(150 days)
Not Found
Unknown
The summary mentions an "interoperable automated glycemic controller (iAGC)" which is responsible for determining insulin delivery based on CGM input. While this function could potentially utilize AI/ML algorithms, the summary does not explicitly state that AI/ML is used within the iAGC or the iLet system. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found". Without further information about the iAGC's internal workings, it's impossible to confirm the presence of AI/ML.
Yes
The device is described as an "ACE pump intended to deliver insulin under the skin," which directly administers a substance for medical treatment.
No
The iLet ACE Pump is intended to deliver insulin based on input from an iCGM and iAGC; it is a therapeutic device that administers treatment, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description explicitly states that the iLet ACE Pump includes a "motor-drivetrain pumping mechanism" and a "wirelessly rechargeable battery," indicating the presence of hardware components beyond just software.
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 derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- iLet ACE Pump Function: The iLet ACE Pump is an insulin delivery system. It receives information from a continuous glucose monitor (iCGM) and an automated glycemic controller (iAGC) and then delivers insulin under the skin. It does not analyze biological specimens.
The device's function is to administer a substance (insulin) based on external data, not to perform diagnostic tests on samples.
N/A
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 (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.
Product codes (comma separated list FDA assigned to the subject device)
OFG
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 may reside 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. 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 (including tubing and base) needs to be changed every 2-3 days for infusion sets with a teflon cannula (Convatec Inset™ and Inset™ 30) and every 1-2 days for infusion sets with a steel cannula (Convatec Contact™ Detach) as indicated in the infusion set manufacturers' labeling. The iCGM sensor needs to be changed every 10 days.
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)
Non-Clinical Performance Data
Analytical Performance
The iLet ACE Pump was tested for dose delivery accuracy and occlusion detection. All tests passed.
Other Supportive Test Data
- Biocompatibility, Sterility, Insulin Compatibility and Stability, Electrical EMC and . Safety, CGM connectivity, Packaging/ Shipping Integrity and Mechanical Tests: The iLet ACE Pump and accessories were subjected to the above tests as applicable. All tests passed.
- Data logging and Interoperability: The iLet ACE Pump has been validated for logging timestamped events, including information related to its state, user inputs, and device settings, as required by special controls. All tests passed. The iLet ACE Pump software has been validated to be interoperable with all connected devices.
- Cybersecurity: The iLet ACE Pump has incorporated adequate mitigations for cybersecurity risks. A cybersecurity analysis was performed using the draft FDA guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Issued October 18, 2020, and the principles outlined in the FDA guidance. Postmarket Management of Cybersecurity in Medical Devices - Issued December 28, 2016. Beta Bionics has provided a software bill of materials and penetration testing.
- Labeling and Training: The iLet bionic pancreas device labeling and training for users and healthcare practitioners was reviewed by the FDA. Labeling is sufficient and satisfies applicable requirements of 21 CFR 801 and 21 CFR 809.
Human Factors and Clinical Performance Data
Human Factors
Beta Bionics executed a human factors and usability engineering process that followed and complied with FDA-recognized standards IEC62366:2015-1 and HE75:2009 as well as the FDA's guidance document. Applying Human Factors and Usability Engineering to Medical Devices - Issued February 3, 2016. Human Factors validation study testing was conducted with the iLet bionic pancreas (iLet ACE Pump with the iLet Dosing Decision Software installed) in a simulated use condition, including associated training and accompanying documentation. All critical tasks were tested in the validation study. The results of the validation study demonstrated the iLet system has been found to be safe and effective for the intended users for its intended uses in its intended use environment.
Clinical Performance
A clinical study was not required for the iLet ACE Pump as insulin delivery from the device can be verified through bench performance testing and use of the device was validated through a human factors validation study (described above).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 19, 2023
Beta Bionics, Inc. Vikram Verma Sr. Director, Regulatory Affairs 300 Baker Avenue, Suite 301 Concord, MA 01742
Re: K223846
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: OFG Dated: May 5, 2023 Received: May 5, 2023
Dear Vikram Verma:
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
1
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 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,
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. Acting Director 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) K223846
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 (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.
