The InPen System is a home-use reusable pen for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient aged 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen Smart Insulin pen allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient aged 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.

For an insulin dose based on amount of carbohydrates, a healthcare 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 provide patient-specific fixed doses/ meal sizes to be programmed into the software prior to use.

Device Description

The InPen App is a software application with versions that are compatible with mobile phones running the iOS or Android operating system. The App is a component of the InPen system and is used with the InPen Smart Insulin pen for the management of insulin-requiring diabetes. The InPen App communicates with the InPen Smart Insulin pen to communicate doses that are delivered by the user. The InPen App is also compatible for use with blood glucose (BG) meters, Medtronic Continuous Glucose Monitors (CGMs), and the Dexcom CGMs. The InPen App includes a dose calculator that can calculate and recommend a dose for the user to review and consider as part of following the treatment plan prescribed by the healthcare provider. The dose calculator features in the App require that a healthcare professional provide patient-specific values for various therapy settings for programming into the App prior to use by the patient. These therapy settings include glucose target(s), duration of insulin action time, insulin sensitivity factor(s), and insulin-to-carbohydrate ratio(s) or fixed insulin doses for meal types and sizes. The dose calculator feature is unavailable to the user until these patient-specific values, provided by the healthcare professional, are programmed and an InPen has been paired to the App. A healthcare provider may also provide long-acting insulin settings to be programmed into the InPen App. The App includes a logbook feature that displays the patient's recent activity related to BG values, meal types and sizes, dose calculations, doses by insulin type (rapid- or long-acting), cartridge replacement and priming. The App also provides reminders and alerts that can notify the user to check their glucose, dose insulin (for potential missed meals, correction doses, and longacting insulin doses) and log doses according to schedule, replace a cartridge, or if the insulin pen has been exposed to very low or very high temperatures. The App can generate a supplemental summary report of recent therapy information for review by the patient or healthcare professional (HCP).

The InPen Cloud includes a therapy report component that the user and the health care provider (HCP) can view and print to assess the overall diabetes control and treatment plan. The report displays data based upon user and HCP-defined inputs, such as glucose, insulin and carb trended information, during the defined period, as well as dose calculator usage and alerts and reminders. The Insulin Notification Service (INS) is a subcomponent of the InPen Cloud that can receive Medtronic CGM sensor glucose measurements from the CareLink Cloud. The INS includes two algorithms that assess "real time" sensor glucose measurements to identify whether a user has missed a dose or if their glucose is rising and a correction dose is needed. If either of these conditions exist, a silent notification is sent by the INS to the InPen App. The InPen App confirms the data and can provide and visual alert to the user. The user can act on the alert by assessing their glucose levels followed by calculating a dose utilizing the InPen App dose calculator.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic MiniMed InPen System. It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence. However, the document does not contain the specific details about acceptance criteria, the study design (including sample size, data provenance, expert ground truth establishment, or adjudication methods), or performance data in the way requested in the prompt.

The "Performance Data" section (Page 10) broadly states that "Software verification and validation testing was performed in accordance with the FDA's Guidance..." and mentions "unit level testing, integration level testing, and systems testing." It also notes "Cybersecurity Testing" and "risk management activities." Finally, it mentions an "additional assessment of the changes to the InPen Cloud occurred through a summative usability evaluation" where "patients...used the InPen Cloud to perform a series of critical tasks involving the use of the InPen App and Cloud, including the additional alerts and reminder."

Therefore, it is not possible to fill in most of the requested information based on the provided text. The document focuses on regulatory arguments for substantial equivalence rather than detailed clinical or technical study results that would typically include such specifics.

Here's a breakdown of what can be extracted and what cannot:

Information that CANNOT be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This detail is not present. The document focuses on showing the device is substantially equivalent to a predicate, not on specific performance metrics against pre-defined acceptance criteria.
Sample sizes used for the test set and the data provenance: No specific sample sizes for particular tests (e.g., test sets for algorithms) are mentioned, nor is the data provenance (country, retrospective/prospective). The "summative usability evaluation" is mentioned, but without sample size or details about the data used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This type of study is more common for diagnostic imaging AI, whereas this device is an insulin management system with a dose calculator.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the InPen App has an algorithm for dose calculation and the InPen Cloud has algorithms for notifications, the document doesn't provide performance data for these algorithms in isolation. The "summative usability evaluation" implies human-in-the-loop testing.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not explicitly stated how the accuracy of the dose calculations or alert effectiveness was verified as "ground truth." The "summative usability evaluation" likely involved checking if users performed tasks correctly, but the underlying ground truth for algorithm accuracy isn't detailed.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Information that CAN be extracted or inferred from the provided text:

