(60 days)
No
The document describes algorithms for calculating insulin doses and identifying missed doses or rising glucose, but these are based on pre-programmed patient-specific parameters and rules, not on learning from data. The term "algorithms" is used, but there is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML models.
Yes
The device is described as a "Smart Insulin pen" and its purpose is for "the management of diabetes," which indicates a therapeutic use. It helps calculate and recommend insulin doses for individuals with diabetes, directly assisting in their treatment.
No
The device is an insulin pen and accompanying app designed for managing insulin delivery and tracking diabetes-related data. While it calculates insulin doses and monitors glucose trends, its primary function is not to diagnose medical conditions but to assist in the management of an already diagnosed condition (diabetes).
No
The device description explicitly states that the InPen App is a component of the InPen system and is used with the InPen Smart Insulin pen, which is a hardware device. The system includes both software and hardware components.
Based on the provided text, the InPen System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- InPen System Function: The InPen System is a device for delivering insulin and a software application for managing diabetes by calculating insulin doses based on user-entered data (blood glucose, carbohydrates, etc.) and healthcare provider settings. It interacts with the body by delivering insulin, but it does not analyze biological specimens in vitro.
The device description and intended use clearly indicate its function is related to insulin delivery and diabetes management through data tracking and dose calculation, not the analysis of biological samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
NDC, FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Patient aged 7 and older for self-injection, or people with diabetes under the supervision of an adult caregiver.
Intended User / Care Setting
Home-use by people with diabetes under the supervision of an adult caregiver, or by a patient aged 7 and older for self-injection. Healthcare professional (HCP) provides patient-specific parameters for the dose calculator.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 (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
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 ( 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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4
1. 510(k) Summary
1.1. InPen App
| Name of Device | InPen System |
|---|---|
| Common Name | Pen Injector with Dose Calculator |
| Predicate Device | |
| Name and Model ID | InPen™ System (MMT-8060/MMT-8061) |
| Predicate 510(k) | |
| Number | K201337 |
| Classification Name | Class II |
| Piston syringe with Drug Dose Calculator | |
| Product Code | FMF, NDC |
| Classification | |
| Regulation | 21 CFR 868.1890; 21 CFR 880.5860 |
| Manufacturer and | |
| Design Facility | Medtronic MiniMed, Inc. |
| 12230 World Trade Drive, Suite 100 | |
| San Diego, California 92128 | |
| Manufacturing | |
| Facility | Jabil Circuit De Chihuahua |
| Av. Alexandro Dumas 11341 | |
| Complejo Industrial Chihuahua | |
| Chihuahua, MX 31136 | |
| Establishment | |
| Number | 3004060780 |
| Primary Contact | |
| Information | Ty Cowart |
| Senior Principal Regulatory Affairs Specialist | |
| Tel: 678-481-9246 | |
| Email: ty.cowart@medtronic.com | |
| Secondary Contact | |
| Information | Christina Rowe |
| Senior Regulatory Affairs Manager | |
| Tel: (818) 942-4875 | |
| Email: 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
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
Attributes | Predicate Device
InPen System
(K201337) | Subject Device
InPen System | Comparison |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | (Class II - NDC - 21 CFR
§868.1890) | (Class II - NDC - 21 CFR
§868.1890) | Same |
| Indications For
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 | The InPen System is a home-use
reusable pen injector for single-
patient use by people with diabetes
under the | Same |
| InPen App
Attributes | Predicate Device
InPen System
(K201337) | Subject Device
InPen System | Comparison |
| | 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 System 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. | 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 System 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. | |
| Prescription Use | Yes | Yes | Same |
| InPen App
Attributes | Predicate Device
InPen System
(K201337) | Subject Device
InPen System | Comparison |
| User Group | Diabetes patients treated with
multiple daily insulin injection
(MDI) therapy | Diabetes patients treated with
multiple daily insulin injection
