device intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.

Special Controls

Alternate controller enabled infusion pumps must comply with the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following: (i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions. (A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes ( *e.g.,* head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.(B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices. (ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration ( *e.g.,* occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.(iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability ( *e.g.,* temperature, light exposure, or other factors as needed).(iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low. (v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance. (vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment. (vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated. (viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing. (2) Design verification and validation activities must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following: (i) Risk control measures shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented. (ii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design. (3) The device shall include validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following: (i) Secure authentication (pairing) to external devices. (ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices. (iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers ( *e.g.,* battery level, reservoir level, pump status, error conditions).(iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified. (v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol. (4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption ( *e.g.,* reverting to a pre-programmed, safe drug delivery rate). Validation testing results must demonstrate that critical events that occur during a loss of communications (*e.g.,* commands, device malfunctions, occlusions, etc.) are handled appropriately during and after the interruption.(5) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the system must, at a minimum, include: (i) A record of all drug delivery (ii) Commands issued to the pump and pump confirmations (iii) Device malfunctions (iv) Alarms and alerts and associated acknowledgements (v) Connectivity events ( *e.g.,* establishment or loss of communications)(6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use. (7) Device labeling must include the following: (i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate. (ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters. (iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is <25 percent, 25 percent to <75 percent, 75 percent to <95 percent, 95 percent to <105 percent, 105 percent to <125 percent, 125 percent to <175 percent, 175 to 250 percent, and >250 percent of the commanded amount. (iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point. (v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps. (vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device. (vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses.

Predicate Devices

• t:slim X2 Insulin Pump with Interoperable Technology (K201214)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K203234

B Applicant

Tandem Diabetes Care, Inc.

C Proprietary and Established Names

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QFG | Class II | 21 CFR 880.5730 - Alternate Controller Enabled Infusion Pump | CH-Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

Modification of the cleared t:slim X2 Insulin Pump with interoperable technology to add the t:connect mobile app to request insulin boluses, receive alerts and alarms, and view pump data.

B Type of Test:

Not applicable.

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) for Use:

The t:slim X2 insulin pump with interoperable technology (the Pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

Remove the t:slim X2 insulin pump before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The magnetic fields and heat could damage the components of the t:slim X2 insulin pump with interoperable technology. Please review your smart phone manufacturer’s instructions before using the t:connect mobile app during any of the procedures listed.

Always ensure the pump has a healthy Bluetooth wireless technology connection with your t:connect mobile app before you use the t:connect mobile app to make treatment decisions. Confirm that the information displayed to you matches your signs and symptoms. If necessary, make sure that your pump and phone are connected and the information displayed matches when making treatment decisions.

For patients who do not self-manage their disease, the Security PIN function should ALWAYS be on when the pump is not being used by a caregiver.

For patients whose insulin administration is managed by a caregiver, ALWAYS turn off the Quick Bolus feature to avoid inadvertent bolus delivery. If the Security PIN is turned on, the Quick Bolus feature is automatically disabled.

IV Device/System Characteristics:

A Device Description:

The t:connect mobile app provides t:slim X2 insulin pump users an optional method of viewing therapy data and partially controlling aspects of their current insulin pump via Android or iOS smart devices. The app is compatible with the cleared t:slim X2 Insulin Pump with Interoperable Technology, which includes an integrated user interface providing functionality such as visualization of glucose values derived from a compatible iCGM (interoperable continuous glucose monitor) as well as the ability to partially control therapeutic delivery of insulin.

Once successfully downloaded, pairing of devices begins with a unique code generated and used by the user to ensure secure Bluetooth communications between the smartphone and the Pump. The t:connect mobile app will allow wireless communication between the user’s

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personal pump and personal Android or iOS device. The t:connect mobile app graphical user interface (GUI), while not identical, includes features of the Pump GUI in form and function.

This optional app-based controller can be utilized by the end user for the purposes of remotely:

- Viewing therapy data and trends displayed on the Pump user interface
- Viewing real-time glucose values and trends
- Programming insulin boluses using bolus calculator to remotely request a bolus delivery as well as cancelling or stopping a requested insulin bolus from being delivered (regardless of bolus request being made on the Pump or the app)
- Viewing alerts and alarms received from the Pump as Push notifications

The app displays glucose information derived from the Dexcom G6 System but does not permit a user to enable automated insulin delivery remotely or program and deliver extended boluses or basal insulin.

