(71 days)
SmartGuard Technology:
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose (SG) values.
SmartGuard technology is intended for the management of 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 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 (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.
Predictive Low Glucose technology suspends and resumes insulin delivery in Manual mode. Manual mode contains a bolus calculator that calculates an insulin dose based on user-entered data.
Predictive Low Glucose technology is intended for the management of 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 requiring insulin.
Predictive Low Glucose technology is intended for single patient use and requires a prescription.
Device Description for SmartGuard Technology
SmartGuard Technology, also referred to as the Advanced Hybrid Closed Loop (AHCL) algorithm, is a software-only interoperable automated glycemic controller (iAGC) intended to adjust basal insulin delivery and perform automatic correction boluses based on user-entered inputs and sensor glucose (SG) values obtained from a compatible integrated continuous glucose monitor (iCGM) or an interoperable Medtronic continuous glucose monitor (CGM). SmartGuard Technology is embedded within the firmware of a compatible alternate controller enabled (ACE) pump, which functions as the host device.
The ACE pump receives SG data from compatible CGM/iCGM devices via Bluetooth Low Energy (BLE) and also collects user inputs through the ACE pump (for pumps that have a screen) or the MiniMed App (for screenless pumps). The AHCL algorithm does not directly communicate with CGMs/iCGMs; instead, the ACE pump transmits CGM/iCGM data and user-entered inputs to the AHCL algorithm and receives the algorithm's output commands.
In SmartGuard Mode, the AHCL algorithm uses adaptive control to adjust insulin delivery every five (5) minutes based on SG values. It delivers an auto basal insulin dose to maintain user-selectable targets of 100, 110, or 120 mg/dL, supports a temporary target of 150 mg/dL for up to 24 hours, and can automatically deliver correction boluses when appropriate.
Meal boluses are the responsibility of the user. The AHCL algorithm includes an integrated bolus calculator that determines user-initiated meal bolus doses based on available SG information, carbohydrate input, and other patient parameters.
The AHCL algorithm is a software-only device with no user interface. All therapy settings, user interactions, and AHCL-related alerts or alarms are managed through the compatible ACE pump or the MiniMed App. An optional App Manager device with the MiniMed App pre-installed is available as an alternative to a user's personal mobile device.
Device Description for Predictive Low Glucose Technology
Predictive Low Glucose Technology, also referred to as the Predictive Low Glucose Management (PLGM) algorithm, is a software-only interoperable automated glycemic controller (iAGC) that is intended to automatically suspend delivery of insulin when sensor glucose (SG) values fall below or are predicted to fall below predefined threshold values based on user-entered inputs. The PLGM algorithm is embedded within the firmware of a compatible alternate controller enabled (ACE) pump, which functions as the host device.
The ACE pump receives SG data from a compatible integrated continuous glucose monitor (iCGM) or interoperable Medtronic CGM via Bluetooth Low Energy (BLE) and collects user-entered inputs through the ACE pump (for pumps that have a screen) or the MiniMed App (for screenless pumps). The PLGM algorithm does not directly communicate with CGM/iCGM devices; instead, the ACE pump transmits CGM/iCGM data and user inputs to the algorithm and receives the resulting suspend and resume commands. PLGM functionality is available only in Manual mode. In this mode, users are responsible for all basal and bolus insulin delivery, including user-defined basal rate patterns and user-initiated boluses, with optional use of the bolus calculator and the max bolus limit feature. When enabled, the PLGM algorithm may suspend insulin delivery for a minimum of 30 minutes and up to 2 hours based on current or predicted SG values and will automatically resume delivery when criteria are met or when the maximum suspend duration is reached. Users may also manually resume delivery at any time.
The PLGM algorithm is a software-only device with no user interface. All therapy settings, user interactions, and PLGM-related alerts or alarms are managed through the compatible ACE pump or the MiniMed App. An optional App Manager device with the MiniMed App pre-installed is available as an alternative to a user's personal mobile device.
N/A
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
February 3, 2026
Medtronic Minimed
Shivani Shah
Senior Regulatory Affairs Specialist
18000 Devonshire St.
Northridge, California 91325
Re: K253701
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, NDC
Dated: November 21, 2025
Received: November 24, 2025
Dear Shivani Shah:
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
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K253701 - Shivani Shah
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required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an 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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K253701 - Shivani Shah
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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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Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K253701
Please provide the device trade name(s).
SmartGuard Technology
Predictive Low Glucose Technology
Please provide your Indications for Use below.
SmartGuard Technology:
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose (SG) values.
