K253743 · Medtronic Minimed, Inc. · QFG · Mar 12, 2026 · Clinical Chemistry
Device Facts
Record ID
K253743
Device Name
MiniMed Flex pump
Applicant
Medtronic Minimed, Inc.
Product Code
QFG · Clinical Chemistry
Decision Date
Mar 12, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5730
Device Class
Class 2
Attributes
Therapeutic, PCCP, Pediatric
Indications for Use
The MiniMed Flex pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The MiniMed Flex pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The MiniMed Flex pump is indicated for use in persons 7 years of age and older. The MiniMed Flex pump is intended for single patient use and requires a prescription.
Device Story
MiniMed Flex pump is an ambulatory, battery-operated, screenless, tubed micro-infusion pump; delivers basal and bolus insulin subcutaneously. Device lacks integrated display; primary user interface is MiniMed app on smartphone. Pump communicates via BLE with compatible iCGMs and automated insulin dosing software (iAGC) to receive/execute dosing commands. Used in home environments by patients. Safety-critical alerts provided via pump-integrated lights and speaker; notifications managed through app. Benefits include automated glycemic control and secure interoperability. Includes Predetermined Change Control Plan (PCCP) for future iCGM integration and age-range expansion.
Clinical Evidence
No clinical data. Evidence consists of bench testing: delivery volume accuracy, catheter occlusion detection, drug stability/compatibility with U-100 insulins (Humalog, NovoLog, Admelog, Fiasp, Lyumjev), software verification/validation, cybersecurity assessment, interoperability testing, and human factors validation.
Technological Characteristics
Ambulatory, screenless, tubed micro-infusion pump; internal lithium-ion rechargeable battery. BLE connectivity for interoperability with iCGMs and iAGCs. Materials compatible with U-100 insulins. Standards: ISO 14971:2019 (risk management), IEC 62304:2006/A1:2016 (software), IEC 60601-1/1-2 (electrical safety/EMC), IEC 62366-1:2015 (human factors).
Indications for Use
Indicated for persons 7 years of age and older with diabetes mellitus requiring insulin therapy. Intended for single patient use by prescription.
Regulatory Classification
Identification
An alternate controller enabled infusion pump (ACE pump) is a device intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.
Special Controls
Alternate controller enabled infusion pumps must comply with the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions.
(A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes (
*e.g.,* head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.(B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices.
(ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration (
*e.g.,* occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.(iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability (
*e.g.,* temperature, light exposure, or other factors as needed).(iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low.
(v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance.
(vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment.
(vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated.
(viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing.
(2) Design verification and validation activities 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 shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented.
(ii) 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 validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to external devices.
(ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices.
(iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers (
*e.g.,* battery level, reservoir level, pump status, error conditions).(iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified.
(v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol.
(4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption (
*e.g.,* reverting to a pre-programmed, safe drug delivery rate). Validation testing results must demonstrate that critical events that occur during a loss of communications (*e.g.,* commands, device malfunctions, occlusions, etc.) are handled appropriately during and after the interruption.(5) 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 system must, at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated acknowledgements
(v) Connectivity events (
*e.g.,* establishment or loss of communications)(6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(7) Device labeling must include the following:
(i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate.
(ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters.
(iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is <25 percent, 25 percent to <75 percent, 75 percent to <95 percent, 95 percent to <105 percent, 105 percent to <125 percent, 125 percent to <175 percent, 175 to 250 percent, and >250 percent of the commanded amount.
(iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point.
(v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps.
(vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses.
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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
K253743
B Applicant
Medtronic MiniMed, Inc.
C Proprietary and Established Names
MiniMed Flex pump
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QFG | Class II | 21 CFR 880.5730 - Alternate Controller Enabled Infusion Pump | CH - Clinical Chemistry |
## E Purpose for Submission:
The purpose of this submission is a) clearance for a new device, MiniMed Flex pump, as an alternate controller enabled (ACE) infusion insulin pump device and to b) establish a predetermined change control plan for integration of new, compatible integrated continuous glucose monitors (iCGMs).
## II Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The MiniMed Flex pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The MiniMed Flex pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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The MiniMed Flex pump is indicated for use in persons 7 years of age and older.
