SmartGuard technology; Predictive Low Glucose technology
Device Facts
| Record ID | K253585 |
|---|---|
| Device Name | SmartGuard technology; Predictive Low Glucose technology |
| Applicant | Medtronic Minimed, Inc. |
| Product Code | QJI · Clinical Chemistry |
| Decision Date | Jan 14, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1356 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Therapeutic, PCCP, Pediatric |
Intended Use
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose values. SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and of Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin. SmartGuard technology is intended for single patient use and requires a prescription. Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. Predictive Low Glucose technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and of Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin. Predictive Low Glucose technology is intended for single patient use and requires a prescription.
Device Story
Software-only interoperable automated glycemic controller (iAGC) residing as embedded firmware on compatible ACE pumps; receives sensor glucose (SG) values via Bluetooth Low Energy (BLE) from iCGMs; AHCL algorithm (SmartGuard) automatically adjusts basal insulin and delivers correction boluses; PLGM algorithm (Predictive Low Glucose) automatically suspends/resumes insulin delivery based on current/predicted glucose thresholds; operated by patients with Type 1 or Type 2 diabetes; provides automated insulin management to improve glycemic control; alerts displayed on host ACE pump; supports firmware-over-the-air updates; requires mandatory user training.
Clinical Evidence
No new clinical studies conducted. Evidence leveraged from previously approved PMA submissions (P160017, P160017/S031, P160017/S118, P160017/S124, P160017/S125) which established safety and effectiveness for the AHCL and PLGM algorithms in Type 1 and Type 2 diabetes populations.
Technological Characteristics
Software-only iAGC algorithms embedded in ACE pump firmware. Connectivity: BLE for CGM data. Updates: Firmware over the Air. Risk management: ISO 14971:2019. Software lifecycle: IEC 62304. Human factors: IEC 62366-1. No physical materials, sterilization, or electrical components as it is a software-only device.
Indications for Use
Indicated for management of Type 1 diabetes (age 7+) and Type 2 diabetes (age 18+) requiring insulin. Requires prescription. For single patient use.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Related Devices
- K253701 — SmartGuard Technology; Predictive Low Glucose Technology · Medtronic Minimed · Feb 3, 2026
- K251217 — SmartGuard technology; Predictive Low Glucose technology · Medtronic Minimed, Inc. · Aug 29, 2025
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
January 14, 2026
Medtronic Minimed, Inc.
Maria Hategan
Principal Regulatory Affairs Specialist
18000 Devonshire St.
Northridge, California 91325
Re: K253585
Trade/Device Name: SmartGuard technology; Predictive Low Glucose technology
Regulation Number: 21 CFR 862.1356
Regulation Name: Interoperable automated glycemic controller
Regulatory Class: Class II
Product Code: QJI, QJS
Dated: November 17, 2025
Received: November 17, 2025
Dear Maria Hategan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253585 - Maria Hategan
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established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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K253585 - Maria Hategan
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
JOSHUA BALSAM -S
Joshua M. Balsam, Ph.D.
Branch Chief
Division of Chemistry and
Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) k253585 | |
| Device Name SmartGuard technology | |
| Indications for Use (Describe) SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose values. SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and of Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin. SmartGuard technology is intended for single patient use and requires a prescription. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
k253585
Device Name
Predictive Low Glucose technology
Indications for Use (Describe)
Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.
Predictive Low Glucose technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and of Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.
Predictive Low Glucose technology is intended for single patient use and requires a prescription.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
# Bundled 510(k) Summary
# SmartGuard Technology and Predictive Low Glucose Technology
510(k) Submitter Information
| Submitter's Name and Address | Medtronic MiniMed, Inc.
18000 Devonshire St
Northridge, CA 91325 USA |
| --- | --- |
| Primary Contact Person | Maria Hategan
Principal Regulatory Affairs Specialist
Medtronic MiniMed Inc.
Email: maria.hategan@medtronic.com |
| Alternate Contact Person | Felicia Haynes, PhD
Senior Regulatory Affairs Manager
Medtronic MiniMed Inc.
Email: felicia.a.haynes@medtronic.com |
| Date Prepared | November 14, 2025 |
Device Information
| Device Trade Name | SmartGuard technology,
Predictive Low Glucose technology |
| --- | --- |
| Device Common Name | Advanced Hybrid Closed Loop (AHCL) algorithm,
Predictive Low Glucose Management (PLGM) algorithm |
| Device Classification Name | Interoperable Automated Glycemic Controller (iAGC) |
| Regulation Number | 21 CFR 862.1356 |
| Product Code | QJI, QJS |
| Device Panel | Clinical Chemistry |
| Device Class | Class II |
Predicate Device Information
| Product Code | Predicate Device |
| --- | --- |
| QJI | SmartGuard technology (K251217) |
| QJS | Predictive Low Glucose technology (K251217) |
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
# Device Description
## SmartGuard technology
SmartGuard technology, also referred to as Advanced Hybrid Closed Loop (AHCL) algorithm, is a software-only device intended for use by people with Type 1 diabetes, ages 7 years or older, and by people with Type 2 diabetes, ages 18 years or older. It is an interoperable automated glycemic controller (iAGC) that is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible interoperable Medtronic continuous glucose monitors (CGM) and compatible alternate controller enabled (ACE) pumps to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose (SG) values.
The AHCL algorithm resides on the compatible ACE pump, which serves as the host device. It is meant to be integrated in a compatible ACE pump and is an embedded part of the ACE pump firmware.
