InPen System App (MMT-8060 (iOS), MMT-8061 (Android))

K242775 · Medtronic Minimed · NDC · Nov 12, 2024 · Anesthesiology

Device Facts

• Record ID: K242775
• Device Name: InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
• Applicant: Medtronic Minimed
• Product Code: NDC · Anesthesiology
• Decision Date: Nov 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

Intended Use

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 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.

Device Story

InPen System comprises smart insulin pen, mobile app (iOS/Android), and cloud platform. System logs insulin doses, calculates mealtime/correction doses, and tracks glucose data. Input: user-entered meal/glucose data, insulin dose data from pen, and real-time CGM data from Carelink Cloud. Operation: app processes inputs via dose calculator (fixed, meal estimation, or carbohydrate counting methods) and provides alerts for missed doses or high glucose. Output: dose recommendations, logbook, and therapy reports. Used in home setting by patients or caregivers. Healthcare providers use reports to adjust therapy parameters. Benefits: improved insulin dosing accuracy and adherence through automated logging and alerts.

Clinical Evidence

No clinical trials performed. Evidence consists of a human factors summative usability evaluation involving adults, caregivers, and pediatric patients to validate the safety and effectiveness of the new alert functionalities. Software regression testing was conducted per FDA guidance to verify system performance.

Technological Characteristics

System includes smart pen, mobile app, and cloud connectivity. Software utilizes rule-based dose calculation algorithms. Connectivity via wireless transfer to app and cloud. Complies with ANSI AAMI ISO 14971:2019 (risk management) and ANSI AAMI IEC 62304:2006/A1:2016 (software lifecycle).

Indications for Use

Indicated for diabetes management in patients aged 7+ or under adult caregiver supervision, undergoing multiple daily injection (MDI) therapy, for insulin dose calculation or carbohydrate intake calculation based on user-entered data.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• InPen™ System (MMT-8060/MMT-8061) (K201337)

Submission Summary (Full Text)

{0}------------------------------------------------

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"

{1}------------------------------------------------

(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.

{2}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{3}------------------------------------------------

#### Indications for Use

510(k) Number (if known) K242775

Device Name InPen System

#### Indications for Use (Describe)

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.

| Type of Use ( <i>Select one or both, as applicable</i> ) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><div> <span> <span style="text-decoration:overline">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> | <div> <span> <span style="text-decoration:overline">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
| <div> <span> <span style="text-decoration:overline">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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 Food and Drug Administration Office of Chief Information Officer 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."

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{4}------------------------------------------------

### 1. 510(k) Summary

#### 1.1. InPen App

| Name of Device | InPen System |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Common Name | Pen Injector with Dose Calculator |
| Predicate Device<br>Name and Model ID | InPen™ System (MMT-8060/MMT-8061) |
| Predicate 510(k)<br>Number | K201337 |
| Classification Name | Class II<br>Piston syringe with Drug Dose Calculator |
| Product Code | FMF, NDC |
| Classification<br>Regulation | 21 CFR 868.1890; 21 CFR 880.5860 |
| Manufacturer and<br>Design Facility | Medtronic MiniMed, Inc.<br>12230 World Trade Drive, Suite 100<br>San Diego, California 92128 |
| Manufacturing<br>Facility | Jabil Circuit De Chihuahua<br>Av. Alexandro Dumas 11341<br>Complejo Industrial Chihuahua<br>Chihuahua, MX 31136 |
| Establishment<br>Number | 3004060780 |
| Primary Contact<br>Information | Ty Cowart<br>Senior Principal Regulatory Affairs Specialist<br>Tel: [phone]<br>Email: [e-mail] |
| Secondary Contact<br>Information | Christina Rowe<br>Senior Regulatory Affairs Manager<br>Tel: [phone]<br>Email: [e-mail] |

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

{5}------------------------------------------------

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.