The MiniMed Flex pump is intended for single patient use and requires a prescription.
## C Special Conditions for Use Statement(s):
Rx – For Prescription Use Only
- Always monitor your glucose during air travel. Changes in air pressure that occur during flight takeoff and landing can cause over-delivery or under-delivery of insulin, which may result in hypoglycemia or hyperglycemia. Be ready to respond to alerts and symptoms. Talk with your healthcare professional to see if you need a different treatment plan in place.
- Do not expose the pump or sensor to MRI equipment, diathermy devices, or other devices that generate strong magnetic fields (for example, x-ray, CT scan, or other types of radiation). Strong magnetic fields can cause the system to malfunction, and result in serious injury. If the pump is exposed to a strong magnetic field, discontinue use and contact 24-Hour Technical Support for further assistance. Magnetic fields, and direct contact with magnets, may affect the accurate functioning of the system which may lead to health risks such as hypoglycemia or hyperglycemia.
- Remove the pump, sensor, and the App Manager or mobile device before entering a room with x-ray, MRI, diathermy, or CT scan equipment. The magnetic fields and radiation in the immediate vicinity of this equipment can make the devices nonfunctional or damage the part of the pump that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia.
- Do not expose the pump to a magnet, such as pump cases that have a magnetic clasp. Exposure to a magnet may interfere with the motor inside the pump. Damage to the motor can cause the device to malfunction, and result in serious injury.
- Do not send the pump or sensor through an x-ray scanning machine. The radiation can damage the pump components that regulate insulin delivery, and may result in over-delivery of insulin and hypoglycemia. All system components, including the pump and sensor, must be removed prior to being screened with a full-body scanner. To avoid system removal, request an alternative screening method, if necessary.
## III Device Description
The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The pump is intended to be used in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery.
The MiniMed Flex pump is an ambulatory, battery-operated, rate-programmable micro-infusion pump. It is a screenless, tubed pump that houses electronics, a pumping mechanism, and a medication reservoir within the same physical device. It is intended for use with compatible
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insulin reservoir and insulin infusion set for delivery of basal and bolus insulin according to settings selected or inputs entered by the user or compatible iAGC software based on healthcare provider recommendations.
The primary user interface and primary display for the MiniMed Flex pump is the MiniMed app, also the user interface for the compatible MiniMed iAGCs, which runs on a compatible iOS or Android device.
## IV Substantial Equivalence Information:
A Predicate Device Name(s):
Minimed 780G insulin pump
B Predicate 510(k) Number(s):
K251032
C Comparison with Predicate(s):
| Device & Predicate Device(s): | Subject Device (K253743) | Predicate Device (K251032) |
| --- | --- | --- |
| Device Trade Name | MiniMed Flex pump | MiniMed 780G insulin pump |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The device is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The device is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The device is intended for single patient use and requires a prescription. | SAME |
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| Intended use population | Persons with diabetes mellitus ages 7 and up | Persons with diabetes mellitus ages 7 and up |
| --- | --- | --- |
| Environment of Use | Home environments | SAME |
| Insulin Type | The following U-100 insulin products: Novolog® Humalog® Admelog® Lyumjev® Fiasp® | SAME |
| Operating Modes | Manual mode, SmartGuard Mode | SAME |
| Insulin Delivery Modes | Basal and Bolus | SAME |
| Bolus Canceling | Supports bolus cancellation | SAME |
| Alarms | Visible, audible, auditory | SAME |
| General Device Characteristic Differences | | |
| Basal Flowrates | 0 – 15 U/hour | 0 – 35 U/hour |
| Bolus Range and increment | Minimum bolus: 0.05 units Maximum bolus: 25 units | Minimum bolus: 0.025 units Maximum bolus: 25 units |
| Pump Notifications, Alerts, Alarms, and Reminders Visible to User | Visible to the user on the pump through sound and lights. | Visible to the user on the pump screen: Reminders, Alerts, Alarms, Notifications |
| Pump Screen/Controls | Screenless. Users receive safety critical alerts from the pump's lights and speaker. The user has limited interaction with the pump through two buttons (the action button and the acknowledge button) and the | Liquid Crystal Display (LCD) Screen + Keypad |
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| | status light. Alerts are communicated to the MiniMed app where notifications are presented for the user to review and acknowledge. | |
| --- | --- | --- |
| Connectivity | Minimed App (installed on compatible smartphone or App manager) | N/A |
| Ingress Protection | IPX8: Protected against immersion in water up to 8 feet (2.4 meters) for up to 1 hour 45 minutes | IPX8: Protected against immersion in water up to 8 feet (2.4 meters) for up to 30 minutes |
In addition to the similarities and differences between the candidate and predicate devices, the candidate device has an authorized Predetermined Change Control Plan (PCCP) to allow for future software modifications that ensure its compatibility and interoperability with new integrated Continuous Glucose Monitors (iCGM). These modifications include updating the electronic interface for sensor pairing, integrating iCGM-specific alerts and status information, adding a sensor data processing module to ensure data from new sensors is in an acceptable format for the pump's embedded therapy algorithms and for expansion of indications for use to users below 7 years of age. See Section VI.C for more information.
