(415 days)
Not Found
Yes
The device description explicitly mentions "adaptive control algorithms that autonomously and continually adapt to the ever-changing insulin requirements of each individual to enable lifelong adaptive learning." This description strongly suggests the use of machine learning or adaptive AI techniques.
Yes
The device is intended for the management of type 1 diabetes mellitus, which is a medical condition, making it a therapeutic device.
No
The device is an insulin dosing decision software that determines and commands insulin delivery based on glucose data. It is not intended to diagnose type 1 diabetes mellitus or any other condition. Its purpose is to manage an already diagnosed condition.
No
The device description explicitly states that the iLet Dosing Decision Software is "embedded in the insulin-only configuration of the iLet ACE Pump" and "works in conjunction with a compatible alternate controller enabled (ACE) pump." This indicates that the software is part of a larger hardware system (the pump) and is not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The iLet Dosing Decision Software is a software that uses data from a continuous glucose monitor (and potentially a blood glucose meter) to autonomously determine and command insulin doses. It is a decision-making and control system for insulin delivery, not a test performed on a biological sample to diagnose or monitor a condition.
- Intended Use: The intended use is for the management of type 1 diabetes mellitus by controlling insulin delivery, not for diagnosing or monitoring the disease through in vitro testing.
- Device Description: The description focuses on the software's algorithms for determining insulin doses based on glucose data, not on analyzing biological samples.
While the device uses glucose data, which is derived from a biological sample (blood), the device itself is not performing the in vitro diagnostic test. The iCGM and SMBG meter are the devices that perform the glucose measurement (the in vitro diagnostic part). The iLet software then uses the results of these measurements to make treatment decisions.
Therefore, the iLet Dosing Decision Software is a therapeutic device (specifically, an automated insulin dosing system) that utilizes data from IVD devices (iCGM and SMBG meter).
No
The provided text does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The phrase "Control Plan Authorized (PCCP) and relevant text Not Found" further supports this.
Intended Use / Indications for Use
The iLet Dosing Decision Software is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps. A self-monitoring of blood glucose (SMBG) meter may also be used for manual input of blood glucose values to continue insulin dosing for a limited period of time when input from the iCGM is temporarily not available. The iLet Dosing Decision Software autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. iLet Dosing Decision Software is intended for the management of type 1 diabetes mellitus in people 6 years of age or older. iLet Dosing Decision Software is intended for single patient use and requires a prescription.
Product codes (comma separated list FDA assigned to the subject device)
OJI
Device Description
The iLet Dosing Decision Software is an iAGC indicated for the management of type 1 diabetes mellitus. It autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. The iLet Dosing Decision Software is intended for the management of type 1 diabetes in people 6 years of age or older.
The iLet Dosing Decision Software works in conjunction with a compatible alternate controller enabled (ACE) pump. The dosing decision software includes adaptive control algorithms that autonomously and continually adapt to the ever-changing insulin requirements of each individual to enable lifelong adaptive learning. The iLet Dosing Decision Software only requires initialization with the user's body mass (body weight).
The iLet Dosing Decision Software does not require carbohydrate counting by the user or the use of carbohydrate- to-insulin ratios. Although the iLet system does not require a user to enter an exact carb amount to calculate and administer a meal bolus, it does require that the user announce the meal (e.g., breakfast, lunch, dinner) AND provide an estimated carb content as "Usual", "More", or "Less" than is routine for that meal type.
The iLet Dosing Decision Software does not require any information about the user's total daily dose of insulin, basal or long-acting insulin requirements, or insulin correction factors. It is an insulin titration system that requires no insulin-dose determinations by the user or provider. During normal operation, the iLet bionic pancreas (iLet ACE Pump with the iLet Dosing Decision Software installed) autonomously responds every five minutes to a glucose signal, from an iCGM that is worn by the user, by computing a control signal that translates to a dose of insulin, which is intended to be delivered to the user through the subcutaneous (SC) route. The iLet dosing decision software has three insulin controllers (algorithms) running in parallel: an adaptive basal insulin controller, which continually adapts to each individual's basal metabolic need for insulin, an adaptive bolus controller which provides doses that are required above and beyond the basal metabolic needs, and an adaptive meal dose controller which provides insulin in response to a meal announcement.
