(89 days)
The MiniMed 780G insulin 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 780G insulin 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 780G insulin pump contains a bolus calculator that calculates an insulin dose based on user-entered data.
The MiniMed 780G insulin pump is indicated for use in individuals 7 years of age and older.
The MiniMed 780G insulin pump is intended for single patient use and requires a prescription.
The MiniMed 780G insulin 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 both alone and in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery.
The MiniMed 780G insulin pump is an ambulatory, battery-operated, rate-programmable micro-infusion pump that contains pump software and houses electronics, a pumping mechanism, a user interface, and a medication reservoir within the same physical device. The pump also contains a bolus calculator that calculates an insulin dose based on user-entered data. It is comprised of several discrete external and internal components including a pump case made of a polycarbonate blend, an electronic printed circuit board assembly stacks and a drive motor system.
The MiniMed 780G insulin pump is an interoperable device that can communicate via a Bluetooth Low Energy (BLE) wireless electronic interface with digitally connected devices. The MiniMed 780G insulin pump is a host device for the iAGC and integrates iAGC algorithm into the pump firmware. The pump is then able to receive, execute, and confirm commands from an iAGC to adjust delivery of insulin. The pump receives sensor glucose (SG) data via BLE interface from a compatible iCGM or a compatible interoperable Medtronic CGM and transmits these CGM data to the embedded iAGCs.
The MiniMed 780G insulin pump can operate in one of two modes: Manual Mode or Auto Mode (also referred to as "SmartGuard Mode"). The pump provides the user with keypad pump controls, as well as a data screen for configuring therapy settings and viewing continuous real-time glucose values, glucose trends, alerts, alarms, and other information. The user interface and alerts provide the user with the ability to interact with the pump delivery system and digitally connected devices.
The provided text is a 510(k) clearance letter and summary for a medical device, specifically an insulin pump. It details the device's characteristics, intended use, comparison to predicate devices, and a summary of non-clinical performance data.
However, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/Machine Learning device for image analysis or diagnostics.
The request asks for details like:
- A table of acceptance criteria and reported device performance (which is present in a limited form for the pump's mechanical performance, but not for AI performance).
- Sample size for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC study details and effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
These specific points are highly relevant to the validation of AI/ML-enabled medical devices, particularly those that interpret or analyze data (like images) to aid in diagnosis or treatment decisions. The MiniMed 780G insulin pump, while having advanced software and interoperability, is primarily an infusion pump with a bolus calculator, not an AI/ML diagnostic or image analysis tool. Its software functions relate to pump control, communication, and basic dose calculation, not complex pattern recognition or inference typically associated with AI in medical devices that would require the detailed validation described in the prompt.
Therefore, I cannot extract the requested information from the provided text because the text describes a different type of medical device and its associated validation. The validation methods mentioned (Delivery Volume Accuracy, Occlusion Detection, Drug Stability, Cybersecurity, Human Factors) are appropriate for an insulin pump but do not align with the AI/ML-specific validation criteria outlined in your prompt.
FDA 510(k) Clearance Letter - MiniMed 780G Insulin Pump
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
July 1, 2025
Medtronic MiniMed Inc.
Hemang Kotecha
Senior Principal Regulatory Affairs Specialist
18000 Devonshire Street
Northridge, California 91325
Re: K251032
Trade/Device Name: MiniMed 780G insulin pump
Regulation Number: 21 CFR 880.5730
Regulation Name: Alternate Controller Enabled Infusion Pump
Regulatory Class: Class II
Product Code: QFG, NDC
Dated: April 3, 2025
Received: April 3, 2025
Dear Hemang Kotecha:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy
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K251032 - Hemang Kotecha Page 2
source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K251032 - Hemang Kotecha Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D.
Branch Chief
Division of Chemistry and
Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K251032
Device Name
MiniMed 780G insulin pump
Indications for Use (Describe)
The MiniMed 780G insulin 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 780G insulin 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 780G insulin pump contains a bolus calculator that calculates an insulin dose based on user-entered data.
The MiniMed 780G insulin pump is indicated for use in individuals 7 years of age and older.
