← Product Code [QFG](/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG) · K241078

# Tandem Mobi Insulin Pump with interoperable technology (K241078)

_Tandem Diabetes Care, Inc. · QFG · Jul 26, 2024 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K241078

## Device Facts

- **Applicant:** Tandem Diabetes Care, Inc.
- **Product Code:** [QFG](/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG.md)
- **Decision Date:** Jul 26, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5730
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Therapeutic, Pediatric

## Indications for Use

The Tandem Mobi 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

Screenless, ambulatory, battery-operated, rate-programmable infusion pump; delivers insulin subcutaneously via motor-driven disposable cartridge and infusion set. Operated via Tandem Mobi Mobile App on iOS smartphone; app serves as primary controller for basal/bolus programming, data viewing, and alert management. Pump communicates via Bluetooth Low Energy (BLE) with compatible interoperable devices (e.g., iCGM, automated insulin dosing software). Provides visual, audible, and vibratory alerts. Used in home setting by patient; requires prescription. Supports management of diabetes by enabling precise insulin delivery based on patient/provider settings; integrates with CGM data for therapy adjustments.

## Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance testing, including insulin compatibility, biocompatibility, and sterilization validation.

## Technological Characteristics

Ambulatory, battery-operated, rate-programmable infusion pump. Uses motor-driven disposable cartridge (2mL/200 units). Connectivity via Bluetooth Low Energy (BLE). Sterilization: Pump non-sterile; cartridge sterilized via Irradiation to SAL 10^-6. Compatible with U-100 insulin (NovoLog or Humalog) and FDA-cleared infusion sets with t:lock connectors.

## Regulatory 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

- Tandem Mobi insulin pump with interoperable technology ([K240309](/device/K240309.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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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

K241078

B Applicant

Tandem Diabetes Care, Inc

C Proprietary and Established Names

Tandem Mobi 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 change the sterilization method from ethylene oxide sterilization to electron beam sterilization.

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

The Tandem Mobi 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

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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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 two years of age and greater.

## C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

The Tandem Mobi insulin pump is not intended for anyone unable or unwilling to:

- Use the pump, CGM, and all other system components in accordance with their respective instructions for use.
- Test blood glucose (BG) levels as recommended by their healthcare provider.
- Maintain sufficient diabetes self-care skills.
- See their healthcare team regularly.
- Demonstrate adequate carbohydrate-counting skills.

The user must also have adequate vision and/or hearing in order to recognize all functions of the pump, including alerts, alarms, and reminders.

The pump is magnetic resonance (MR) unsafe. You must take off your pump, transmitter, and sensor and leave them outside the procedure room.

Do not expose your pump, transmitter, or sensor to X-ray, CT, MRI, PET, or other exposure to radiation.

Some skin care products such as lotions, sunscreens, and insect repellents can cause cracks in the plastic used to manufacture the pump and cartridge. DO NOT allow these products to come in contact with the pump or cartridge. ALWAYS remove your pump before applying these products and ALWAYS wash your hands before handling your pump or cartridge after using such products. ALWAYS change your cartridge if it becomes exposed to such products and immediately clean your pump. Failure to do so may result in damage to the pump and cartridge and in some cases over or under delivery of insulin.

The Tandem Mobi insulin pump with interoperable technology and the Tandem Mobi Cartridge are compatible with the following U-100 insulins: Humalog and Novolog.

## III Device Description:

The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the Tandem Mobi Mobile Application and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set.

K241078 - Page 2 of 6

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The Tandem Mobi Mobile Application (“Mobile app”) displays all information from, and is the primary controller of, the pump. Through the Mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications, and messages. The Tandem Mobi Mobile Application will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The Tandem Mobi Mobile Application will be made available via the Apple® App Store for iOS compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump.

The pump may be used in combination with a compatible integrated continuous glucose monitor (iCGM) system or with compatible interoperable automated glycemic controllers (iAGC). Use of iCGM and iAGC is optional.

