FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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. 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.

AI/ML Overview

This document describes a Special 510(k) Notification for a device modification, specifically updating the User Guide and Quick Reference Guide to indicate that the iLet bionic pancreas can be used with U-100 Fiasp® PumpCart® (insulin aspart) in a pre-filled 1.6 mL cartridge. The core device (iLet® ACE Pump) itself has not undergone significant technological changes. Because this is a modification to an already cleared device (K223846) to support compatibility with a new insulin formulation, the information provided focuses heavily on non-clinical testing for this specific change and cross-references prior clinical data.

Based on the provided text, a full description of acceptance criteria and the study proving the device meets all acceptance criteria (including for its original clearance) cannot be fully extracted, especially regarding clinical studies for the core device's efficacy. The document explicitly states: "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."

However, I can provide information relevant to this specific modification and what the document implies about the original clearance and its support for a new insulin type.

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

1. Table of Acceptance Criteria and Reported Device Performance (for this modification)

For this specific modification (Fiasp® compatibility), the criteria and performance are focused on non-clinical aspects related to the insulin itself, not the overall pump performance.

Acceptance Criteria Category (for Fiasp® compatibility)	Specific Criteria	Reported Device Performance/Conclusion
Non-Clinical Testing	In-Use Stability (with Fiasp®)	"The same test methods previously established in K223846 for In-Use Stability... were followed, with acceptance criteria specific to Fiasp." (Implies satisfactory performance based on these tests, otherwise, a Special 510(k) would not be granted).
	In-Use Compatibility (with Fiasp®)	"The same test methods previously established in K223846 for... In-Use Compatibility... were followed, with acceptance criteria specific to Fiasp." (Implies satisfactory performance).
	Preservative Efficacy (with Fiasp®)	"The same test methods previously established in K223846 for... Preservative Efficacy were followed, with acceptance criteria specific to Fiasp." (Implies satisfactory performance).
Clinical Testing	Clinical effectiveness and safety with Fiasp® (Algorithm)	"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." (This implies that efficacy/safety for the algorithm's interaction with Fiasp was previously established and met criteria in K220916).
Overall Conclusion	No New Questions of Safety or Effectiveness (Modification)	"Modifications to the device labeling do not raise any new or different questions of safety or effectiveness."

Note: The document does not provide the specific numerical data or thresholds for the acceptance criteria for In-Use Stability, Compatibility, or Preservative Efficacy, only that the same methods and Fiasp-specific criteria were met.

Regarding the other requested information, the document does not provide details for the iLet ACE Pump's initial clearance (K223846) or the clinical data for Fiasp (K220916). It only references their existence. Therefore, many of the subsequent points will indicate that the information is "Not provided in this document."

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

For this K231485 Special 510(k) (Fiasp® compatibility):
- Test set sample size: Not specified for the non-clinical tests (In-Use Stability, Compatibility, Preservative Efficacy). These would typically involve laboratory testing, not human subjects, so "sample size" refers to the number of test units.
- Data provenance: Not specified, but generally, such non-clinical testing is done in a lab environment.
- Retrospective/Prospective: Not applicable for non-clinical lab testing.
For K220916 (Clinical data for Fiasp® with the iLet Dosing Decision Software):
- Test set sample size: Not provided in this document.
- Data provenance: Not provided in this document.
- Retrospective/Prospective: Not provided in this document.

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

Not applicable to this Special 510(k) directly. This type of information is typically relevant for studies involving human interpretation or clinical endpoints. The current submission focuses on technical compatibility with a new insulin type.
For the referenced clinical study (K220916), this information is not provided in this document.

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

Not applicable to this Special 510(k) directly.
For the referenced clinical study (K220916), this information is not provided in this document.

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 insulin pump with an automated glycemic controller, not an AI-assisted diagnostic imaging device that involves human "readers."

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

The iLet ACE Pump's automated glycemic controller (iAGC) is inherently designed for "algorithm-only" performance in terms of calculating insulin needs based on iCGM input. While human interaction is part of its use (e.g., loading insulin, changing cartridges, responding to alerts), the core insulin delivery decisions are automated.
The document implies that the iAGC's performance (including with Fiasp) has been evaluated, "Clinical data to support use of Fiasp® (insulin aspart) with the iLet Dosing Decision Software was reviewed under K220916." However, the specifics of that study (e.g., comparison to human-in-the-loop) are not provided in this document.

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

For the non-clinical Fiasp® compatibility: Ground truth would be based on laboratory measurements and standards for insulin stability, compatibility with materials, and preservative efficacy.
For the referenced clinical study (K220916) concerning the iLet Dosing Decision Software with Fiasp®: The ground truth would likely involve clinically measured glucose levels, HbA1c, and adverse event rates, and potentially comparison to a standard of care for diabetes management. This information is not provided in this document.

8. The sample size for the training set:

Not provided in this document. (Relevant for the iAGC algorithm development, but not the current K231485 submission).

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

Not provided in this document. (Relevant for the iAGC algorithm development, but not the current K231485 submission).

Summary

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.