SmartGuard Technology; Predictive Low Glucose Technology

K253701 · Medtronic Minimed · QJI · Feb 3, 2026 · Clinical Chemistry

Device Facts

• Record ID: K253701
• Device Name: SmartGuard Technology; Predictive Low Glucose Technology
• Applicant: Medtronic Minimed
• Product Code: QJI · Clinical Chemistry
• Decision Date: Feb 3, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1356
• Device Class: Class 2
• Attributes: Therapeutic, PCCP, Pediatric

Intended Use

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 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 Story

Software-only interoperable automated glycemic controller (iAGC) embedded in ACE pump firmware. Inputs: sensor glucose (SG) values from compatible CGM/iCGM via Bluetooth Low Energy; user-entered data (carbohydrates, parameters). SmartGuard (AHCL) algorithm: adaptive control adjusts basal insulin every 5 minutes; delivers auto-correction boluses; maintains user-selectable glucose targets (100-120 mg/dL). Predictive Low Glucose (PLGM) algorithm: suspends insulin delivery when SG falls below or is predicted to fall below thresholds; resumes automatically. Used in home/clinical settings by patients. Output: commands to ACE pump for insulin delivery/suspension. Healthcare providers use output to manage glycemic control; patients use integrated bolus calculator for meal doses. Benefits: automated glycemic management, reduced hypoglycemia risk, improved glucose stability.

Clinical Evidence

No new clinical trials conducted. Evidence relies on previously cleared clinical data (CIP335, CIP336, CIP341) and in silico Virtual Patient (VP) model validation. VP models demonstrated safety and effectiveness by showing equivalency between VPs and real patients using fixed acceptance criteria from pivotal studies. Bench testing included software verification, cybersecurity assessment, interoperability testing, and human factors validation.

Technological Characteristics

Software-only iAGC; embedded firmware in ACE pump. Connectivity: Bluetooth Low Energy (BLE) for CGM data. Adaptive control algorithm. Supports U-100 insulins (Novolog, Humalog, Admelog, Fiasp, Lyumjev). Complies with ISO 14971:2019, IEC 62304:2006/A1:2016, and IEC 62366-1:2015.

Indications for Use

Indicated for management of Type 1 diabetes (age 7+) and Type 2 diabetes (age 18+) requiring insulin. Requires prescription. For use with compatible iCGM/CGM and ACE pumps.

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

• SmartGuard Technology and Predictive Low Glucose Technology (K251217)
• MiniMed 780G insulin pump (K251032)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K253701

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 | II | 21 CFR 862.1356 | Clinical Chemistry |
| NDC | II | 21 CFR 868.1890 | Clinical Chemistry |

## E Purpose for Submission:

Modifications to a cleared device. The subject devices are modified as follows:

- New user interface, “MiniMed App,” installed on a smartphone
- A predetermined change control plan focused on making device changes to enable and maintain device interoperability with continuous glucose monitors and insulin pumps.

The devices reviewed in this submission include other changes compared to the predicate device which were cleared in separate submissions as described below:

- K253585: IFU expansion to include people with Type 2 Diabetes 18 years of age and older requiring insulin
- K253585: Addition of U-100 insulins Lyumjev® and Fiasp® as compatible insulins

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use statement

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 (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.

C Special Conditions for Use Statement(s):

SmartGuard Technology:
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.

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- 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:

Prescription Use Only

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

MiniMed SmartGuard Technology and Predictive Low Glucose Technology algorithms are interoperable automated glycemic controllers (iAGC) that are core software components of MiniMed's automated insulin delivery (AID) systems.

The SmartGuard and Predictive Low Glucose Technology algorithms are embedded in the firmware of a compatible ACE pump and allow the pump to operate in two different modes based on which of the subject MiniMed iAGCs is active:

- SmartGuard Mode (also referred to as "Auto Mode") or
- Manual Mode with the Predictive Low Glucose Technology algorithm.

The MiniMed App provides the primary display and user interface for the MiniMed iAGCs when connected to a compatible screenless ACE pump. The MiniMed App is a software application installed on a compatible mobile device with the iOS or Android operating system. The MiniMed App is a component of the iAGCs and serves as the primary display and user interface (UI) for the MiniMed iAGCs and compatible screenless ACE pump.

The MiniMed App digitally communicates with the following devices:

- Compatible ACE pumps through Bluetooth Low Energy (BLE),
- Compatible iCGMs/Medtronic MiniMed CGMs via the ACE pump,
- Cloud-based services through an available cellular or Wi-Fi connection for backend processing and connection to the CareLink Therapy Management System.