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) |
|---|---|
| ----------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
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K223846 510(k) Summary
Manufacturer
| 510(k) Owner: | Beta Bionics, Inc. |
|---|---|
| Address: | 300 Baker Avenue, Ste. 301, Concord, MA 01742 |
| Phone: | (978) 602-6239 |
Contact Person
| Name of Contact Person: | Vikram Verma |
|---|---|
| E-mail: | vverma@betabionics.com |
| Date of Summary Preparation: | May 17, 2023 |
Device Names and Classification
Trade Name of Device: iLet® ACE Pump
Common Name of Device: Alternate controller enabled infusion pump (ACE pump)
Classification Name: Alternate controller enabled infusion pump (21 CFR 880.5730, QFG)
Predicate Devices
t:slim X2 insulin pump with interoperable technology (Tandem Diabetes Care, Inc., K201214)
Description of the iLet ACE Pump
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 may reside 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 Bionic Pancreas System components are shown in Figure 1 below.
4
Image /page/4/Figure/0 description: The image shows the title of a figure. The title is "Figure 1: iLet Bionic Pancreas System". The title is written in a bold, sans-serif font. The figure number is 1.
Image /page/4/Figure/1 description: The image shows a diagram of a medical device and its components. The components are labeled with letters from a to i. Some of the components include a cannula, flexible tubing, a syringe, and a Dexcom G6 sensor.
The iLet Bionic Pancreas System: (a) iLet ACE Pump; (b) iLet Cartridge (ready to fill cartridge); (c) Filling Syringe (Becton Dickinson); (d) Needle (Becton Dickinson); (e) iLet Connect (Luer connection adapter); (f) Infusion Set Base and infusion tube (Convatec) (g) Insulin Infusion Set (Convatec), (h) iCGM (Dexcom G6 sensor and transmitter), 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: The image shows a diagram of a continuous glucose monitoring (CGM) system. The system consists of a CGM sensor, an insulin set cannula, and an iLet device. The CGM sensor continuously measures blood glucose levels, and the iLet device receives input from the CGM and uses a control algorithm to analyze and regulate blood glucose levels. The insulin set cannula is a tiny tube that is inserted under the skin to deliver insulin.
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 insulin being 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 (including tubing and base) needs to be changed every 2-3 days for infusion sets with a teflon cannula (Convatec Inset™ and Inset™ 30) and every 1-2 days for infusion sets with a steel cannula (Convatec Contact™ Detach) as indicated in the infusion set manufacturers' labeling. The iCGM sensor needs to be changed every 10 days.
Indications for Use for iLet ACE Pump
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.
6
Intended Use, Technological and Performance Characteristics of Subject Device Compared with Predicate Device
| Element of
Comparison | Tandem t:slim X2 Pump
(Predicate Device) (K201214) | iLet ACE Pump
(Subject Device) | Comment |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | 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 | Alternate controller enabled
(ACE) infusion pump | Identical |
| Specific Drug /
Biologic Use | U-100 Insulin
Indicated for use with NovoLog
or Humalog | U-100 Insulin
System tested with NovoLog,
Humalog | Similar |
| Prescription
Status | Prescription Device | Prescription Device | Identical |
| Size | 7.95 cm L x 5.08 cm W x 1.52 cm
H | 9.10 cm L x 5.90 cm W x 1.50
cm H | Similar |
| Weight | 3.95 ounces (112 grams) | 110 grams (without infusion set) | Similar |
| Operating
Conditions | Temperature: 41°F (5°C) to
98.6°F (37°C)
Humidity: 20% to 90% RH non-
condensing | Temperature: 41°F (5°C) to
104°F (40°C)
Humidity: 15% to 90% RH non-
condensing | Similar |
| Atmospheric
Pressure | -1,300 feet to 10,000 feet (-396
meters to 3,048 meters) | 15.4 to 10.2 psia (Relative
altitude -1300 feet to 10,000 feet) | Identical |
| Moisture
Protection | IPX7: Watertight to a depth of 3
feet (0.91 meters) for up to 30
minutes | IPX8: Protected against
immersion in water for up to 12
feet for 30 minutes | Similar |
| Maximum Basal
Rate | 15 units/hr. | 0 - 11.5 units/hr | Basal rate in subject
device is internal and
cannot be set.