Device Type: Insulin management system (reusable pen, app with dose calculator).
Regulatory Class: Class II (Product Code: NDC).
Software Level of Concern: Major.
Key Software Features: Dose calculator (insulin dose based on carbohydrates or fixed/variable meal sizes), logging, reminders, alerts (missed dose, high glucose).
New Features (compared to predicate):
- Two new algorithms in the InPen Cloud (Insulin Notification Service) to identify and send "silent notifications" to the InPen App for missed insulin doses or rising glucose.
- Two new visual and audible alerts in the InPen App for missed insulin doses or high glucose, for users with a Medtronic CGM.
- Improved existing Long-Acting Reminder to include both audible and visual alerts.
Performance Data (General Statement): "Software verification and validation testing was performed in accordance with the FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions'', and FDA's guidance "General Principles of Software Validation". Verification and validation activities included software testing consisting of unit level testing, integration level testing, and systems testing of the InPen App and InPen Cloud. Cybersecurity Testing was performed... Risk management activities... were undertaken... Additional assessment of the changes to the InPen Cloud occurred through a summative usability evaluation."

In summary, the provided document is a regulatory submission focused on substantial equivalence, not a detailed technical report of study results with specific performance metrics and study methodologies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 12, 2024

Medtronic MiniMed Ty Cowart Senior Principal Regulatory Specialist 18000 Devonshire Street Northridge. California 92325

Re: K242775

Trade/Device Name: InPen System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: September 13, 2024 Received: September 13, 2024

Dear Ty Cowart:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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"

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(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 OS 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 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-safetyreporting-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 Rue"). 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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

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Indications for Use

510(k) Number (if known) K242775

Device Name InPen System

Indications for Use (Describe)

For an insulin dose based on fixed/variable meal sizes, a healthcare provide patient-specific fixed doses/ meal sizes to be programmed into the software prior to use.

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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1. 510(k) Summary

1.1. InPen App

Name of Device	InPen System
Common Name	Pen Injector with Dose Calculator
Predicate DeviceName and Model ID	InPen™ System (MMT-8060/MMT-8061)
Predicate 510(k)Number	K201337
Classification Name	Class IIPiston syringe with Drug Dose Calculator
Product Code	FMF, NDC
ClassificationRegulation	21 CFR 868.1890; 21 CFR 880.5860
Manufacturer andDesign Facility	Medtronic MiniMed, Inc.12230 World Trade Drive, Suite 100San Diego, California 92128
ManufacturingFacility	Jabil Circuit De ChihuahuaAv. Alexandro Dumas 11341Complejo Industrial ChihuahuaChihuahua, MX 31136
EstablishmentNumber	3004060780
Primary ContactInformation	Ty CowartSenior Principal Regulatory Affairs SpecialistTel: 678-481-9246Email: ty.cowart@medtronic.com
Secondary ContactInformation	Christina RoweSenior Regulatory Affairs ManagerTel: (818) 942-4875Email: christina.rowe@medtronic.com

Table 1-1: General Information

2. Device Description

2.1. InPen App

The InPen App is a software application with versions that are compatible with mobile phones running the iOS or Android operating system. The App is a component of the InPen

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Medtronic MiniMed Traditional 510(k) InPen System 510(k) Summary

system and is used with the InPen Smart Insulin pen for the management of insulin-requiring diabetes. The InPen App communicates with the InPen Smart Insulin pen to communicate doses that are delivered by the user. The InPen App is also compatible for use with blood glucose (BG) meters, Medtronic Continuous Glucose Monitors (CGMs), and the Dexcom CGMs. The InPen App includes a dose calculator that can calculate and recommend a dose for the user to review and consider as part of following the treatment plan prescribed by the healthcare provider. The dose calculator features in the App require that a healthcare professional provide patient-specific values for various therapy settings for programming into the App prior to use by the patient. These therapy settings include glucose target(s), duration of insulin action time, insulin sensitivity factor(s), and insulin-to-carbohydrate ratio(s) or fixed insulin doses for meal types and sizes. The dose calculator feature is unavailable to the user until these patient-specific values, provided by the healthcare professional, are programmed and an InPen has been paired to the App. A healthcare provider may also provide long-acting insulin settings to be programmed into the InPen App. The App includes a logbook feature that displays the patient's recent activity related to BG values, meal types and sizes, dose calculations, doses by insulin type (rapid- or long-acting), cartridge replacement and priming. The App also provides reminders and alerts that can notify the user to check their glucose, dose insulin (for potential missed meals, correction doses, and longacting insulin doses) and log doses according to schedule, replace a cartridge, or if the insulin pen has been exposed to very low or very high temperatures. The App can generate a supplemental summary report of recent therapy information for review by the patient or healthcare professional (HCP).

The InPen Cloud 2.2.

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Medtronic MiniMed Traditional 510(k) InPen System 510(k) Summary

the user. The user can act on the alert by assessing their glucose levels followed by calculating a dose utilizing the InPen App dose calculator.

