iLet® ACE Pump

K223846 · Beta Bionics, Inc. · QFG · May 19, 2023 · Clinical Chemistry

Device Facts

• Record ID: K223846
• Device Name: iLet® ACE Pump
• Applicant: Beta Bionics, Inc.
• Product Code: QFG · Clinical Chemistry
• Decision Date: May 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin under the skin based on input from an integrated continuous glucose monitor (iCGM) and an interoperable automated glycemic controller (iAGC), in people 6 years of age or older with diabetes mellitus. The iLet ACE Pump is intended for single-person use; it is not to be shared.

Device Story

iLet ACE Pump is an alternate controller enabled (ACE) insulin pump; delivers insulin subcutaneously via motor-drivetrain mechanism from user-loaded cartridge. Device integrates with iCGM and iAGC to automate insulin delivery; provides graphical user interface and alerts for user interaction. Used in home environment by single patient; wirelessly rechargeable battery. Healthcare providers use device data via iLet Go App and Beta Bionics Cloud for therapy management. Automated delivery based on iAGC commands; system stops dosing if CGM connection lost. Benefits include automated glycemic control for diabetes management.

Clinical Evidence

No clinical study was required. Safety and effectiveness were established through non-clinical bench testing (dose delivery accuracy, occlusion detection, biocompatibility, sterility, electrical safety, EMC, and cybersecurity) and a human factors validation study conducted in simulated use conditions. The human factors study confirmed that all critical tasks were performed safely and effectively by the intended user population.

Technological Characteristics

ACE pump; motor-drivetrain mechanism; rechargeable lithium battery with wireless charging. Dimensions: 9.10 cm x 5.90 cm x 1.50 cm; Weight: 110g. Connectivity: Bluetooth (iCGM), wireless charging. Moisture protection: IPX8. Software: Interoperable with iAGC and iCGM. Sterilization: Not specified (disposables).

Indications for Use

Indicated for people 6 years of age or older with diabetes mellitus requiring subcutaneous insulin delivery via an interoperable automated glycemic controller (iAGC) and integrated continuous glucose monitor (iCGM). Contraindicated for use during radiation therapy, MRI, CT scans, or diathermy; do not expose to equipment used for pacemaker/AICD placement, cardiac catheterization, or nuclear stress tests.

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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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K223846

B Applicant

Beta Bionics, Inc.

C Proprietary and Established Names

iLet® ACE Pump

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QFG | Class II | 21 CFR 880.5730 – Alternate Controller Enabled Infusion Pump (ACE 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 iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin under the skin based on input from an integrated continuous glucose monitor (iCGM) and an interoperable automated glycemic controller (iAGC), in people 6 years of age or older with diabetes mellitus. The iLet ACE Pump is intended for single-person use; it is not to be shared.

C Special Conditions for Use Statement(s):

Rx – For prescription use only.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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The iLet System is only for use with insulin U-100 lispro (Humalog) or insulin U-100 aspart (Novolog).

Remove the iLet device, steel infusion set, CGM sensor, and CGM transmitter before undergoing radiation therapy, Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment procedures. Exposure of the iLet device, steel infusion set, CGM sensor, or CGM transmitter to any of these may damage them.

Do not expose your iLet device, steel infusion set, CGM transmitter, or CGM sensor to equipment used in procedures for Pacemaker/Automatic Implantable Cardioverter Defibrillator (AICD) placement or reprogramming, Cardiac Catheterization, or Nuclear Stress Test.

The iLet Go App is compatible with the iOS platform. The iLet Go App provides the ability to perform over-the-air updates and / or pull data from an iLet device to share with the Beta Bionics Cloud. The iLet Go App is not currently compatible with Android or other platforms.

If your CGM is offline for an extended period of time, dosing will stop and you should switch to alternative therapy until you are able to reconnect to a CGM sensor. A countdown timer will appear before dosing would stop.

## III Device Description

The iLet ACE Pump is an alternate controller enabled (ACE) pump intended to automatically deliver insulin under the skin based on commands from an interoperable automated glycemic controller (iAGC) in people with diabetes mellitus. The iLet ACE Pump provides a graphical user interface and alerts to interact with the iLet delivery system and an iAGC.

The iLet ACE Pump includes a motor-drivetrain pumping mechanism, which actuates the delivery of insulin from a cartridge that is separately loaded into the iLet. The insulin is injected under the skin via continuous infusion.

