← Product Code [QFG](/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG) · K253470 # MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (K253470) _Medtronic Minimed, Inc. · QFG · Jan 15, 2026 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K253470 ## Device Facts - **Applicant:** Medtronic Minimed, Inc. - **Product Code:** [QFG](/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG.md) - **Decision Date:** Jan 15, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5730 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry - **Attributes:** Therapeutic, PCCP, Pediatric ## Indications for 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 persons 7 years of age and older. The MiniMed 780G insulin pump is intended for single patient use and requires a prescription. ## Device Story Ambulatory, battery-operated, rate-programmable microinfusion pump; delivers insulin subcutaneously at set/variable rates. Inputs: user-entered data (carbohydrates, blood glucose) via keypad/display; commands from compatible, digitally connected devices (iCGMs, iAGCs). Operation: bolus calculator computes insulin doses based on user input and active insulin (insulin on board). Output: insulin delivery; real-time glucose info; alerts/alarms. Used in home/professional settings by patients/caregivers. Benefits: automated insulin management; interoperability with connected devices. Hardware/pumping mechanism identical to predicate K251032; updated to support additional U-100 insulins (Fiasp, Lyumjev). ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing, including delivery volume accuracy, catheter occlusion detection, drug stability/compatibility, cybersecurity evaluation, and human factors validation. ## Technological Characteristics Polycarbonate case; battery-operated (1 AA); BLE wireless connectivity; IPX8 moisture protection. Infusion pump mechanism; LCD screen with keypad. Software-based bolus calculator. Compatible with U-100 insulins (Novolog, Humalog, Admelog, Fiasp, Lyumjev). ## Regulatory 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. ## Predicate Devices - MiniMed 780G Insulin Pump ([K251032](/device/K251032.md)) - InPen Dose Calculator ([K242775](/device/K242775.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ## I Background Information: A 510(k) Number K253470 B Applicant Medtronic MiniMed, Inc. C Proprietary and Established Names MiniMed 780G Insulin 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 | | NDC | Class II | 21 CFR 868.1890 – Calculator, Drug Dose | CH - Clinical Chemistry | ## E Purpose for Submission: This submission includes the following changes: - Addition of compatible U-100 insulins Fiasp® and Lyumjev® for use with the MiniMed 780G insulin pump ## A Intended Use(s): See Indications for Use below. ## B Indication(s) for 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. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} 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 persons 7 years of age and older. The MiniMed 780G insulin pump is intended for single patient use and requires a prescription. ## C Special Conditions for Use Statement(s): Rx - For Prescription Use Only - Do not use the MiniMed 780G insulin pump or additional system devices next to other electrical equipment, which may cause interference. This includes mobile communication devices such as cell phones that are not paired with the MiniMed 780G system, GPS navigation systems, anti-theft systems, and any electrical equipment that has an output transmitter power greater than 1 W. The recommended separation distance between the insulin pump and common RF emitters is 12 in (30 cm). - Special Precautions regarding Electromagnetic Compatibility (EMC): This body-worn device is intended to be operated within a residential, domestic, public or work environment, where common levels of radiated "E" (V/m) or "H" fields (A/m) exist. Technologies that emit these fields include: cellular phones that are not paired with the MiniMed 780G system, wireless technology, electric can openers, microwaves, and induction ovens. The MiniMed 780G system generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the provided instructions, may cause harmful interference to radio communications. - 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 and sensor 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. - Always monitor your blood glucose (BG) 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. K253470 - Page 2 of 7 {2} - Do not wear or place your pump more than 14 in (35.5 cm) above your infusion site. Doing so can cause an over-delivery of insulin, which may result in hypoglycemia. ## II Device Description The MiniMed 780G Insulin Pump is an alternate controller enabled (ACE) insulin pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump can reliably and securely communicate with compatible, digitally connected medical devices, including interoperable continuous glucose monitors (iCGMs) and interoperable automated glycemic controllers (iAGCs). The pump is intended to be used both alone and in conjunction with compatible digitally connected medical devices for the purpose of insulin delivery. The MiniMed 780G Insulin Pump is an ambulatory, battery-operated, rate-programmable microinfusion pump that contains pump software and houses electronics, a pumping