SmartGuard technology is intended for the management of 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 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 (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.
Predictive Low Glucose technology suspends and resumes insulin delivery in Manual mode. Manual mode contains a bolus calculator that calculates an insulin dose based on user-entered data.
Predictive Low Glucose technology is intended for the management of 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 requiring insulin.
Predictive Low Glucose technology is intended for single patient use and requires a prescription.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Bundled 510(K) Summary
SmartGuard Technology and Predictive Low Glucose Technology
510(k) Submitter and Device Information
| Submitter's Name and Address | Medtronic MiniMed, Inc.18000 Devonshire StNorthridge, CA 91325 USA |
|---|---|
| Primary Contact Person | Shivani ShahSenior Regulatory Affairs SpecialistMedtronic MiniMed Inc.shivani.a.shah@medtronic.com |
| Alternate Contact Person | Siddhi RasamSenior Regulatory Affairs ManagerMedtronic MiniMed Inc.siddhi.rasam@medtronic.com |
| Device Trade Name | SmartGuard Technology,Predictive Low Glucose Technology |
| Device Common Name | Advanced Hybrid Closed Loop Algorithm,Predictive Low Glucose Management Algorithm |
| Device Classification Name | Interoperable Automated Glycemic Controller |
| Regulation Number | 21 CFR 862.1356 |
| Product Codes | QJI, QJS, NDC |
| Predicate Device | K251217 - SmartGuard Technology and Predictive Low Glucose TechnologyK251032 - MiniMed 780G insulin pump |
| Device Panel | Clinical Chemistry |
| Device Class | Class II |
Device Description for SmartGuard Technology
SmartGuard Technology, also referred to as the Advanced Hybrid Closed Loop (AHCL) algorithm, is a software-only interoperable automated glycemic controller (iAGC) intended to adjust basal insulin delivery and perform automatic correction boluses based on user-entered inputs and sensor glucose (SG) values obtained from a compatible integrated continuous glucose monitor (iCGM) or an interoperable Medtronic continuous glucose monitor (CGM). SmartGuard
Page 6
Technology is embedded within the firmware of a compatible alternate controller enabled (ACE) pump, which functions as the host device.
The ACE pump receives SG data from compatible CGM/iCGM devices via Bluetooth Low Energy (BLE) and also collects user inputs through the ACE pump (for pumps that have a screen) or the MiniMed App (for screenless pumps). The AHCL algorithm does not directly communicate with CGMs/iCGMs; instead, the ACE pump transmits CGM/iCGM data and user-entered inputs to the AHCL algorithm and receives the algorithm's output commands.
In SmartGuard Mode, the AHCL algorithm uses adaptive control to adjust insulin delivery every five (5) minutes based on SG values. It delivers an auto basal insulin dose to maintain user-selectable targets of 100, 110, or 120 mg/dL, supports a temporary target of 150 mg/dL for up to 24 hours, and can automatically deliver correction boluses when appropriate.
Meal boluses are the responsibility of the user. The AHCL algorithm includes an integrated bolus calculator that determines user-initiated meal bolus doses based on available SG information, carbohydrate input, and other patient parameters.
The AHCL algorithm is a software-only device with no user interface. All therapy settings, user interactions, and AHCL-related alerts or alarms are managed through the compatible ACE pump or the MiniMed App. An optional App Manager device with the MiniMed App pre-installed is available as an alternative to a user's personal mobile device.
Indications for Use / Intended Use for SmartGuard Technology
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose (SG) values.
SmartGuard technology is intended for the management of 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 requiring insulin.
SmartGuard technology is intended for single patient use and requires a prescription.
Page 7
Device Description for Predictive Low Glucose Technology
Predictive Low Glucose Technology, also referred to as the Predictive Low Glucose Management (PLGM) algorithm, is a software-only interoperable automated glycemic controller (iAGC) that is intended to automatically suspend delivery of insulin when sensor glucose (SG) values fall below or are predicted to fall below predefined threshold values based on user-entered inputs. The PLGM algorithm is embedded within the firmware of a compatible alternate controller enabled (ACE) pump, which functions as the host device.
The ACE pump receives SG data from a compatible integrated continuous glucose monitor (iCGM) or interoperable Medtronic CGM via Bluetooth Low Energy (BLE) and collects user-entered inputs through the ACE pump (for pumps that have a screen) or the MiniMed App (for screenless pumps). The PLGM algorithm does not directly communicate with CGM/iCGM devices; instead, the ACE pump transmits CGM/iCGM data and user inputs to the algorithm and receives the resulting suspend and resume commands. PLGM functionality is available only in Manual mode. In this mode, users are responsible for all basal and bolus insulin delivery, including user-defined basal rate patterns and user-initiated boluses, with optional use of the bolus calculator and the max bolus limit feature. When enabled, the PLGM algorithm may suspend insulin delivery for a minimum of 30 minutes and up to 2 hours based on current or predicted SG values and will automatically resume delivery when criteria are met or when the maximum suspend duration is reached. Users may also manually resume delivery at any time.