Inputs to the AHCL algorithm (e.g., SG values, user inputs) are received from the ACE pump (host device), and outputs from the AHCL algorithm (e.g., insulin delivery commands) are sent by the algorithm to the ACE pump. As an embedded part of the firmware, the AHCL algorithm does not connect to or receive data from compatible CGMs; instead, sensor glucose (SG) values or other inputs received by the ACE pump from compatible CGMs via Bluetooth Low Energy (BLE) technology are transmitted to the embedded AHCL algorithm.
The AHCL algorithm works in conjunction with the ACE pump and is responsible for controlling insulin delivery when the ACE pump is in Auto Mode. It includes adaptive control algorithms that autonomously and continually adapt to the ever-changing insulin requirements of each individual.
The AHCL algorithm requires specific therapy settings (target setpoint, insulin-to-carb ratios and active insulin time) that need to be established with the help of a health care provider (HCP) before activation. It also requires five (5) consecutive hours of insulin delivery history, a minimum of two (2) days of total daily dose (TDD) of insulin, a valid sensor glucose (SG) and blood glucose (BG) values to start automated insulin delivery.
When activated, the AHCL algorithm adjusts the insulin dose at five-minute intervals based on CGM data. A basal insulin dose (auto basal) is commanded by the AHCL algorithm to manage glucose levels to the user's target setpoint of $100\mathrm{mg/dL}$, $110\mathrm{mg/dL}$ or $120\mathrm{mg/dL}$. The user can
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
also set a temporary target of 150 mg/dL for up to 24 hours. In addition, under certain conditions the algorithm can also automatically command correction boluses (auto correction bolus) without user input.
Meal boluses are the responsibility of the user. The AHCL algorithm includes an integrated bolus calculation feature for user-initiated boluses for meals. When the user inputs their carbohydrate intake, the AHCL algorithm automatically calculates a bolus amount based off available glucose information, entered carbohydrate amount and other patient parameters.
The AHCL algorithm contains several layers of “safeguards” (mitigations) to provide protection against over-delivery or under-delivery of insulin to reduce risk of hypoglycemia and hyperglycemia, respectively.
The AHCL algorithm is a software-only device and does not have a user interface (UI). The compatible ACE pump provides a UI to the user to configure the therapy settings and interact with the algorithm. The AHCL-related alerts/alarms are displayed and managed by the pump.
## Predictive Low Glucose technology
Predictive Low Glucose technology, also referred to as the Predictive Low Glucose Management (PLGM) algorithm is a software-only device intended for use by people with Type 1 diabetes, ages 7 years or older, and by people with Type 2 diabetes, ages 18 years or older. It is an interoperable automated glycemic controller (iAGC) that is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible interoperable Medtronic continuous glucose monitors (CGM) and compatible alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.
The PLGM algorithm resides on the compatible ACE Pump, which serves as the host device. It is meant to be integrated in a compatible ACE pump and is an embedded part of the ACE pump firmware.
Inputs to PLGM algorithm (e.g., sensor glucose values, user inputs) are received from the ACE pump (host device), and outputs from PLGM algorithm (e.g., suspend/resume commands) are sent by the algorithm to the ACE pump. As an embedded part of the ACE pump firmware, the PLGM algorithm does not connect to or receive data from compatible CGMs; instead, sensor glucose (SG) values or other inputs are received by the ACE pump from compatible CGMs via Bluetooth Low Energy (BLE) technology are transmitted to the embedded PLGM algorithm.
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
The PLGM algorithm works in conjunction with the ACE pump. When enabled, the PLGM algorithm is able to suspend insulin delivery for a minimum of 30 minutes and for a maximum of 2 hours based on current or predicted sensor glucose values. It will automatically resume insulin delivery when maximum suspend time of 2 hours has elapsed or when underlying conditions resolve. The user is also able to manually resume insulin at any time.
The PLGM algorithm is a software-only device and does not have a user interface (UI). The compatible ACE pump provides the UI to configure therapy settings and interact with the algorithm. The PLGM-related alerts/alarms are displayed and managed by the pump.
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
# Indications for Use / Intended Use
## SmartGuard technology
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose values.
SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and of Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.
SmartGuard technology is intended for single patient use and requires a prescription.
## Predictive Low Glucose technology
Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.
Predictive Low Glucose technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and of Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.
Predictive Low Glucose technology is intended for single patient use and requires a prescription.
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
# Summary of Technological Characteristics – Subject Device Compared to Predicate Device
SmartGuard technology [Product Code: QJI]
The table below provides a side-by-side comparison of the subject device, SmartGuard technology compared to its predicate device, SmartGuard technology for Product Code: QJI
| | Subject Device
SmartGuard technology
(Advanced Hybrid Closed Loop algorithm) | Predicate Device
SmartGuard technology
(K251217) |
| --- | --- | --- |
| Manufacturer | Medtronic MiniMed Inc. | Medtronic MiniMed Inc. |
| Device Trade Name | SmartGuard technology | SmartGuard technology |
| Device Classification | Class II | SAME |
| Regulation Name | Interoperable Automated Glycemic Controller
(under 21 CFR 862.1356) | SAME |
| Intended Use | SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), and alternate controller enabled (ACE) pumps to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose values.
