Tandem Mobi Insulin Pump with Interoperable Technology

K223213 · Tandem Diabetes Care, Inc. · QFG · Jul 10, 2023 · Clinical Chemistry

Device Facts

• Record ID: K223213
• Device Name: Tandem Mobi Insulin Pump with Interoperable Technology
• Applicant: Tandem Diabetes Care, Inc.
• Product Code: QFG · Clinical Chemistry
• Decision Date: Jul 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5730
• Device Class: Class 2
• 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.

Device Story

Tandem Mobi is a screenless, wearable, Alternate Controller Enabled (ACE) insulin pump; delivers subcutaneous insulin via motor-driven disposable cartridge and infusion set. Controlled primarily via t:connect mobile app; provides visual, auditory, and vibratory status alerts. Designed for single-patient home use; communicates with compatible digitally connected devices (e.g., automated insulin dosing software) to receive/execute commands. Healthcare providers use pump data for therapy management; patients use app to program basal rates and boluses. Benefits include precise insulin delivery and integration with interoperable diabetes management systems.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including basal and bolus delivery accuracy (n=32 pumps, aged and unaged), occlusion detection performance, biocompatibility (ISO 10993), sterility (ISO 11135), electromagnetic compatibility (IEC 60601-1-2), and human factors validation. All testing met pre-defined acceptance criteria.

Technological Characteristics

Ambulatory, battery-operated, rate-programmable infusion pump. Screenless design with LED/sound/vibratory alerts. Connectivity: Bluetooth Low Energy (BLE). Sterilization: Ethylene Oxide (cartridge). Software: Mobile-app controlled (iOS). Complies with IEC 60601, ANSI/AAMI/IEC 62366-1, and ANSI AAMI IEC 62304.

Indications for Use

Indicated for individuals six years of age and greater requiring insulin therapy for diabetes mellitus management. Requires prescription. For single patient, home use.

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

K223213

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 Pump | CH - Clinical Chemistry |

E Purpose for Submission:

New device

## 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 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 six 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):

This device is for prescription use only.

The Tandem Mobi insulin pump is not intended for anyone unable or unwilling to:
- Use the pump, and other system components in accordance with their respective instructions for use.
- Test blood glucose (BG) levels as recommended by their healthcare team.
- Maintain sufficient diabetes self-care skills.
- See their healthcare team regularly.
- Demonstrate adequate carbohydrate-counting skills (preferred, not required).

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

The device must be removed before Magnetic Resonance Imaging (MRI).

Exposure of the pump to X-ray, Computed Tomography (CT) scan, MRI, Positron Emission Topography (PET) can damage the pump.

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 Tandem Mobi insulin pump with interoperable technology is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. It is screenless and includes visual LED, sound and vibratory indicators to alert the user of the Pump status. The pump also includes: the t:connect mobile app and a 2mL (200 insulin unit) Mobi™ Cartridge and a compatible FDA cleared infusion set. The t:connect mobile app displays all information from, and is the primary controller for the pump.

The pump includes a disposable cartridge which is a motor driven to deliver patient programmed basal rates and boluses through an infusion set into subcutaneous tissues.

The pump is designed to be used by a single person and has a useful life of 4 years. The disposable cartridge should be changed every 3 days.

IV Substantial Equivalence Information:

A Predicate Device Name(s):

t:slim X2 Insulin Pump with interoperable technology (with t:connect Mobile app)

B Predicate 510(k) Number(s):

K203234

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C Comparison with Predicate(s):

| Device & Predicate Device(s): | K223213 | K203234 |
| --- | --- | --- |
| Device Trade Name | Tandem Mobi insulin pump with interoperable technology | t:slim X2 insulin pump with interoperable technology (with t:connect Mobile app) |
| General Device Characteristic Similarities | | |
| Intended Use/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 six years of age and greater. | 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. |
| General Device Characteristic Differences | | |
| Specific Drug/Biologic Use | U-100 Insulin. Humalog or Novolog | Same |

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| Insulin Delivery Modes | Both basal and bolus | Same |
| --- | --- | --- |
| Insulin Basal Rate Delivery Range | 0 – 15 U/hour | Same |
| Insulin Bolus Delivery Range | 0.01 U at volumes greater than 0.05 U, Max bolus volume 25 U | Same |

