embecta Insulin Delivery System

K234027 · Embecta Medical I, LLC · QFG · Aug 30, 2024 · Clinical Chemistry

Device Facts

• Record ID: K234027
• Device Name: embecta Insulin Delivery System
• Applicant: Embecta Medical I, LLC
• Product Code: QFG · Clinical Chemistry
• Decision Date: Aug 30, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5730
• Device Class: Class 2
• Attributes: Therapeutic, PCCP

Indications for Use

The embecta Insulin Delivery System with interoperable technology (the Patch) is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and older. The Patch 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 patch is intended for single patient, home use and requires a prescription.

Device Story

Disposable, wearable patch pump for subcutaneous insulin delivery; 300 U reservoir capacity; 72-hour wear time. Operated by a locked-down smartphone controller app via Bluetooth Low Energy (BLE) and Wi-Fi. System delivers basal and bolus insulin doses; provides status notifications (battery, reservoir, occlusion, faults). Used in home settings by patients; programmed by patient via smartphone app. Interoperable with automated insulin dosing software to receive/execute commands. Benefits include precise insulin delivery, remote programming, and integration with digital diabetes management ecosystems.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including basal and bolus delivery accuracy (n=90 pumps), occlusion detection timing, biocompatibility (ISO 10993), sterility (SAL 10^-6), electromagnetic compatibility, and human factors validation (n=16 lay users, n=16 HCPs).

Technological Characteristics

Tubeless patch pump; 300U reservoir; gear-driven delivery. Materials: medical-grade adhesive. Connectivity: BLE. Sterilization: Ethylene Oxide. Software: Android-based controller app. Standards: IEC 60601-1, IEC 60601-1-11, IEC 62304, ISO 10993, ISO 14971.

Indications for Use

Indicated for subcutaneous insulin delivery for diabetes mellitus management in patients 18 years and older. Contraindicated for patients unable to monitor glucose levels, maintain contact with healthcare providers, or follow system instructions.

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

• Omnipod DASH Insulin Management System with interoperable technology (K191679)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K234027

B Applicant

embecta Medical I, LLC

C Proprietary and Established Names

embecta Insulin Delivery System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QFG | Class II | 21 CFR 880.5730 - Alternate Controller Enabled Pump | CH - Clinical Chemistry |
| NDC | Class II | 21 CFR 868.1890 - Predictive pulmonary-function value calculator | 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 embecca Insulin Delivery System (the Patch) with interoperable technology is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and older. The Patch is able to reliably and securely communicate with compatible, digitally connected devices, including automated

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

insulin dosing software, to receive, execute and confirm commands from these devices. The Patch is intended for single patient, home use and requires a prescription.

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

This device is for prescription use only.

This device is intended for one-person use ONLY. Do not share the system with anyone – including other family members.

Insulin pump therapy is NOT recommended for people who are:

- Unable to monitor glucose levels as recommended by their health care provider.
- Unable to maintain contact with their health care provider.
- Unable to use the embecta Insulin Delivery System according to instructions.

Do Not adjust your Bolus Calculator or your Bolus Presets without the presence of your healthcare provider. Only your healthcare provider can help you change your Target and Minimum Glucose Level(s), Insulin-to-Carb Ratio, Insulin Sensitivity Factor, Duration of Insulin Action, and Bolus Presets. Incorrect settings can result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

Before having an X-ray, magnetic resonance imaging (MRI), diathermy, electrocautery, or computed tomography (CT) scan (or any similar test or procedure), you'll need to disconnect and remove your patch. These types of tests and procedures can make your patch stop working. After your procedure is done, you can start over with a new patch.

The patch and controller are designed to use rapid-acting U-100 insulin. The following U-100 rapid acting insulin analogs have been tested and found to be safe for use in the pump: NovoLog or Humalog U-100 insulin for ages 18 years and older. NovoLog and Humalog are compatible with the system for use up to 72 hours (3 days). If you have questions about using other insulins, contact your health care provider. Always consult your health care provider and refer to the insulin labeling prior to use.

