The iLet ACE Pump described herein includes changes to the graphic user interface (GUI) and alarms to improve the safety of the device. Instructions were added to the User Guide and Quick Reference Guide to advise users regarding CGM sensor calibration.

No significant changes have been made to the technological characteristics of the device.

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 provides a graphical user interface and alerts to interact with the iLet delivery system and an iAGC. The iLet Bionic Pancreas System is a collection of wearable medical devices that work together to deliver insulin with minimal user oversight. The iLet System is made up of the iLet bionic pancreas (consisting of the iLet ACE Pump (with accessories) and iAGC which resides on the ACE pump hardware), ACE pump disposables and accessories, CGM and infusion set. The insulin is filled for iLet use by a user, in a ready-to-fill cartridge (from an insulin vial supplied by a drug manufacturer) with the use of the syringe and needle.

The iLet System consists of the iLet ACE Pump (K231485) with iLet Dosing Decision Software (K232224) and disposable consumables.

The iLet System is only for use with a compatible CGM and U-100 rapid acting insulin.

The CGM communicates with the iLet via Bluetooth. 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 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. The insulin infusion set and CGM sensor need to be changed as indicated in the manufacturers' labeling.

AI/ML Overview

The provided FDA 510(k) Clearance Letter for the iLet ACE Pump (K252770) describes a device modification to an already cleared predicate device (iLet ACE Pump, K231485). As such, the information regarding acceptance criteria and the study that proves the device meets the acceptance criteria is focused on verifying that the changes did not introduce new safety or effectiveness concerns and that the device remains substantially equivalent to its predicate.

Based on the provided document, the focus of the clearance is on non-clinical testing related to software and labeling changes, rather than a new clinical performance study establishing general efficacy and safety from scratch.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a device modification, the "acceptance criteria" are predominantly related to the successful verification of the specific changes made and continuous compliance with existing standards. The "reported device performance" refers to the outcome of these verification activities.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Software Functionality	Changes to Graphic User Interface (GUI) and alarms perform as expected.	All software verification tests passed. Changes performed as expected and did not produce unintended consequences.
Safety - Unintended Consequences	No unintended consequences from GUI and alarm software changes.	All software verification tests passed. No unintended consequences reported.
Labeling Compliance	Labeling is sufficient and satisfies applicable requirements of 21 CFR 801, 21 CFR 809, and 21 CFR 880.5730.	Labeling was reviewed by the FDA and found to be sufficient and satisfying applicable requirements.
Special Controls Compliance	Device meets all Special Controls for 21 CFR 880.5730 (Alternate controller enabled infusion pumps, product code QFG).	Device meets all Special Controls.
Substantial Equivalence	Modified device is as safe and effective as the Predicate Device and does not raise new or different questions of safety or effectiveness.	The modified device has been evaluated to be as safe and effective as the Predicate Device. Modifications do not raise any new or different questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document does not specify a numerical sample size for software verification testing (e.g., number of test cases, number of alarm scenarios). It broadly states "Software design verification testing was performed."
Data Provenance: The data is generated from non-clinical software verification testing performed internally by Beta Bionics, Inc. The document does not specify country of origin for this testing but implies it aligns with internal design controls and regulatory requirements. It is a "prospective" evaluation of the modified software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in this context. For software verification testing of GUI and alarms, the "ground truth" is defined by the device's functional specifications and regulatory requirements. The testing is performed against these engineering and regulatory specifications, not against expert clinical consensus or pathology findings.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Software verification testing involves comparing observed software behavior against predefined requirements and expected outcomes, not an adjudication process by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an Alternate Controller Enabled (ACE) infusion pump, which delivers insulin based on CGM input and an automated glycemic controller (iAGC). It is not an AI-assisted diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC study with human readers is not relevant to this specific clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The "Software Design Verification Testing" implies a standalone evaluation of the modified GUI and alarms. This testing would assess the functionality of these software components in a controlled environment, confirming they operate according to specifications without direct real-time human intervention in the loop of the test itself (though a human designed and executed the tests). The iAGC (automated glycemic controller) within the pump itself operates autonomously based on CGM input, representing an "algorithm only" component that was part of the original device's clearance. This specific 510(k) did not require new clinical performance testing for the iAGC algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the software modifications addressed in this 510(k), the "ground truth" is primarily based on:

Functional Specifications: The intended design and behavior of the GUI and alarms as defined by Beta Bionics.
Regulatory Requirements: Compliance with relevant FDA regulations for medical device software and labeling.

8. The sample size for the training set

Not applicable. This 510(k) is for a device modification involving GUI and alarm changes. The underlying iAGC algorithm (which would have had a "training set" in its development phase) was previously cleared (K231485 & K232224). No new training or re-training of the core control algorithm was indicated by these specific modifications.

