iLet ACE Pump

K253976 · Beta Bionics, Inc. · QFG · Apr 30, 2026 · Clinical Chemistry

Device Facts

• Record ID: K253976
• Device Name: iLet ACE Pump
• Applicant: Beta Bionics, Inc.
• Product Code: QFG · Clinical Chemistry
• Decision Date: Apr 30, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5730
• Device Class: Class 2
• Attributes: Therapeutic, PCCP, 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

The iLet ACE Pump is an alternate controller enabled (ACE) infusion pump for subcutaneous insulin delivery. It receives glucose data every 5 minutes from an integrated continuous glucose monitor (iCGM) and uses an interoperable automated glycemic controller (iAGC) to calculate insulin needs. The device features a touchscreen for meal announcements, alert responses, and glucose viewing; a motor-drivetrain mechanism for insulin delivery; and a wirelessly rechargeable battery. It is intended for single-patient home use. The device includes a 'Pause Insulin' feature for temporary suspension of delivery. The healthcare provider uses the system to automate insulin dosing based on real-time sensor data, reducing the burden of manual calculations and potentially improving glycemic control. The device is not MR safe and must be removed for imaging procedures like MRI, CT, or X-ray.

Clinical Evidence

No new clinical testing was required for this submission. The device relies on previously established clinical performance and bench testing supporting insulin compatibility.

Technological Characteristics

Alternate controller enabled (ACE) infusion pump; motor-drivetrain mechanism; color LCD display; wirelessly rechargeable lithium battery; IPX8 moisture protection; dimensions 49x91x16 mm; weight 95g. Connectivity via Bluetooth for CGM data. Complies with 21 CFR 880.5730 special controls.

Indications for Use

Indicated for people 6 years of age or older with diabetes mellitus. Contraindicated for use in people who are pregnant, on dialysis, or critically ill. Do not use if taking hydroxyurea.

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

• iLet ACE Pump (K252770)

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
K253976

B Applicant
Beta Bionics, Inc.

C Proprietary and Established Names
iLet ACE Pump

D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QFG | II | 21 CFR 880.5730 - Alternate Controller Enabled Infusion Pump | CH - Clinical Chemistry |

## E Purpose for Submission:

Modification to the iLet ACE Pump cleared under K252770 with the following changes:

- Implementation of a color LCD display, updated charging electronics for efficiency, replaced end-of-life components, and a reduction in the size of the iLet ACE Pump by removing unused space occupied by the alternate drug channel.
- Implementation of a Pause Insulin feature that allows a user to temporarily suspend insulin delivery analogous to shutting off the pump and manually reconnecting.
- The User Guide and Quick Reference Guide are being updated to indicate that the iLet bionic pancreas can be used with the vial presentation of U-100 Fiasp (insulin aspart).
- Establish a predetermined change control plan for addition of a new FDA-approved insulin product presentation of a previously FDA-approved insulin product to the list of compatible insulin products.

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

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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.

Do not use the iLet ACE Pump and Dosing Decision Software if you are unable or unwilling to test blood glucose (BG) levels with an SMBG meter when input from the iCGM is not available.

Do not use the iLet ACE Pump and Dosing Decision Software if you are unable or unwilling to recognize and respond to iLet safety alerts.

Do not use the iLet System if you are taking hydroxyurea, also known as Hydrea. This medication is sometimes used in the treatment of blood disorders and some kinds of cancer. The use of hydroxyurea can result in falsely elevated sensor glucose readings. The iLet System relies on sensor glucose readings to adjust insulin, provide insulin doses, and provide high and low glucose alerts. If the iLet System receives sensor readings that are higher than actual glucose levels, it could result in missed hypoglycemia alerts and potential errors in diabetes management, such as too much insulin being delivered. The use of hydroxyurea can also result in errors when reviewing, analyzing, and interpreting historical patterns for assessing glucose control.

Do not use the iLet ACE Pump and Dosing Decision Software in people who are pregnant, on dialysis or critically ill. The iLet ACE Pump and Dosing Decision Software have not been studied in these populations.

The iLet System is only for use with a compatible iCGM. When using the iLet Device, wear an iCGM.

Do not expose your iLet System, including your iLet Device and steel infusion set to X-ray (screening at airports or other facilities and procedures), Computed Tomography (CT) scan, Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET) scan.

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

Your iLet System, including your iLet Device and steel infusion set, is not magnetic resonance (MR) safe. Your iLet System must be left outside of the procedure room if you are receiving an MRI scan.