## III Device Description

The embecca Insulin Delivery System is a prescription home use device intended to support insulin therapy for diabetes mellitus management. The pump is a disposable Insulin Delivery Device that is controlled by a Bluetooth Low Energy enabled Wireless Controller App housed on a locked down Android smartphone. In addition, the pump and controller will be packed with a syringe and needle for filling. The pump is a single use disposable sterile tubeless patch pump device intended to be worn by the patient for a nominal period of up to 72 hours. The pump is adhered to the patient using a medical grade adhesive patch and delivers insulin using a pump-gear mechanism. The body-worn pump stores and administers up to 300U of user-filled U-100 insulin with a selected basal and bolus dosage setting that is agreed upon between the user and their healthcare practitioner or provider. The U-100 insulin is delivered to the patient subcutaneously and both the pump and the controller app will send feedback on interrupted or

K234027 - Page 2 of 11

{2}

fault status to the patient. This will include successful activation and status changes such as calculation of a low or empty insulin reservoir volume, and pump failure (expiry/near expiry, hardware, software, communication failures, and occlusion).

The embecta-provided smartphone will be non-sterile and is locked to run only the embecta controller app that enables controlling the pump discreetly. The controller will enable the user to pair, prime, and program a basal and bolus dose via wireless transmission to the pump as well as provide users with system alerts, including status information and notifications. This includes, but is not limited to, battery life, total insulin delivered, calculation of a low insulin reservoir volume, occlusion, and other possible device faults. The controller's app is designed to program and display the patient's basal insulin delivery rate, delivered bolus doses, historical data, and insulin usage on a color display touch screen. The controller can be recharged with the provided charger.

## IV Substantial Equivalence Information:

A Predicate Device Name(s):

Omnipod DASH Insulin Management System with Interoperable Technology

B Predicate 510(k) Number(s):

K191679

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K234027 | K191679 |
| --- | --- | --- |
| Device Trade Name | embecta Insulin Delivery System | Omnipod DASH Insulin Management System with Interoperable Technology |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Intended for the subcutaneous delivery of insulin at variable rates for the management of diabetes mellitus in people requiring insulin. Intended to be interoperable with connected devices including CGMs and automated insulin | Same |

K234027 - Page 3 of 11

{3}

| | dosing algorithms. | |
| --- | --- | --- |
| Operating Environment | Home Use | Same |
| Insulin Delivery Modes | Both basal and bolus | Same |
| Bolus Dose Range | 0.05 – 30 U | 0.05 – 30 U |
| General Device Characteristic Differences | | |
| Specific Drug/Biologic Use | U-100 Insulin.
System has been tested with Novolog and Humalog. | U-100 Insulin.
System has been tested with Novolog, Humalog, Admelog and Apidra. |
| Reservoir Capacity | 300 U | 200 U |

V Standards/Guidance Documents Referenced:

- FDA Guidance “Infusion Pumps Total Product Life Cycle” dated December, 2014
- FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices” dated February, 2016
- FDA Guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”, September, 2023
- FDA Guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices” dated September 6, 2017
- FDA Guidance “Content of Human Factors Information in Medical Device Marketing Submissions”, dated December, 2022
- ISO 10993-1:2018 Biological Evaluation of Medical Devices: Evaluation and Testing
- ISO 10993-3:2014 Biological Evaluation of Medical Devices – Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
- ISO 10993-4:2017 Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions with Blood.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for in Vitro Cytotoxicity.
- ISO 10993-6: 2016 Biological Evaluation of Medical Devices – Part 6: Tests for Local Effects after Implantation.
- ISO 10993-10:2021 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.

K234027 - Page 4 of 11

{4}

- ISO 10993-23:2021 Biological Evaluation of Medical Devices – Part 23: Tests for Irritation.
- ISO 14971 Third Edition 2019 Medical Devices – Application of Risk Management to Medical Devices
- IEC 60601-1-2 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 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-8 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 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 62304:2015 Medical Device Software – Software Life Cycle Processes
- IEC 62366-1:2020 Medical Devices – Part 1: Application Of Usability Engineering To Medical Devices
- ISO 11607-1:2019 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
- IEC 62366-1:2020 Medical Devices – Part 1: Application of Usability Engineering to Medical Devices, including Amendment 1.