SmartGuard technology is intended for single patient use and requires a prescription. | SAME |
| Prescription Use | Prescription is required | SAME |
| Clinical Application | Type 1 and Type 2 diabetes mellitus | Type 1 diabetes mellitus |
| Intended Population | Type 1 diabetes mellitus in persons 7 years of age and older, and Type 2 diabetes mellitus in persons 18 years of age and older. | Type 1 diabetes mellitus in persons 7 years of age and greater. |
| Principal Operator | Patient or caregiver | SAME |
| Number Of Users | Single user | SAME |
| Principle Of Operation | Algorithmic software device intended to automatically increase, decrease, suspend and resume delivery of insulin based on sensor glucose values | SAME |
| Compatible Host device/Hardware | ACE Pump | SAME |
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
| | Subject Device SmartGuard technology (Advanced Hybrid Closed Loop algorithm) | Predicate Device SmartGuard technology (K251217) |
| --- | --- | --- |
| Compatible CGM | Integrated Continuous Glucose Monitors (iCGMs) Interoperable Medtronic Continuous Glucose Monitors (CGMs) | SAME |
| Communication With ACE Pump | Communicates with an ACE Pump via software interface | SAME |
| Specific Drug/Biological Use | U-100 insulin: Novolog® Humalog® Admelog® Lyumjev® Fiasp® | U-100 insulin: Novolog® Humalog® Admelog® |
| Total Daily Dose (TDD) Of Insulin | 8 to 250 units a day | SAME |
| Active Insulin Time | User adjustable (between 2 - 8 hours) | SAME |
| Basal Insulin Adjustment | AHCL algorithm can be used to adjust or suspend basal insulin delivery every 5 minutes and automatically deliver correction boluses based on current and trending CGM values, target setpoint and insulin delivery history. | SAME |
| Glucose Target (Target Settings) | Glucose Targets (Target Setpoint): • 100 mg/dL • 110 mg/dL • 120 mg/dL Temp Target: 150 mg/dL | SAME |
| Auto Basal Operating Modes | AHCL algorithm does not have separate auto basal operating modes. The default mode is auto basal (which includes setting a temporary target). AHCL algorithm can transition to a set limited basal delivery rate should conditions arise. | SAME |
| Auto Correction Bolus Target | 120 mg/dL | SAME |
| Auto Correction Bolus Rate | Calculated at 5-minute intervals | SAME |
| Meal / Food Bolus | Users must manually deliver meal boluses they can calculate using the integrated bolus calculator. An SG or BG value is used for meal boluses. | SAME |
| Manual Algorithm Deactivation | Users can manually turn off closed loop therapy | SAME |
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
| | **Subject Device**
SmartGuard technology
(Advanced Hybrid Closed Loop algorithm) | **Predicate Device**
SmartGuard technology
(K251217) |
| --- | --- | --- |
| **Auto Mode Exit** | Algorithm automatically de-activates and exits
auto mode when conditions arise. | SAME |
| **Alarms/Alerts** | ACE pump will display algorithm-related alerts to
the user | SAME |
| **Mechanism Of
Software Update** | Firmware over the Air | SAME |
| **Training** | There is mandatory user training before the user
can use AHCL Algorithm | SAME |
Page 8 of 22
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
# Predictive Low Glucose technology [Product Code: QJS]
The table below provides a side-by-side comparison of the subject device, Predictive Low Glucose technology, compared to its predicate device, Predictive Low Glucose technology for Product Code: QJS
| | Subject Device Predictive Low Glucose technology (Predictive Low Glucose Management algorithm) | Predicate Device Predictive Low Glucose technology (K251217) |
| --- | --- | --- |
| Manufacturer | Medtronic MiniMed Inc. | Medtronic MiniMed Inc. |
| Device Trade Name | Predictive Low Glucose technology | Predictive Low Glucose technology |
| Device Classification | Class II | SAME |
| Regulation Name | Interoperable automated glycemic controller (under 21 CFR 862.1356) | SAME |
| Intended Use | Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM) and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin when the sensor glucose value is predicted to fall below predefined threshold values. Predictive Low Glucose technology is intended for single patient use and requires a prescription. | SAME |
| Prescription Use | Prescription is required | SAME |
| Clinical Application | Type 1 and Type 2 diabetes mellitus | Type 1 diabetes mellitus |
| Intended Population | Type 1 diabetes mellitus in persons 7 years of age and older, and Type 2 diabetes mellitus in persons 18 years of age and older. | Type 1 diabetes mellitus in persons 7 years of age and greater. |
| Number Of Users | Single user | SAME |
| Principle Of Operation | Algorithmic software device that utilizes CGM sensor readings to suspend and resume insulin based on the current and predicted sensor values. | SAME |
| Compatible Host Device / Intended Hardware | ACE Pump | SAME |
| Compatible CGM | Integrated Continuous Glucose Monitors (iCGMs) Interoperable Medtronic Continuous Glucose Monitors (CGMs) | SAME |
| Communication With ACE Pump | Communicates with an ACE Pump via software interface | SAME |
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
| | Subject Device Predictive Low Glucose technology (Predictive Low Glucose Management algorithm) | Predicate Device Predictive Low Glucose technology (K251217) |
| --- | --- | --- |
| Specific Drug/Biological Use | U-100 insulin: Novolog® Lyumjev® Humalog® Fiasp® Admelog® | U-100 insulin: Novolog® Humalog® Admelog® |
| Commands Suspension of Insulin Delivery Based On Current and Predicted CGM Values | Yes | SAME |
| Manual Bolus during Suspension | A new bolus cannot be initiated until insulin delivery is resumed | SAME |
| Manual Algorithm Deactivation | User can manually turn off the therapy/algorithm | SAME |
| Alarms/Alerts | ACE pump will display algorithm-related alerts to the user | SAME |
| Mechanism Of Software Update | Firmware over the Air | SAME |
| Training | There is mandatory user training before the user can use the PLGM algorithm | SAME |
# Summary of Non-Clinical Performance Data
Medtronic conducted performance testing for SmartGuard technology (AHCL algorithm) and Predictive Low Glucose technology (PLGM algorithm), collectively referred to as "Medtronic iAGCs", to demonstrate substantial equivalence to the predicate device(s) and to ensure that the subject device(s) (Medtronic iAGCs) meets all applicable iAGC Special Controls requirements defined in 21 CFR 862.1356. These are summarized below:
# Software Verification and Validation
Software Verification activities were performed in accordance with IEC 62304 and FDA's 2023 guidance "Content of Premarket Submissions for Device Software Functions".
