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

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 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

February 15, 2022

Tandem Diabetes Care, Inc. Ashley Reynolds Regulatory Affairs Specialist II 11075 Roselle Street San Diego, CA 92121

Re: K203234

Trade/Device Name: t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate controller enabled infusion pump Regulatory Class: Class II Product Code: OFG Dated: August 27, 2021 Received: August 30, 2021

Dear Ashley Reynolds:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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,

Kellie B. Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K203234

### Device Name

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

### 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 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.

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|

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Type of Use (Select one or both, as applicable)

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Image /page/3/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left side of the logo 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 a dark blue, bold font. Below that is the text "Diabetes Care" in a lighter blue font.

## 510(k) Summary: K203234

| Company | Tandem Diabetes Care, Inc<br>11075 Roselle Street San Diego, CA 92121 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------|
| Prepared | 7 February 2022 |
| Contact | Ashley Reynolds<br>Sr. Regulatory Affairs Specialist I<br>[phone]<br>[e-mail] |
| Product Trade Name | t:slim X2 Insulin Pump with Interoperable Technology (with<br>t:connect mobile app) |
| Common Name | Ambulatory Insulin Pump |
| Classification Name | Alternate Controller Enabled Infusion Pump |
| Regulation Number | 21 CFR 880.5730 |
| Device Class | Class II |
| Classification Product Code | QFG |
| Predicate Device | K201214 t:slim X2 Insulin Pump with Interoperable<br>Technology |

#### I. Purpose of Traditional 510(k)

Request to add the t:connect mobile app that can be wirelessly paired to the t:slim X2 Insulin Pump with Interoperable Technology (Predicate "The Pump") for the purposes of allowing limited control of bolus insulin therapy.

#### II. Indications for Use/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 with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.

#### III. Subject Device Description and Technological Characteristics

The t:connect mobile app can be wirelessly paired to the t:slim X2 Insulin Pump with Interoperable Technology, for the purposes of allowing limited control of bolus insulin therapy. The t:connect mobile app is available on iOS and Android compatible smartphones via the Apple Store® and Google Play Store®. When successfully paired with The Pump, users have the ability to perform the following via the t:connect mobile app:

- View The Pump therapy data, trends, alerts, alarms, notifications, and reminders as a secondary display.
- Program Correction Boluses, Bolus Override, and Food (Standard) Boluses.

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Image /page/4/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left side of the logo 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, sans-serif font, with the words "Diabetes Care" underneath in a lighter blue.

- Terminate (Cancel or stop) all bolus types regardless of origin of bolus request ● being made on the t:slim X2 Insulin Pump or the t:connect mobile app.
Outside of programming and terminating boluses, the t:connect mobile app will have no other controlling action on The Pump.

Important: The Pump functions independently from the t:connect mobile app, therefore users can still view pump therapy data/trends, program requests, and cancel or stop boluses from their Pump. The t:connect mobile app does not control, or otherwise impact, any automated dosing algorithms of Interoperable Automated Glycemic Controllers such as Basal-IQ Technology (K193483) and Control-IQ Technology (K200467) to aid in diabetes management.