The MiniMed 780G insulin pump is intended for single patient use and requires a prescription.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1
Page 5
510(K) Summary
510(k) Submitter Information
| Submitter's Name and Address | Medtronic MiniMed, Inc.18000 Devonshire StNorthridge, CA 91325 USA |
|---|---|
| Primary Contact Person | Hemang KotechaSenior Principal Regulatory Affairs Specialist+1 857-203-1151hemang.kotecha@medtronic.com |
| Secondary Contact Person | Carli SmithSenior Regulatory Affairs Specialist+1 805-558-2408carli.smith@medtronic.com |
| Date Prepared | June 23, 2025 |
Device Information
| Device Trade Name | MiniMed 780G insulin pump |
|---|---|
| Device Common Name | Alternate Controller Enabled Infusion Pump (ACE Pump) |
| Device Classification Name | Alternate Controller Enabled (ACE) Infusion Pump, Calculator, Drug Dose |
| Regulation Number | 21 CFR 880.5730, 21 CFR 868.1890 |
| Product Codes | QFG, NDC |
| Device Panel | Clinical Chemistry |
| Device Class | Class II |
Predicate Device Information
| Product Code | Predicate Device |
|---|---|
| QFG | Tandem t:slim X2 Insulin Pump with Interoperable Technology (K232380) |
| NDC | InPen Dose Calculator (K242775) |
Page 6
Device Description
The MiniMed 780G insulin 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 both alone and in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery.
The MiniMed 780G insulin pump is an ambulatory, battery-operated, rate-programmable micro-infusion pump that contains pump software and houses electronics, a pumping mechanism, a user interface, and a medication reservoir within the same physical device. The pump also contains a bolus calculator that calculates an insulin dose based on user-entered data. It is comprised of several discrete external and internal components including a pump case made of a polycarbonate blend, an electronic printed circuit board assembly stacks and a drive motor system.
The MiniMed 780G insulin pump is an interoperable device that can communicate via a Bluetooth Low Energy (BLE) wireless electronic interface with digitally connected devices. The MiniMed 780G insulin pump is a host device for the iAGC and integrates iAGC algorithm into the pump firmware. The pump is then able to receive, execute, and confirm commands from an iAGC to adjust delivery of insulin. The pump receives sensor glucose (SG) data via BLE interface from a compatible iCGM or a compatible interoperable Medtronic CGM and transmits these CGM data to the embedded iAGCs.
The MiniMed 780G insulin pump can operate in one of two modes: Manual Mode or Auto Mode (also referred to as "SmartGuard Mode"). The pump provides the user with keypad pump controls, as well as a data screen for configuring therapy settings and viewing continuous real-time glucose values, glucose trends, alerts, alarms, and other information. The user interface and alerts provide the user with the ability to interact with the pump delivery system and digitally connected devices.
Page 7
Indications for Use / Intended Use
The MiniMed 780G insulin 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 780G insulin 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 780G insulin pump contains a bolus calculator that calculates an insulin dose based on user-entered data.
The MiniMed 780G insulin pump is indicated for use in individuals 7 years of age and older.
The MiniMed 780G insulin pump is intended for single patient use and requires a prescription.
Summary of Technological Characteristics of Subject Device Compared to Predicate Device
The two (2) tables below provide a side-by-side comparison of the subject device, MiniMed 780G insulin pump compared to its predicate device for each Product Code: QFG and NDC.