# Data Logging
Medtronic iAGCs with compatible ACE pump have been verified for logging or recording timestamped critical events as required by the special controls.
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
## Cybersecurity
The cybersecurity activities for the Medtronic iAGCs were all completed per cybersecurity plan and cybersecurity risks were assessed for impact to confidentiality, integrity, and availability. A robust cybersecurity risk assessment was conducted, all cybersecurity risks with potential to impact safety were mitigated. The information relating to the penetration testing conducted and software bill of materials was provided.
## Human Factors Validation
A human factors and usability engineering process was performed on Medtronic iAGCs integrated with the compatible ACE pump and paired with a compatible CGM, in accordance with IEC 62366-1:2015, HE75:2009 and FDA’s guidance document, *Applying Human Factors and Usability Engineering to Medical Devices* (February 2016). Results of the human factors validation testing demonstrated that the device is safe and effective for the intended users, intended uses and expected tasks, and intended use environments.
## Labeling and Training
Medtronic iAGCs’ labeling and training for users and healthcare practitioners is sufficient and satisfies applicable requirements of 21 CFR 801.
## Other Supportive Test Data:
The following additional testing was conducted, per currently authorized PCCP:
- Qualification and Integration of iAGCs with compatible new ACE Pump, SW v6.60
- Qualification and Integration of iAGCs with compatible iCGM (Instinct, made by Abbott)
The following tests are not applicable to Medtronic iAGCs as they are software-only devices – Analytical Performance, Biocompatibility, Sterility, Insulin Compatibility and Stability, Electrical Safety, EMC/EMI and RF Wireless, CGM connectivity, Reliability and Shelf Life, Packaging/ Shipping Integrity and Mechanical Tests.
## Risk Management
Risk management was completed in accordance with ISO 14971: 2019. Risk control measures identified for each hazard were implemented and verified to be effective at reducing risk, Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met, and the device is safe for use. All risks have been reduced as far as possible. The benefit risk analysis has determined that the benefits of using the device outweigh the residual risk, and the overall residual risk is acceptable.
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
# Summary of Clinical Performance Data for SmartGuard Technology and Predictive Low Glucose Technology
# Clinical Testing for SmartGuard Technology (AHCL Algorithm)
AHCL with Simplera Sync CGM (Type 1 Diabetes) – provided in K251217
Safety and effectiveness evaluation of the AHCL algorithm in the MiniMed 780G System used in combination with the Simplera Sync CGM (in Type 1 Diabetes patients) was reviewed in K251217.
The pivotal clinical data provided in K251217 confirmed the safety and effectiveness of the modified iAGC AHCL algorithm) integrated in the compatible ACE Pump (MiniMed 780G ACE pump) used in combination with the compatible interoperable Simplera Sync sensor in patients with type 1 diabetes. The study demonstrated improved glycemic outcomes (reduction in HbA1c) compared to baseline, superiority for time in range and non-inferiority for reduction HbA1c.
AHCL with Simplera Sync CGM (Type 2 Diabetes) – provided in this submission [approved in P160017/S124]
Safety and effectiveness of the MiniMed 780G System used in combination with Simplera Sync CGM and Guardian 4 CGM in adults with insulin-requiring Type 2 Diabetes is provided in this submission to support an indication expansion for MiniMed 780G system use in Type 2 (also approved under P160017/S124).
This study was a multi-center, single arm study in insulin-requiring adults with type 2 diabetes, conducted in two phases. The study phases used two versions of the MiniMed 780G insulin pump (Phase 1 – AHCL and Phase 2 – modified AHCL) with two different CGMs (Phase 1 – Guardian 4 CGM, Phase 2 – DS5 Simplera Sync sensor).
The demographic of subjects of the intended-to-treat population (ITT) enrolled in Phase 1 of the study (MiniMed 780G with Guardian 4 CGM) and in Phase 2 of the study (MiniMed 780G with Simplera Sync sensor) are presented in the tables below.