(MDI) therapy | Same |
| Communication
with insulin pumps | No | No | Same |
| Software Level of
Concern | Major | Major | Same |
| Wireless
Connectivity | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) | Same |
| Control or affect
glucose
measurements | No | No | Same |
| Control or affect
insulin delivery | No | No | Same |
| Reports, graphs,
and Electronic
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
Calculator | Calculates insulin doses for
meals and corrections while
accounting for insulin on board | Calculates insulin doses for meals
and corrections while accounting
for insulin on
board | Same |
| Carbohydrate
Calculator | Calculates carbohydrate intake
based on user-entered data | Calculates carbohydrate intake
based on user-entered
data | Same |
| Manual Dose Entry | Yes | Yes | Same |
| InPen Dose Entry | Yes | Yes | Same |
| Tracking of
residual bolus
insulin to mitigate
stacking | 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 Cloud
Communication
with Carelink
Cloud to receive
Medtronic CGM
glucose
measurements | Can receive the most recent
CGM glucose measurements
from the Carelink Cloud. The
CGM data can be viewed on the
InPen App for the user and in
therapy reports generated by the
InPen Cloud for the HCP and
the user. | Can receive the Medtronic CGM
sensor glucose measurements in real
time (every 5minutes) from the
Carelink Cloud. Two software
algorithms have been added to the
InPen Cloud that include
computational methods to identify
whether a user has missed an
insulin dose or if
their glucose is rising. If | Addition of two algorithms in
the InPen Cloud (Insulin
Notification Service) to
identify and send a silent
notification to the InPen App.
Two new visual and audible
alerts have been added to the
InPen App to alert the user to
the presence of a missed
insulin dose or when their
glucose level is high. |
| InPen App
Attributes | Predicate Device
InPen System
(K201337) | Subject Device
InPen System | Comparison |
| | | either of these conditions exist, a
silent notification is sent to the
InPen App. The InPen App
confirms the data and is responsible
for providing an audible and visual
alert to the user.
The CGM data can be displayed
and printed in therapy reports by
the HCP and user from the InPen
App and InPen Cloud. | |
| Long-Acting Dose
Reminder | An optional user-enabled alert
which is provided to the user.
User sets a time when their
prescribed Long- Acting Insulin
is taken. If the Long-Acting
Dose is not taken, the App will
present a visual reminder to the
user dose is not taken by the
user. | An optional user-enabled audible
and visual reminder which is
provided to the user. The alert's
status has been changed to allow its
presentation to be active if the phone
volume is turned down or in a Do
Not Disturb Mode. If the Long-
Acting Dose is not taken, the App
will present an audible and visual
reminder to the user. | Improved the existing
Long-Acting Reminder to
include both an audible and
visual alert. |
| Missed Dose Alert | A user enabled missed dose
reminder is currently available
to the user and is a time-based
meal reminder. The user
configures their meal-time
window for each meal type
(breakfast, lunch, dinner). If the
alert is enabled by the user an
alert is supplied if no insulin
dose was logged within the user
set meal-time window. | A user-enabled missed dose alert
(audible and visual) for users of the
InPen System and a Medtronic
CGM. The InPen App will alert the
user when their sensor glucose level
indicates that a missed insulin dose
has occurred.
Non-CGM users or CGM users who
do not enable the alert can choose to
enable and receive the existing
missed dose reminder. | A user enabled Alert added
as an option for users of a
Medtronic CGM. |
| Correct High
Glucose Alert | A user enabled alert that reminds
the user to check their glucose
level 2 hours after a dose and
check their glucose level before
their bedtime. After checking
their glucose and if their glucose
is high, the user can use the dose
calculator to obtain a dose
recommendation. | A user-enabled Correct High alert for
users of the InPen System and a
Medtronic CGM. The InPen App
will alert the user when their glucose
is rising high and is above the default
value of 180 md/dL.
Non-CGM users or CGM users
who do not enable the alert can
choose to enable and receive the
existing reminders to check their | A user enabled Alert added
as an option for users of a
Medtronic CGM. |
| InPen App
Attributes | Predicate Device
InPen System
(K201337) | Subject Device
InPen System | Comparison |
| | | glucose level 2 hours after a
dose and before their
bedtime. | |
7
Medtronic MiniMed
Traditional 510(k)
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Medtronic MiniMed
Traditional 510(k)
9
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.