9. How the ground truth for the training set was established

Not applicable to this specific 510(k). For the original iAGC algorithm, the "ground truth" for its training (if an AI/ML approach was used) would have been established through extensive physiological modeling, clinical trial data, and expert endocrinologist input regarding optimal glycemic control targets and safety parameters. However, this information is not part of the provided document for this modification submission.

Summary

FDA 510(k) Clearance Letter - iLet ACE Pump

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.06.10

September 29, 2025

Beta Bionics, Inc.
Liz Cooper
Principal Regulatory Affairs Specialist
300 Baker Ave, Suite 301
Concord, Massachusetts 01742

Re: K252770
Trade/Device Name: iLet ACE Pump
Regulation Number: 21 CFR 880.5730
Regulation Name: Alternate controller enabled infusion pump
Regulatory Class: Class II
Product Code: QFG
Dated: August 29, 2025
Received: September 2, 2025

Dear Liz Cooper:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Page 2

K252770 - Liz Cooper
Page 2

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

JOSHUA BALSAM -S

Joshua M. Balsam, Ph.D.
Branch Chief
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 3

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K252770

Device Name: iLet ACE Pump

Indications for Use (Describe):

Type of Use (Select one or both, as applicable):
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 4

510(k) K252770 Summary

Device Modification - iLet® ACE Pump

Prepared: September 25, 2025

Company: Beta Bionics, Inc.
300 Baker Avenue, Ste. 301,
Concord, MA 01742

Contact Person: Liz Cooper
Principal Regulatory Affairs Specialist

Product Trade Name: iLet® ACE Pump

Common Name: Alternate controller enabled infusion pump (ACE pump)

Classification Name: Alternate controller enabled infusion pump

Regulation Number, Device Class and Pro Code: 21CFR 880.5730, Class II, QFG

Predicate Device: iLet® ACE Pump (Beta Bionics, Inc., K231485)

Device Description:

No significant changes have been made to the technological characteristics of the device.

The iLet System consists of the iLet ACE Pump (K231485) with iLet Dosing Decision Software (K232224) and disposable consumables.

The iLet System is only for use with a compatible CGM and U-100 rapid acting insulin.

Page 5

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.

Table 1: Comparison of the Modified Device to the Cleared Device

Feature	iLet ACE Pump (Predicate Device) (K231485)	iLet ACE Pump (Subject Device)
Intended Use	An ACE pump which is intended to work with an CGM and iAGC to deliver insulin subcutaneously for the management of diabetes mellitus.	Identical
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 (CGM) 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.	IdenticalThe indications for use are unchanged for this submission.
Pump Type	Alternate controller enabled (ACE) infusion pump	Identical
Specific Drug / Biologic Use	U-100 InsulinSystem tested with NovoLog, Humalog, and Fiasp PumpCart®	Identical
Prescription Status	Prescription Device	Identical
Size	59 W X 91 L X 15 H millimeters	49 W X 91 L X 16 H millimeters
Weight	110 grams (without infusion set)	95 grams (without infusion set)
LCD	Monochromatic	Color
Operating Conditions	Temperature: 41°F (5°C) to 104°F (40°C)Humidity: 15% to 90% RH non-condensing	Identical
Atmospheric Pressure	15.4 to 10.2 psia (Relative altitude -1300 feet to 10,000 feet)	Identical
Moisture Protection	IPX8: Protected against immersion in water for up to 12 feet for 30 minutes	Identical
Maximum Basal Rate	0 – 11.5 units/hr	Identical
Power Requirements	Rechargeable lithium battery powered device, wireless charging through a charging pad connected to a DC Adapter	Identical

Page 6

Non-Clinical Testing and Compliance with Special Controls:

Software Design Verification Testing: Software verification testing was performed to verify that the changes to the graphic user interface (GUI) and alarms performed as expected and did not produce any unintended consequences. All tests passed.
Labeling: The iLet ACE Pump labelling was reviewed by the FDA. Labelling is sufficient and satisfies applicable requirements of 21 CFR 801, 21 CFR 809, and 21 CFR 880.5730.
Special Controls: The device meets all Special Controls for this product as required by 21 CFR 880.5730 for Alternate controller enabled infusion pumps, product code QFG.

Clinical Performance:

No new clinical testing was required for this Special 510(k) notification.

Design Controls:

The iLet ACE Pump was specified and developed by Beta Bionics. Beta Bionics complies with the FDA Quality System Regulation as specified in 21 CFR 820, as well as ISO 13485.

Conclusions:

The modified device has been evaluated to be as safe and effective as the Predicate Device. Modifications to the device GUI, alarms, and labeling do not raise any new or different questions of safety or effectiveness.

Regulation Number and Section

§ 880.5730 Alternate controller enabled infusion pump.

(a)
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.(b)
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 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.