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

Intended 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

November 3, 2023

Tandem Diabetes Care, Inc. Christin Dunn Senior Regulatory Affairs Specialist 12400 High Bluff Drive San Diego, California 92130

#### Re: K232380

Trade/Device Name: t:slim X2 Insulin Pump with Interoperable Technology Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate Controller Enabled Infusion Pump Regulatory Class: Class II Product Code: QFG Dated: August 4, 2023 Received: August 8, 2023

Dear Christin Dunn:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Joshua Balsam -S

Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) k232380

Device Name

t:slim X2 Insulin Pump with Interoperable Technology

#### Indications for Use (Describe)

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 melliting 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.

| 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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Image /page/3/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left is a blue square with rounded corners, and a white "T" inside. To the right of the square is the text "TANDEM" in a dark blue, with "Diabetes Care" underneath in a lighter blue.

# 510(K) SUMMARY FOR K232380

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for the t:slim X2 Insulin Pump with Interoperable Technology is provided below:

# Submitter Information

| Name | Tandem Diabetes Care, Inc. |
|-------------------|--------------------------------------|
| | 12400 High Bluff Drive |
| | San Diego, CA 92130 |
| | Phone: [phone] |
| Applicant Contact | Christin Dunn |
| | Senior Regulatory Affairs Specialist |
| | Phone: [phone] |
| | [e-mail] |
| | Tandem Diabetes Care, Inc. |
| | 12400 High Bluff Drive |
| | San Diego, CA 92130 |
| Secondary Contact | Lan Herrington |
| | Director, Regulatory Affairs |
| | [phone] |
| | [e-mail] |
| | Tandem Diabetes Care, Inc. |
| | 12400 High Bluff Drive |
| | San Diego, CA 92130 |
| Date Prepared: | October 26, 2023 |

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Image /page/4/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left is a blue square with rounded corners, and a white "T" inside. To the right of the square is the text "TANDEM" in a dark blue, and below that is "Diabetes Care" in a lighter blue.

| Trade name | t:slim X2 Insulin Pump with Interoperable Technology |
|-----------------------|--------------------------------------------------------------------------------------------|
| Common name | alternate controller enabled insulin infusion pump |
| Regulation Name | alternate controller enabled insulin infusion pump |
| Classification number | 21 CFR 880.5730 |
| Product code | QFG |
| Regulatory class | II |
| Predicate devices | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app (K203234)) |

## Intended 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.

#### 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 t:slim X2 insulin pump includes a disposable cartridge with a 300 unit reservoir which is filled with insulin by the user with the use of the syringe and needle. The cartridge needs to be changed every 48-72 hours depending on the type of insulin used.

The pump is motor driven to deliver patient programmed basal rates and boluses through an

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Image /page/5/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left side of the image is a blue square with rounded corners. Inside the square is a white "T". To the right of the square is the text "TANDEM" in dark blue, with the text "Diabetes Care" in a lighter blue below it.

infusion set into subcutaneous tissue. The desired timing and quantity of insulin delivery (bolus or basal) is programmed by the patient based on their healthcare provider's recommendations.

The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, execute, and confirm commands from these devices.

The t:connect mobile app enables a user to connect a smartphone to the pump using Bluetooth® wireless technology to display pump information and perform some pump functions on the smartphone as well as display pump notifications. The t:connect mobile app can transmit pump and therapy data from the pump to the cloud as long as the user's smartphone is connected to the internet.

The pump is designed to be able to receive and display alerts and alarms to users based on information received from other interoperable devices.

The pump is compatible with Interoperable Automated Glycemic Controllers, such as Basal-IQ Technology (K193483) and Control IQ Technology (K200467) to aid in diabetes management. The latter is being submitted concurrently.

In addition, the Subject Device is compatible with iCGM systems cleared under K223931 21 CFR 862.1355.

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Image /page/6/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left side of the image is a blue square with rounded corners. Inside the square is a white letter T. To the right of the square is the text "TANDEM" in a dark blue font, with the text "Diabetes Care" underneath in a lighter blue font.