The PLGM algorithm is a software-only device with no user interface. All therapy settings, user interactions, and PLGM-related alerts or alarms are managed through the compatible ACE pump or the MiniMed App. An optional App Manager device with the MiniMed App pre-installed is available as an alternative to a user's personal mobile device.
Indications for Use / Intended Use for Predictive Low Glucose Technology
Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.
Predictive Low Glucose technology suspends and resumes insulin delivery in Manual mode. Manual mode contains a bolus calculator that calculates an insulin dose based on user-entered data.
Page 8
Predictive Low Glucose technology is intended for the management of 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 requiring insulin.
Predictive Low Glucose technology is intended for single patient use and requires a prescription.
Summary of Technological Characteristics of Subject Device Compared to Predicate Device
The table below provides a side-by-side comparison of the subject device, SmartGuard Technology, compared to its predicate device for Product Code QJI.
| Predicate DeviceSmartGuard Technology(Advanced Hybrid Closed Loop (AHCL) Algorithm)(K251217) | Subject DeviceSmartGuard Technology(Advanced Hybrid Closed Loop (AHCL) Algorithm) |
|---|---|
| Manufacturer | Medtronic MiniMed Inc. |
| Device Trade Name | SmartGuard Technology |
| Device Classification | Class II |
| Product Code | QJI |
| Regulation Name | Interoperable Automated Glycemic Controller (under 21 CFR 862.1356) |
| Indications For Use/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 the management of Type 1 diabetes mellitus in persons 7 years of age and older requiring insulin.SmartGuard technology is intended for single patient use and requires a prescription. |
| Prescription Use | Prescription is required |
Page 9
| Environment Of Use | Professional healthcare facilities and home environments | SAME |
|---|---|---|
| Intended Population | Type 1 diabetes mellitus in persons 7 years of age and greater. | Type 1 diabetes mellitus in persons 7 years of age and greater.Type 2 diabetes mellitus in persons 18 years of age and greater¹ |
| Principal Operator | Patient or caregiver | SAME |
| Number Of Users | Single user | SAME |
| Principle Of Operation | Algorithmic software device intended to automatically increase, decrease, and suspend delivery of insulin based on current and trending CGM values, insulin delivery history and user input. | SAME |
| Specific Drug/Biological Use | U-100 insulin:Novolog®Humalog®Admelog® | U-100 insulin:²Novolog®Humalog®Admelog®Fiasp®Lyumjev® |
| Total Daily Dose (TDD) Of Insulin | 8 to 250 units a day | SAME |
| Active Insulin Time | User adjustable (between 2 - 8 hours) | SAME |
| Insulin Adjustment | AHCL algorithm can be used to manage Bolus and Basal rate every 5 minute interval. | SAME |
| Glucose Target (Target Settings) | Glucose Targets (Target Setpoint):• 100 mg/dL• 110 mg/dL• 120 mg/dLTemp Target: 150 mg/dL | SAME |
| Auto Correction Bolus Target | 120 mg/dL | SAME |
The table below provides a side-by-side comparison of the subject device, Predictive Low Glucose Technology, compared to its predicate device for Product Code QJS.
| Predicate DevicePredictive Low Glucose Technology(Predictive Low Glucose Management (PLGM) Algorithm) | Subject DevicePredictive Low Glucose Technology(Predictive Low Glucose Management (PLGM) Algorithm) |
|---|---|
| Manufacturer | Medtronic MiniMed Inc. |
| Device Trade Name | Predictive Low Glucose Technology |
| Device Classification | Class II |
| Product Code | QJS |
¹ SmartGuard Technology for the management of Type 2 diabetes is cleared under K253585.
² The use of Lyumjev and Fiasp insulins is cleared under K253470.
