t:slim X2 Insulin Pump with Interoperable Technology

K232380 · Tandem Diabetes Care, Inc. · QFG · Nov 3, 2023 · Clinical Chemistry

Device Facts

• Record ID: K232380
• Device Name: t:slim X2 Insulin Pump with Interoperable Technology
• Applicant: Tandem Diabetes Care, Inc.
• Product Code: QFG · Clinical Chemistry
• Decision Date: Nov 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5730
• Device Class: Class 2
• Attributes: 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 in individuals 2 years of age and greater.

Device Story

Ambulatory, battery-operated, rate-programmable infusion pump; delivers insulin subcutaneously via infusion set. User fills disposable 300-unit cartridge using syringe/needle; cartridge replaced every 48-72 hours. Patient programs basal rates and boluses based on provider recommendations. Device communicates via Bluetooth with smartphones (t:connect app) and interoperable automated glycemic controllers (e.g., Basal-IQ, Control-IQ) and iCGM systems; receives/executes commands from connected devices; displays alerts/alarms. Used in home setting by patients. Benefits include automated insulin delivery management and remote data transmission to cloud via smartphone.

Clinical Evidence

No new clinical trials were conducted. Substantial equivalence for the expanded age indication (2+ years) was supported by leveraging human factors studies previously performed under K203234, with additional justification provided by the sponsor.

Technological Characteristics

Ambulatory, battery-operated, rate-programmable infusion pump. Includes disposable insulin cartridge, motor-driven delivery mechanism, and infusion set. Connectivity via Bluetooth for interoperability with automated insulin dosing software and iCGM systems. Software-controlled for basal/bolus delivery. Class II device, product code QFG.

Indications for Use

Indicated for individuals 2 years of age and older with diabetes mellitus requiring insulin for subcutaneous delivery at set and variable rates.

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 (with t:connect mobile app (K203234))

Submission Summary (Full Text)

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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K232380

B Applicant

Tandem Diabetes Care, Inc.

C Proprietary and Established Names

t:slim X2 Insulin Pump with Interoperable Technology

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 |

E Purpose for Submission:

Modification to a cleared device to expand the age indication (from ≥ 6 years old to ≥ 2 years old).

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

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 in individuals 2 years of age and greater.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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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.

III Device Description

The t:slim X2 Insulin Pump with Interoperable Technology is an ambulatory, battery operated, rate programmable infusion pump designed for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump consists of an user-operated interface display, an electronic microprocessor software control system including Bluetooth radio and signal processing algorithms that allows the pump to receive continuous glucose monitoring data from an integrated continuous glucose monitoring system. Based on this data, and the thresholds set by users in consultation with healthcare providers, the pump can identify high or low glucose levels, as well as rapidly rising or falling glucose conditions.

The pump also houses an audible speaker and vibrator to provide alarms, alerts and reminders to the user. The insulin cartridge is designed to hold up to 3 mL, or 300 Unites of U-100 insulin. The insulin cartridge is intended to be replaced at least once every three days.

The t:slim X2 system is compatible with interoperable Automated glycemic controllers, such as the Basal-IQ Technology and the Control IQ Technology to aid in diabetes management.

IV Substantial Equivalence Information:

A Predicate Device Name(s):

t:slim X2 Insulin Pump with Interoperable Technology

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B Predicate 510(k) Number(s):

K203234

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K232380 | K203234 |
| --- | --- | --- |
| Device Trade Name | t:slim X2 Insulin Pump with Interoperable Technology | Same |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. Intended 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. | Same |
| General Device Characteristic Differences | | |
| Intended User Population | 2 years and older with Type 1 diabetes mellitus. | 6 years and older with Type 1 diabetes mellitus. |

V Standards/Guidance Documents Referenced:

Not applicable.

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VI Performance Characteristics:

A. Analytical Performance

The accuracy in basal delivery, bolus delivery and occlusion detection remain unchanged from the predicate.

B. Other Supportive Instrument Performance Characteristics Data

a) Software: Sponsor made minor changes to the software including modifications to the user interface. Software documentation was reviewed and found to be adequate.

b) Human Factors: Sponsor leveraged human factors studies previously performed under K203234 for the six years and older age group for their current submission with adequate justification.

VII Proposed Labeling:

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

VIII Conclusion:

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

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