The iLet is intended to dose insulin based on CGM data. In the events where CGM stops providing glucose data to the iLet Dosing Decision Software BG-run mode feature will serve to temporarily continue insulin delivery. BG-run mode will determine and command basal insulin based on past requirements and will allow announcement of meals and entry of fingerstick BG measurements, which will be treated as iCGM data and may result in commanding administration of insulin or temporary suspension of basal insulin. BG-run mode use should always be for the shortest duration possible with the goal to resume CGM.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Study Design: A prospective, multi-center, randomized controlled trial (RCT) was conducted with 440 adult and child participants with Type 1 diabetes at 16 clinical sites in the United States. The primary objective of the study was to assess the efficacy and safety of the iLet Dosing Decision Software (embedded in the insulin-only configuration of the iLet ACE Pump) relative to standard care in adults and children with type 1 diabetes (T1D).
Participants were randomized to use of the iLet Bionic Pancreas System or standard of care (SC) and followed for 13-weeks. An optional 48-60 hour ancillary study followed the RCT in which blood glucose meter input was used for the iLet rather than continuous glucose monitor input to evaluate the BG-run feature.
Methods: The study had three parts: the 13-week RCT, the 2-4 day Transition Phase for the iLet Bionic Pancreas Group, and the optional Blood Glucose (BG) Test Run Ancillary Study for the iLet Bionic Pancreas Group.
Informed consent was obtained and eligibility was assessed. As part of screening/baseline testing, psychosocial questionnaires were completed, and baseline Dexcom G6 Continuous Glucose Monitor (CGM) data were obtained unless the participant was using a personal Dexcom G6 with at least 85% of possible glucose data in last 14 days in which case the participant could skip the CGM data collection (personal CGM data used for baseline).
Adult participants 18 years old were randomly assigned in a 2:2:1 ratio to:
- iLet Bionic Pancreas (BP) Group with Novolog or Humalog (iLet-N/H)
- iLet Bionic Pancreas Group with Fiasp (iLet-F)
- Standard Care (SC) Group
Pediatric participants (6-180 mg/dL
- Time >250 mg/dL
- Standard deviation
- Additional CGM metrics
Separately, the iLet-F Group was compared with the adult iLet-N/H Group and the adult SC Group.
Safety outcomes included Severe hypoglycemia, diabetic ketoacidosis, and other serious adverse events.
Conclusions: Use of the bionic pancreas with Novolog/ Humalog or Fiasp was safe when compared with standard of care. Two diabetic ketoacidosis events occurred in the iLet Group related to infusion set failures. The ancillary BG run, along with the analysis of data collected through the 13-week RCT period, demonstrated that the bionic pancreas can be safely used with the blood glucose meter input temporarily instead of CGM should this become necessary for a user.
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
§ 862.1356 Interoperable automated glycemic controller.
(a)
Identification. An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
(A) The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
(B) For devices indicated for use with multiple therapeutic agents for the same therapeutic effect (
e.g., more than one type of insulin), data demonstrating performance with each product or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed.(C) When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events.
(ii) Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(iii) A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices.
(iv) Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to (
e.g., specification of glucose sensor performance) or accept commands from (e.g., specifications for drug infusion pump performance) the controller, and a detailed strategy for ensuring that connected devices meet these specifications.(v) Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices.
(vi) Documentation demonstrating that appropriate, as determined by FDA, measures are in place (
e.g., validated device design features) to ensure that safe therapy is maintained when communication with digitally connected devices is interrupted, lost, or re-established after an interruption. Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled and logged appropriately during and after the interruption to maintain patient safety.(vii) A detailed plan and procedure for assigning postmarket responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller.