## VI Performance Characteristics:

### A. Analytical Performance

#### 1. Basal delivery accuracy

To assess basal delivery accuracy at 0.05, 1.0 and 30.0 U/h, 44 aged pumps and 45 unaged pumps were tested. 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 and intermediate rates (0.1 and 1.0 U/hr) and 1h and 6h intervals for maximum rate (25 U/hr).

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

K234027 - Page 5 of 11

{5}

Table 1: Amount of fluid delivered after 1, 6, and 12 hours with 0.05 U/hr (minimum) basal rate setting

| 0.1 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 0.05 U | 0.30 U | 0.60 U |
| Median amount delivered [min, max] | 0.048 U
[0.00, 0.18] | 0.29 U
[0.07, 0.45] | 0.58 U
[0.27, 0.72] |

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

| 1 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 1.0 U | 6.0 U | 12.0 U |
| Median amount delivered [min, max] | 0.99 U
[0.74, 1.20] | 5.98 U
[5.21, 6.14] | 11.97 U
[10.94, 12.26] |

Table 3: Amount of fluid delivered after 1, 6, and 12 hours with 30 U/hr (high) basal rate setting

| 25 U/hr Basal Duration | 1 hour | 6 hours |
| --- | --- | --- |
| Total expected delivery volume | 30 U | 180 U |
| Median amount delivered [min, max] | 30.13 U
[29.77, 30.58] | 180.49 U
[180.10, 180.93] |

2. Bolus delivery accuracy

To assess bolus delivery accuracy, a total of 90 pumps were used, half of which were aged. 30 pumps each were tested by delivering at minimum, intermediate, and maximum bolus volumes (0.05 U, 6.0 U, and 30 U).

Tables 4-6 below show the number (and %) of boluses within the specified range of the minimum bolus, one intermediate bolus and the maximum bolus volume.

K234027 - Page 6 of 11

{6}

Table 4: Amount of fluid delivered after a 0.05 U bolus request (n=15000 boluses)

| Units delivered after a 0.2 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <0.0125
(<25%) | 0.0125 - 0.0375
(25-75%) | 0.0375- 0.045
(75-90%) | 0.045- 0.0475
(90-95%) | 0.0475- 0.0525
(95-105%) | 0.0525- 0.055
(105-110%) | 0.055- 0.0625
(110-125%) | 0.0625- 0.0875
(125-175%) | 0.0875- 0.125
(175-250%) | >0.125
(>250%) |
| Number and percent of boluses | 5/15000
(0.03 %) | 66/15000
(0.44 %) | 1678/150000
(11.19 %) | 4259/150000
(28.39 %) | 7077/15000
(47.18 %) | 1105/150000
(7.37 %) | 792/15000
(5.28 %) | 18/15000
(0.12 %) | 0/150000
(0 %) | 0/15000
(0 %) |

Table 5: Amount of fluid delivered after a 6.0 U bolus request (n=750 boluses)

| Units delivered after a 6.0 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <1.50
(<25%) | 1.50-4.50
(25-75%) | 4.5-5.40
(75-90%) | 5.40-5.70
(90-95%) | 5.70-6.30
(95-105%) | 6.30-6.60
(105-110%) | 6.60-7.5
(110-125%) | 7.5-10.5
(125-175%) | 8.75-15.0
(175-250%) | >15.0
(>250%) |
| Number and percent of boluses | 0/750
(0.0%) | 0/750
(0.0%) | 0/750
(0.0%) | 1/750
(0.13%) | 749/750
(99.87%) | 0/750
(0.0%) | 0/750
(0.0%) | 0/750
(0.0%) | 0/750
(0.0%) | 0/750
(0.0%) |

Table 6: Amount of fluid delivered after a 30 U bolus request (n=300 boluses)

| Units delivered after a 30.0 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <7.5
(<25%) | 7.5-22.5
(25-75%) | 22.5-27.0
(75-90%) | 27.0-28.5
(90-95%) | 28.5-31.5
(95-105%) | 31.5-33.0
(105-110%) | 33.0-37.5
(110-125%) | 37.5-52.5
(125-175%) | 52.5-75.0
(175-250%) | >75.0
(>250%) |
| Number and percent of boluses | 0/300
(0.0%) | 0/300
(0.0%) | 0/300
(0.0%) | 0/300
(0.0%) | 300/300
(100%) | 0/300
(0.0%) | 0/300
(0.0%) | 0/300
(0.0%) | 0/300
(0.0%) | 0/300
(0.0%) |

K234027 - Page 7 of 11

{7}

K234027 - Page 8 of 11

3. Occlusion detection

To assess occlusion detection performance and unintended bolus upon occlusion release performance, 160 pumps were tested, half of which were aged.