The MiniMed App allows for user interaction with the connected devices of the AID system. Key features of the app include:

- Pairing and viewing the status of connected devices;
- Facilitating reservoir or infusion set changes;
- Displaying current and historical insulin therapy, sensor glucose activity, and status (e.g. sensor glucose (SG) values and trends, status, alarms, advisories and messages);

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- Setting up and making changes to settings (e.g. insulin delivery, sensor glucose and alarm/alert settings); and
- Sending user-initiated requests or inputs to the connected devices (e.g. bolus calculation requests, manual bolus requests, and logging blood glucose).

The MiniMed App remains active, receiving and sending data, while running in either the foreground or background (i.e., when the user is using their mobile device for other tasks). Users must log in with a CareLink account before they can use the MiniMed App and pair/interact with connected devices.

## IV Substantial Equivalence Information:

### A Predicate Device Name(s):

SmartGuard Technology

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

K251217

### C Comparison with Predicate(s):

| Device & Predicate Device(s): | K251217 | K253701 |
| --- | --- | --- |
| Device Trade Name | SmartGuard Technology | SmartGuard Technology |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For 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 | Same |

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| | intended for single patient use and requires a prescription. | |
| --- | --- | --- |
| Product Code | QJI | Same |
| Prescription Use | Prescription is required | 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 |
| Glucose Target (Target Settings) | 100 mg/dL
110 mg/dL
120 mg/dL
Temp Target: 150 mg/dL | Same |
| Auto Correction Bolus Target | 120 mg/dL | Same |
| Meal / Food Bolus | Manual input of meal size for delivery of bolus either through blood glucose based insulin dose calculator or through iAGC | Same |
| Compatible Continuous Glucose Monitoring Systems | Integrated Continuous Glucose Monitors (iCGMs)
Interoperable Medtronic MiniMed Continuous Glucose Monitors (CGMs) | Same |
| General Device Characteristic Differences | | |
| Intended Populations | Type 1 diabetes mellitus in persons 7 years of age and greater. | Type 1 diabetes mellitus in persons 7 years of age and older and Type 2 diabetes mellitus in |

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| | | persons 18 years of age
and older |
| --- | --- | --- |
| Compatible U-100
Insulins | Novolog®
Humalog®
Admelog® | Novolog®
Humalog®
Admelog®
Lyumjev®
Fiasp® |
| Alerts/Alarms | Compatible ACE pump
displays algorithm-related
alerts/alarms | MiniMed app will display
alerts/alarms on user’s
smartphone or dedicated
handheld device, or
Compatible ACE pump
displays algorithm-related
alerts/alarms |
| Primary User Interface | ACE Pump | MiniMed app and
compatible ACE Pump |
| Device & Predicate Device(s): | K251217 | K253701 |
| --- | --- | --- |
| Device Trade Name | Predictive Low Glucose Technology | Predictive Low Glucose Technology |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For 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. | Same |

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| | Predictive Low Glucose Technology is intended for single patient use and requires a prescription. | |
| --- | --- | --- |
| Product Code | QJS | Same |
| Prescription Use | Prescription is required | 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 |
| Glucose Target (Target Settings) | 100 mg/dL
110 mg/dL
120 mg/dL
Temp Target: 150 mg/dL | Same |
| Auto Correction Bolus Target | 120 mg/dL | Same |
| Meal / Food Bolus | Manual input of meal size for delivery of bolus either through blood glucose based insulin dose calculator or through iAGC | Same |
| Compatible Continuous Glucose Monitoring Systems | Integrated Continuous Glucose Monitors (iCGMs)
Interoperable Medtronic MiniMed Continuous Glucose Monitors (CGMs) | Same |
| General Device Characteristic Differences | | |

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| Intended Populations | Type 1 diabetes mellitus in persons 7 years of age and greater. | 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 |
| --- | --- | --- |
| Compatible U-100 Insulins | Novolog®
Humalog®
Admelog® | Novolog®
Humalog®
Admelog®
Lyumjev®
Fiasp® |
| Alerts/Alarms | Compatible ACE pump displays algorithm-related alerts/alarms | MiniMed app will display alerts/alarms on user's smartphone or dedicated handheld device, or
Compatible ACE pump displays algorithm-related alerts/alarms |
| Primary User Interface | ACE Pump | MiniMed app and ACE Pump |
| Bolus Calculator | Blood glucose insulin calculator embedded in 780G firmware | Predictive Low Glucose Technology contains a bolus calculator that calculates an insulin dose based on user-entered blood glucose data |