(2) Design verification and validation documentation 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 to address device system hazards;
(ii) Design decisions related to how the risk control measures impact essential performance; and
(iii) 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 appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to connected devices;
(ii) Secure, accurate, and reliable means of data transmission between the controller and connected devices;
(iii) Sharing of necessary state information between the controller and any connected devices (
e.g., battery level, reservoir level, sensor use life, pump status, error conditions);(iv) Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified;
(v) A detailed process and procedures for sharing the controller's interface specification with connected devices and for validating the correct implementation of that protocol; and
(vi) A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance.
(4) 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 controller must, at a minimum, include:
(i) Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices;
(ii) Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices (
e.g., infusion pump occlusion, glucose sensor shut down);(iii) Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and
(iv) Connectivity events (
e.g., establishment or loss of communications).(5) The device must only receive glucose input from devices cleared under § 862.1355 (integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section.
(6) The device must only command drug delivery from devices cleared under § 880.5730 of this chapter (alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section.
(7) An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable.
(8) The labeling required under § 809.10(b) of this chapter must include:
(i) A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part.
(ii) A prominent statement identifying any populations for which use of this device has been determined to be unsafe.
(iii) A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate.
(iv) The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (b)(1)(iii) of this section.
(v) A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate.
(vi) A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (b)(1)(i) of this section.
(vii) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(viii) For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in two lines. The FDA logo is a recognizable symbol associated with the regulation and oversight of food and drug products in the United States.
May 19, 2023
Beta Bionics, Inc. Vikram Verma Senior Director Regulatory Affairs 300 Baker Ave Ste 301 Concord, MA 01742-2131
Re: K220916
Trade/Device Name: iLet® Dosing Decision Software Regulation Number: 21 CFR 862.1356 Regulation Name: Interoperable Automated Glycemic Controller Regulatory Class: Class II Product Code: OJI Dated: December 20, 2022 Received: December 20, 2022
Dear Vikram Verma:
We have reviewed vour 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 mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220916
Device Name iLet® Dosing Decision Software
Indications for Use (Describe)
The iLet Dosing Decision Software is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps. A self-monitoring of blood glucose (SMBG) meter may also be used for manual input of blood glucose values to continue insulin dosing for a limited period of time when input from the iCGM is temporarily not available. The iLet Dosing Decision Software autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. iLet Dosing Decision Software is intended for the management of type 1 diabetes mellitus in people 6 years of age or older. iLet Dosing Decision Software is intended for single patient use and requires a prescription.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
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
K220916 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
iLet® Dosing Decision Software Trade Name of Device:
Interoperable Automated Glycemic Controller (iAGC) Common Name of Device:
Classification Name: Interoperable automated glycemic controller (21 CFR 862.1356. OJI)
Predicate Devices
Control-IQ Technology (Tandem Diabetes Care, Inc., K200467)
Description of Device and Principle of Operation
The iLet Dosing Decision Software is an iAGC indicated for the management of type 1 diabetes mellitus. It autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. The iLet Dosing Decision Software is intended for the management of type 1 diabetes in people 6 years of age or older.
The iLet Dosing Decision Software works in conjunction with a compatible alternate controller enabled (ACE) pump. The dosing decision software includes adaptive control algorithms that autonomously and continually adapt to the ever-changing insulin requirements of each individual to enable lifelong adaptive learning. The iLet Dosing Decision Software only requires initialization with the user's body mass (body weight).
The iLet Dosing Decision Software does not require carbohydrate counting by the user or the use of carbohydrate- to-insulin ratios. Although the iLet system does not require a user to enter an exact carb amount to calculate and administer a meal bolus, it does require that the user announce the meal (e.g., breakfast, lunch, dinner) AND provide an estimated carb content as "Usual", "More", or "Less" than is routine for that meal type.