Summary of Demographic and Other Baseline Characteristics, ITT Population (Phase 1)
| Characteristic | Number of Subjects=95 |
| --- | --- |
| Age (Years) | |
| n | 95 |
| Mean (SD) | 60.3 (10.8) |
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
| Characteristic | Number of Subjects=95 |
| --- | --- |
| Median | 62.0 |
| Min, Max | 27.0, 80.0 |
| Gender, N (%) | |
| Female | 47 (49.5%) |
| Male | 48 (50.5%) |
| Race, N (%) | |
| White | 76 (80.0%) |
| Black or African American | 16 (16.8%) |
| Asian | 2 (2.1%) |
| Asian/White | 1 (1.1%) |
| Ethnicity, N (%) | |
| Hispanic Or Latino | 5 (5.3%) |
| Not Hispanic Or Latino | 89 (93.7%) |
| Not Reported | 1 (1.1%) |
| Baseline Therapy, N (%) | |
| Closed Loop Therapy (Pump + CGM + Algorithm) | 7 (7.4%) |
| CSII | 9 (9.5%) |
| Injection | 58 (61.1%) |
| Other | 2 (2.1%) |
| SAP (Pump + CGM) | 19 (20.0%) |
| Diabetes History (Years) | |
| n | 95 |
| Mean (SD) | 18.6 (8.6) |
| Median | 19.8 |
| Min, Max | 3.3, 43.1 |
| Height (cm) | |
| n | 95 |
| Mean (SD) | 171.6 (8.8) |
| Median | 170.2 |
| Min, Max | 153.7, 198.1 |
| Weight (kg) | |
| n | 95 |
| Mean (SD) | 105.8 (21.8) |
| Median | 103.1 |
| Min, Max | 66.3, 192.8 |
| BMI (kg/m²) | |
| n | 95 |
| Mean (SD) | 36.0 (7.4) |
| Median | 35.2 |
| Min, Max | 21.4, 68.6 |
| Baseline HbA1C (%) | |
| n | 95 |
| Mean (SD) | 7.9 (1.0) |
| Median | 7.9 |
| Min, Max | 5.5, 9.8 |
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
Summary of Demographic and Other Baseline Characteristics, ITT Population (Phase 2)
| Characteristic | Combined*
Number of Subjects = 302 | Transition
Number of Subjects = 66 | Naïve
Number of Subjects = 236 |
| --- | --- | --- | --- |
| Age (Years) | | | |
| n | 302 | 66 | 236 |
| Mean (SD) | 60.3 (11.3) | 62.6 (11.2) | 59.7 (11.2) |
| Median | 61.5 | 64.0 | 61.0 |
| Min, Max | 24.0, 82.0 | 28.0, 82.0 | 24.0, 80.0 |
| Gender, N (%) | | | |
| Female | 168 (55.6%) | 30 (45.5%) | 138 (58.5%) |
| Male | 134 (44.4%) | 36 (54.5%) | 98 (41.5%) |
| Race, N (%) | | | |
| American Indian or Alaska Native | 2 (0.7%) | N/A | 2 (0.8%) |
| American Indian or Alaska Native, White | 1 (0.3%) | N/A | 1 (0.4%) |
| Asian | 18 (6.0%) | 1 (1.5%) | 17 (7.2%) |
| Asian, Black or African American | 1 (0.3%) | N/A | 1 (0.4%) |
| Asian, White | 1 (0.3%) | N/A | 1 (0.4%) |
| Black or African American | 38 (12.6%) | 8 (12.1%) | 30 (12.7%) |
| Native Hawaiian / Other Pacific Islander | 1 (0.3%) | N/A | 1 (0.4%) |
| Not reported | 4 (1.3%) | 2 (3.0%) | 2 (0.8%) |
| Other (Detribalized indigenous) | 1 (0.3%) | N/A | 1 (0.4%) |
| Other (Hispanic) | 1 (0.3%) | N/A | 1 (0.4%) |
| Other (Persian) | 1 (0.3%) | N/A | 1 (0.4%) |
| Other (White / Native American) | 1 (0.3%) | N/A | 1 (0.4%) |
| Other (Hispanic) | 1 (0.3%) | N/A | 1 (0.4%) |
| Unknown | 2 (0.7%) | N/A | 2 (0.8%) |
| White | 229 (75.8%) | 55 (83.3%) | 174 (73.7%) |
| Ethnicity, N (%) | | | |
| Hispanic or Latino | 44 (14.6%) | 4 (6.1%) | 40 (16.9%) |
| Not Hispanic or Latino | 256 (84.8%) | 62 (93.9%) | 194 (82.2%) |
| Not Reported | 1 (0.3%) | N/A | 1 (0.4%) |
| Unknown | 1 (0.3%) | N/A | 1 (0.4%) |
| Diabetes History (Years) | | | |
| n | 302 | 66 | 236 |
| Mean (SD) | 19.4 (9.6) | 20.1 (9.1) | 19.2 (9.7) |
| Median | 19.0 | 20.5 | 18.6 |
| Min, Max | 2.4, 60.4 | 4.2, 44.7 | 2.4, 60.4 |
| Baseline Height (cm) | | | |
| n | 301 | 66 | 235 |
| Mean (SD) | 170.2 (9.9) | 172.5 (8.8) | 169.6 (10.1) |
| Median | 170.2 | 170.7 | 170.0 |
| Min, Max | 147.3, 198.1 | 157.2, 198.1 | 147.3, 198.1 |
| Baseline Weight (kg) | | | |
| n | 301 | 66 | 235 |
| Mean (SD) | 100.5 (23.6) | 109.4 (24.1) | 98.0 (22.8) |
| Median | 98.6 | 105.2 | 96.1 |
| Min, Max | 50.4, 204.2 | 64.7, 204.2 | 50.4, 178.7 |
| Baseline BMI (kg/m²) | | | |
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
| Characteristic | Combined*
Number of Subjects = 302 | Transition
Number of Subjects = 66 | Naïve
Number of Subjects = 236 |
| --- | --- | --- | --- |
| n | 301 | 66 | 235 |
| Mean (SD) | 34.7 (7.7) | 36.9 (8.5) | 34.0 (7.3) |
| Median | 33.5 | 35.3 | 32.9 |
| Min, Max | 20.3, 72.7 | 23.4, 72.7 | 20.3, 67.6 |
| Baseline Therapy, N(%) | | | |
| Closed Loop Therapy
(Pump+CGM+Algorithm) | 66 (21.9%) | 58 (87.9%) | 8 (3.4%) |
| CSII | 7 (2.3%) | N/A | 7 (3.0%) |
| Injection | 191 (63.2%) | 1 (1.5%) | 190 (80.5%) |
| Other | 2 (0.7%) | N/A | 2 (0.8%) |
| Sap (Pump + CGM) | 36 (11.9%) | 7 (10.6%) | 29 (12.3%) |
| Baseline A1C (%) | | | |
| n | 302 | 66 | 236 |
| Mean (SD) | 7.6 (0.9) | 7.1 (0.7) | 7.7 (0.9) |
| Median | 7.5 | 6.9 | 7.7 |
| Min, Max | 5.6, 9.9 | 5.9, 9.0 | 5.6, 9.9 |
* The Combined subjects group included both Naïve and Transition subjects.
