SmartGuard technology; Predictive Low Glucose technology

K251217 · Medtronic Minimed, Inc. · QJI · Aug 29, 2025 · Clinical Chemistry

Device Facts

• Record ID: K251217
• Device Name: SmartGuard technology; Predictive Low Glucose technology
• Applicant: Medtronic Minimed, Inc.
• Product Code: QJI · Clinical Chemistry
• Decision Date: Aug 29, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1356
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, PCCP, Pediatric

Indications for 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 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 requiring insulin. Predictive Low Glucose technology is intended for single patient use and requires a prescription.

Device Story

Software-only interoperable automated glycemic controllers (iAGC) comprising SmartGuard (Advanced Hybrid Closed Loop) and Predictive Low Glucose (PLGM) algorithms. Inputs: sensor glucose (SG) values and user settings from compatible ACE pumps. SmartGuard transforms inputs into basal insulin adjustments and correction bolus commands; PLGM transforms inputs into insulin suspend/resume commands. Used by patients with Type 1 diabetes (age 7+) in home settings. Operates via software interface with ACE pumps. Healthcare providers configure therapy settings (target setpoint, insulin-to-carb ratios, active insulin time). Output affects insulin delivery to maintain glycemic control; benefits include automated management of glucose levels and prevention of hypoglycemia. PCCP included for future integration with new iCGMs and ACE pumps.

Clinical Evidence

No new clinical studies conducted. Evidence leveraged from prior PMA approvals (P160017, P160017/S031, P160017/S118). Subject algorithms are identical to those previously approved. Non-clinical performance supported by software verification/validation, hazard analysis, and interoperability testing with 780G ACE pump (SW 6.42) and compatible Medtronic CGMs.

Technological Characteristics

Software-only iAGC algorithms. SmartGuard (AHCL) and PLGM. Interoperable with iCGMs and ACE pumps via software interface. Requires specific therapy settings (target setpoint, insulin-to-carb ratios, active insulin time). Complies with ISO 14971, IEC 62304, and IEC 62366-1. PCCP established for interoperability maintenance.

Indications for Use

Indicated for management of Type 1 diabetes mellitus in persons 7 years of age and older requiring insulin. Contraindicated for persons under age 7. Not recommended for persons with significant cognitive/physical impairment, children without capable caregivers, persons unable to perform BG meter readings, or persons unable to maintain contact with healthcare professionals. SmartGuard contraindicated for those requiring <8 or >250 units of total daily insulin.

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

• Control-IQ Technology (K232382)

Submission Summary (Full Text)

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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K251217

B Applicant

Medtronic MiniMed Inc.

C Proprietary and Established Names

SmartGuard technology

Predictive Low Glucose technology

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QJI | Class II | 21 CFR 862.1356 - Interoperable Automated Glycemic Controller | CH - Clinical Chemistry |
| QJS | Class II | 21 CFR 862.1356 - Interoperable Automated Glycemic Controller | CH - Clinical Chemistry |

## E Purpose for Submission:

- Clearance of the SmartGuard technology and the Predictive Low Glucose technology as interoperable automated glycemic controllers (iAGCs).
- Establish a Predetermined Change Control Plan (PCCP) for qualifying and integrating with compatible FDA-cleared integrated continuous glucose monitors (iCGMs) and compatible FDA-cleared alternate controller enabled (ACE) pumps.

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) for 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 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 requiring insulin.

Predictive Low Glucose technology is intended for single patient use and requires a prescription.

C Special Conditions for Use Statement(s):

SmartGuard Technology

Rx - For Prescription Use Only

- SmartGuard technology is contraindicated for use in persons under age 7.
- SmartGuard technology is not recommended for people with a significant cognitive or physical impairment that affects their ability to safely operate the pump, including a lack of physical dexterity.
- SmartGuard technology is not recommended for children who are not under the care of a parent or caregiver who is capable of safely operating the pump for the patient.
- SmartGuard technology is not recommended for persons who are unwilling or unable to perform BG meter readings.
- SmartGuard technology is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.
- Do not use the SmartGuard feature for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to use the SmartGuard feature.

Predictive Low Glucose Technology

Rx - For Prescription Use Only

- Predictive Low Glucose technology is contraindicated for use in persons under age 7.

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- Predictive Low Glucose technology is not recommended for people with a significant cognitive or physical impairment that affects their ability to safely operate the pump, including a lack of physical dexterity.
- Predictive Low Glucose technology is not recommended for children who are not under the care of a parent or caregiver who is capable of safely operating the pump for the patient.
- Predictive Low Glucose technology is not recommended for persons who are unwilling or unable to perform BG meter readings.
- Predictive Low Glucose technology is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.