The iLet ACE Pump has a wirelessly rechargeable battery and is designed to be used by a single person and have a useful life of at least 4 years. The iLet is charged on a wireless charging pad which comes with the device. The Luer connector and drug cartridge should be changed every 3 days.

## IV Substantial Equivalence Information:

A Predicate Device Name(s):

t:slim X2 Insulin Pump with Interoperable Technology

B Predicate 510(k) Number(s):

K201214

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C Comparison with Predicate(s):

| Device & Predicate Device(s): | K223846 | K201214 |
| --- | --- | --- |
| Device Trade Name | iLet® ACE Pump | t:slim X2 insulin pump |
| 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 dosing algorithms | Same |
| Age Range of Intended Users | Ages 6 years and older | Same |
| Operating Environment | Home Use | Same |
| Specific Drug/Biologic Use | U-100 insulins: NovoLog and Humalog | Same |
| General Device Characteristic Differences | | |
| Control Modes | iAGC closed-loop control only | iAGC closed-loop control, or open-loop manual control using basal and bolus delivery modes |
| Reservoir volume | 1.6 mL | 3.0 mL |

V Standards/Guidance Documents Referenced:

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff

Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff

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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Guidance for Industry and FDA Staff

General Principles of Software Validation: Guidance for Industry and FDA Staff

Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff

Electromagnetic Compatibility (EMC) of Medical Devices, Guidance for Industry and Food and Drug Administration Staff

ANSI/AAMI ST72:2011 - Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing

ASTM D4169:2016 - Standard Practice for Performance Testing of Shipping Containers and Systems Performance Testing of Shipping Containers and Systems

ASTM F1140:2020 - Internal Pressurization Failure Resistance of Unrestrained Packages

ASTM F1980:2016 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM F2503:2013 - Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

ASTM F88:2015 - Standard Test Method for Seal Strength of Flexible Barrier Materials

IEC 60601-1:2005+AMD1:2012 Consolidated version - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-10:2008/A1:2013 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard: Requirements for the development of physiologic closed-loop controllers

IEC 60601-1-11:2015 - 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 60601-1-2: Edition 4.1 (2020-09) CONSOLIDATED VERSION - 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+A1:2013 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

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IEC 60601-1- 8:2006/A1:2012 - 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 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

IEC 62133-2:2017 - Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-2:2006 - Biological evaluation of medical devices - Part 2: Animal welfare requirements

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: Screening tests for blood to assess interactions

ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - In vitro methods

ISO 10993-6:2016 - Biological evaluation of medical devices - Part 6: Tests for evaluation of local effects after implantation

ISO 10993-10:2010/R 2014- 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 10993-12:2021 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

ANSI AAMI ISO 11137- 1:2006/(R)2015 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11137-2:2013 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

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ISO 11607-1:2019 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11608-3:2012 - Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers

ANSI AAMI ISO 11737-1:2018 - Sterilization of health care products - Microbiological methods - Part 1: Determination of the population of microorganisms on product

ANSI AAMI ISO 11737-2:2019 - Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

ISO 14644-1:2015 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

ISO 14971:2019 - Medical devices - Application of risk management to medical devices

EN ISO 15223-1:2016 - Medical devices - Symbols to be used with medical device labels, labelling and information supplied – Part 1: General requirements

ISO 80369-20:2015 - Small bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

EN ISO 80369-7:2021 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

ISO 8537:2016 - Sterile single-use syringes, with or without needle, for Insulin

ISO 9626:2016 - Stainless steel needle tubing for the manufacture of medical devices

ISO 11040-4 2015 - Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

ISO 7000:2019 - Graphical symbols for use on equipment - Registered symbols

ISO/IEC 15459 - 2:2015 - Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures

ISO/IEC 15459-4:2014 - Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages

ISO/IEC 15459-6:2014 - Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings (corrected 2016-09-01)

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ISO/IEC 646:1991 - Information technology - ISO 7-bit coded character set for information interchange

UL 1642 - Standard for Lithium Batteries

## VI Performance Characteristics:

### A. Analytical Performance

#### 1. Basal delivery accuracy

To assess basal delivery accuracy, iLet ACE pumps were tested by delivering at minimum, intermediate, and maximum basal rates (0.1, 1.0, and 10.0 U/hr). A total of 30 devices (15 new and 15 aged) were tested at all basal rates. For both aged and unaged pumps, all cartridges were new. Water was used as a substitute for insulin. Water was pumped into a container on a scale and the weight of the liquid at various time points was used to assess pumping accuracy.