The t:connect mobile app is not a replacement for the information displayed on the Pump, therefore users can still view pump therapy data/trends, program requests, and cancel or stop boluses from their Pump without the t:connect mobile app.

## B Instrument Description Information:

1. Instrument Name:
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

2. Specimen Identification:
Not applicable.

3. Specimen Sampling and Handling:
Not applicable.

4. Calibration:
Not applicable.

5. Quality Control:
Not applicable.

## V Substantial Equivalence Information:

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A Predicate Device Name(s):
t:slim X2 Insulin Pump with Interoperable Technology

B Predicate 510(k) Number(s):
K201214

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K203234 | K201214 |
| --- | --- | --- |
| Device Trade Name | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | t:slim X2 Insulin Pump with Interoperable Technology |
| General Device Characteristic Similarities | | |
| Intended Use/Indications for Use | The t:slim X2 insulin pump with interoperable technology (the Pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater. | Same |

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| General Device Characteristic Differences | | |
| --- | --- | --- |
| User Interface (UI) | Touchscreen on the pump or a compatible smartphone running the t:connect mobile app. | Touchscreen on the Pump |

VI Standards/Guidance Documents Referenced:

- ANSI/AAMI/EN ISO 14971:2007(R)2010 Medical Devices - Application of Risk Management to Medical Devices (FDA Recognition Number 5-40)
- ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes [Including Amendment 1 (2016)] (FDA Recognition Number 13-79)
- ANSI AAMI HE 75:2009 Human Factors Engineering-Design of Medical Devices (FDA Recognition Number 5-57)
- ANSI/AAMI/IEC 62366-1:2015 Medical devices - Part 1: Application of Usability Engineering to Medical Devices (FDA Recognition Number 5-114)

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:
Not applicable.

2. Linearity:
Not applicable.

3. Analytical Specificity/Interference:
Not applicable.

4. Accuracy (Instrument):
Not applicable.

5. Carry-Over:
Not applicable.

B Other Supportive Instrument Performance Characteristics Data:

a. Human Factors: Human factors validation tests were conducted with the app installed on a compatible mobile device. The final device design was evaluated in the summative study performed with 70 representative participants from four distinct user groups interacting with the device in a simulated use environment. Those four user groups are:

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- The adult responsible for their own insulin therapy, ages over 19, with representative proportion of pump users and non-pump users with Android or iOS smartphones.
- The pediatric responsible for their own insulin therapy, ages 12-19, with representative proportion of pump users and non-pump users with Android or iOS smartphones.
- The pediatric who shares responsibility for their insulin therapy with a parent or caregiver, ages 8-15, with representative proportion of pump users and non-pump users with Android or iOS smartphones.
- The pediatric whose parent is responsible for their child’s insulin therapy, ages 6-11, with representative proportion of pump users and non-pump users with Android or iOS smartphones.

All study participants received training that was consistent with the training that patients would receive with the commercial product. Usability evaluations assessed comprehension and usability of the device for critical device tasks. Results of the study demonstrated that the device could be used safely by intended users in the intended use environment when used in combination with a digitally connected device.

b. **Data Logging**: Software verification testing has demonstrated the device records timestamped critical events, including information related to its state, user inputs, and device settings, as required by the special controls. The mobile application will retrieve history logs from the pump as necessary. The mobile application uploads history logs from the pump to the Connected Health Service. The mobile app operates similarly to the existing pump history log uploader; it uploads logs that the Connected Service does not have yet.

c. **Interoperability**: The Interoperable Device Verification and Validation activities were performed to ensure the t:slim X2 pump software was compatible with the t:connect mobile app and met the interoperable device special controls. These activities included: Battery Life Testing, RF communications Range Testing, and Penetration Testing.

d. **Cybersecurity**: Tandem provided a software bill of materials, which provided details on all software used in the device and the hardware platform that the device was installed on. This included all manufacturer-developed, commercially licensed, open source, and off-the-shelf software components (including firmware as relevant), along with an identification of the hardware runtime environment in which each resides, with relevant version and/or model information, as well as details on whether each component was actively supported by its manufacturer or legacy licensed. Tandem completed various verification various verification and validation activities including penetration testing.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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