V Standards/Guidance Documents Referenced:
- Medical devices - Application of risk management to medical devices ISO 14971 Third Edition 2019-12; 5-125
- Medical device software - Software life cycle processes IEC 62304 Edition 1.1 2015-06 Consolidated version; 13-79
- Medical Devices – Part 1: Application of usability engineering to medical devices IEC 62366-1 Edition 1.1 2020-06 Consolidated Version; 5-129
- Medical Devices – Information to be supplied by the manufacturer ISO 20417 First Edition 2021-04 Correction version 2021-12; 5-135

VI Performance Characteristics:

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## A. Non-Clinical Performance

### Human Factors

Human Factors validation testing assessed users with either type 1 diabetes or type 2 diabetes with a total of 60 users tested across four distinct user groups and included independent users and dependent users with their caregiver. The users were assessed in using a complete system including a representative screenless ACE pump and the MiniMed App.

The users had a mix of insulin pump and automated insulin delivery experience and consisted of users currently on multiple daily injections of insulin, current users of the MiniMed 780G, and users who utilize other pumps or automated insulin delivery systems. Training was tailored to specific users’ needs and consisted of both virtual training via video and training through a certified trainer that was trained by the manufacturer.

The results of the validation testing support that the subject device is substantially equivalent to the predicate.

## B. Clinical Studies:

No new clinical data was provided for the changes reviewed in this submission.

See K253585 for the IFU expansion of SmartGuard and Predictive Low Glucose Technology to be used for the management of type 2 diabetes in persons 18 years of age and older requiring insulin, as well as for the addition of Fiasp and Lyumjev as compatible insulin products.

## C. Other Supportive Device Performance Characteristics Data

### Software:

The software documentation including risk management, software requirements, design specifications, lifecycle management, architecture, and unresolved anomalies supports substantial equivalence.

### Cybersecurity:

The cybersecurity documentation supports substantial equivalence.

### Predetermined Change Control Plan (PCCP):

The PCCP describes planned modifications to support interoperability of MiniMed iAGCs with future compatible connected devices, including:

1. Qualification and integration of new ACE pumps and new iCGMs
2. Updates to the MiniMed CareLink App to ensure continued compatibility with future interoperable devices
3. Continued maintenance of previously marketed and qualified ACE pumps, iCGMs, and the Patient App

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The scope of the modifications are restricted to interoperability and some of the key modifications are as follows:

- One-Time Patient app software updates for iCGM integration such as:
- NFC-activation and pairing for iCGM
- Sensor change capability between compatible CGMs
- BG-check UI updates for iCGM
- Alert messaging and parameters for iCGM
- Compatibility checking processes
- Future App updates:
- Software updates for device integration
- Support for multiple device configurations
- Requalification of previously marketed ACE Pumps, iCGMs, and patient apps

For new ACE pumps the method for implementing a modification is as follows:

- Assess compatibility with ACE Pump Compatibility and Performance Specifications
- Conduct risk analysis
- Complete software design integration and perform integration V&V testing
- Document qualification and integration evidence
- Release Risk Management Report
- Update labeling, notify users, and launch

For additions of new iCGMs the method for implementing the modification is as follows:

- Assess compatibility with iCGM Sensor Specifications and Compatibility/Performance Specifications
- Conduct risk management
- Conduct Virtual Patient Model Equivalency Testing (one-time establishment of acceptance criteria)
- Develop Sensor Error Model
- Conduct Virtual Patient Model Clinical Trial Testing (using pre-established acceptance criteria)
- Complete software design integration and perform integration V&V testing
- Document qualification and integration evidence
- Release Risk Management Report
- Update labeling, notify users, and launch

For previously marketed devices the process would be similar for respective ACE pump and iCGM qualification but would scale testing to assess impacted features only and potentially leverage previous testing where appropriate.

All changes via PCCP will be verified and validated per the following:

- Product Level Functional Verification Testing
- System Verification Testing
- Cybersecurity Testing (risk assessment and penetration testing)

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- EMC and RF Wireless Testing
- Human Factors Validation

Finally, the changes implemented via the PCCP need to also follow an impact assessment as the changes cannot impact the intended use of the MiniMed iAGCs, therapy delivered remains equivalent to the predicate device, no new questions of safety and effectiveness are raised, and modifications should enhance flexibility and scalability while maintaining safety and clinical performance.

## VII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## VIII Conclusion:

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

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