# Technological Characteristics Compared to Predicate Device

| | Predicate Device<br>T:Slim X2 Insulin Pump with Interoperable<br>Technology (K203234) | Subject Device<br>(K232380) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indication<br>for Use | The t:slim X2 insulin pump with interoperable<br>technology (the Pump) is intended for the<br>subcutaneous delivery of insulin, at set and<br>variable rates, for the management of<br>diabetes mellitus in persons requiring insulin.<br>The Pump is able to reliably and securely<br>communicate with compatible, digitally<br>connected devices, including automated<br>insulin dosing software, to receive, execute,<br>and confirm commands from these devices.<br>The Pump is intended for single patient,<br>home use and requires a prescription. The<br>Pump is indicated for use with NovoLog or<br>Humalog U-100 insulin. The Pump is<br>indicated for use in individuals 6 years of age<br>and greater. | Different:<br>Removal of the<br>compatible insulins<br>NovoLog and Humalog<br>from indications.<br>Moved to compatible<br>insulins section of the<br>user guide.<br>The Pump is indicated<br>for use in individuals 2<br>years of age and<br>greater. |
| | Predicate Device<br>T:Slim X2 Insulin Pump with Interoperable<br>Technology (K203234) | Subject Device<br>(K232380) |
| Technological<br>Characteristics | The t:slim X2 insulin pump with interoperable<br>technology is an ambulatory, battery<br>operated, rate-programmable infusion pump<br>designed for the subcutaneous delivery of<br>insulin, at set and variable rates, for the<br>management of diabetes mellitus in persons<br>requiring insulin. The device includes a<br>disposable cartridge which is motor driven to<br>deliver patient programmed basal rates and<br>boluses through an infusion set into<br>subcutaneous tissue. | Same |
| Classification | II | Same |
| Product Code | QFG | Same |
| Specific<br>Drug/Biological<br>Use | U-100 Insulin | Same |
| Pump Type | ACE pump, t:slim X2 system | Same |
| Components | Infusion Pump,<br>Sterile disposable insulin cartridge | Same |
| | Predicate Device<br>T:Slim X2 Insulin Pump with Interoperable<br>Technology (K203234) | Subject Device<br>(K232380) |
| Accessories | Compatible FDA cleared infusion sets 3 mL<br>sterile syringe and 26 gauge needle (for filling<br>cartridge).<br>AC power supply and DC car adaptor power<br>supply with USB.<br>Tandem Device Updater.<br>Alternate USB Cable. | Similar<br>DC car adaptor power<br>supply is not provided<br>with the subject<br>device. |

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Image /page/7/Picture/0 description: The image contains the logo for Tandem Diabetes Care. The logo consists of a blue square with a white "T" inside, followed by the word "TANDEM" in dark blue. Below "TANDEM" is the phrase "Diabetes Care" in a lighter shade of blue.

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Image /page/8/Picture/0 description: The image contains the logo for Tandem Diabetes Care. The logo consists of a blue square with a white "T" inside on the left. To the right of the square is the text "TANDEM" in a dark blue font, with the words "Diabetes Care" underneath in a lighter blue font.

The t:slim X2 insulin pump with interoperable technology is an ambulatory, battery operated, rateprogrammable 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 subject device is the same as the predicate device with the following changes:

- . Lowered the age indication to individuals of 2 years of age and greater.
## Performance Data

Clinical testing was performed to support the expanded age indication. The clinical data demonstrates that the device shows continued assurance of safety and effectiveness.

Evaluation and adherence of the Special Controls listed in 21 CFR 880.5730 demonstrate the continued assurance of the safety and effectiveness of the device.

## Substantial Equivalence

The subject device serves the same function as the predicate device with the addition of the 2–5 year-old population. The clinical testing provided in this 510(k) demonstrate that the t:slim X2 Insulin Pump with Interoperable Technology is the same as the predicate device in safety and effectiveness. Therefore, the subject device has been evaluated to be substantially equivalent to the predicate device and does not raise new or different questions of safety or effectiveness.