(29 days)
Yes
The device description explicitly mentions an "interoperable automated glycemic controller (iAGC)" which resides on the ACE pump hardware and is part of the "iLet Bionic Pancreas System" that works together to deliver insulin with "minimal user oversight". While the terms AI or ML are not directly used, the concept of an "automated glycemic controller" that makes dosing decisions based on iCGM input and aims for minimal user intervention strongly suggests the use of an algorithm that learns or adapts to manage blood glucose, which is characteristic of AI/ML in this context. The reference to "iLet Dosing Decision Software" in the performance studies further supports this interpretation.
Yes
The device is intended to deliver insulin to people with diabetes mellitus, which is a therapeutic intervention aimed at managing a medical condition.
No
The device is described as an "alternate controller enabled (ACE) pump intended to deliver insulin." Its primary function is to administer insulin, not to diagnose a condition.
No
The device description explicitly states that the iLet ACE Pump includes a "motor-drivetrain pumping mechanism" and is a "collection of wearable medical devices," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the iLet ACE Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is typically used for diagnosis, monitoring, or screening.
- iLet ACE Pump Function: The iLet ACE Pump is described as a device that delivers insulin under the skin. It works in conjunction with an iCGM and iACC to manage blood glucose levels. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for delivering insulin based on input from other devices, not for analyzing samples.
Therefore, the iLet ACE Pump falls under the category of a therapeutic device (delivering medication) rather than an in vitro diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found".
Intended Use / 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 (iACC), 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.
Product codes
QFG
Device Description
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 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, iCGM 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
under the skin
Indicated Patient Age Range
6 years of age or older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No new clinical testing was required for this Special 510(k) notification. Clinical data to support use of Fiasp® (insulin aspart) with the iLet Dosing Decision Software was reviewed under K220916.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Beta Bionics, Inc. Liz Cooper Senior Regulatory Affairs Specialist 300 Baker Avenue, Suite 301 Concord, MA 01742
Re: K231485
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: May 22, 2023 Received: May 23, 2023
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 (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 located 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.
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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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
2
Indications for Use
510(k) Number (if known) K231485
Device Name iLet® ACE Pump
Indications for Use (Describe)
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 (iACC), 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.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 201 Subpart D) |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
X 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."
3
510(k) Summary K231485: Device Modification - iLet® ACE Pump Prepared: June 16, 2023
| Company: | Beta Bionics, Inc.
300 Baker Avenue, Ste. 301, Concord, MA 01742
(978) 602-6239 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Liz Cooper
Senior Regulatory Affairs Specialist
lcooper@betabionics.com
(732) 275-5848 |
| 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, QFC |
| Predicate Device: | iLet® ACE Pump (Beta Bionics, Inc., K223846) |
Purpose of Special 510(k) Notification:
The User Guide and Quick Reference Guide are being updated to indicate that the iLet bionic pancreas can be used with U-100 Fiasp® PumpCart® (insulin aspart) in a pre-filled 1.6mL cartridge.
No significant changes have been made to the technological characteristics of the device.
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 Description and Technological Characteristics:
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 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, iCGM and infusion set. The
4
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 Bionic Pancreas System components are shown in Figure 1 below.
Image /page/4/Figure/1 description: The image shows a medical device and its components. The components are labeled with letters from a to i. The device includes a cannula, flexible tubing, a syringe, and a charger. The image appears to be a diagram or illustration of the device and its parts.
Figure 1: iLet Bionic Pancreas System
The iLet Bionic Pancreas System: (a) iLet ACE Pump; (b) iLet Cartridge (ready to fill cartridge); (c) Filling Syringe; (d) Needle; (e) iLet Connection adapter); (f) Infusion Set Base and infusion tube (g) Insulin Infusion Set, (h) iCGM (sensor and transmitter, example shown), and (i) iLet Charger (charging pad, micro-USB cable with power adapter)
For a better understanding of how the iLet bionic pancreas is used spatially on a person, it is shown applied to a human body in Figure 2 below. The iCGM is shown communicating with the iLet via Bluetooth. The iLet ACE Pump gets glucose readings from the iCGM every 5 minutes and the iAGC uses that information as one of the inputs to calculate the person's insulin needs.
5
Image /page/5/Figure/0 description: This image shows a diagram of a continuous glucose monitoring (CGM) system. The system includes a CGM sensor that continuously measures blood glucose levels, an insulin set with a cannula that delivers insulin under the skin, and an iLet device that receives input from the CGM and uses a control algorithm to analyze and regulate blood glucose levels. The insulin set side view shows the cannula inserted under the skin. The iLet device receives input from the CGM and uses a control algorithm to analyze and regulate blood glucose level.
Figure 2: iLet Bionic Pancreas on a Person with Diabetes
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 figure above shows injected from the iLet through an infusion set. The infusion set must be placed at least 3 inches away from the iCGM 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 iCGM sensor need to be changed as indicated in the manufacturers' labeling.
6
| Element of
| Comparison | iLet ACE Pump (Predicate Device) (K223846) | Subject Device |
|---|---|---|
| Intended Use | An ACE pump which is intended to work with an iCGM | |
| and iAGC to deliver insulin subcutaneously for the | ||
| management of diabetes mellitus | Identical | |
| Pump Type | Alternate controller enabled (ACE) infusion pump | Identical |
| Specific Drug / | ||
| Biologic Use | U-100 Insulin | |
| System tested with NovoLog, Humalog | U-100 Insulin | |
| System tested with NovoLog, | ||
| Humalog, and Fiasp | ||
| Prescription | ||
| Status | Prescription Device | Identical |
| Size | 9.10 cm L X 5.90 cm W X 1.50 cm H | Identical |
| Weight | 110 grams (without infusion set) | Identical |
| 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 |
Table 1: Comparison of the Modified Device to the Cleared Device
Discussion of Non-Clinical Testing:
The same test methods previously established in K223846 for In-Use Stability, In-Use Compatibility, and Preservative Efficacy were followed, with acceptance criteria specific to Fiasp.
Discussion of Clinical Testing
No new clinical testing was required for this Special 510(k) notification. Clinical data to support use of Fiasp® (insulin aspart) with the iLet Dosing Decision Software was reviewed under K220916.
Conclusions
The modified device has been evaluated to be as safe and effective as the Predicate Device. Modifications to the device labeling do not raise any new or different questions of safety or effectiveness.