mechanism, a user interface, and a medication reservoir within a single physical device. The pump includes a bolus calculator that calculates insulin doses based on user-entered data. The pump provides the user with keypad controls and a display screen for configuring therapy settings and viewing real-time glucose information, glucose trends, alerts, alarms, and other therapy-related information. The user interface and alerting system enable user interaction with the pump delivery system and interoperable automated glycemic control functionality when used with compatible devices. Product code NDC applies solely to the embedded bolus calculator function and does not constitute a drug evaluation or combination-product review. ## III Substantial Equivalence Information: ### A Predicate Device Name(s): MiniMed 780G Insulin Pump Medtronic InPen dose calculator ### B Predicate 510(k) Number(s): K251032 K242775 ### C Comparison with Predicate(s): | Device & Predicate Device(s): | K253470 | K251032 | | --- | --- | --- | | Device Trade Name | MiniMed 780G insulin pump | MiniMed 780G insulin pump | | General Device Characteristic | K253470 | K251032 | K253470 - Page 3 of 7 {3} K253470 - Page 4 of 7 | 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 | | General Device Characteristic Differences | **K253470** | **K251032** | | Compatible Insulins | U-100 insulin (e.g., Humalog®, NovoLog®, Admelog®, Fiasp®, Lyumjev®) | U-100 insulin (e.g., Humalog®, NovoLog®, Admelog®) | | Software | Pump software version 6.61, implemented under the PCCP authorized in K251032 to enable pump-side interoperability with compatible interoperable CGMs, along with related configuration and user-interface updates | Pump software version 6.42 | | Cybersecurity | Cybersecurity controls consistent with the predicate device; updates implemented under the PCCP authorized in K251032 to support pump-side interoperability and routine cybersecurity maintenance | Cybersecurity controls consistent with ACE pump special controls | | Device & Predicate Device(s): | **K253470** | **K242775** | {4} K253470 - Page 5 of 7 | Device Trade Name | MiniMed 780G insulin pump | InPen Dose Calculator | | --- | --- | --- | | General Device Characteristic Similarities | K253470 | K242775 | | Intended Use / Indications for Use | The device calculates an insulin dose based on user-entered data. | Same | | Prescription Use | Prescription is required | Same | | Principles of Operation | Calculate insulin doses for meals and corrections while accounting for active insulin (insulin on board). | Same | | Requires BG for bolus dose calculation | Yes | Same | | Manual data entry | Yes | Same | | Intended use population | 7 years and older | Same | | General Device Characteristic Differences | K253470 | K242775 | | Compatible Insulins | U-100 insulin (e.g., Humalog®, NovoLog®, Admelog®, Fiasp®, Lyumjev®) | U-100 insulin: NovoLog® Humalog® Fiasp® | | Therapy Type | Insulin pump therapy | Multiple daily insulin injection therapy | | Carbohydrate estimate | Based on user-entered data | Based on either user-entered carbohydrate, meal size estimation, or fixed meal doses | | Environment of Use | Professional healthcare facilities and home environments | Home use | | Therapy Type | Insulin pump therapy | Multiple daily injection (MDI) insulin therapy | {5} K253470 - Page 6 of 7 ## IV 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* ## V Performance Characteristics: ### A. Non-Clinical Performance The MiniMed 780G insulin pump in this submission is identical in hardware design, pumping mechanism, and essential performance characteristics to the device cleared under K251032. There are no changes to insulin delivery accuracy, reliability, biocompatibility, shelf life, or essential performance. Accordingly, the following non-clinical performance data were leveraged from K251032 and remain applicable: - Delivery Volume Accuracy (DVA) testing (basal and bolus) - Mechanical and functional performance testing - Reliability and expected service life testing - Electrical safety and EMC testing - Wireless and RF performance testing - Biocompatibility of patient-contacting materials - Shelf-life and packaging validation New non-clinical testing in this submission is limited to drug compatibility and catheter occlusion testing supporting the addition of Fiasp® and Lyumjev®, leveraging previously reviewed data from P160017/S125. ### B. Clinical Studies: Clinical studies evaluating the performance of the MiniMed 780G system with Fiasp® and Lyumjev® were previously reviewed under P160017/S125 and are leveraged for this submission. {6} K253470 - Page 7 of 7 C. Other Supportive Device Performance Characteristics Data Human factors and cybersecurity controls remain consistent with those previously reviewed and accepted under K251032, and software updates implemented under the PCCP do not introduce new use-related or cybersecurity risks affecting safety or essential performance. VI Proposed Labeling: The labeling, updated to reflect the addition of compatible insulins, supports the finding of substantial equivalence for this device. VII Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K253470](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K253470) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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