## III Device Description

### SmartGuard Technology

The SmartGuard Technology, also referred to as the Advanced Hybrid Closed Loop (AHCL) algorithm, is a software-only device intended for use by people with Type 1 diabetes for ages 7 years or older. It is an interoperable automated glycemic controller (iAGC) that is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible 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.

Inputs to the AHCL algorithm (e.g., SG values, user inputs) are received from the ACE pump, and outputs from the AHCL algorithm (e.g., insulin delivery commands) are sent by the algorithm to the ACE pump.

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. 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 5 consecutive hours of insulin delivery history, a minimum of 2 days of total daily dose (TDD) of insulin, a valid SG and blood glucose (BG) values to start automated insulin delivery.

### Predictive Low Glucose Technology

The 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 for ages 7 years or older. It is an iAGC that is intended for use with compatible iCGMs, compatible Medtronic CGMs and compatible ACE pumps to automatically suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

Inputs to the PLGM algorithm (e.g., SG 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 via software interface.

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

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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.

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## IV Substantial Equivalence Information:

A Predicate Device Name(s): Control-IQ Technology

B Predicate 510(k) Number(s): K232382

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K251217 | K232382 |
| --- | --- | --- |
| Device Trade Name | SmartGuard technology | Control-IQ technology |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Intended for use with compatible 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. | Same |
| Principles of Operation | Algorithmic software device intended to automatically increase, decrease, suspend and resume delivery of insulin based on sensor glucose values | Same |
| Device Hosting Controller | ACE Pump | Same |
| Communication with ACE Pump | Software interface | Same |
| General Device Characteristic Differences | | |

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| Intended Use Population | 7 years and older with type 1 diabetes mellitus | 2 years and older with type 1 diabetes mellitus |
| --- | --- | --- |
| Insulin Type | U-100 insulin: Novolog, Humalog, Admelog | U-100 insulin: Novolog, Humalog |
| Compatible CGM | Integrated Continuous Glucose Monitors (iCGMs), qualified Medtronic Continuous Glucose Monitors (Simplera Sync, Guardian 4 Sensor) | iCGMs |
| Total Daily Dose (TDD) of Insulin | 8 to 250 units a day | 5 to 200 units a day |
| Active Insulin Time | Between 2-8 hours (user adjustable) | 5 hours |
| Auto Correction Bolus Rate | Calculated at 5-minute intervals | Up to once every 60 minutes |
| Glucose Target (Target Settings) | Glucose Targets (Target Setpoint):
• 100 mg/dL
• 110 mg/dL
• 120 mg/dL
Temp Target: 150 mg/dL | Glucose Target (Target Range):
• Default: 112.5 - 160 mg/dL
• Sleep Mode: 112.5 - 120 mg/dL
• Exercise Mode: 140 - 160 mg/dL |
| Device & Predicate Device(s): | K251217 | K232382 |
| --- | --- | --- |
| Device Trade Name | Predictive Low Glucose technology | Control-IQ technology |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Intended for use with compatible 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 | Same |

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| | predefined threshold values. | |
| --- | --- | --- |
| Device Hosting Controller | ACE Pump | Same |
| Principles of Operation | Algorithmic software device that utilizes CGM sensor readings to suspend and resume insulin based on the current and predicted sensor values | Same |
| General Device Characteristic Differences | | |
| Intended Use Population | 7 years and older with type 1 diabetes mellitus | |
| Insulin Type | U-100 insulin: Novolog, Humalog, Admelog | |
| Compatible CGM | Integrated Continuous Glucose Monitors (iCGMs), qualified Medtronic Continuous Glucose Monitors (Simplera Sync, Guardian 4 Sensor) | iCGMs |

V Standards/Guidance Documents Referenced:

- Special controls established under 21 CFR 862.1356
- ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION 13-79 Medical device software - Software life cycle processes
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION 15-129 Medical devices - Part 1: Application of usability engineering to medical devices

VI Performance Characteristics (if/when applicable):

A. Analytical Performance

Not applicable.

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## B. Other Supportive Instrument Performance Characteristics Data

### Clinical Performance Data

No new clinical studies were conducted to support substantial equivalence of the subject devices. The subject SmartGuard technology algorithm was previously approved as part of the MiniMed 780G System under P160017/S118. The subject Predictive Low Glucose technology algorithm was previously approved as part of the MiniMed 670G System under P160017, including P160017/S031, as well as the MiniMed 780G System under P160017/S118. SmartGuard technology and Predictive Low Glucose technology are the same algorithms as reviewed in these respective PMAs, with the exception of the updated intended uses to include interoperability and the PCCP described below. Therefore, prior pivotal clinical data were leveraged from P160017, P160017/S031, and P160017/S118. Summaries of the results of these prior clinical studies are provided in the Summary of Safety and Effectiveness Data (SSED) for those submissions.