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| Environment Of Use | Professional healthcare facilities and home environments | SAME |
|---|---|---|
| Intended Population | Type 1 diabetes mellitus in persons 7 years of age and greater. | Type 1 diabetes mellitus in persons 7 years of age and greater.Type 2 diabetes mellitus in persons 18 years of age and greater¹ |
| Principal Operator | Patient or caregiver | SAME |
| Number Of Users | Single user | SAME |
| Principle Of Operation | Algorithmic software device intended to automatically increase, decrease, and suspend delivery of insulin based on current and trending CGM values, insulin delivery history and user input. | SAME |
| Specific Drug/Biological Use | U-100 insulin:Novolog®Humalog®Admelog® | U-100 insulin:²Novolog®Humalog®Admelog®Fiasp®Lyumjev® |
| Total Daily Dose (TDD) Of Insulin | 8 to 250 units a day | SAME |
| Active Insulin Time | User adjustable (between 2 - 8 hours) | SAME |
| Insulin Adjustment | AHCL algorithm can be used to manage Bolus and Basal rate every 5 minute interval. | SAME |
| Glucose Target (Target Settings) | Glucose Targets (Target Setpoint):• 100 mg/dL• 110 mg/dL• 120 mg/dLTemp Target: 150 mg/dL | SAME |
| Auto Correction Bolus Target | 120 mg/dL | SAME |
The table below provides a side-by-side comparison of the subject device, Predictive Low Glucose Technology, compared to its predicate device for Product Code QJS.
| Predicate DevicePredictive Low Glucose Technology(Predictive Low Glucose Management (PLGM) Algorithm) | Subject DevicePredictive Low Glucose Technology(Predictive Low Glucose Management (PLGM) Algorithm) |
|---|---|
| Manufacturer | Medtronic MiniMed Inc. |
| Device Trade Name | Predictive Low Glucose Technology |
| Device Classification | Class II |
| Product Code | QJS |
¹ SmartGuard Technology for the management of Type 2 diabetes is cleared under K253585.
² The use of Lyumjev and Fiasp insulins is cleared under K253470.
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| Regulation Name | Interoperable automated glycemic controller, insulin suspend (under 21 CFR 862.1356) | SAME |
|---|---|---|
| Indications For Use/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 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 requiring insulin.Predictive Low Glucose 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 (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.Predictive Low Glucose technology suspends and resumes insulin delivery in Manual mode. Manual mode contains a bolus calculator that calculates an insulin dose based on user-entered data.Predictive Low Glucose technology is intended for the management of 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 requiring insulin.Predictive Low Glucose technology is intended for single patient use and requires a prescription. |
| Prescription Use | Prescription is required | SAME |
| Environment Of Use | Professional healthcare facilities and home environments | SAME |
| Intended Population | Type 1 diabetes mellitus in persons 7 years of age and greater. | Type 1 diabetes mellitus in persons 7 years of age and greater.Type 2 diabetes mellitus in persons 18 years of age and greater.³ |
| Number Of Users | Single user | SAME |
| Principle Of Operation | Algorithmic software device that utilizes CGM sensor readings to stop and resume insulin based on the current and predicted (30 minutes into the future) sensor values. | SAME |
| Specific Drug/Biological Use | U-100 insulin:Novolog®Humalog®Admelog® | U-100 insulin:⁴Novolog®Humalog®Admelog®Fiasp®Lyumjev® |
| Can Automatically Resume Insulin Delivery | Yes | SAME |
| Basal Insulin Delivery Suspension | Suspend on Low: Based on the current CGM value is less than or equal to the low limit (50 to 90 mg/dL). | SAME |
³ Predictive Low Glucose technology for the management of Type 2 diabetes is cleared under K253585.
⁴ The use of Lyumjev and Fiasp insulins is cleared under K253470.
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| Suspend before Low: | Based on 30 minute predictive CGM value is less than equal to low limit (50 to 90 mg/dL) and current sensor glucose values. |
|---|---|
| Bolus Insulin Delivery Suspension | Any ongoing bolus delivery will be cancelled. |
| Minimum – 30 minutesMaximum - 2 hoursUser can resume delivery at any time | SAME |
| Predetermined changed control plan (PCCP) | The MiniMed 780G insulin pump was cleared with an authorized PCCP that included modifications for integrating with additional interoperable devices in the future. |
The table below provides a side-by-side comparison of the subject device, Predictive Low Glucose Technology, compared to its predicate device for Product Code NDC.
