Insulia Bolus Companion

K232451 · Voluntis Sa. · NDC · Dec 12, 2023 · Anesthesiology

Device Facts

• Record ID: K232451
• Device Name: Insulia Bolus Companion
• Applicant: Voluntis Sa.
• Product Code: NDC · Anesthesiology
• Decision Date: Dec 12, 2023
• 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 Insulia Bolus Companion is indicated for the management of diabetes by adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software. This can be done through a dedicated, secured web portal.

Device Story

Prescription software for diabetes management; calculates bolus insulin doses or suggests carbohydrate intake. Inputs: user-entered blood glucose (BG) measurements, meal information, time of day, and past injections. Operation: HCP programs patient-specific parameters (target BG, insulin sensitivity, active insulin duration, max dose) via secure web portal. Patient uses mobile app (iOS/Android) to log data and receive dose suggestions based on pre-planned treatment program. Output: insulin dose recommendation or carbohydrate intake suggestion. Used in home and professional settings. Benefits: provides structured guidance for bolus insulin administration, assisting patients in following HCP-prescribed regimens.

Clinical Evidence

No clinical trials performed. Evidence consists of human factors/usability studies demonstrating that representative subjects (patients >20 years and HCPs) can safely perform critical tasks associated with device features. Software documentation provided per FDA guidance for major level of concern.

Technological Characteristics

Software-only device; mobile application (iOS/Android) and web-based HCP portal. Connectivity via private cloud environment. Operates using rule-based algorithms derived from clinical practice standards. Complies with ISO 14971:2019 for risk management.

Indications for Use

Indicated for management of diabetes in adults. Requires healthcare professional to program patient-specific target blood glucose, insulin doses (fixed/variable meal sizes), and insulin sensitivity parameters.

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 Dose Calculator (K190487)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K232451

B Applicant

Voluntis, S.A.

C Proprietary and Established Names

Insulia Bolus Companion

D Regulatory Information

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

E Purpose for Submission

New device

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

The Insulia Bolus Companion is indicated for the management of diabetes by adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data.

Prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software. This can be done through a dedicated, secured web portal.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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Insulia Bolus Companion should not be used:
- By pregnant people with diabetes
- By people using basal insulin only or premixed insulin
- By healthcare professionals who do not have experience in the treatment of people with diabetes using a basal-bolus insulin regimen

## III Device Description:

Insulia Bolus Companion is a prescription device indicated for the management of diabetes, for adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data; and for healthcare professionals (HCP) having experience in the management of people with diabetes treated with bolus insulin.

Insulia Bolus Companion includes a Bolus Calculator intended to provide direction to the patient in response to blood glucose (BG) and health events, within the scope of a pre-planned treatment program prescribed by their HCP for insulin suggestions. The guidance is similar to the directions provided to patients as a part of routine clinical practice: prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software.

Insulia Bolus Companion includes three components:
- A mobile application for use by people with diabetes on commercially available smartphones (iPhone or Android) and tablets, enabling patients to document BG measurements, meals, and generate dose suggestions for bolus insulin
- A web-based application for use by HCPs in professional healthcare settings through a compatible web browser on a computer, allowing patient inclusion and patient monitoring in-person and by distance
- A secure database hosted in a private cloud environment and used to securely store patient data

## IV Substantial Equivalence Information:

A Predicate Device Name(s):
InPen Dose Calculator

B Predicate 510(k) Number(s):
K190487

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K232451 | K190487 |
| --- | --- | --- |
| Device Trade Name | Insulia Bolus Companion | InPen Dose Calculator |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the management of diabetes by people with diabetes, by calculating | Same |

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| | an insulin dose or suggesting carbohydrates intake based on user entered data. | |
| --- | --- | --- |
| Prescription Use | Yes | Same |
| Intended users | Healthcare providers (HCP) and their Diabetes patients | Same |
| Insulin Dosing Guidance | Prior to use, a HCP must provide patient-specific parameters to be programmed into the software, such as target blood glucose, insulin sensitivity, active insulin duration, and maximum dose. | Same |
| Inputs of Dose recommendation | Blood glucose values, meal information, time of day, past injections | Same |
| Management of low BG values | No titration when BG below 70 mg/dL and recommendation to treat low BG by eating carbs. | Same |
| **General Device Characteristic Differences** | | |
| Patient age | Adults | Age 12 and older |
| Environment of Use | Home and professional healthcare settings | Unspecified |
| User Interface | Patient mobile App and HCP Portal | Patient/HCP mobile App |
| Supported insulins | Rapid acting or short acting insulin products | NovoLog U-100, Humalog U-100, and Fiasp U-100 |
| Meal documentation model | Fixed meal, Meal Estimation | Fixed meal, Meal Estimation, Carb counting |

V Standards/Guidance Documents Referenced:

- ISO 14971: 2019 Medical devices - Application of risk management to medical devices
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
- IEC 62366-1 Edition 1.1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices

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VI Performance Characteristics (if/when applicable):

Usability:
Protocols and results were provided from human factors studies to demonstrate that users can perform all critical tasks associated with the new device features. Subjects were representative of the device’s intended use population, including patients over 20 years of age and healthcare providers. The results of these studies were adequate to demonstrate safe use of the device and support substantial equivalence to the predicate.

Software:
The provided software documentation is consistent with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005), and consistent with software with a major level of concern. Software documentation was acceptable.

VII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.

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

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