ACE Insulin Pump (Product Code: QFG):
| Predicate DeviceTandem t:slim X2 insulin pump with interoperable technology(K232380) | Subject DeviceMiniMed 780G insulin pump | |
|---|---|---|
| Manufacturer | Tandem Diabetes Care, Inc. | Medtronic MiniMed Inc. |
| Device Trade Name | Tandem t:slim X2 insulin pump with interoperable technology | MiniMed 780G insulin pump |
| Device Classification | Class II | SAME |
| Product Code | QFG | SAME |
| Device Type/Regulation | Alternate Controller Enabled Infusion Pump (under 21 CFR 880.5730) | SAME |
Page 8
| Predicate DeviceTandem t:slim X2 insulin pump with interoperable technology(K232380) | Subject DeviceMiniMed 780G insulin pump | |
|---|---|---|
| Indications for Use/Intended Use | The t:slim X2 Insulin Pump with Interoperable Technology (the 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 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 Pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use in individuals 2 years of age and greater. | The MiniMed 780G insulin 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 780G insulin 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 780G insulin pump is indicated for use in individuals 7 years of age and older. The MiniMed 780G insulin pump is intended for single patient use and requires a prescription. |
| Prescription Use | Prescription is required | SAME |
| Environment of Use | Professional healthcare facilities and home environments | SAME |
| Patient Environment | On-body wearable ambulatory pump | SAME |
| Age Limitations | 2 years and older | 7 years and older |
| Glucose Target (Target Range Settings) | The Tandem t:slim X2 insulin pump targets the following glucose range: 112.5 – 160 mg/dL (6.2 – 8.9 mml/L) | The MiniMed 780G insulin pump dynamically adjusts to target the following glucose setpoints: 100 mg/dL (5.6 mmol/L), 110 mg/dL (6.1 mmol/L), 120 mg/dL (6.7 mmol/L) |
| Technological Characteristics | The t:slim X2 insulin pump with interoperable technology is an ambulatory, battery operated, rate-programmable infusion pump designed for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The device includes a disposable cartridge which is motor driven to deliver patient programmed basal rates and boluses through an infusion set into subcutaneous tissue. | The MiniMed 780G insulin pump is an ambulatory, battery-operated, rate-programmable micro-infusion pump designed for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The device houses electronics, a pumping mechanism, a user interface, and a medication reservoir to deliver patient-programmed basal rates and boluses through an infusion set into the subcutaneous tissue. |
| Intended Population | Persons with diabetes mellitus ages 2 and up | Persons with diabetes mellitus ages 7 and up |
| Specific Drug/Biological Use | U-100 insulin: Novolog®, Humalog® | U-100 insulin: Novolog®, Humalog®, Admelog® |
Page 9
| Predicate DeviceTandem t:slim X2 insulin pump with interoperable technology(K232380) | Subject DeviceMiniMed 780G insulin pump | |
|---|---|---|
| Principles of Operation | Delivery of insulin (Bolus and Basal) programmed by the patient based on healthcare provider recommendations. | SAME |
| Insulin Delivery Modes | Both basal and bolus | SAME |
| Pump Operating Modes | Manual Mode, Auto Mode | SAME |
| Insulin Basal Rate Delivery Range | 0 – 15 U/hour | 0 – 35 U/hour |
| Insulin Delivery Profiles (Basal and Bolus) | 6 | 8 |
| Insulin Bolus Delivery Range | Minimum bolus: 0.05 units, Maximum bolus: 25 units | Minimum bolus: 0.025 units, Maximum bolus: 25 units |
| Bolus Increments (Bolus Resolution) | 0.01 units | 0.025 units |
| Basal Delivery Accuracy (per 60601-2-24) | ±5% | SAMEIntermediate basal delivery (1 UPH) must meet ±5% of expected |
| Bolus Delivery Accuracy (per 60601-2-24) | ±5% | SAMEDelivery accuracy for bolus volumes ≥ 0.1 unit is ±5%. |
| Bolus Canceling | Supports bolus cancellation | SAME |
| Active insulin (IOB) | Programmable active insulin duration | SAME |
| Active insulin (IOB) tracking | Pump keeps track of the amount of active insulin from food and correction boluses (insulin on board, IOB) to prevent insulin stacking | SAME |
| Pump Device Accessories | Compatible FDA cleared infusion sets, 3mL sterile syringe, 26 gauge needle, AC power supply, DC car adaptor power supply with USB, Tandem Device Updater, Alternate USB Cable | MiniMed Mobile App (optional accessory, secondary display, Class II 510k-exempt), Compatible FDA cleared infusion sets (Class II), Compatible FDA cleared reservoirs (Class II), Belt Clip (non-medical device), Pump Covers/Cases (non-medical device) |
Page 10
| Predicate DeviceTandem t:slim X2 insulin pump with interoperable technology(K232380) | Subject DeviceMiniMed 780G insulin pump | |
|---|---|---|
| Compatible Interoperable Devices | Integrated Continuous Glucose Monitors (iCGMs), Interoperable Automated Glycemic Controllers (iAGCs) | Integrated Continuous Glucose Monitors (iCGMs), Interoperable Automated Glycemic Controllers (iAGCs), Compatible Interoperable Medtronic Continuous Glucose Monitors (CGMs) |