The pivotal clinical data (T2D) confirmed the safety and effectiveness of the MiniMed 780G system with Guardian 4 Sensor (Phase 1) and of the MiniMed 780G (modified AHCL) system with Simplera Sync Sensor (Phase 2), and use of AHCL SmartGuard was associated with improved glucose control in adult patients with insulin-requiring T2D. There were no reported device-related serious adverse events. In the target range of 70 to 180 mg/dL, a significant TIR of 80.9% of SG values was observed in Phase 1 and a TIR of 85.4% of SG values in Phase 2
AHCL with Guardian 4 CGM and Insulins (Type 1 Diabetes) – provided in this submission [approved under P160017/S125]
Safety and effectiveness of the MiniMed 780G System in combination with Guardian 4 CGM used in Type 1 Diabetes utilizing Lyumjev and Fiasp insulins is provided in this submission to support the use of additional insulins (also reviewed in P160017/S125).
AHCL with Guardian 4 and Lyumjev insulin
The study using Lyumjev® insulin lispro-aabc in the MiniMed 780G system was a single-arm, multi-center, home clinical investigation in insulin-requiring adult and pediatric subjects with type 1 diabetes. Altogether, the run-in period and study period were approximately 120 days long.
The baseline demographics of subjects 7–80 years of age that entered the study period for Lyumjev with SmartGuard (i.e. ITT population) are presented below.
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
Summary of Subject Demographic and Other Baseline (at Screening) Characteristics, ITT Population
| Characteristic | Age 7-17 Years (N=101) | Age 18-80 Years (N=110) |
| --- | --- | --- |
| Age (Years) | | |
| Number of subjects, N | 101 | 110 |
| Mean (SD) | 13.0 (2.6) | 45.0 (14.2) |
| Median | 13.0 | 45.5 |
| Min, Max | 8.0, 17.0 | 18.0, 75.0 |
| Gender N (%) | | |
| Female | 51 (50.5%) | 49 (44.5%) |
| Male | 50 (49.5%) | 61 (55.5%) |
| Race N (%) | | |
| White | 85 (84.2%) | 103 (93.6%) |
| American Indian or Alaska Native, Asian, Black or African American | 0 (0.0%) | 1 (0.9%) |
| Black or African American | 8 (7.9%) | 4 (3.6%) |
| Asian, White | 1 (1.0%) | 0 (0.0%) |
| Asian | 2 (2.0%) | 0 (0.0%) |
| Native Hawaiian or Other Pacific Islander | 1 (1.0%) | 0 (0.0%) |
| Other, Mediterranean | 0 (0.0%) | 1 (0.9%) |
| Unknown | 1 (1.0%) | 0 (0.0%) |
| Not Reported | 3 (3.0%) | 1 (0.9%) |
| Ethnicity N (%) | | |
| Hispanic or Latino | 19 (18.8%) | 7 (6.4%) |
| Not Hispanic or Latino | 81 (80.2%) | 103 (93.6%) |
| Not Reported | 1 (1.0%) | 0 (0.0%) |
| Diabetes History (Years) | | |
| Number of subjects, N | 101 | 110 |
| Mean (SD) | 6.1 (3.8) | 26.9 (12.0) |
| Median | 5.4 | 25.8 |
| Min, Max | 1.1, 17.2 | 2.6, 59.6 |
| Height(cm) | | |
| Number of subjects, N | 101 | 110 |
| Mean (SD) | 157.2 (15.8) | 173.5 (10.3) |
| Median | 157.7 | 172.0 |
| Min, Max | 103.0, 186.6 | 149.0, 200.7 |
| Weight (kg) | | |
| Number of subjects, N | 101 | 110 |
| Mean (SD) | 55.7 (17.5) | 87.0 (19.4) |
| Median | 55.6 | 83.9 |
| Min, Max | 20.0, 116.5 | 52.4, 135.4 |
| Body Mass Index (kg/m2) | | |
| Number of subjects, N | 101 | 110 |
| Mean (SD) | 22.0 (4.6) | 28.8 (5.3) |
| Median | 21.4 | 28.1 |
| Min, Max | 14.5, 41.6 | 15.9, 45.3 |
| Treatment Method at Baseline N (%) | | |
| Closed Loop Therapy (Pump + CGM + Algorithm) | 85 (84.2%) | 73 (66.4%) |
| CSII | 2 (2.0%) | 12 (10.9%) |
| Injection | 0 (0.0%) | 1 (0.9%) |
Page 16 of 22
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
| Characteristic | Age 7-17 Years (N=101) | Age 18-80 Years (N=110) |
| --- | --- | --- |
| Sap (Pump + CGM) | 14 (13.9%) | 24 (21.8%) |
| Baseline A1C (%) | | |
| Number of subjects, N | 101 | 110 |
| Mean (SD) | 7.6 (1.1) | 7.4 (0.9) |
| Median | 7.6 | 7.3 |
| Min, Max | 5.4, 9.8 | 5.8, 9.8 |
For subjects 7-17 years of age, Lyumjev insulin lispro-aabc was used with the MiniMed 780G system and the Guardian 4 continuous glucose monitor (CGM) during the Study Period with no reported serious adverse events.