The following tables (1a – 3b) report the typical basal performance (median) observed, along with the lowest and highest results observed for the low, medium, and high basal rates settings for all pumps tested with no warm-up period. For each time period, the tables show the volume of insulin requested in the first row and the volume that was delivered as measured by the scale in the second row.

Table 1a: Amount of fluid delivered (by new pumps) after 1, 6, and 12 hours with 10 U/hr (maximum) basal rate setting

| 10 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 10 U | 60 U | 120 U |
| Median amount delivered
[min, max] | 9.98 U
[9.70, 10.36] | 60.00 U
[58.93, 60.67] | 120.02 U
[118.63, 121.01] |

Table 1b: Amount of fluid delivered (by aged pumps) after 1, 6, and 12 hours with 10 U/hr (maximum) basal rate setting

| 10 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 10 U | 60 U | 120 U |
| Median amount delivered
[min, max] | 9.98 U
[9.69, 10.32] | 59.90 U
[59.07, 60.78] | 119.81 U
[118.62, 121.12] |

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Table 2a: Amount of fluid delivered (by new pumps) 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 U | 6 U | 12 U |
| Median amount delivered
[min, max] | 0.99 U
[0.61, 1.37] | 5.94 U
[5.56, 6.35] | 11.90 U
[11.39, 12.33] |

Table 2b: Amount of fluid delivered (by aged pumps) 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 U | 6 U | 12 U |
| Median amount delivered
[min, max] | 0.98 U
[0.61, 1.33] | 5.88 U
[5.33, 6.28] | 11.74 U
[11.04, 12.31] |

Table 3a: Amount of fluid delivered (by new pumps) 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
[0.02, 0.12] | 0.56 U
[0.29, 0.65] | 1.21 U
[0.77, 1.25] |

Table 3b: Amount of fluid delivered (by aged pumps) 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
[0.02, 0.11] | 0.55 U
[0.33, 0.63] | 1.11 U
[0.79, 1.20] |

2. Bolus Delivery Accuracy

To assess bolus delivery accuracy, 15 iLet devices were tested by delivering consecutive minimum, intermediate, and maximum bolus volumes (0.5, 5.0, and 30 units). All devices were new, and 15 additional devices were aged to simulate four years of regular use and tested by delivering consecutive intermediate bolus volumes. For both aged an unaged devices, all devices were tested with a new cartridge. Table 4 shows the number of total and consecutive boluses delivered in this testing for each delivery volume.

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Table 4: Summary of bolus testing protocol

| Bolus size (units) | Number of pumps tested | Consecutive boluses per pump | Total boluses |
| --- | --- | --- | --- |
| 0.5 units | 15 | 25 | 375 |
| 5.0 units | 30 | 25 | 750 |
| 30 units | 15 | 16 | 240 |

Water was used as a substitute for insulin. The water was pumped into a container on a scale, and the weight of the liquid at various time points was used to assess pumping accuracy. Delivered bolus volumes were compared to the requested bolus volume delivery for minimum, intermediate, and maximum bolus volumes. Tables 5 – 7 below show average, minimum, and maximum bolus sizes observed, as well as the number of boluses which were observed to be within the specified range of each target bolus volume.

Table 5: Amount of fluid delivered after a 0.5 U bolus request

| Units delivered after a 0.5 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <25% | 25-75% | 75-90% | 90-95% | 95-105% | 105-110% | 110-125% | 125-175% | 175-250% | >250% |
| Number and percent of boluses | 0/375 - | 3/375 (1.1%) | 13/375 (3.5%) | 71/375 18.9%) | 253/375 (67.5%) | 29/375 (7.7%) | 5/375 (1.3%) | 0/375 - | 0/375 - | 0/375 - |

Table 6a Amount of fluid delivered after a 5.0 U bolus request – New pumps

| Units delivered after a 5.0 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <25% | 25-75% | 75-90% | 90-95% | 95-105% | 105-110% | 110-125% | 125-175% | 175-250% | >250% |
| Number and percent of boluses | 0/375 - | 0/375 - | 0/375 - | 8/375 (2.1%) | 362/375 (96.5%) | 5/375 (1.3%) | 0/375 - | 0/375 - | 0/375 - | 0/375 - |