| Communication with Compatible Interoperable Devices | Bluetooth Low Energy (BLE) | SAME |
| Compatible Blood Glucose Meters | Commercially available BG meters | Commercially available BG meters that meet ISO 15197:2013 |
| Alarm Type(s) | Visible, audible, vibratory | SAME |
| Pump Notifications, Alerts, Alarms, and Reminders Visible to User | The following are visible on the pump: • Reminders • Alerts • Alarms • Notifications | SAME |
| Logging Records of Critical Events | Critical events logged by the system include: • A record of all drug delivery • Commands issued to the pump and pump confirmations • Device malfunctions • Alarms and alerts and associated acknowledgements • Connectivity events (e.g., establishment or loss of communications) • Bolus requests and terminations (canceling and stopping a bolus) from the t:connect mobile app | Critical events logged by the system include: • A record of all drug delivery • A record of all user/therapy settings and changes to those settings • Device malfunctions • Alarms and alerts and associated acknowledgements • Connectivity events (e.g., establishment or loss of communications) |
| Battery Type/ Power Requirements | The pump uses a re-chargeable lithium-polymer battery | The pump requires one AA (1.5V) battery |
| Pump Operating Conditions | Temperature: 41°F (5°C) to 98.6°F (37°C), Humidity: 20% to 90% relative humidity | SAME |
| Pump Storage Conditions | Temperature: -4°F (-20°C) to 140°F (60°C), Humidity: 20% to 90% R relative humidity | Temperature: -4°F (-20°C) to 122°F (50°C), Humidity: 20% to 90% R relative humidity |
| Moisture Protection | IPX7: Watertight to a depth of 3 feet (0.91 meters) for up to 30 minutes | IPX8: Protected against immersion in water up to 8 feet (2.4 meters) for up to 30 minutes |
| Pump Screen/Controls | Liquid Crystal Display (LCD) touchscreen | Liquid Crystal Display (LCD) Screen + Keypad |
Page 11
| Predicate DeviceTandem t:slim X2 insulin pump with interoperable technology(K232380) | Subject DeviceMiniMed 780G insulin pump | |
|---|---|---|
| Wireless control of bolus insulin therapy | The t:connect mobile app can allow limited, wireless control of bolus insulin therapy | The MiniMed 780G insulin pump does not have the capability to wirelessly control bolus insulin delivery via a mobile app. |
Bolus Calculator (Product Code: NDC)
| Predicate DeviceInPen Dose Calculator(K242775) | Subject DeviceMiniMed 780G insulin pump | |
|---|---|---|
| Manufacturer | Medtronic | SAME |
| Device Trade Name | InPen Dose Calculator | MiniMed 780G insulin pump |
| Device Type | Predictive Pulmonary-Function Value Calculator (under 21 CFR 868.1890) | SAME |
| Device Classification | Class II | SAME |
| Product Code | NDC | SAME |
| Prescription Use | Prescription is required | SAME |
| Operating Environment | Home Use | Professional healthcare facilities and home environments |
| Indications for Use/Intended Use | The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 7 and older by calculating an insulin dose or carbohydrate intake based on user entered data. The device is indicated for use with Fiasp, NovoLog®, or Humalog® U-100 insulin. For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/ meal sizes to be programmed into the software prior to use. | The MiniMed 780G insulin pump contains a bolus calculator that calculates an insulin dose based on user-entered data. |
Page 12
| Predicate DeviceInPen Dose Calculator(K242775) | Subject DeviceMiniMed 780G insulin pump | |
|---|---|---|
| Therapy Type | Diabetes patients treated with multiple daily insulin injection (MDI) therapy | Diabetes patients treated with insulin pump therapy in which calculator is integrated |
| Age Indication | Ages 7 and up | SAME |
| Specific Drug/Biological Use | U-100 insulin: NovoLog®, Humalog®, Fiasp® | U-100 insulin: NovoLog®, Humalog®, Admelog® |
| Principles of Operation | Calculate insulin doses for meals and corrections while accounting for active insulin (insulin on board). | SAME |
| Carbohydrate Calculator | Calculation based on either user-entered carbohydrate, meal size estimation, or fixed meal doses. | Calculates carbohydrate intake based on user-entered data. |
| Manual Data Entry | Yes | SAME |
| Requires BG for calculation | Yes | SAME |
| Operating Platform | Android and iOS | Pump firmware |
Summary of Non-Clinical Performance Data
Medtronic conducted extensive performance bench testing for MiniMed 780G insulin pump to demonstrate substantial equivalence to the predicate device and to ensure that the subject device meets all applicable ACE Special Controls requirements defined in 21 CFR 880.5730. These are summarized below:
Delivery Volume Accuracy
Delivery volume accuracy (DVA) testing for the MiniMed 780G insulin pump was conducted to assess the delivery volume accuracy performance of the pump for foreseeable use conditions as required by the ACE special controls requirements stated in 21 CFR 880.5730(b). The test results support that the device is safe to use under foreseeable use conditions and expected environments.