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

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Depending on the equipment being used during general anesthesia, your iLet System may need to be removed. You do not need to remove iLet System components for electrocardiograms (EKGs) or colonoscopies. Metal detectors and body scanners at airports are also acceptable. Remove your iLet System prior to any laser surgery as some lasers can create interference and cause your iLet System to alert you.

Your iLet System is for single patient use only. Sharing any part of your iLet System may lead to transfer of germs, infection, or over/under delivery of insulin.

Use of accessories, cables, adapters, and chargers other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

The iLet ACE Pump and Dosing Decision Software were evaluated in an outpatient setting for home use. The system has not been evaluated in hospitalized people.

Avoid exposure of your iLet Device to temperatures below 40°F (5°C) or above 104°F (40°C). Insulin can freeze at low temperatures and degrade at high temperatures. Insulin exposed to conditions outside of the manufacturer's recommended ranges can affect the safety and performance of your iLet System.

## III Device Description

The iLet ACE Pump with the iLet Dosing Decision Software is a component of the iLet System that consists with the following:

a. The iLet ACE Pump: automatically delivers insulin subcutaneously based on input from an integrated continuous glucose monitor (iCGM) and/or a self-monitoring blood glucose (SMBG) meter, and an interoperable automated glycemic controller (iAGC). In the absence of input from an iCGM, the iAGC can instead use blood glucose entries from an SMBG meter. Insulin is injected from the iLet ACE Pump through an infusion set.

b. iLet Cartridge: Glass container with a soft membrane and a red rubber plunger is filled with insulin and inserted into the iLet ACE Pump.

c. Insulin Infusion Set: Contains the insulin infusion set base, flexible tubing, and inserter, and is used to attach the insulin infusion set base to user body.

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 (CGM) and an interoperable automated glycemic controller (iAGC) in people 6 years of age or older with diabetes mellitus. The iLet ACE Pump gets glucose readings from the CGM every 5 minutes and the iAGC uses that information as one of the inputs to calculate the person's insulin needs.

The iLet ACE Pump includes a motor–drivetrain pumping mechanism, which independently actuates the delivery of insulin from a cartridge that is separately loaded into the iLet. Insulin is injected under the skin via continuous infusion. The infusion set must be placed at least 3 inches away from the CGM sensor.

The iLet ACE Pump has a touchscreen where users can access the meal announcement feature, view their blood glucose level, and respond to any alerts. The circular icon shown in the middle

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of the screen rotates when the iLet device is running. The iLet ACE Pump also has a Sleep/Wake button on the top that the user touches to turn the touchscreen and backlight on and off.

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 need to be changed every 3 days.

## IV Substantial Equivalence Information:

A Predicate Device Name(s):

iLet ACE Pump

B Predicate 510(k) Number(s):

K252770

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K253976 | K252770 |
| --- | --- | --- |
| Device Trade Name | iLet ACE Pump | iLet ACE Pump |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | 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. | Same |
| General Device Characteristic Differences | | |
| Drug Use | U-100 Insulins: NovoLog, Kirsty, Humalog, Fiasp, and Fiasp PumpCart. | U-100 Insulins: NovoLog, Kirsty, Humalog, and Fiasp PumpCart. |
| Pause Insulin feature | Present | Not present |
| Display size and color | Color: 49W × 91L × 16H mm | Monochromatic: 59W × 91L × 15H mm |

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Predetermined Change Control Plan (PCCP):

In addition to the similarities and differences between the candidate and predicate devices listed in the table above, the candidate device has an authorized PCCP to add a new, prespecified insulin product presentation of a previously FDA-approved insulin product to the list of compatible insulin products. See Section VI.C for more information.

V Standards/Guidance Documents Referenced:

- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software - Software life cycle processes
- ISO 14971 Third Edition 2019-12, Medical devices - Application of risk management to medical devices
- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- 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 Edition 3.2 2020-07 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION, 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 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION, 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 Edition 2.1 2020-07 CONSOLIDATED VERSION, 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
- AAMI TIR69:2017/(R2020), Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems

VI Performance Characteristics:

A. Non-Clinical Performance

1. Basal Delivery Accuracy

To assess basal delivery accuracy, 44 (29 new and 15 aged), 30 (15 new and 15 aged), and 30 (15 new and 15 aged) pumps were respectively tested at low (0.1U/hr), medium (1.0U/hr), and high (10.0 U/hr) basal rates. The aged pumps went through simulated use cycles representing four (4) years of use. For both aged and unaged pumps, all cartridges were new. Water used as a substitute for insulin was pumped into a container on a scale and the weight of the liquid at various time points was used to assess pumping accuracy.