V Standards/Guidance Documents Referenced:
- ISO 14971 Third Edition 2019-12, Medical devices - Application of risk management to medical devices
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software - Software life cycle processes
- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices - Part 1: Application of usability engineering to medical devices
- ISO 10993-1 Fifth edition 2018-08, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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VI Performance Characteristics:
A. Non-Clinical Performance
1. Basal Delivery Accuracy
To assess basal delivery accuracy, 16 new and 16 aged pumps for a total of 32 unique pumps were tested for each basal rate by delivering insulin at low, medium, and high basal rates (0.05, 1.00, and 15.0 U/hr). The 16 aged pumps were pre-conditioned with simulated 4-year service life, and with real-time shelf-life aging for 6 months.
U-100 Humalog placebo was used for testing. The placebo insulin was pumped into a container on a scale and the weight of the liquid at various time points was used to assess basal delivery accuracy.
The following tables report the typical basal performance (median) observed, along with the lowest and highest results observed for the low, medium, and high basal rate settings for all pumps tested with no warmup period. For each time period, the tables show the volume of insulin requested in the first row and the volume that was delivered as measured by the scale in the second row.
Table 1: Amount of fluid delivered after 1, 6, and 12 hours with 0.05 U/hr (low) basal rate setting
| 0.05 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 0.05 U | 0.3 U | 0.6 U |
| Median amount delivered | 0.063 U | 0.329 U | 0.670 U |
| [min, max] | [0.039, 0.093] | [0.239, 0.393] | [0.512, 0.775] |
Table 2: Amount of fluid delivered after 1, 6, and 12 hours with 1 U/hr (medium) basal rate setting
| 1 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 1 U | 6 U | 12 U |
| Median amount delivered | 0.94 U | 5.84 U | 11.75 U |
| [min, max] | [0.86, 0.98] | [5.41, 6.01] | [11.55, 11.99] |
Table 3: Amount of fluid delivered after 1, 6 and 12 hours with 15 U/hr (high) basal rate setting
| 15 U/hr Basal Duration | 1 hour | 6 hours | 12 hours |
| --- | --- | --- | --- |
| Total expected delivery volume | 15 U | 90 U | 180 U |
| Median amount delivered | 14.66 U | 88.49 U | 177.02 U |
| [min, max] | [14.38, 14.77] | [88.26, 88.72] | [176.70, 177.43] |
2. Bolus Delivery Accuracy
To assess bolus delivery accuracy, 16 new and 16 aged pumps for a total of 32 unique pumps were tested for each bolus size by delivering minimum, intermediate, and maximum bolus amounts (0.025, 2.5, and 35 Units). The 16 aged pumps were pre-conditioned to simulate six months of shelf life and 4-year service life.