For subjects 18-80 years of age, Lyumjev insulin lispro-aabc was used with the MiniMed 780G system and the Guardian 4 CGM during the Study Period. One non-device related serious adverse event was reported during the Screening period. No serious adverse events were reported during the run-in period when subjects used the system in either Manual Mode or with SmartGuard with Auto Correction turned off, or during the Study Period when subjects used the system in SmartGuard with Lyumjev.
The pivotal clinical data with Lyumjev (provided in P160017/S125 and in this submission) confirmed the safety and effectiveness of the Lyumjev insulin lispro-aabc when used in combination with the MiniMed 780G system. The results also confirm that use of Lyumjev with the MiniMed 780G Auto Correction feature was associated with improved glucose control in all age groups.
## AHCL with Guardian 4 and Fiasp insulin
The study using Fiasp (insulin aspart), faster-acting insulin injection with the MiniMed 780G system was a global multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes. The run-in period and study period was approximately 120 days long.
The baseline demographics of subjects 7-80 years of age that entered the study period with Fiasp and SmartGuard (i.e. ITT population) are presented below.
Summary of Subject Demographic and Other Baseline (at Screening) Characteristics, ITT Population
| Characteristic | Age 7-17 Years (N=107) | Age 18-80 Years (N=116) |
| --- | --- | --- |
| Age (Years) | | |
| n | 107 | 116 |
| Mean (SD) | 14.0 (2.4) | 48.3 (14.5) |
| Median | 15.0 | 49.0 |
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
| Characteristic | Age 7-17 Years (N=107) | Age 18-80 Years (N=116) |
| --- | --- | --- |
| Min, Max | 7.0, 17.0 | 18.0, 80.0 |
| Gender N (%) | | |
| Female | 56 (52.3%) | 54 (46.6%) |
| Male | 51 (47.7%) | 62 (53.4%) |
| Country N (%) | | |
| Australia | 9 (8.4%) | 0 (0.0%) |
| Canada | 9 (8.4%) | 7 (6.0%) |
| United States | 89 (83.2%) | 109 (94.0%) |
| Race N (%) | | |
| White | 82 (76.6%) | 105 (90.5%) |
| American Indian or Alaska Native,White | 1 (0.9%) | 0 (0.0%) |
| Asian,White | 2 (1.9%) | 0 (0.0%) |
| American Indian or Alaska Native | 0 (0.0%) | 1 (0.9%) |
| Asian | 2 (1.9%) | 4 (3.4%) |
| Asian,Native Hawaiian / Other Pacific Islander | 1 (0.9%) | 0 (0.0%) |
| Black or African American | 7 (6.5%) | 5 (4.3%) |
| Native Hawaiian / Other Pacific Islander | 1 (0.9%) | 0 (0.0%) |
| Other (Biracial) | 0 (0.0%) | 1 (0.9%) |
| Not reported | 11 (10.3%) | 0 (0.0%) |
| Ethnicity N (%) | | |
| Hispanic or Latino | 16 (15.0%) | 3 (2.6%) |
| Not Hispanic or Latino | 82 (76.6%) | 113 (97.4%) |
| Not reported | 9 (8.4%) | 0 (0.0%) |
| Diabetes History (Years) | | |
| n | 107 | 116 |
| Mean (SD) | 7.1 (3.3) | 29.0 (14.6) |
| Median | 6.9 | 26.7 |
| Min, Max | 1.1, 15.0 | 2.1, 63.4 |
| Baseline Height (cm) | | |
| n | 107 | 116 |
| Mean (SD) | 161.6 (14.3) | 171.4 (10.2) |
| Median | 163.8 | 171.0 |
| Min, Max | 122.8, 194.6 | 150.0, 195.6 |
| Baseline Weight (kg) | | |
| n | 107 | 116 |
| Mean (SD) | 61.6 (16.9) | 86.2 (19.1) |
| Median | 61.3 | 87.2 |
| Min, Max | 22.1, 105.5 | 52.4, 139.7 |
| Baseline BMI (Kg/m²) | | |
| n | 107 | 116 |
| Mean (SD) | 23.2 (4.5) | 29.3 (6.2) |
| Median | 22.5 | 28.3 |
| Min, Max | 14.7, 36.1 | 19.0, 54.6 |
| Treatment Method at Baseline | | |
| Closed Loop Therapy (Pump + CGM + Algorithm) | 66 (61.7%) | 89 (76.7%) |
| CSII | 10 (9.3%) | 13 (11.2%) |
| Other | 1 (0.9%) | 1 (0.9%) |
| SAP (Pump + CGM) | 30 (28.0%) | 13 (11.2%) |
| Baseline A1C (%) | | |
Page 18 of 22
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Medtronic
Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
| Characteristic | Age 7-17 Years (N=107) | Age 18-80 Years (N=116) |
| --- | --- | --- |
| n | 107 | 116 |
| Mean (SD) | 7.8 (0.9) | 7.4 (0.8) |
| Median | 7.7 | 7.4 |
| Min, Max | 5.8, 9.9 | 5.6, 9.5 |
For all subjects 7-80 years of age, the Fiasp (insulin aspart), faster-acting insulin injection was used with the MiniMed 780G system and Guardian 4 continuous glucose monitor (CGM) during the Study period with no device-related serious adverse events reported.
The pivotal clinical data with Fiasp (provided in P160017/S125 and in this submission) confirmed the safety and effectiveness of Fiasp (insulin aspart), faster-acting insulin injection when used in combination with the MiniMed 780G system. The results also confirm that use of Fiasp (insulin aspart) with the MiniMed 780G Auto Correction feature was associated with improved glucose control in all age groups.