| Subject DeviceMiniMed 780G ACE pump(K251032) | Subject DevicePredictive Low Glucose Technology(Predictive Low Glucose Management (PLGM) Algorithm) |
|---|---|
| Manufacturer | Medtronic |
| Device Trade Name | MiniMed 780G ACE insulin pump |
| Device Type | Predictive Pulmonary-Function Value Calculator (21 CFR 868.1890) |
| Device Classification | Class II |
| Product Code | NDC |
| Indications for Use/Intended Use | The 780G Pump contains a bolus calculator that calculates an insulin dose based on user-entered data. |
| Therapy Type | Diabetes patients treated with insulin pump therapy in which calculator is integrated |
| Specific Drug/Biological Use | U-100 insulins |
| Principles of Operation | Calculate insulin doses for meals and corrections while accounting for active insulin (insulin on board). |
| Carbohydrate Calculator | Calculates carbohydrate intake based on user-entered data. |
| Manual Data Entry | Yes |
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| Requires BG for calculation | Yes | SAME |
|---|
Summary of Non-Clinical Performance Data
Medtronic MiniMed conducted performance testing for SmartGuard Technology and Predictive Low Glucose Technology, summarized below, to demonstrate substantial equivalence to the predicate devices and to ensure that the subject devices meet all applicable iAGC Special Controls requirements defined in 21 CFR 862.1356.
Special Controls
Evaluation and adherence to the Special Controls of the Predicate Device (K251217) demonstrates continued assurance of the safety and effectiveness of the Subject Devices.
Software Verification and Validation
Software verification activities were performed in accordance with ISO 14971:2019, "Medical Devices - Application of Risk Management to Medical Devices," IEC 62304:2006/A1:2016, "Medical Device Software - Software Life Cycle Processes," and FDA guidance, "Content of Premarket Submissions for Device Software Functions" (June 2023).
Additionally, cybersecurity activities were all completed per a 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.
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 in 21 CFR 862.1356.
Human Factors Validation
A human factors and usability engineering process was performed on Subject Devices with compatible Medtronic CGM and compatible Medtronic ACE pump 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
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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
Medtronic MiniMed iAGCs' labeling and training for users and healthcare practitioners is sufficient and satisfies applicable requirements of 21 CFR 801.
Pre-determined Change Control Plan (PCCP)
A pre-determined change control plan (PCCP) for planned modifications to the SmartGuard Technology and Predictive Low Glucose Technology was provided in accordance with the FDA Draft Guidance, "Predetermined Change Control Plans for Medical Devices" (August 2024). It included modifications for integrating with potential interoperable devices in the future. The PCCP included a description of modifications, a modification protocol, traceability from modifications to the modification protocols and an impact assessment.
Summary of Clinical Performance Data
The SmartGuard Technology and Predictive Low Glucose Technology remains consistent with previously cleared algorithm designs and indications with no changes to the algorithm design, architecture, features, logical flows, safeguards, or principles of operation from the AHCL and PLGM algorithms previously reviewed and cleared by the FDA under K251217 as iAGCs. The indication for the SmartGuard Technology and Predictive Low Glucose Technology expanded from Type 1 diabetes management to Type 2 diabetes management (cleared under K253585) and compatibility with additional U-100 insulins, Fiasp and Lyumjev (cleared under K253470).
All clinical evidence referenced in this 510(k) is identical to evidence previously reviewed and subsequently cleared by the FDA.
Virtual Patient Model
The Virtual Patient (VP) model was used to demonstrate safety and effectiveness of the iAGC algorithms with compatible iCGMs, compatible interoperable Medtronic CGM, and compatible ACE pumps. The validation activities of the virtual patient model—following the framework from FDA Guidance, "Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions: Guidance for Industry and FDA Staff" (November 2023)—remain unchanged from what was provided in K25127, P160017/S124, and P160017/S125.
Medtronic demonstrated equivalency between the VPs and real patients (RPs) in terms of fixed acceptance criteria from pivotal clinical studies for the AHCL and PLGM algorithms:
- CIP335 (Lyumjev); G220010
- CIP336 (Fiasp); G210307; and
- CIP341(Type 2); G210352
The equivalency testing provided for CIP337 (G220306) remains unchanged from what was provided in K251217.
Conclusion
The subject devices, SmartGuard Technology and Predictive Low Glucose Technology, have the same intended use and similar indications for use and are intended to be used in the same environment as their respective predicate devices, with minor technological differences that do not raise new safety or effectiveness questions. Non-clinical and clinical performance data, including Virtual Patient Model in silico evidence, demonstrate both subject devices meet all iAGC Special Controls requirements per 21 CFR 862.1356 and provide a reasonable assurance of safety and effectiveness and establish SmartGuard Technology as substantially equivalent to predicate SmartGuard Technology (Product Code QJI) and Predictive Low Glucose Technology as substantially equivalent to predicate Predictive Low Glucose Technology (Product Code QJS) and MiniMed 780G insulin pump (Product Code NDC).
§ 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.