3. Indications For Use

The current Indications for Use statement is provided below:

The InPen System is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp ® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.

For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patientspecific 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 patientspecific fixed doses/meal sizes to be programmed into the software prior to use.

4. Technological Characteristics and Substantial Equivalence (SE)

InPen AppAttributes	Predicate DeviceInPen System(K201337)	Subject DeviceInPen System	Comparison
Classification	(Class II - NDC - 21 CFR§868.1890)	(Class II - NDC - 21 CFR§868.1890)	Same
Indications ForUse	The InPen System is a home-usereusable pen injector for single-patient use by people withdiabetes under the supervision ofan adult caregiver, or by a	The InPen System is a home-usereusable pen injector for single-patient use by people with diabetesunder the	Same
InPen AppAttributes	Predicate DeviceInPen System(K201337)	Subject DeviceInPen System	Comparison
	patient age 7 and older for theself-injection of a desired doseof insulin. The pen injector iscompatible with LillyHumalog® U-100 3.0 mLcartridges, Novo NordiskNovolog® U-100 3.0 mLcartridges, and Novo NordiskFiasp® U-100 3.0 mL cartridgesand single-use detachable anddisposable pen needles (notincluded). The pen injectorallows the user to dial thedesired dose from 0.5 to 30 unitsin one-half (1/2) unit increments.The InPen System dosecalculator, a component of theInPen app, is indicated for themanagement of diabetes bypeople with diabetes under thesupervision of an adultcaregiver, or by a patient age 7and older for calculating aninsulin dose or carbohydrateintake based on user entereddata.For an insulin dose based onamount of carbohydrates, ahealthcare professional mustprovide patient-specific targetblood glucose, insulin-to-carbohydrate ratio, and insulinsensitivity parameters to beprogrammed into the softwareprior to use.For an insulin dose based onfixed/variable meal sizes, ahealthcare professional mustprovide patient-specific fixeddoses/meal sizes to beprogrammed into the softwareprior to use.	supervision of an adult caregiver, orby a patient age 7 and older for theself- injection of a desired dose ofinsulin. The pen injector iscompatible with Lilly Humalog® U-100 3.0 mL cartridges, NovoNordisk Novolog® U-100 3.0 mLcartridges, and Novo NordiskFiasp® U-100 3.0 mL cartridges andsingle-use detachable and disposablepen needles (not included). The peninjector allows the user to dial thedesired dose from 0.5 to 30 units inone-half (1/2) unit increments.The InPen System dose calculator, acomponent of the InPen app, isindicated for the management ofdiabetes by people with diabetesunder the supervision of an adultcaregiver, or by a patient age 7 andolder for calculating an insulin doseor carbohydrate intake based on userentered data.For an insulin dose based on amountof carbohydrates, a healthcareprofessional must provide patient-specific target blood glucose,insulin-to- carbohydrate ratio, andinsulin sensitivity parameters to beprogrammed into the software priorto use.For an insulin dose based onfixed/variable meal sizes, a healthcareprofessional must provide patient-specific fixed doses/meal sizes to beprogrammed into the software priorto use.
Prescription Use	Yes	Yes	Same
InPen AppAttributes	Predicate DeviceInPen System(K201337)	Subject DeviceInPen System	Comparison
User Group	Diabetes patients treated withmultiple daily insulin injection(MDI) therapy	Diabetes patients treated withmultiple daily insulin injection(MDI) therapy	Same
Communicationwith insulin pumps	No	No	Same
Software Level ofConcern	Major	Major	Same
WirelessConnectivity	Bluetooth Low Energy (BLE)	Bluetooth Low Energy (BLE)	Same
Control or affectglucosemeasurements	No	No	Same
Control or affectinsulin delivery	No	No	Same
Reports, graphs,and ElectronicLogbook	Yes	Yes	Same
Meal Size Entry	Grams of carbohydrates	Grams of carbohydrates	Same
Fixed Dose Setting	Set by User	Set By User	Same
Insulin DoseCalculator	Calculates insulin doses formeals and corrections whileaccounting for insulin on board	Calculates insulin doses for mealsand corrections while accountingfor insulin onboard	Same
CarbohydrateCalculator	Calculates carbohydrate intakebased on user-entered data	Calculates carbohydrate intakebased on user-entereddata	Same
Manual Dose Entry	Yes	Yes	Same
InPen Dose Entry	Yes	Yes	Same
Tracking ofresidual bolusinsulin to mitigatestacking	Yes	Yes	Same
Operating platform	Android and iOS platforms	Android and iOS platforms	Same
UI Standards	Android and iOS standards	Android and iOS standards	Same
InPen CloudCommunicationwith CarelinkCloud to receiveMedtronic CGMglucosemeasurements	Can receive the most recentCGM glucose measurementsfrom the Carelink Cloud. TheCGM data can be viewed on theInPen App for the user and intherapy reports generated by theInPen Cloud for the HCP andthe user.	Can receive the Medtronic CGMsensor glucose measurements in realtime (every 5minutes) from theCarelink Cloud. Two softwarealgorithms have been added to theInPen Cloud that includecomputational methods to identifywhether a user has missed aninsulin dose or iftheir glucose is rising. If	Addition of two algorithms inthe InPen Cloud (InsulinNotification Service) toidentify and send a silentnotification to the InPen App.Two new visual and audiblealerts have been added to theInPen App to alert the user tothe presence of a missedinsulin dose or when theirglucose level is high.
InPen AppAttributes	Predicate DeviceInPen System(K201337)	Subject DeviceInPen System	Comparison
		either of these conditions exist, asilent notification is sent to theInPen App. The InPen Appconfirms the data and is responsiblefor providing an audible and visualalert to the user.The CGM data can be displayedand printed in therapy reports bythe HCP and user from the InPenApp and InPen Cloud.
Long-Acting DoseReminder	An optional user-enabled alertwhich is provided to the user.User sets a time when theirprescribed Long- Acting Insulinis taken. If the Long-ActingDose is not taken, the App willpresent a visual reminder to theuser dose is not taken by theuser.	An optional user-enabled audibleand visual reminder which isprovided to the user. The alert'sstatus has been changed to allow itspresentation to be active if the phonevolume is turned down or in a DoNot Disturb Mode. If the Long-Acting Dose is not taken, the Appwill present an audible and visualreminder to the user.	Improved the existingLong-Acting Reminder toinclude both an audible andvisual alert.
Missed Dose Alert	A user enabled missed dosereminder is currently availableto the user and is a time-basedmeal reminder. The userconfigures their meal-timewindow for each meal type(breakfast, lunch, dinner). If thealert is enabled by the user analert is supplied if no insulindose was logged within the userset meal-time window.	A user-enabled missed dose alert(audible and visual) for users of theInPen System and a MedtronicCGM. The InPen App will alert theuser when their sensor glucose levelindicates that a missed insulin dosehas occurred.Non-CGM users or CGM users whodo not enable the alert can choose toenable and receive the existingmissed dose reminder.	A user enabled Alert addedas an option for users of aMedtronic CGM.
Correct HighGlucose Alert	A user enabled alert that remindsthe user to check their glucoselevel 2 hours after a dose andcheck their glucose level beforetheir bedtime. After checkingtheir glucose and if their glucoseis high, the user can use the dosecalculator to obtain a doserecommendation.	A user-enabled Correct High alert forusers of the InPen System and aMedtronic CGM. The InPen Appwill alert the user when their glucoseis rising high and is above the defaultvalue of 180 md/dL.Non-CGM users or CGM userswho do not enable the alert canchoose to enable and receive theexisting reminders to check their	A user enabled Alert addedas an option for users of aMedtronic CGM.
InPen AppAttributes	Predicate DeviceInPen System(K201337)	Subject DeviceInPen System	Comparison
		glucose level 2 hours after adose and before theirbedtime.