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

{6}------------------------------------------------

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 App<br>Attributes | Predicate Device<br>InPen System<br>(K201337) | Subject Device<br>InPen System | Comparison |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | (Class II - NDC - 21 CFR<br>§868.1890) | (Class II - NDC - 21 CFR<br>§868.1890) | Same |
| Indications For<br>Use | The InPen System is a home-use<br>reusable pen injector for single-<br>patient use by people with<br>diabetes under the supervision of<br>an adult caregiver, or by a | The InPen System is a home-use<br>reusable pen injector for single-<br>patient use by people with diabetes<br>under the | Same |
| InPen App<br>Attributes | Predicate Device<br>InPen System<br>(K201337) | Subject Device<br>InPen System | Comparison |
| | patient age 7 and older for the<br>self-injection of a desired dose<br>of insulin. The pen injector is<br>compatible with Lilly<br>Humalog® U-100 3.0 mL<br>cartridges, Novo Nordisk<br>Novolog® U-100 3.0 mL<br>cartridges, and Novo Nordisk<br>Fiasp® U-100 3.0 mL cartridges<br>and single-use detachable and<br>disposable pen needles (not<br>included). The pen injector<br>allows the user to dial the<br>desired dose from 0.5 to 30 units<br>in one-half (1/2) unit increments.<br>The InPen System dose<br>calculator, a component of the<br>InPen app, is indicated for the<br>management of diabetes by<br>people with diabetes under the<br>supervision of an adult<br>caregiver, or by a patient age 7<br>and older for calculating an<br>insulin dose or carbohydrate<br>intake based on user entered<br>data.<br>For an insulin dose based on<br>amount of carbohydrates, a<br>healthcare professional must<br>provide patient-specific target<br>blood glucose, insulin-to-<br>carbohydrate ratio, and insulin<br>sensitivity parameters to be<br>programmed into the software<br>prior to use.<br>For an insulin dose based on<br>fixed/variable meal sizes, a<br>healthcare professional must<br>provide patient-specific fixed<br>doses/meal sizes to be<br>programmed into the software<br>prior to use. | supervision of an adult caregiver, or<br>by a patient age 7 and older for the<br>self- injection of a desired dose of<br>insulin. The pen injector is<br>compatible with Lilly Humalog® U-<br>100 3.0 mL cartridges, Novo<br>Nordisk Novolog® U-100 3.0 mL<br>cartridges, and Novo Nordisk<br>Fiasp® U-100 3.0 mL cartridges and<br>single-use detachable and disposable<br>pen needles (not included). The pen<br>injector allows the user to dial the<br>desired dose from 0.5 to 30 units in<br>one-half (1/2) unit increments.<br>The InPen System dose calculator, a<br>component of the InPen app, is<br>indicated for the management of<br>diabetes by people with diabetes<br>under the supervision of an adult<br>caregiver, or by a patient age 7 and<br>older for calculating an insulin dose<br>or carbohydrate intake based on user<br>entered data.<br>For an insulin dose based on amount<br>of carbohydrates, a healthcare<br>professional must provide patient-<br>specific target blood glucose,<br>insulin-to- carbohydrate ratio, and<br>insulin sensitivity parameters to be<br>programmed into the software prior<br>to use.<br>For an insulin dose based on<br>fixed/variable meal sizes, a healthcare<br>professional must provide patient-<br>specific fixed doses/meal sizes to be<br>programmed into the software prior<br>to use. | |
| Prescription Use | Yes | Yes | Same |
| InPen App<br>Attributes | Predicate Device<br>InPen System<br>(K201337) | Subject Device<br>InPen System | Comparison |
| User Group | Diabetes patients treated with<br>multiple daily insulin injection<br>(MDI) therapy | Diabetes patients treated with<br>multiple daily insulin injection<br>(MDI) therapy | Same |
| Communication<br>with insulin pumps | No | No | Same |
| Software Level of<br>Concern | Major | Major | Same |
| Wireless<br>Connectivity | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) | Same |
| Control or affect<br>glucose<br>measurements | No | No | Same |
| Control or affect<br>insulin delivery | No | No | Same |
| Reports, graphs,<br>and Electronic<br>Logbook | Yes | Yes | Same |
| Meal Size Entry | Grams of carbohydrates | Grams of carbohydrates | Same |
| Fixed Dose Setting | Set by User | Set By User | Same |
| Insulin Dose<br>Calculator | Calculates insulin doses for<br>meals and corrections while<br>accounting for insulin on board | Calculates insulin doses for meals<br>and corrections while accounting<br>for insulin on<br>board | Same |
| Carbohydrate<br>Calculator | Calculates carbohydrate intake<br>based on user-entered data | Calculates carbohydrate intake<br>based on user-entered<br>data | Same |
| Manual Dose Entry | Yes | Yes | Same |
| InPen Dose Entry | Yes…