Effective Rates are
provided
corresponding to
isolated basal doses |
| Power
Requirements | Rechargeable lithium battery
powered device, USB-A wired
charging through a DC Adapter | Rechargeable lithium battery
powered device, wireless
charging through a charging pad
connected to a DC Adapter | Similar |
Table 1: iLet ACE Pump Comparison with Predicate Device
Hazard Analysis, Risk Mitigation
A hazard analysis was conducted to account for the unique design elements, intended use, and risks of the iLet bionic pancreas. The hazard analysis accounted for the risks associated with interoperability between the device and other third-party digital devices which met predefined criteria but were not specifically identified, including scenarios in which the device was put into an environment in which both compatible and incompatible digital devices attempted to communicate with the device and deliver commands. This analysis identified hazards which could reasonably be anticipated to impact the proper use of the device, traced all identified risks
7
to adequate design controls, and demonstrated that design features were appropriately implemented and validated.
In addition, a Use Related Risk Analysis (URRA) was conducted that identifies all User Groups, User Tasks, Possible Use Errors, Potential Clinical Harm to Patient, Severity of Harm, Risk Mitigations and Validation Methods associated with use of the iLet device. Critical tasks per the FDA's guidance document Applying Human Factors and Usability Engineering to Medical Devices 2016 are identified within the URRA. The URRA includes all warnings, cautions, and contraindications.
Summary of Non-Clinical Performance Data and Conclusions including compliance with Special Controls
Analytical Performance
The iLet ACE Pump was tested for dose delivery accuracy and occlusion detection. All tests passed.
Other Supportive Test Data
-
Biocompatibility, Sterility, Insulin Compatibility and Stability, Electrical EMC and . Safety, CGM connectivity, Packaging/ Shipping Integrity and Mechanical Tests:
The iLet ACE Pump and accessories were subjected to the above tests as applicable. All tests passed. -
Data logging and Interoperability: ●
The iLet ACE Pump has been validated for logging timestamped events, including information related to its state, user inputs, and device settings, as required by special controls. All tests passed.
The iLet ACE Pump software has been validated to be interoperable with all connected devices.
-
Cybersecurity:
The iLet ACE Pump has incorporated adequate mitigations for cybersecurity risks. A cybersecurity analysis was performed using the draft FDA guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Issued October 18, 2020, and the principles outlined in the FDA guidance. Postmarket Management of Cybersecurity in Medical Devices - Issued December 28, 2016. Beta Bionics has provided a software bill of materials and penetration testing. -
Labeling and Training: ●
The iLet bionic pancreas device labeling and training for users and healthcare
8
practitioners was reviewed by the FDA. Labeling is sufficient and satisfies applicable requirements of 21 CFR 801 and 21 CFR 809.
Special Controls
The iLet bionic pancreas was found to be compliant with all Special Controls for Alternate controller enabled infusion pump (21 CFR 880.5730, QFG).
Summary of Human Factors and Clinical Performance Data and Conclusions
Human Factors
Beta Bionics executed a human factors and usability engineering process that followed and complied with FDA-recognized standards IEC62366:2015-1 and HE75:2009 as well as the FDA's guidance document. Applying Human Factors and Usability Engineering to Medical Devices - Issued February 3, 2016. Human Factors validation study testing was conducted with the iLet bionic pancreas (iLet ACE Pump with the iLet Dosing Decision Software installed) in a simulated use condition, including associated training and accompanying documentation. All critical tasks were tested in the validation study. The results of the validation study demonstrated the iLet system has been found to be safe and effective for the intended users for its intended uses in its intended use environment.
Clinical Performance
A clinical study was not required for the iLet ACE Pump as insulin delivery from the device can be verified through bench performance testing and use of the device was validated through a human factors validation study (described above).
Conclusions drawn from non-clinical tests that demonstrate safety, effectiveness, and performance to be as well as or better than predicate device
The preceding summary of predicate device comparison, non-clinical bench testing which supports the subject device design, and human factors study testing, demonstrate that the subject device performance in terms of safety and effectiveness is comparable to the predicate device.