Table 6b: Amount of fluid delivered after a 5.0 U bolus request – Aged pumps

| Units delivered after a 5.0 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <25% | 25-75% | 75-90% | 90-95% | 95-105% | 105-110% | 110-125% | 125-175% | 175-250% | >250% |
| Number and percent of boluses | 0/375 - | 0/375 - | 1/375 (0.3%) | 7/375 (1.9%) | 366/375 (97.6%) | 0/375 - | 1/375 (0.3%) | 0/375 - | 0/375 - | 0/375 - |

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Table 7: Amount of fluid delivered after a 30 U bolus request

| Units delivered after a 25 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <25% | 25-75% | 75-90% | 90-95% | 95-105% | 105-110% | 110-125% | 125-175% | 175-250% | >250% |
| Number and percent of boluses | 0/240 | 0/240 | 0/240 | 0/240 | 240/240 (100%) | 0/240 | 0/240 | 0/240 | 0/240 | 0/240 |

3. Occlusion Detection

Occlusion detection testing was conducted using 29 pumps for each delivery profile. To test the time between occlusion and pump alarm, pumps were physically occluded by closing the patient end of a connected infusion set after priming and either a 4 U bolus or a 0.1 or 1.0 U/hr basal rate was initiated. For each test, the time between occlusion and pump detection of occlusion was determined. The typical time to occlusion detection in the table below is the average for the samples measured and the maximum time is the absolute maximum. Results are presented in Table 8 below. After pumps alarmed, the occlusions were cleared, and the total amount of fluid delivered was measured. Typical volumes were 4 U.

Table 8: Delivery profiles used for occlusion detection testing

| | Typical time to occlusion detection | Maximum time to occlusion detection |
| --- | --- | --- |
| 4.0 U Bolus | 11 seconds | 15 seconds |
| 1.0 U/hr Basal | 2 hours 51 minutes | 3 hours 52 minutes |
| 0.1 U/hr Basal | 29 hours 29 minutes | 39 hours 25 minutes |

B. Other Supportive Instrument Performance Characteristics Data

1. Hazard Analysis

As part of this submission, the sponsor provided a comprehensive hazard analysis, in which design inputs and outputs, risks, and risk mitigations for hardware and software associated with proper functioning of the insulin pump were reviewed. 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

Human factors validation tests were conducted on the iLet System and described in more detail in the Decision Summary for K220916.

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3. Biocompatibility

The iLet ACE pump was tested for biocompatibility in accordance with International Standard ISO-10993-1 as an external device with a permanent duration of patient contact. The biocompatibility information was reviewed and found to be acceptable.

4. Sterility

The iLet accessories (i.e., iLet Go Connect and iLet Go Cartridge underwent gamma sterilization validation in accordance with ISO 11137-1 and ISO 11137-2 using the VDMax method. The sterility information was reviewed and found to be acceptable.

5. Insulin Compatibility and Stability

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

6. Additional Bench Testing

Additional verification testing that was conducted for the subject device is as follows:

| Functional Testing |
| --- |
| Water Ingress Testing |
| Drop Resistance Testing |
| Shock and Vibration Testing |
| Battery Single Charge Operational Life Testing |
| Battery Charge Time Testing |
| Low Battery Notification Testing |
| Cartridge Volume Testing |
| Cartridge Insertion Safety Testing |
| Prime Time Testing |
| Environmental Operation Testing |
| Alarm Pressure Level Testing |
| Operational Range Testing |
| Pump History Testing |
| Lead Screw Retraction Testing |
| Luer Lock Mechanical Integrity Testing |
| Fault Insertion Testing |

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7. Electromagnetic Compatibility and Wireless Coexistence

Electromagnetic compatibility (EMC), electromagnetic immunity (EMI) and wireless coexistence testing was performed for the iLet ACE 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.

9. Data Logging

Software verification testing has demonstrated the device records timestamped critical events, including information related to its state, user inputs, and device settings, as required by the special controls.

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" (issued on September 6, 2017) and found to be adequate to support and clearly specify expectations, requirements, and interface specifications to potential interoperable devices. In addition, the plans covered the sponsor's approach to working with third party manufacturers of digitally connected devices regarding contractual issues, 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 digitally 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 acceptable.

11. Software

Detailed information on software of the device was reviewed and found to be acceptable.

12. Cybersecurity

Detailed information on cybersecurity of the device was reviewed and found to be acceptable.

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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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