U-100 Humalog placebo was used for testing. The placebo insulin was pumped into a container on a scale and the weight of the liquid at various time points was used to assess bolus delivery
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accuracy. The number of total and consecutive boluses delivered in this testing for each delivery volume is described in Table 4 below:
Table 4: Summary of bolus testing protocol
| Bolus size (units) | Number of pumps tested | Consecutive boluses per pump | Total boluses |
| --- | --- | --- | --- |
| 0.05 units | 32 | 25 | 800 |
| 2.5 units | 32 | 25 | 800 |
| 25 units | 32 | 10 | 320 |
Table 5: Amount of fluid delivered after a 0.05 U bolus request
| Units delivered after a 0.05 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <25% | 25-75% | 75-90% | 90-95% | 95-105% | 105-110% | 110-125% | 125-175% | 175-250% | >250% |
| Number and percent of boluses | 4/800 (0.5%) | 36/800 (4.5%) | 159/800 (19.9%) | 172/800 (21.5%) | 194/800 (24.3%) | 109/800 (13.6%) | 115/800 (14.4%) | 11/800 (1.4%) | 0/800 - | 0/800 - |
Table 6: Amount of fluid delivered after a 2.5 U bolus request
| Units delivered after a 2.5 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <25% | 25-75% | 75-90% | 90-95% | 95-105% | 105-110% | 110-125% | 125-175% | 175-250% | >250% |
| Number and percent of boluses | 0/800 - | 0/800 - | 8/800 (1.0%) | 44/800 (5.5%) | 742/800 (92.8%) | 4/800 (0.5%) | 2/800 (0.3%) | 0/800 - | 0/800 - | 0/800 - |
Table 7: Amount of fluid delivered after a 25 U bolus request
| Units delivered after a 25 U bolus request (% of commanded units) | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <25% | 25-75% | 75-90% | 90-95% | 95-105% | 105-110% | 110-125% | 125-175% | 175-250% | >250% |
| Number and percent of boluses | 0/320 - | 0/320 - | 0/320 - | 0/320 - | 320/320 (100%) | 0/320 - | 0/320 - | 0/320 - | 0/320 - | 0/320 - |
3. Occlusion Detection
Occlusion detection testing was conducted using 32 pumps and 4 delivery profiles: 25 U Bolus, 0.05 U/hr basal, 1 U/hr Basal, and 15 U/hr basal. Sixteen of the pumps were new, and 16 were aged to simulate 6 months of shelf life and 4 years of regular use. New and aged reservoirs and infusion sets were also used as part of testing. To test the time between occlusion and pump alarm, each pump was physically occluded by clamping the cannula. The time elapsed and the units delivered until an occlusion alarm occurred were recorded.
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The typical time to occlusion detection in the table below is the average for the samples measured and the maximum time is the absolute maximum.
Table 8: Occlusion detection testing
| | Typical time to occlusion detection | Maximum time to occlusion detection |
| --- | --- | --- |
| 25 U Bolus | 33 seconds | 47 seconds |
| 0.05 U/hr basal | 42 hours and 49 minutes | 71 hours, 19 minutes |
| 1 U/hr Basal | 1 hours and 52 minutes | 2 hours and 41 minutes |
| 15 U/hr basal | 7 minutes | 9 minutes |
At 1 U/hr the maximum post-clearance bolus was 1.61 U.
## B. Other Supportive Device Performance Characteristics Data
### 4. Additional Bench Testing
In addition to the performance testing described above, other device verification testing was conducted to demonstrate that the system meets its intended use and is safe, reliable, and all safety and reliability critical requirements have been adequately verified.
- Delivery accuracy was tested with 4 head height conditions using 16 new and 16 aged pumps for a total of 32 unique pumps.
- Delivery accuracy was tested with 8 new and 8 aged pumps, all with aged consumables after exposure to cyclical stressors of chemicals, drops, cleaning, motor use, infusion set swapping, and button pressing.
- Delivery accuracy was tested under a total of 6 static and dynamic environmental profiles with 16 new and 16 aged pumps for a total of 32 unique pumps.
### 5. Software and Cybersecurity
The software and cybersecurity documentation provided was determined to be adequate to support substantial equivalence.
### 6. Interoperability
A plan and approach for interoperability were provided according to the FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices" and determined to be adequate to support and clearly specify expectations, requirements, and interface specifications to potential interoperable devices. In addition, their plan covered their approach to working with connected device companies regarding contractual approaches, interfaces for data communication and exchange, and post-market reporting procedures and responsibilities (e.g., who is responsible for investigating and reporting complaints, malfunctions, and adverse events).