V Standards/Guidance Documents Referenced:

- FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices” dated February 3, 2016
- FDA Guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” dated October, 2018
- FDA Guidance “General Principles of Software Validation” dated January, 2002
- ISO 10993-1:2018 Biological Evaluation of Medical Devices: Evaluation and Testing
- ISO 10993-3:2014 Biological Evaluation of Medical Devices: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
- ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-11:2017 Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity
- ISO 14971: 2019 +A11:2021 Medical Devices – Application of Risk Management to Medical Devices
- IEC 60601-1:2005+AMD 1:2012 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2:2014 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances- Requirements and Tests
- IEC 60601-1-6:2010 + AMD 1:2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-8:2006 + AMD 1:2012 Medical Electrical Equipment – Part 1-8: General Requirements for Basic Safety and Essential Performance – Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems
- IEC 60601-1-11 Issued: 2015/01/20 Ed.2 Medical Electrical Equipment – Part 1-11: General Requirements for Basic Safety and Essential Performance – Collateral Standard- Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 62304:2006 Medical Device Software – Software Life Cycle Processes
- IEC 62366-1: 2005 Medical Devices – Part 1: Application Of Usability Engineering To Medical Devices

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- ISO 11607-1:2020 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems [including Amendment 1 (2014)
- ISO 11135: 2014 Sterilization of health care products – Ethylene Oxide – Requirements for development, validation and routine control of a sterilization process for medical devices.

## VI Performance Characteristics:

### A. Analytical Performance

#### 1. Basal delivery accuracy

To assess basal delivery accuracy, 32 pumps were tested by delivering at minimum, intermediate, and maximum basal rates (0.1, 2.0, and 15 U/hr). Sixteen of the pumps were new and 16 had been aged to simulate at least four years of regular use. For both aged and unaged pumps, eight pumps were tested with a new cartridge, and eight with a cartridge which underwent two years of aging. Delivery accuracy was assessed by pumping insulin into a container on a scale and measuring the weight of the liquid at 1h, 6h, and 12h intervals for minimum, intermediate rates and maximum basal rates of 0.1, 2.0 U/hr and 15 U/hr, respectively. For the minimum basal rate, accuracy is reported after a 1-hour warm-up period.

The following tables report the typical basal performance (average) observed, along with the lowest and highest results observed for minimum, intermediate, and maximum basal rate settings for all pumps tested.

Table 1: Amount of fluid delivered after 1, 6, and 12 hours with 0.1 U/hr (minimum) basal rate setting

| 0.1 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 0.1 U | 0.6 U | 1.2 U |
| Median amount delivered [min, max] | 0.09 U
[0.07, 0.18] | 0.60 U
[0.37, 0.73] | 1.21 U
[0.84, 1.38] |

Table 2: Amount of fluid delivered after 1, 6, and 12 hours with 2.0 U/hr (medium) basal rate setting

| 2.0 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 2.0 U | 12.0 U | 24.0 U |
| Median amount delivered [min, max] | 1.9 U
[1.5, 2.1] | 12.1 U
[10.7, 12.5] | 24.4 U
[21.8, 25.0] |

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Table 3: Amount of fluid delivered after 1, 6, and 12 hours with ${15.0}\mathrm{U}/\mathrm{{hr}}$ (high) basal rate setting

| 15.0 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 15.0 U | 90.0 U | 180.0 U |
| Median amount delivered [min, max] | 15.3 U [12.3, 15.6] | 90.5 U [84.4, 91.0] | 180.0 U [174.2, 181.4] |

# 2. Bolus delivery accuracy

To assess bolus delivery accuracy, 32 pumps were tested by delivering at minimum, intermediate, and maximum bolus volumes (0.05, 2.5, and $25\mathrm{U}$ ). Sixteen of the pumps were new and 16 had been aged to simulate five years of regular use. For both aged and unaged pumps, eight pumps were tested with an unaged cartridge, and eight with a cartridge which underwent one year of accelerated aging.

Tables 4-6 below show the number (and %) of boluses within the specified range of each target bolus volume.