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Medtronic MiniMed
Traditional 510(k)

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Medtronic MiniMed
Traditional 510(k)

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Medtronic MiniMed
Traditional 510(k)

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5. Performance Data

Software verification and validation testing was performed in accordance with the FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions'', and FDA's guidance "General Principles of Software Validation". Verification and validation activities included software testing consisting of unit level testing, integration level testing, and systems testing of the InPen App and InPen Cloud.

Cybersecurity Testing was performed to assess data integrity to ensure that data remains consistent and accurate. Cyclic redundancy checks (CRC) were used for all data transmissions and stored dose records.

As part of the evaluation, risk management activities in accordance with ISO 14971: 2019 Medical Devices-Application of risk management to medical devices, were undertaken, including a risk management plan, risk assessment, and a risk management report.

Additional assessment of the changes to the InPen Cloud occurred through a summative usability evaluation. In the summative evaluation, patients with sufficient diabetes knowledge completed self-training and then used the InPen Cloud to perform a series of critical tasks involving the use of the InPen App and Cloud, including the additional alerts and reminder.

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5.Substantial Equivalence Conclusion

Based on the 510(k) Summary and information provided herein, Medtronic concludes that the subject device, InPen App and InPen Cloud (K201337) is substantially equivalent to the predicate InPen App (K201337) in its intended use, safety, effectiveness, and underlying scientific and operating principles. The proposed enhancements to the existing alerts of the InPen App do not raise additional questions or concerns for the safety and efficacy of the products that are included in this submission.

6. Conclusions

The subject device is considered substantially equivalent to the predicate device, as demonstrated by verification and validation data while maintaining the same intended use, technological characteristics, and principles of operation.

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).