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The following tables report the typical basal performance (median) observed, along with the lowest and highest results observed for the low, medium, and high basal rate settings for all pumps tested with no warmup period.

Table 1.a: Amount of fluid delivered after 1, 6, and 12 hours with $0.1\mathrm{U / hr}$ (low) basal rate setting (new pump)

| 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 | 0.09 U | 0.56 U | 1.12 U |
| [min, max] | [0.00, 0.13] | [0.29, 0.67] | [0.79, 1.31] |

Table 1.b: Amount of fluid delivered after 1, 6, and 12 hours with $0.1\mathrm{U / hr}$ (low) basal rate setting (aged pump)

| 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 | 0.09 U | 0.55 U | 1.11 U |
| [min, max] | [0.00, 0.12] | [0.24, 0.64] | [0.71, 1.23] |

Table 2.a: Amount of fluid delivered after 1, 6, and 12 hours with $1.0\mathrm{U / hr}$ (medium) basal rate setting (new pump)

| 1 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 1 U | 6 U | 12 U |
| Median amount delivered | 0.99 U | 5.95 U | 11.90 U |
| [min, max] | [0.80, 1.17] | [5.50, 6.15] | [11.23, 12.15] |

Table 2.b: Amount of fluid delivered after 1, 6, and 12 hours with $1.0\mathrm{U / hr}$ (medium) basal rate setting (aged pump)

| 1 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 1 U | 6 U | 12 U |
| Median amount delivered | 0.99 U | 5.95 U | 11.93 U |
| [min, max] | [0.79, 1.28] | [5.47, 6.28] | [11.17, 12.22] |

Table 3.a: Amount of fluid delivered after 1, 6, and 12 hours with $10.0\mathrm{U / hr}$ (high) basal rate setting (new pump)

| 10 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 10 U | 60 U | 120 U |
| Median amount delivered | 9.92 U | 59.52 U | 118.97 U |
| [min, max] | [9.20, 10.50] | [58.36, 60.49] | [117.43, 120.46] |

Table 3.b: Amount of fluid delivered after 1, 6, and 12 hours with $10.0\mathrm{U / hr}$ (high) basal rate setting (aged pump)

| 10 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 10 U | 60 U | 120 U |
| Median amount delivered | 10.00 U | 60.04 U | 120.02 U |
| [min, max] | [9.74, 10.19] | [59.29, 60.54] | [118.65, 120.84] |

# 2. Bolus Delivery Accuracy

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To assess bolus delivery accuracy, 15 new and 15 aged pumps for a total of 30 unique pumps were tested for each bolus size by delivering minimum, intermediate, and maximum bolus amounts (0.5, 5, and 30 Units). The aged pumps went through simulated use cycles representing four (4) years of use. For both aged and unaged pumps, all cartridges were new. Water used as a substitute for insulin 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 number of total and consecutive boluses delivered in this testing for each delivery volume is described in Table 4 below:

Table 4: Summary of bolus testing protocol

| Bolus size (units) | Pumps | Number of pumps tested | Consecutive boluses per pump | Total boluses |
| --- | --- | --- | --- | --- |
| 0.5 units | New | 15 | 25 | 375 |
| | Aged | 15 | 25 | 375 |
| 5 units | New | 15 | 25 | 375 |
| | Aged | 15 | 25 | 375 |
| 30 units | New | 15 | 16 | 240 |
| | Aged | 15 | 16 | 240 |

The actual bolus volume delivered was compared to the expected bolus volume for minimum, intermediate, and maximum boluses. Tables 5-7 below show the number (and %) of boluses within the specified range of each target bolus volume.