The iLet Dosing Decision Software does not require any information about the user's total daily dose of insulin, basal or long-acting insulin requirements, or insulin correction factors. It is an
4
insulin titration system that requires no insulin-dose determinations by the user or provider. During normal operation, the iLet bionic pancreas (iLet ACE Pump with the iLet Dosing Decision Software installed) autonomously responds every five minutes to a glucose signal, from an iCGM that is worn by the user, by computing a control signal that translates to a dose of insulin, which is intended to be delivered to the user through the subcutaneous (SC) route. The iLet dosing decision software has three insulin controllers (algorithms) running in parallel: an adaptive basal insulin controller, which continually adapts to each individual's basal metabolic need for insulin, an adaptive bolus controller which provides doses that are required above and beyond the basal metabolic needs, and an adaptive meal dose controller which provides insulin in response to a meal announcement.
The iLet is intended to dose insulin based on CGM data. In the events where CGM stops providing glucose data to the iLet Dosing Decision Software BG-run mode feature will serve to temporarily continue insulin delivery. BG-run mode will determine and command basal insulin based on past requirements and will allow announcement of meals and entry of fingerstick BG measurements, which will be treated as iCGM data and may result in commanding administration of insulin or temporary suspension of basal insulin. BG-run mode use should always be for the shortest duration possible with the goal to resume CGM.
Indications for Use
The iLet Dosing Decision Software is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps. A self-monitoring of blood glucose (SMBG) meter may also be used for manual input of blood glucose values to continue insulin dosing for a limited period of time when input from the iCGM is temporarily not available. The iLet Dosing Decision Software autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. iLet Dosing Decision Software is intended for the management of type 1 diabetes mellitus in people 6 years of age or older. iLet Dosing Decision Software is intended for single patient use and requires a prescription.
Intended Use. Technological and Performance Characteristics of Subject Device Compared with Predicate Device
| | Control IQ
(Predicate Device) (K200467) | iLet Dosing Decision Software
(Subject Device) | Comment |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | An iAGC which is intended to
work with an iCGM and ACE
pump to increase, decrease, or
suspend delivery of insulin for
management of type 1 diabetes | An iAGC which is intended to
work with an iCGM and ACE
pump to increase, decrease, or
suspend delivery of insulin for
management of type 1 diabetes | Identical |
| Communication | Communicates with an ACE
pump | Communicates with an ACE
pump | Identical |
| | Control IQ
(Predicate Device) (K200467) | iLet Dosing Decision Software
(Subject Device) | Comment |
| Required user input
settings | Personal Profiles:
up to 6 sets that combine basal
rate, insulin-to-carb ratio, insulin
correction factor, target glucose
value for particular times of the
day, active insulin time | User's weight
Although the iLet system does
not require a user to enter an
exact carb amount to calculate
and administer a meal bolus, it
does require that the user
announce the meal (e.g.,
breakfast, lunch, dinner) AND
provide an estimated carb
content as "Usual", "More", or
"Less" than is routine for that
meal type.
No meal announcement is
advised if a meal contains a very
small amount of carbohydrates
(approximately less than a
quarter of usual). | The iLet Dosing
Decision Software
iAGC determines all
doses autonomously
every 5 minutes without
any required
programmed rates,
factors, ratios, profiles,
settings, or duration of
insulin action, except
the user's weight. No
basal rates, insulin
delivery profiles, basal
rate segments, basal
rate increments or
temp basal rate
settings are required to
be set or used and
entering these settings
is not needed. No
bolus setup, insulin-to-
carb ratio, correction
factor, quick bolus
increments or
extended bolus time
settings are required to
be set or used and
entering these settings
is not needed.
Target glucose setting is
available. Meal
announcements do not
involve carb counting;
instead, the user can
select one of three
qualitative meal sizes
for each type of meal
(breakfast, lunch, or
dinner) as having Usual
for me, More, or Less
carbs. |
| 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. |
| BG Target Value | When Control-IQ is set to ON,
Target BG is fixed to 110 mg/dL.