Page 13
The following accuracy data for basal delivery, bolus delivery, and occlusion detection were collected and evaluated by Medtronic and confirmed to be acceptable.
To assess basal and bolus delivery accuracy and occlusion detection, 32 MiniMed 780G insulin pumps were tested by delivering at minimum, intermediate, and max basal rates (0.025, 1.0, and 35 U/hr). Sixteen of the pumps were new, and 16 had been aged to simulate four years of regular use. For both aged and unaged pumps, eight pumps were tested with new infusion sets and reservoirs, and eight with infusion sets and reservoirs which underwent real time aging. Humalog placebo was used as a substitute for insulin for this testing. The Humalog placebo was pumped into a container on a scale, and the weight of the liquid at various time points was used to assess pumping accuracy.
Basal Delivery:
The following tables report the typical basal performance (median) observed, along with the lowest and highest results observed for minimum, intermediate, and max basal rate settings for all pumps tested.
Minimum Basal Rate Delivery Performance (0.025 U/hr)
| Basal Duration(Number of Units Delivered with 0.025 U/hr Setting) | 1 hour(0.025 U) | 6 hours(0.15 U) | 12 hours(0.3 U) |
|---|---|---|---|
| Amount Delivered [min, max] | 0.041 U[0.000 U, 0.094 U] | 0.219 U[0.052 U, 0.364 U] | 0.518 U[0.171 U, 0.695 U] |
Intermediate Basal Rate Delivery Performance (1.0 U/hr)
| Basal Duration(Number of Units Delivered with 1.0 U/hr Setting) | 1 hour(1U) | 6 hours(6 U) | 12 hours(12 U) |
|---|---|---|---|
| Amount Delivered [min, max] | 0.89 U[0.81 U, 0.98 U] | 5.81 U[5.62 U, 6.03 U] | 11.79 U[11.46 U, 12.11 U] |
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Maximum Basal Rate Delivery Performance (35.0 U/hr)
| Basal Duration(Number of Units Delivered with 35.0 U/hr Setting) | 1 hour(35 U) | 6 hours(210 U) |
|---|---|---|
| Amount Delivered [min, max] | 33.21 U[31.53 U, 34.39 U] | 205.33 U[203.31 U, 206.18 U] |
Bolus Delivery:
Delivered bolus volumes were compared to the requested bolus volume delivery for minimum, intermediate, and maximum bolus volumes.
The table below shows average, minimum, and maximum bolus sizes observed.
Summary of Bolus Delivery Performance (n=32 pumps)
| Individual Bolus Accuracy Performance | Target Bolus Size (U) | Mean Bolus Size (U) | Min Bolus Size (U) | Max Bolus Size (U) |
|---|---|---|---|---|
| Min Bolus Delivery Performance (n=800 boluses) | 0.025 | 0.024 | 0.004 | 0.041 |
| Intermediate Bolus Delivery Performance (n=800 boluses) | 2.50 | 2.45 | 2.23 | 2.57 |
| Max Bolus Delivery Performance (n=320 boluses) | 25.00 | 24.58 | 22.43 | 25.91 |
The following tables below show the number of boluses which were observed to be within the specified range for min bolus, intermediate bolus, and max bolus, respectively.