## IV Substantial Equivalence Information:

### A Predicate Device Name(s):

Tandem Mobi insulin pump with interoperable technology

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

K240309

### C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K241078 | K240309 (predicate)  |
| --- | --- | --- |
|  Device Trade Name | Tandem Mobi Insulin Pump with interoperable technology | Tandem Mobi Insulin Pump with interoperable technology  |
|  General Device Characteristic Similarities |  |   |
|  Intended 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 be interoperable with connected devices including CGMs and automated insulin | Same  |

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|   | dosing algorithms. |   |
| --- | --- | --- |
|  Insulin Type | NovoLog or Humalog U-100 insulin | Same  |
|  Communication with Compatible Interoperable Devices | Bluetooth Low Energy (BLE) | Same  |
|  General Device Characteristic Differences |  |   |
|  Sterilization | The pump is provided non-sterile. | The pump is provided non-sterile.  |
|   |  The cartridge is provided sterile via Irradiation to a Sterility Assurance Level (SAL) 10-*. | The cartridge is provided sterile via Ethylene Oxide Gas to a Sterility Assurance Level (SAL) 10-*.  |

# V Standards/Guidance Documents Referenced:

ISO 14971 Third Edition 2019-12: Medical Devices – Application of Risk Management to Medical Devices. Complete FDA recognition 5-125.

ISO 10993-1 Fifth Edition 2018-08. Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process. Partial FDA recognition 2-258.

ISO 10993-3 Third Edition 2014-10-1: Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity. Partial FDA Recognition 2-228.

ISO 10993-5 Third Edition 2009-06-01: Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity. Complete FDA Recognition 2-245.

ISO 10993-10 Fourth edition 2021-11: Biological Evaluation of Medical Devices – Part 10: Tests for Skin Sensitization. Partial FDA Recognition 2-296.

ISO 10993-11 Third Edition 2017-09: Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity. Complete FDA Recognition 2-255].

ISO 10993-12 Fifth edition 2021-01: Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials. Complete FDA Recognition 2-289.

ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05 AMD1 2022-05: Biological Evaluation of Medical Devices – Part 18: Chemical Characterization of Medical Device Materials within a Risk Management Process. Partial FDA Recognition 2-298.

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ISO/TS 10993-19 Second edition: Biological Evaluation of Medical Devices – Part 19: Physicochemical, Morphological and Topographical Characterization of Materials. Complete FDA Recognition 2-281.

ISO 10993-23 First Edition 2021-01: Biological Evaluation of Medical Devices – Part 23: Tests for Irritation. Partial FDA Recognition 2-291.

ISO 11137-1: Third Edition 2006-04-15: “Sterilization of Health Care Products – Radiation – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices [Including Amendment 1 (2013) and Amendment 2 (2018)].” Complete FDA Recognition 14-528.

ISO 11137-2: Third Edition 2013-06 [Including AMD1:2022: “Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose [Including Amendment 1 (2022)].” Complete FDA Recognition 14-580.

## VI Performance Characteristics:

### A Analytical Performance:

Bench testing data is leveraged from K223213.

### B Other Supportive Instrument Performance Characteristics Data:

The following non-clinical tests related to the design changes of the Mobi cartridge were conducted: Drug Compatibility, Biocompatibility, Sterilization Validation, Package Testing, Pump infusion delivery hazard detection and accuracy, and Mobi cartridge mechanical design testing

#### Drug Compatibility

Drug compatibility testing for U-100 NovoLog and U-100 Humalog was performed for the updated Tandem Mobi cartridge with updated materials and sterilization changes. Study results included in this 510(k) submission were found to be acceptable.

#### Biocompatibility

Biocompatibility testing was performed per ISO 10993-1:2018, FDA Guidance Document: Use of International Standard ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” and FDA special controls for alternate controller enabled infusion pumps for the updated cartridge. All endpoints were tested adequately, and results were acceptable.

#### Sterilization Validation

The Tandem Mobi Cartridge and components used to fill the cartridge are provided sterile. The cartridge is terminally sterilized in its final package using Irradiation and the process has been validated to assure a Sterility Assurance Level (SAL) of 10⁻⁶ using the VDmax25 method in accordance with ISO 11137-2: Third Edition 2013-06 [Including AMD1:2022]: “Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose [Including Amendment 1 (2022)].” The test results were found to be acceptable.

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Package Testing

The Tandem Mobi cartridge 10 pack and 2 pack packaging and sterile barrier were tested and the results were found to be acceptable.

Pump Infusion Delivery Hazard Detection and Accuracy

Pump delivery hazard detection and accuracy requirements related to design changes included in this submission were tested and found to be acceptable.

Mobi Cartridge Mechanical Design Testing

Mobi cartridge mechanical design requirements related to design changes included in this submission were tested and found to be acceptable.

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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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K241078](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K241078)

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