Table 4: Amount of fluid delivered after a ${0.05}\mathrm{U}$ bolus request (n=800 boluses)

| Units delivered after a 0.05 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <0.0125 | 0.0125 - 0.0375 | 0.0375- 0.045 | 0.045- 0.0475 | 0.0475- 0.0525 | 0.0525- 0.0550 | 0.055- 0.0625 | 0.0625- 0.0875 | 0.0875- 0.125 | >0.125 |
| | (<25 %) | (25-75 %) | (75-90 %) | (90-95 %) | (95-105 %) | (105-110 %) | (110-125 %) | (125-175 %) | (175-250 %) | (>250 %) |
| Number and percent of boluses | 0/800 (0.0 %) | 2/800 (1 %) | 17/800 (2 %) | 42/800 (5 %) | 495/800 (62 %) | 185/800 (23 %) | 59/800 (7 %) | 0/800 (0 %) | 0/800 (0 %) | 0/800 (0 %) |

Table 5: Amount of fluid delivered after a ${2.5}\mathrm{U}$ bolus request (n=800 boluses)

| Units delivered after a 2.5 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <0.625 | 0.625-1.875 | 1.875-2.25 | 2.25-2.375 | 2.375-2.625 | 2.625-2.75 | 2.75-3.125 | 3.125-4.375 | 4.375-6.25 | >6.25 |
| | (<25 %) | (25-75 %) | (75-90 %) | (90-95 %) | (95-105 %) | (105-110 %) | (110-125 %) | (125-175 %) | (175-250 %) | (>250 %) |
| Number and percent of boluses | 0/800 (0 %) | 0/800 (0 %) | 2/800 (0 %) | 19/800 (3 %) | 736/800 (92 %) | 43/800 (6 %) | 0/800 (0 %) | 0/800 (0 %) | 0/800 (0 %) | 0/800 (0 %) |

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Table 6: Amount of fluid delivered after a 25 U bolus request (n=192 boluses)

| Units delivered after a 25 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <6.25 | 6.25-18.75 | 18.75-22.5 | 22.5-23.75 | 23.75-26.25 | 26.25-27.5 | 27.5-31.25 | 31.25-43.75 | 43.75-62.5 | >62.5 |
| | (<25 %) | (25-75 %) | (75-90 %) | (90-95 %) | (95-105 %) | (105-110 %) | (110-125 %) | (125-175 %) | (175-250 %) | (>250 %) |
| Number and percent of boluses | 0/192 (0 %) | 0/192 (0 %) | 0/192 (0 %) | 0/192 (0 %) | 192/192 (100 %) | 0/192 (0 %) | 0/192 (0 %) | 0/192 (0 %) | 0/192 (0 %) | 0/192 (0 %) |

3. Occlusion detection

To assess occlusion detection performance and unintended bolus upon occlusion release performance, 32 pumps that were also used for bolus and basal accuracy were used here. The occlusion tests were performed with bolus sizes of 2.5 U and 25 U and basal rates of 0.1 and 2 U/hr and typical and maximum time to occlusion detection are shown below in Table 7.

Table 7: Timing of occlusion detection alarms

| | Typical time to occlusion detection | Maximum time to occlusion detection |
| --- | --- | --- |
| ≥ 2.5 U Bolus | 46 seconds | 3 minutes |
| 2 U/hr Basal | 40 minutes | 2 hours |
| 0.1 U/hr Basal | 17 hours 11 minutes | 36 hours |

B. Other Supportive Instrument Performance Characteristics Data

1. Hazard Analysis

A comprehensive hazard analysis was reviewed, in which design inputs and outputs, risks, and risk mitigations for hardware and software associated with proper functioning of the insulin pump were reviewed. The sponsor performed a hazard analysis to account for the unique intended use, design elements, and risks of their ACE pump. This analysis identified hazards which could reasonably be anticipated to impact the proper use of the device, traced all identified risks to adequate design controls, and demonstrated that design features were appropriately implemented and validated.

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2. Human Factors

Human factors validation tests were conducted with the Tandem Mobi pump. All study participants received training that was consistent with the training that patients would receive with the commercial product. Usability evaluations assessed comprehension and usability of the device for critical device tasks. Results of the study demonstrated that the ACE Pump is validated for its intended use.