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Min Bolus Delivery Performance (0.025U) (n=800 boluses)
Units of Insulin Delivered After a 0.025 U Bolus Request
| <0.006(<25%) | 0.006–0.019(25–75%) | 0.019–0.023(75–90%) | 0.023–0.024(90–95%) | 0.024–0.026(95–105%) | 0.026–0.028(105–110%) | 0.028–0.031(110–125%) | 0.031 –0.044(125–175%) | 0.044–0.063(175–250%) | >0.063(>250%) |
|---|---|---|---|---|---|---|---|---|---|
| 2/800(0.3%) | 116/800(14.5%) | 179/800(22.4%) | 72/800(9.0%) | 133/800(16.6%) | 111/800(13.9%) | 106/800(13.3%) | 81/800(10.1%) | 0/800(0.0%) | 0/800(0.0%) |
Intermediate Bolus Delivery Performance (2.5U) (n=800 boluses)
Units of Insulin Delivered After a 2.5 U Bolus Request
| <0.625(<25%) | 0.625–1.875(25–75%) | 1.875–2.25(75–90%) | 2.25–2.375(90–95%) | 2.375–2.625(95–105%) | 2.625–2.75(105–110%) | 2.75–3.125(110–125%) | 3.125–4.375(125–175%) | 4.375–6.25(175–250%) | >6.25(>250%) |
|---|---|---|---|---|---|---|---|---|---|
| 0/800(0.0%) | 0/800(0.0%) | 1/800(0.1%) | 25/800(3.1%) | 774/800(96.8%) | 0/800(0.0%) | 0/800(0.0%) | 0/800(0.0%) | 0/800(0.0%) | 0/800(0.0%) |
Max Bolus Delivery Performance (25U) (n=320 boluses)
Units of Insulin Delivered After a 25 U Bolus Request
| <6.25(<25%) | 6.25–18.75(25–75%) | 18.75–22.5(75–90%) | 22.5–23.75(90–95%) | 23.75–26.25(95–105%) | 26.25–27.5(105–110%) | 27.5– 31.25(110–125%) | 31.25–43.75(125–175%) | 43.75–62.5(175–250%) | >62.5(>250%) |
|---|---|---|---|---|---|---|---|---|---|
| 0/320(0.0%) | 0/320(0.0%) | 0/320(0.0%) | 0/320(0.0%) | 320/320(100.0%) | 0/320(0.0%) | 0/320(0.0%) | 0/320(0.0%) | 0/320(0.0%) | 0/320(0.0%) |
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Occlusion Detection:
To assess occlusion detection activity, the pumps were tested by placing a hemostat clamp on the cannula of an infusion site (to simulate an occlusion) and then delivering either a 10-unit bolus tested at two different bolus speeds (Standard and Quick) or at three different basal rates denoted as "minimum", "intermediate", and "maximum". Upon start of each test leg, the time elapsed between start of delivery and when the occlusion alarm occurred via the MiniMed 780G insulin pump was recorded. All samples tested met performance that is presented in the table below.
Bolus Duration for Standard and Quick Speeds
| Characteristic | Value |
|---|---|
| Bolus – Standard Speed | 1.5 units/min |
| Bolus – Quick Speed | 15 units/min |
Time to Occlusion Alarm*
| Operating Rate | Typical | Maximum |
|---|---|---|
| Bolus (Standard Speed – 10 units) | 1 minute, 42 seconds | 2 minutes, 24 seconds |
| Bolus (Quick Speed – 10 units) | 10 seconds | 16 seconds |
| Basal (1 units/hr) | 2 hours, 58 minutes | 4 hours, 3 minutes |
| Basal (35 units/hr) | 2 minutes, 30 seconds | 4 minutes |
| Basal (0.025 units/hr) | 174 hours, 53 minutes | 199 hours |
*The time to occlusion alarm is based on insulin volume not delivered. During an occlusion event, boluses of less than 3 units may not trigger an occlusion alarm if no basal insulin is being delivered. The bolus amount will reduce the time to occlusion depending on the Basal Rate.