Table 5.a: Amount of fluid delivered after a 0.5 U bolus request (new pump)

| 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 - | 2/375 - | 5/375 (1.3%) | 33/375 (8.8%) | 319/375 (85.1%) | 16/375 (4.3%) | 2/375 (0.5%) | 0/375 - | 0/375 - | 0/375 - |

Table 5.b: Amount of fluid delivered after a 0.5 U bolus request (aged pump)

| 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 - | 2/375 - | 2/375 (0.5%) | 29/375 (7.7%) | 319/375 (85.1%) | 22/375 (5.9%) | 3/375 (0.8%) | 0/375 - | 0/375 - | 0/375 - |

Table 6.a: Amount of fluid delivered after a 5 U bolus request (new pump)

| 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 - | 0/375 - | 375/375 (100%) | 0/375 - | 0/375 - | 0/375 - | 0/375 - | 0/375 - |

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Table 6.b: Amount of fluid delivered after a 5 U bolus request (aged pump)

| 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 | 6/375 (1.6%) | 369/375 (98.4%) | 0/375 | 0/375 | 0/375 | 0/375 | 0/375 |

Table 7.a: Amount of fluid delivered after a 30 U bolus request (new pump)

| Units delivered after a 30.0 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 | 0/240 | 0/240 | 0/240 | 0/240 | 240/240 (100%) | 0/240 | 0/240 | 0/240 | 0/240 | 0/240 |

Table 7.b: Amount of fluid delivered after a 30 U bolus request (aged pump)

| Units delivered after a 30.0 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 | 0/240 | 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 and 3 delivery profiles: 5U Bolus, 0.1U/hr basal, and 1U/hr Basal. The pumps were tested for the time between occlusion and pump alarm sequentially and for the 3 delivery profiles. 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.

Table 8: Occlusion detection testing

| | Typical time to occlusion detection | Maximum time to occlusion detection |
| --- | --- | --- |
| 5 U Bolus | 29 seconds | 1 minute |
| 1 U/hr basal | 2 hours and 30 minutes | 3 hours and 20 minutes |
| 0.1 U/hr Basal | 25 hours and 2 minutes | 37 hours and 30 minutes |

The insulin delivered until an occlusion alarm occurred was within the acceptance criteria of 4U.

B. Clinical Studies:

NA

C. Other Supportive Device Performance Characteristics Data

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4. Additional Bench Testing

In addition to the performance testing described above, 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, including:

a. Delivery accuracy was tested at high and low set points for temperature, pressure, and humidity with 29 unique pumps.
b. Delivery accuracy was tested under a total of 21 static and dynamic environmental profiles of temperature and pressure with 3 unique pumps.
c. Delivery accuracy was tested with 29 unique pumps after exposure to drop and shock and vibe.
d. Delivery accuracy and connectivity were tested with 3 unique pumps after exposure to stressors sequentially: chemicals, shock, vibe, drop, and ingress of water.
e. Ingress of water was tested to achieve IPX8 using 15 pumps.

5. Insulin Compatibility

The provided information supports compatibility with the vial presentation of U-100 Fiasp (insulin aspart) for up to 3 days.

6. Software

The software documentation provided was determined to be adequate to support substantial equivalence.

7. Electromagnetic compatibility and Electrical Safety

Electromagnetic compatibility and electromagnetic immunity testing was performed for the pump according to IEC 60601-4-2. All tests demonstrated that the device would perform as expected in the home healthcare environment.

8. Wireless Coexistence

Evaluated per ANSI/IEEE C63.27-2021, as well as range and household coexistence protocols. Reports demonstrated robust BLE communication in coexistence, range, and household environments with no loss of safety or performance.

9. Leveraged Information

a. Risk analysis: The System Risk Analysis and Risk management Plan and Report were leveraged from the predicate device cleared under K252770.
b. Biocompatibility: Since there are no changes to tissue contacting materials in this submission, biocompatibility testing was leveraged from previous versions of the device cleared under K223846 and K220916.
c. Sterility: Sterility was leveraged from previous versions of the device cleared under K252770.
d. Human Factors: Human Factors testing was leveraged from the original device cleared under K220916. An evaluation of the Human Factors decision flow chart was performed for the device with the color display and the Pause Insulin Feature. There are no new critical tasks introduced, nor are existing critical tasks impacted. The existing Human Factors validation results continue to be valid.
e. Cybersecurity: Cybersecurity of the device is unchanged compared to the device cleared under K252770.

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f. Interoperability: Interoperability risk assessment is unchanged compared to the device cleared under K252770.

10. Predetermined Change Control Plan (PCCP)

The PCCP documents how the labeling for the iLet pump will be modified to add a new, pre-specified FDA-approved presentation of a previously FDA-approved insulin product to the list of compatible insulin products.

The performance evaluation methods for validating this modification are described below:

- In-use compatibility testing between the iLet insulin pump and the new insulin product presentation will be conducted following a specified protocol. The same protocol was previously used to establish insulin compatibility with another presentation of the same insulin product.
- The pre-specified acceptance criteria include limits on insulin product quality attributes specific to the particular insulin product.

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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