InPen Dose Calculator

K190487 · Companion Medical, Inc. · NDC · Feb 18, 2020 · Anesthesiology

Device Facts

• Record ID: K190487
• Device Name: InPen Dose Calculator
• Applicant: Companion Medical, Inc.
• Product Code: NDC · Anesthesiology
• Decision Date: Feb 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

Indications for Use

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. The device is indicated for use with NovoLog® or Humalog® U-100 insulin. 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 professional must provide patient-specific fixed doses/ meal sizes to be programmed into the software prior to use.

Device Story

InPen app component; manages wireless insulin dose data transfer; logs insulin data; provides dose calculator for MDI therapy patients. Inputs: user-entered carbohydrate amounts or meal sizes; programmed clinical parameters (target glucose, insulin-to-carbohydrate ratio, insulin sensitivity). Operation: calculates insulin doses for meals/corrections; accounts for insulin-on-board (IOB) to mitigate stacking. Output: recommended insulin dose. Used by patients (age 12+) in home/clinic settings. Healthcare providers program parameters. Output assists patient in determining insulin bolus; reduces risk of insulin stacking; improves diabetes management.

Clinical Evidence

No clinical trials; bench testing and usability evaluation only. Summative usability evaluation with patients demonstrated ability to perform critical tasks after self-training without critical errors. Hazard analysis performed per ISO 14971. Dose calculation logic validated against standard clinical approaches and published insulin action duration studies (Mudaliar et al., 1999).

Technological Characteristics

Software-based insulin dose calculator integrated into a mobile app. Communicates via Bluetooth with a manual pen injector. Operates in three modes: carb counting, meal estimation, and fixed dosing. Requires HCP-programmed patient-specific parameters. Complies with IEC 60601-1-6 (usability) and ISO 14971 (risk management).

Indications for Use

Indicated for management of diabetes in patients age 12 and older undergoing multiple daily injection (MDI) therapy. Compatible with NovoLog or Humalog U-100 insulin. Requires HCP-programmed parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity, or fixed doses/meal sizes).

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 (K160629)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K190487

B Applicant

Companion Medical, Inc.

C Proprietary and Established Names

InPen Dose Calculator

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NDC | Class II | 21 CFR 868.1890 - Predictive Pulmonary-Function Value Calculator | Clinical Chemistry (75) |

## II Submission/Device Overview:

A Purpose for Submission:

Addition of new functionality to an existing bolus dose calculator for an existing device.

B Type of Test:

Insulin dose (bolus) calculation.

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) for Use:

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. The device is indicated for use with NovoLog® or Humalog® U-100 insulin.

For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.

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

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

For use with the InPen System only.

The insulin dose calculations provided by this device are meant for patients undergoing multiple daily injection (MDI) therapy.

IV Device/System Characteristics:

A Device Description:

The InPen Dose Calculator is an insulin dosing calculator within the InPen app. The InPen app is used in conjunction with the InPen System, which consists of a manually-controlled pen injector and a smartphone app containing a data logbook and the InPen Dose Calculator. The InPen is a manual pen injector containing a non-replaceable battery and electronics to communicate via Bluetooth with the app on an iOS mobile device. The intended insulin dose of the InPen is manually set by the user by rotating a dose knob. The insulin is injected by manually depressing the dose knob which causes the piston in the insulin cartridge to expel the intended dose. The InPen is provided in two different models for compatibility with Humalog, Novolog, and Fiasp U-100 insulin cartridges.

Prior to use, the HCP (healthcare professional) must provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software. The dose calculator function is locked out from the user until an InPen has been paired with a mobile device and the user's insulin settings have been confirmed.

At initial use, the InPen and mobile device are paired. Once paired, the InPen and app communicate to ensure all doses from InPen have been sent to the app. The database records in the InPen and app are synchronized so that doses made while disconnected from the app, e.g. airplane mode, are updated in the app and incorporated into insulin-on-board (IOB) calculations upon reconnection. Instructions for re-pairing in the event of the user obtaining a new mobile device or a replacement InPen are included in the Instructions for Use.

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The InPen dose calculator includes three modes for determining insulin dose; carb counting mode, meal estimation mode, and fixed dosing mode. Prior to use, the HCP will prescribe the appropriate dosing mode. For a description of the carb counting mode, as well as the algorithm for calculating insulin dose and insulin on board, see k160629. The carb counting mode is the same as was reviewed in the predicate device.

In fixed dosing mode, the InPen dose calculator will provide a fixed dose insulin recommendation at meal times. After choosing your meal, users enter BG for a dose recommendation.

In meal estimation mode, the InPen dose calculator will provide an insulin recommendation based on meal size at meal times. After choosing a meal and meal size, users enter BG for a dose recommendation.

The sponsor provided information only to support the use of NovoLog or Humalog U-100 insulin with the fixed dosing and meal estimation modes of the InPen dose calculator in this submission.

For a table of device characteristics, see "Comparison of Technology to Predicate Devices" below.

B Instrument Description Information:

| Modes of Operation | Yes | No |
| --- | --- | --- |
| Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? | ☑ | ☐ |
| Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? | ☑ | ☐ |
| Software | | |
| FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types. | ☑ | ☐ |

1. Instrument Name:
InPen Dose Calculator

2. Specimen Identification:
Not Applicable.

3. Specimen Sampling and Handling:
Not Applicable.

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4. Calibration:
Not Applicable.

5. Quality Control:
Not Applicable.

## V Substantial Equivalence Information:

A Predicate Device Name(s):
InPen System

B Predicate 510(k) Number(s):
K160629

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K190487 | K160629 |
| --- | --- | --- |
| Device Trade Name | Same | InPen Dose Calculator |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Same | Calculation of insulin dose or carbohydrate intake based on user entered data |
| User group | Same | Diabetes patients treated with multiple daily insulin injection therapy |
| General Device Characteristic Differences | | |
| Dose calculation | Calculation based either on user entered carbohydrates, meal size estimation, or fixed meal doses | Calculation based on user entered carbohydrates |

## VI Standards/Guidance Documents Referenced:

IEC 60601-1-6: Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability, version 3.1

ISO 14971: Medical Devices- Application of risk management to medical devices

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VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:
Not applicable.

2. Linearity:
Not applicable.

3. Analytical Specificity/Interference:
Not applicable.

4. Accuracy (Instrument):
Not applicable.

5. Carry-Over:
Not applicable.

B Other Supportive Instrument Performance Characteristics Data:

The Carb Counting mode for calculating insulin dosage, including the method for determination of insulin on board are unchanged from the predicate device. These features were reviewed in k160629.

Usability:
The sponsor provided protocols and results from human factors testing to demonstrate that users can perform all critical tasks associated with the new device modes (fixed meal and meal estimation dosing). Subjects were representative of the device’s intended use population, including pediatric and adult subjects with both Type 1 and Type 2 diabetes. The results of this study were adequate to demonstrate safe use of the device and support substantial equivalence to the predicate.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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