3. 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 disposable cassette, pump and the disposable cassette packaging and dust cover. All endpoints were tested adequately, and results were acceptable.

4. Sterility

The Tandem Mobi cartridge and components used to fill the cartridge are provided sterile. The cartridge is terminally sterilized in its final package using Ethylene Oxide and the process has been validated to ensure a Sterility Assurance Level (SAL) of 10⁻⁶ in accordance with ISO 11135: 2014. In addition, testing performed per ISO 10993-7:2008+A1:2019 and ISO 11135:2014 was found acceptable.

5. Insulin Compatibility and Stability

The Tandem Mobi pump cartridge is compatible with U-100 insulins Novolog (insulin aspart) and Humalog (insulin lispro) for up to 3 days.

6. Additional Bench Testing

In addition to the performance testing described above, mechanical testing, simulated use testing, and other device verification testing was conducted to demonstrate that the system meets its intended use and is safe, reliable, and all safety and reliability critical requirements have been adequately verified. Summaries for reliability, safety, and verification testing follow:

| Testing to Support System Reliability |
| --- |
| Durability of pumping mechanism |
| Bolus Button |
| Pump Alarm |
| Pump and cartridge mating |
| Pump Battery |
| Remote Interface including screen, volume button, vibration interface, battery |
| Vibration and shock |
| Chemical stressors (e.g. insect repellents, lotions) |

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| Testing to Support System Safety |
| --- |
| Environmental Safety Testing to 60601-1-11 |
| Safety and Essential Performance Testing to 60601-1 |
| Occlusion Detection Testing |
| Design specific tests: Volume Cross Checks, Inter and Intra Delivery Leaks |
| Alarms Testing |
| Data Handling Testing |
| Pump Activation and Deactivation Testing |
| Pump/Controller Connectivity Testing |
| User Guide Testing |
| Insulin Delivery Verification Testing |
| Incidental Delivery |
| Worst Case Accuracy |
| Testing to Support System Verification |
| --- |
| Environmental Safety Testing to 60601-1-11 |
| Safety and Essential Performance Testing to 60601-1 |
| Occlusion Detection Testing |
| Infusion pressure Testing |
| Alarms Testing |
| Data Handling Testing |
| Pump Activation Testing |
| Pump/Controller Connectivity Testing |
| User Guide Testing |
| Insulin Delivery Verification Testing |
| Environmental conditions Testing |

7. Electromagnetic Compatibility and Wireless Coexistence

Electromagnetic compatibility (EMC), electromagnetic immunity (EMI) and wireless coexistence testing was performed for the pump in compliance with IEC 60601-1-2 and RTCA DO-160G. The device passed all required testing with appropriate acceptance criteria and no deviations. Radiofrequency wireless testing was conducted, including wireless coexistence. Testing demonstrated that the device can operate in the presence of RF interference and co-exists with other wireless devices operating in the same vicinity. All tests passed.

8. Basic Safety and Essential Performance (Electrical Safety)

The sponsor provided verification evidence for compliance with the IEC 60601-1 and applicable collateral standards. Verification results support the finding of substantial equivalence for this device.

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## 9. Data Logging

The sponsor provided a summary of pump and controller logging capability which enable the device to record critical events including insulin delivery, pump commands and confirmations, connectivity states, malfunctions, and alarms. These were reviewed and found to be adequate.

## 10. Interoperability

A plan and approach for interoperability were provided according to the FDA Guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff” and determined to be adequate to support and clearly specify expectations, requirements, and interface specifications to potential interoperable devices. In addition, their plan covered their approach to working with connected device companies regarding contractual approaches, interfaces for data communication and exchange, and post-market reporting procedures and responsibilities (e.g., who is responsible for investigating and reporting complaints, malfunctions, and adverse events).

The sponsor additionally provided validated software protocols intended to ensure secure, accurate, and reliable communication with digital interfacing devices, as well as failsafe design features to mitigate the risks associated with interruption of communication with digitally connected devices. These protocols were reviewed and found to be adequate.

## 11. Software and Cybersecurity

Detailed information on software and cybersecurity of the device was reviewed and found 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.