When Control- IQ is set to OFF,
there are 16-time segments with
individually settable Target | CGM targets of 110 mg/dL, 120
mg/dL and 130 mg/dL | Similar; design feature
and operation are
supported by clinical
study. |
| | Control IQ
(Predicate Device) (K200467) | iLet Dosing Decision Software
(Subject Device) | Comment |
| | BGs 70 to 250 mg/dL in 1 mg/dL increments | | |
| Maximum Bolus
Size | 25 units | 24 units for meal announcement,
30 units overall. | Similar |
| Maximum
Automatic Bolus
Size | 6 units | 3 units in response to CGM glucose, 6 units in response to
isolated BG when CGM is offline | Similar |
Table 1: iLet Dosing Decision Software Comparison With Predicate Device
5
6
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 which includes the iLet Dosing Decision Software. 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 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
Analytical Performance testing is not applicable to the iLet Dosing Decision Software.
Other Supportive Test Data
-
Biocompatibility, Sterility, Insulin Compatibility and Stability, Electrical EMC and ● Safety, CGM connectivity, Packaging/ Shipping Integrity and Mechanical Tests:
These tests are not applicable to the iLet Dosing Decision Software as it is a software device. -
Data logging and Interoperability: ●
The iLet ACE Pump and iLet Dosing Decision Software have 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.
7
The iLet ACE Pump and iLet Dosing Decision software have been validated to be interoperable with all connected devices.
-
Cybersecurity: .
The iLet Dosing Decision Software 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, including the iLet Dosing Decision Software. 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.
Special Controls
The iLet Dosing Decision Software was found to be compliant with all Special Controls for Interoperable Automatic Glycemic Controller (21 CFR 862.1356, QJI).
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. 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 pivotal clinical study was conducted to evaluate the use of the iLet Dosing Decision Software. A summary of the clinical performance data and conclusions is provided below:
Study Design: A prospective, multi-center, randomized controlled trial (RCT) was conducted with 440 adult and child participants with Type 1 diabetes at 16 clinical sites in the United States. The primary objective of the study was to assess the efficacy and safety of the iLet Dosing Decision Software (embedded in the insulin-only configuration of the iLet ACE Pump) relative to standard care in adults and children with type 1 diabetes (T1D).
Participants were randomized to use of the iLet Bionic Pancreas System or standard of care (SC) and followed for 13-weeks. An optional 48-60 hour ancillary study followed the RCT in which
8
blood glucose meter input was used for the iLet rather than continuous glucose monitor input to evaluate the BG-run feature.
Methods: The study had three parts: the 13-week RCT, the 2-4 day Transition Phase for the iLet Bionic Pancreas Group, and the optional Blood Glucose (BG) Test Run Ancillary Study for the iLet Bionic Pancreas Group.
Informed consent was obtained and eligibility was assessed. As part of screening/baseline testing, psychosocial questionnaires were completed, and baseline Dexcom G6 Continuous Glucose Monitor (CGM) data were obtained unless the participant was using a personal Dexcom G6 with at least 85% of possible glucose data in last 14 days in which case the participant could skip the CGM data collection (personal CGM data used for baseline).
Adult participants 18 years old were randomly assigned in a 2:2:1 ratio to:
- iLet Bionic Pancreas (BP) Group with Novolog or Humalog (iLet-N/H) ●
- iLet Bionic Pancreas Group with Fiasp (iLet-F)
- Standard Care (SC) Group
Pediatric participants (6-180 mg/dL ●
- . Time >250 mg/dL
9
- Standard deviation
- Additional CGM metrics ●
Separately, the iLet-F Group was compared with the adult iLet-N/H Group and the adult SC Group.
Safety outcomes included Severe hypoglycemia, diabetic ketoacidosis, and other serious adverse events.
Conclusions: Use of the bionic pancreas with Novolog/ Humalog or Fiasp was safe when compared with standard of care. Two diabetic ketoacidosis events occurred in the iLet Group related to infusion set failures. The ancillary BG run, along with the analysis of data collected through the 13-week RCT period, demonstrated that the bionic pancreas can be safely used with the blood glucose meter input temporarily instead of CGM should this become necessary for a user.
The preceding summary of predicate device comparison, non-clinical bench testing which supports the subject device design, human factors study testing, and the pivotal study clinical validation results demonstrate that the subject device performance is substantially equivalent to the predicate device.