### Non-Clinical Performance Data

There have been no changes to the SmartGuard technology’s design, architecture, features, logical flows, or principles of operation from the version approved under P160017/S118 (version 5.3A), nor changes to the Predictive Low Glucose technology’s design, architecture, features, logical flows, or principles of operation since the version approved under P160017 (version 1.0.0.0). Therefore, non-clinical studies were leveraged from previous submissions. For example, prior non-clinical information included: Software Verification and Validation, Data Logging, Cybersecurity, and Human Factors Validation.

The sponsor conducted additional product functional verification activities with the 780G ACE pump SW 6.42 (cleared under K251032) and system verification activities with the 780G ACE pump SW 6.42 with qualified compatible Medtronic CGMs (Simplera Sync and Guardian 4 Sensor approved under P250012) to confirm that the controllers perform as intended and meet all specified requirements, including iAGC design verification and validation special controls.

### Interoperability

A plan and approach for interoperability were provided and determined to be adequate to support and clearly specify expectations, requirements, and interface specifications for potential interoperable devices. Provided interoperability documentation included a description of the respective device interface and its specifications, interoperability design and architecture, and the strategy for the subject iAGCs to be interoperable with compatible connected devices, including the PCCP described below. The SmartGuard technology and Predictive Low Glucose technology algorithms are designed to be interoperable with the qualified Medtronic Simplera Sync and Guardian 4 Sensor, qualified Medtronic ACE pumps, and qualified iCGMs. In addition, their plan provided Medtronic’s approach to working with third-party connected iCGM device companies regarding contractual issues, quality agreement, data communication and exchange, and post-market reporting procedures and responsibilities.

### Hazard Analysis

Hazard analyses were provided for the SmartGuard technology and Predictive Low Glucose technology algorithms, respectively, in which risks and risk mitigations for software and interoperable hardware components associated with the safe and effective functioning of the

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devices were provided, as well as verification and validation activities for implemented risk control measures. In particular, these hazard analyses accounted for the risks associated with interoperability between the software devices developed by the sponsor and other third-party interoperable devices (i.e, iCGMs).

## PCCP

This submission included a PCCP that Medtronic will follow (1) for qualifying and integrating new compatible iCGMs and ACE pumps and (2) for continued maintenance of previously marketed and qualified connected iCGMs and ACE pumps. The PCCP includes a description of the modifications, a modification protocol, and an impact assessment. The PCCP specifies the testing methods, validation activities, and performance requirements to implement the specified modifications such that SmartGuard technology and Predictive Low Glucose technology remain as safe and as effective as their predicate device and continue to comply with 21 CFR 862.1356(b). The sponsor's PCCP comprises the following for each subject iAGC:

- A new candidate iCGM must have demonstrated compatibility to established minimum iCGM performance, compatibility, and sensor specifications FDA found appropriate during this review before proceeding with qualification.
- Medtronic will conduct virtual clinical trial testing with virtual patients, with predefined acceptance criteria based on virtual patient equivalency testing and glycemic outcomes from the iAGC clinical study. Software design integration of the new iCGM with the subject iAGC will then be completed, and integration V&amp;V testing will be conducted according to the established PCCP. If integration V&amp;V testing meets the PCCP's prespecified acceptance criteria, the iCGM may be added as an interoperable component to the subject iAGC
- A new candidate ACE pump must have demonstrated compatibility to established minimum ACE pump compatibility and performance specifications defined in the PCCP before proceeding to software design integration with the subject iAGC. Integration V&amp;V testing will then be conducted according to the established PCCP. If integration V&amp;V testing meets the PCCP's prespecified acceptance criteria, the ACE pump may be added as an interoperable component to the subject iAGC.
- Modifications to previously marketed and qualified iCGM and ACE pump devices will be evaluated and, as needed, re-qualified according to the PCCP. For iCGMs, re-qualification requires demonstrated continued compatibility to the minimum iCGM specifications, virtual clinical trial testing as needed, and integration V&amp;V testing. Modified ACE pumps are re-qualified through demonstrated continued compatibility to the minimum ACE pump specifications defined in the PCCP and successful integration V&amp;V testing.
- Related iAGC labeling will be revised as needed to identify new qualified and integrated compatible devices or to remove previously compatible devices found to no longer be compatible. Communication will be provided through various channels to notify users about a new compatible device or previously compatible but now incompatible device.

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VII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device and met the special controls for 21 CFR 862.1356.

VIII Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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