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Catheter Occlusion Detection
Catheter Occlusion Detection testing for the MiniMed 780G insulin pump was conducted with Humalog, NovoLog, and Admelog U100 insulins to demonstrate the incidence of catheter blockage due to insulin crystallization. The test results confirmed that there were no pump malfunctions or infusion set occlusions.
Drug Stability and Compatibility
Drug stability and compatibility testing was performed with U100 insulins (Humalog, NovoLog, Admelog) used with the MiniMed 780G insulin pump. The test results demonstrated that the MiniMed 780G insulin pump does not adversely affect the insulins being delivered, and that the insulin types do not adversely affect the pump.
Data Logging
The MiniMed 780G insulin pump has been tested and verified for logging or recording timestamped critical events as required by the ACE pump special controls.
Cybersecurity
The cybersecurity activities for the MiniMed 780G insulin pump were all completed per cybersecurity plan and cybersecurity risks were assessed for impact to confidentiality, integrity, and availability. A robust cybersecurity risk assessment was conducted, all cybersecurity risks with potential to impact safety were mitigated. The information relating to the penetration testing conducted as part of MiniMed 780G insulin pump's cybersecurity evaluation and software bill of materials was provided.
Human Factors Validation
A human factors and usability engineering process was performed on MiniMed 780G insulin pump with compatible Medtronic CGMs and compatible Medtronic iAGCs in accordance with IEC 62366-1:2015, HE75:2009 and FDA's guidance document, Applying Human Factors and Usability Engineering to Medical Devices (February 2016). Results of the human factors validation testing demonstrated that the device is safe and effective for the intended users, intended uses and expected tasks, and intended use environments.
Labeling
The MiniMed 780G insulin pump's device labeling for users and healthcare practitioners is sufficient and satisfies applicable requirements of 21 CFR 801.
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Other Supportive Test Data:
The following additional testing was conducted:
| Product Verification (Hardware and Functional) | Electrical, Mechanical and Thermal (EMT) Safety |
|---|---|
| Biocompatibility | Electromagnetic Compatibility (EMC) & RF Wireless Communication |
| Reliability | Software Verification |
| Shelf Life | Packaging and Shipping |
| Reprocessing (Cleaning instructions) |
The MiniMed 780G insulin pump and accessories were subjected to the above tests. All tests passed and met the acceptance criteria. The test results demonstrate that the device met the specified requirements.
Risk Management
Risk management was completed in accordance with ISO 14971: 2019. Risk control measures identified for each hazard were implemented and verified to be effective at reducing risk, Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met, and the device is safe for use. All risks have been reduced as far as possible. The benefit risk analysis has determined that the benefits of using the device outweighs the residual risk, and the overall residual risk is acceptable.
Interoperability
Interoperability documentation was provided in accordance with FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (September 2017)" and the requirements defined by the ACE special controls 21 CFR 880.5730(b)(3)-(5). It outlined the interoperability strategy and approach for the MiniMed 780G insulin pump and how it is interoperable with compatible iAGCs, compatible iCGMs, and compatible interoperable Medtronic CGMs. It also specified expectations, requirements, and interface specifications for current and future interoperable devices. In addition, it outlined Medtronic's approach to working with connected device companies.
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Predetermined Change Control Plan (PCCP)
A Predetermined change control plan (PCCP) for planned modifications to the MiniMed 780G insulin pump, was provided in accordance with the FDA Draft Guidance, "Predetermined Change Control Plans for Medical Devices (August 2024)". It included modifications for integrating with potential additional commercialized interoperable devices in the future. The PCCP included a description of modifications, a modification protocol, traceability from modifications to the modification protocols and an impact assessment.
Conclusion
Based on the information provided in this Traditional 510k, Medtronic concludes that the subject device, MiniMed 780G insulin pump, is substantially equivalent to the predicate device, Tandem t:slim X2 insulin pump with interoperable technology (K232380) for the Product Code QFG.
Additionally, Medtronic concludes the bolus calculator within the MiniMed 780G insulin pump is substantially equivalent to the predicate device, the Medtronic InPen Dose Calculator (K242775) for the Product Code NDC. Furthermore, the subject device meets all the Special Controls requirements for Alternate controller enabled infusion pump defined in 21 CFR 880.5730.
§ 880.5730 Alternate controller enabled infusion pump.
(a)
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.(b)
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 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.