The sponsor additionally provided validated software protocols intended to ensure secure, accurate, and reliable communication with digital interfacing devices, as well as failsafe design features to mitigate the risks associated with interruption of communication with digitally connected devices. These protocols were reviewed and found to be adequate.
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7. Biocompatibility
Biocompatibility testing was performed per FDA Guidance Document: Use of International Standard ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” and FDA special controls for alternate controller enabled infusion pump. Results support a determination of substantial equivalence.
8. Sterility
The Minimed Flex pump is non-sterile. Medtronic has performed adequate cleaning validation to demonstrate substantial equivalence.
9. Human Factors
Human Factors validation testing assessed users aged 2+ years old diagnosed 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 had a mix of insulin pump experience and consisted of users currently on multiple daily injections of insulin, current MiniMed pump users 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.
10. Electromagnetic Compatibility and Electrical Safety
Electromagnetic compatibility and electromagnetic immunity and wireless coexistence testing was performed for the pump. The sponsor provided verification evidence for compliance with the IEC 60601-1 and applicable collateral standards. All tests demonstrated that the device would perform as expected in the home healthcare environment.
11. Wireless Coexistence
Evaluated per ANSI/IEEE C63.27-2021, as well as range and household coexistence protocols. Reports demonstrated robust BLE communication in coexistence, range, and household environments with no loss of safety or performance.
12. Leveraged Information
The Minimed Flex pump shares the same fluid pathway as that of the predicate device and hence the insulin compatibility was leveraged from predicate device.
13. PCCP
The PCCP documents how the MiniMed Flex ACE Pump will be modified via software updates to be compatible with integrated Continuous Glucose Monitors (iCGM). It describes the modification protocols, traceability, and impact assessment for these integrations.
The planned modifications include:
1. iCGM Integration and Pairing: Updating the pump's electronic interface and communication protocols to support pairing and data exchange with new iCGM sensors.
2. Pump-side Data Processing: Migrating and implementing several data processing functions from the CGM to the pump firmware and historical data backfilling.
3. Updated Status and Alert Handling: Integrating iCGM-specific status information, state information, and alerts into the pump's software.
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The scope of the modifications is restricted to software changes for iCGM interoperability, and the modifications and their associated testing are provided below:
| Specific Modifications | Performance Evaluation Methods for Verifying and Validating PCCP Modifications |
| --- | --- |
| Updates to the pump's electronic interface for new iCGM sensor information and sensor pairing | • Software Verification
• Pump Product Verification
• System Verification
• EMC and RF Wireless Testing
• Cybersecurity Testing
• Human Factors Assessment |
| Integration of iCGM-related status and state information | • Software Verification
• Pump Product Verification
• System Verification
• Human Factors Assessment |
| Updates to the pump's electronic interface for new iCGM sensor information and sensor pairing. | • Software Verification Testing
• Pump Product Verification Testing
• System Verification Testing |
| Addition of a sensor data processing module to ensure iCGM data is in an acceptable format for the glycemic controller algorithm embedded in the pump. | • Software Verification Testing
• Pump Product Verification Testing
• System Verification Testing |
| Migration of the specific firmware from the CGM to the pump firmware. | • Software Verification Testing
• Pump Product Verification Testing
• System Verification Testing |
| Implementation of sensor backfill data processing to handle data from periods of lost communication. | • Software Verification Testing
• Pump Product Verification Testing
• System Verification Testing |
| Expand age indications to include 2- to 6-year-olds | • Human Factors Assessment |
For the MiniMed Flex ACE Pump, the method for implementing a modification is as follows:
- Evaluate modifications within the existing risk management framework and implement them in accordance with the quality management system procedures.
- Implement the changes in a future iterative software version.
- Update labeling (Instructions for Use, System Technical Guide) to include iCGM-related information.
- Deploy software updates to the pump via a Firmware-Over-The-Air (FOTA) process.
- Communicate the availability of the software upgrade to users and healthcare providers.
- Conduct post-market surveillance to collect and analyze data on the device's performance.
Finally, the changes implemented via the PCCP need to also follow an impact assessment, as the changes do not impact the intended use of the MiniMed Flex pump, do not introduce new or significantly modified risks, nor raise new questions of safety and effectiveness.
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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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Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