The following table depicts the typical (average) time to occlusion detection for three different situations when using U-100 insulin.

Table 7: Timing of occlusion detection alarms
| | Typical time to occlusion detection | Maximum time to occlusion detection |
| --- | --- | --- |
| 5.35 U Bolus* | 2 minutes 15 seconds | 3 minutes 34 seconds |
| 1.0 U/hr Basal | 4 hour 4 minutes | 5 hours 27 minutes |
| 0.05 U/hr Basal | 79 hours 59 minutes | 80 hours (Pump expiration) |

*A 30 U bolus was commanded, and the reported value represents maximum amount of fluid at occlusion detection.

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.

2. Human Factors

The results of Human Factors (HF) validation study for the embecca Insulin Delivery System, a patch style insulin pump, support substantial equivalence to the predicate device. The HF validation study focused on two user groups: people with diabetes mellitus who are 18+ years or older and treated as adults and healthcare providers (HCP). The people with diabetes mellitus consisted of 16 "lay users," where there were 6 pump-inexperienced, 6 pump-experienced, and 4 patients with caregivers represented as a dyad. The HCP group consisted of 15 certified diabetes care and education specialists and 1 clinical pharmacist. Users were trained according to a "train the trainer" model where trainers from embecca provided training to HCPs (registered nurses, diabetes educators, etc.) and the trained HCPs provided training to the people with diabetes. Lay-user training consisted of two one-on-one training sessions spread across two days. The first training focused on initial device set-up and basic

{8}

pump functionality and the second training focused on advanced pump functionality. There was a 1-hour decay period after training prior to validation testing. The tasks evaluated during simulated use testing consisted of administering a single rate basal program, manual boluses, adjusting time zones, temporary basal programs, multi-rate basal programs, bolus calculation based on carbohydrate and blood glucose values, pausing insulin delivery, alert customization, disposal of the device, and responding to alerts and alarms. Lay-users were not validated to set-up a new insulin pump independently and initial pump set-up, which consists of inputting pump settings such as setting up target glucose levels, preset boluses, insulin to carb ratio, insulin sensitivity factor, duration of insulin action, and minimum glucose level should occur under the supervision of a healthcare provider.

3. Biocompatibility

Biocompatibility testing was performed per 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 pump. Results support a determination of substantial equivalence.

4. Sterility

The patch pump and filling syringe are provided sterile in a sealed sterile barrier tray. These components are 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.

5. Insulin Compatibility and Stability

The embecta system was found to be compatible with U-100 insulin 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 |
| --- |
| Pump lifetime testing |
| Transient Temperature |
| Transient Pressure |
| Ingress Protection |
| Cleaning |
| Label legibility |

K234027 - Page 9 of 11

{9}

| Against mechanical stressors (e.g., vibrations, shock) |
| --- |
| Against chemical stressors (e.g., sunscreens, insect repellents, chlorine and saltwater, cleaning agents) |
| Delivery Accuracy and Occlusion Detection Testing |
| Testing to Support System Safety |
| --- |
| Environmental Safety Testing to 60601-1-11 |
| Safety and Essential Performance Testing to 60601-1 |
| Worst Case Accuracy |
| Incidental Delivery |
| Occlusion Detection Testing |
| Leakage |
| User Guide |
| Testing to Support System Verification |
| --- |
| Environmental Safety Testing to 60601-1-11 |
| Safety and Essential Performance Testing to 60601-1 |
| Occlusion Detection |
| Insulin Delivery Verification |
| Environmental Conditions |

7. Electromagnetic Compatibility and Wireless Coexistence

Electromagnetic compatibility, electromagnetic immunity and wireless coexistence testing was performed for the pump. All tests demonstrated that the device would perform as expected in the home healthcare environment.

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 equivalent for this device.

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

K234027 - Page 10 of 11

{10}

"Medical Devices" 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.

K234027- Page 11 of 11