| | Predicate Device<br>K201214 | Subject Device<br>K203234 |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use/ IntendedUse | The t:slim X2 insulin pump with<br>interoperable technology (the Pump)<br>is intended for the subcutaneous<br>delivery of insulin, at set and<br>variable rates, for the management<br>of diabetes mellitus in persons<br>requiring insulin. The Pump is able<br>to reliably and securely<br>communicate with compatible,<br>digitally connected devices,<br>including automated insulin dosing<br>software, to receive, execute, and<br>confirm commands from these<br>devices. The Pump is intended for<br>single patient, home use and<br>requires a prescription. The Pump is<br>indicated for use with NovoLog or<br>Humalog U-100 insulin. The Pump<br>is indicated for use in individuals 6<br>years of age and greater. | Same |
| Intended Hardware,<br>Materials and<br>Accessories | An Alternate Controller Enabled<br>Infusion Pump (cleared under 21<br>CFR 880.5730) | Same |
| Principles of<br>Operation | Delivery of insulin (Bolus and Basal)<br>programmed by the patient based on<br>health care provider<br>recommendations. | Same |
| Prescription Use | Yes | Same |
| Compatible<br>Interoperable<br>Devices | The Pump is compatible with:<br>#DEN170088: Dexcom G6 Continuous Glucose<br>Monitoring System or other<br>compatible iCGM#K193483: Basal-IQ<br>Technology#K200467: Control IQ<br>Technology | Same |
| Includes Bolus<br>Calculator | Yes | Same<br>------<br>In addition, the t:connect mobile<br>app will also include a built-in<br>Bolus Calculator that has the same<br>purpose and same functionas The<br>Pump.<br><br>The Pump shall send the t:connect<br>mobile app information required to<br>calculate boluses via the Bolus<br>Calculator. |
| Pump Notifications,<br>Alerts, and Alarms<br>and Reminders<br>Visible to User | The following are visible on The<br>Pump:<br>RemindersAlertsAlarmsNotifications | Same<br>------<br>The t:connect mobileapp will<br>display The Pump Notifications,<br>Alerts, and Alarms and Reminders.<br>The t:connect mobile app cannot<br>clear or alter notifications, alerts,<br>alarms, and reminders. To clear or<br>alter |
| | | these, the user must go to The<br>Pump.<br>The t:connect mobile app will<br>display specific alerts below:<br>Pump Connection Lost Alert- t:connect Mobile App Incomplete Bolus Alert- t:connect Mobile App |
| | | The t:connect mobile app will<br>display the specific notification<br>below:<br>Bolus in Progress on Pump |
| Logging records of<br>critical events | Critical events logged by the system<br>include:<br>-A record of all drug delivery<br>-Commands issued to the pump and<br>pump confirmations<br>- Device malfunctions<br>-Alarms and alerts and associated<br>acknowledgements<br>-Connectivity events (e.g.,<br>establishment or loss of<br>communications) | Same<br>----<br>All critical events remain stored<br>by the system.<br>In addition, The Pump will also<br>log bolus requests and<br>terminations (cancelling and<br>stopping a bolus) from the<br>t:connect mobile app.<br>The t:connect mobile app will<br>also log actions of bolus |

#### Comparison with Predicate IV.

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Image /page/5/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, sans-serif font, with the words "Diabetes Care" underneath in a lighter blue color.

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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 logo 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, sans-serif font. Below the word "TANDEM" is the text "Diabetes Care" in a lighter blue, sans-serif font.

#### V. Discussion of the Non-Clinical Testing

Human factors and software verification and validation tests were conducted to confirm that the Subject Device when paired with the t:connect mobile app, met specified requirements, and performed as intended.

Human factors validation testing was conducted to demonstrate the intended users can effectively use the Subject Device for its intended purpose in expected use environments. Usability tasks were evaluated in accordance to ANSI AAMI HE 75:2009 Human Factors Engineering- Design of Medical Devices, ANSI/AAMI/IEC 62366-1:2015 Medical devices - Part 1: Application of Usability Engineering To Medical Devices and Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices - February 3, 2016. The results from the human factors study demonstrates users can safely and effectively use the feature of the Subject Device.

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Image /page/7/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left side of the logo is a blue square with a white "T" inside. 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.

Software development activities included establishing detailed software requirements, linking requirements with associated verification and validation activities, software code inspection, software code walkthrough, static code analysis, unit testing, and system level testing to ensure that the software conforms to patient needs and intended uses. Software verification and validation testing was carried out in accordance with ISO 14971:2019 Medical Devices -Application of Risk Management to Medical Devices, ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes, FDA guidance General Principles of Software Validation: Final Guidance for Industry and FDA Staff, Mobile Medical Applications -Guidance for Industry and Food and Drug Administration Staff, February 9, 2015, and FDA guidance Multiple Function Device Products: Policy and Considerations- Guidance for Industry and Food and Drug Administration Staff, July 29, 2020.

In addition, Cybersecurity evaluations were carried out in accordance to Content of Premarket Submissions for Management of Cybersecurity in Medical Devices- Guidance for Industry and Food and Drug Administration Staff, both Final and Draft versions issued October 2, 2014 and October 18, 2018 respectively.

Evaluation and adherence of the Special Controls listed in the Predicate Device (K201214), demonstrate continued assurance of the safety and effectiveness of the addition of the t:connect mobile app as a compatible interoperable device.

#### VI. Discussion of Clinical Testing

No new clinical testing was required for this Traditional 510(k) Notification.

#### VII. Conclusions

The t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) has been evaluated to be substantially equivalent to the Predicate and does not raise any new or different questions of safety or effectiveness.