# Supplemental Clinical Data (AHCL Algorithm)
In Silico Simulation with Guardian 4 Sensor and AHCL (in Type 1) – provided in K251217
In-silico studies and results for AHCL in Type 1 were provided in K251217, and the study results provided in this submission are comparable for the compatible configurations of the MiniMed 780G system when used with either the Simplera Sync CGM or the Guardian 4 CGM.
In Silico Simulation with Simplera Sync Sensor and AHCL (in Type 2) – provided in this submission [approved under P160017/S124]
The Type 2 Diabetes (T2D) virtual patient (VP) model matched the T2D adult real patient (RP) population and generated outcomes that are equivalent for time in range (70-180 mg/dL), glucose management indicator (GMI), and a number of other glucose metrics.. In summary, the data shows robust equivalency of characteristics and outcomes between the T2D VPs and T2D RPs in a clinical study setting in CIP341 (G210352) Phase 1 for the AHCL algorithm and Guardian 4 sensor (G4S) CGM and CIP341 Phase 2 for the AHCL algorithm) and the DS5 CGM for adults with T2D.
Additionally, the virtual clinical trial in T2D subjects predicted the safety and effectiveness of use of the AHCL algorithm and the G4S CGM, when assessed according to the thresholds
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Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
evaluated in CIP341 Phase 2. The thresholds, which reflect the ADA recommendation for percentage time in target range (70-180 mg/dL), were exceeded with statistical significance. These observations support the expectation that real T2D patients could experience a TIR that is at least as favorable as, or significantly greater than, the recommended ADA TIR target when using AHCL with the G4S CGM.
*In Silico Simulation with Guardian 4 CGM and AHCL (in Type 1) utilizing Lyumjev and Fiasp insulins – provided in this submission [approved under P160017/S125]*
The VP model matched the RP population and generated outcomes that are equivalent for time in range (70-180 mg/dL), GMI, and a number of other glucose metrics. In summary, the data in these analyses shows robust equivalency of characteristics and outcomes between the T1D VPs and RPs in a clinical study setting in CIP335 (G220010) and CIP336 (G210307) for the AHCL algorithm and the G4S CGM with Lyumjev and Fiasp.
The virtual clinical trial predicted the safety and effectiveness of use of the AHCL algorithm and the G4S and Simplera Sync CGMs when assessed according to the thresholds evaluated in CIP335 and CIP336 for Lyumjev and Fiasp for both type 1 diabetes and type 2 diabetes.
## Clinical Testing for Predictive Low Glucose Technology (PLGM Algorithm)
PLGM algorithm was evaluated for safety in a multi-center, single-arm, in-clinic study of the MiniMed 640G System, and study results were provided in K251217.
## Supplemental Clinical Data (PLGM Algorithm)
*In Silico Simulation Studies with PLGM (in Type 2 and Type 1 with Lyumjev/Fiasp) – provided in this submission [reviewed in P160017/S124 and P160017/S125]*
PLGM – Type 2 (G210352, CIP341), Lyumjev (G220010, CIP335), Fiasp (G210307, CIP336)
The results for the analyses conducted for the primary endpoint metric of percentage time in hypoglycemia <70 mg/dL fell within the margin for the adult age group, indicating equivalency between the RPs and VPs with regards to time spent below 70 mg/dL with PLGM use.
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Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
## Interoperability
Interoperability documentation was provided in accordance with FDA Guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (September 2017)” and the requirements defined by the iAGC special controls 21 CFR 862.1356. The documentation included a description of interface and its specifications, interoperability design and architecture, and the strategy for the Medtronic iAGCs to be interoperable with compatible connected devices (ACE pumps and CGMs). It also specified host device specifications, expectations, interoperability and compatibility requirements, and interface specifications for current and future connected devices. In addition, it provided Medtronic’s approach to working with third-party connected device companies regarding contractual issues, quality agreement, data communication and exchange, and post-market reporting procedures and responsibilities.
## Predetermined Change Control Plan (PCCP)
A Predetermined Change Control Plan (PCCP) to add potential interoperable connected devices (ACE pumps and iCGMs) in the future, as well as for continued maintenance of previously marketed and qualified connected devices, was provided in accordance with the FDA Draft Guidance, “Predetermined Change Control Plans for Medical Devices (August 2024)”. It outlined the process for qualifying and integrating additional future connected devices, as well as re-qualification of previously marketed and qualified connected devices to ensure continued compatibility. The PCCP includes a description of modifications, the expected compatibility specifications and the interface specifications for potential future interoperable devices (ACE pumps and iCGMs), a modification protocol (which outlines qualification process and integration test plans with pre-specified acceptance criteria), and an impact assessment.
## Conclusion
The subject devices, SmartGuard technology and Predictive Low Glucose technology, have the same intended use and indications for use (except for minor differences in the intended population) and are intended to be used in the same environment as their respective predicate devices, with no differences in technological characteristics between the subject and predicate devices. The required non-clinical and clinical performance data, including in-silico evidence from Virtual Patient Model, provided in this Traditional 510(k) in addition to the data provided in K251217 demonstrate that the subject devices are as safe and as effective as the predicate devices.
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Medtronic Diabetes
Bundled 510(k) Summary
SmartGuard technology and Predictive Low Glucose technology
Based on the information provided in this Bundled Traditional 510(k), Medtronic concludes that the subject device, SmartGuard technology, is substantially equivalent to the predicate device, SmartGuard technology for the Product Code QJI, and the subject device, Predictive Low Glucose technology, is substantially equivalent to the predicate device, Predictive Low Glucose technology for the Product Code QJS. Furthermore, the subject devices meet all the iAGC Special Controls requirements defined in 21 CFR 862.1356.
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