Insulia Diabetes Management Companion

K202596 · Voluntis Sa. · NDC · Jun 4, 2021 · Anesthesiology

Device Facts

• Record ID: K202596
• Device Name: Insulia Diabetes Management Companion
• Applicant: Voluntis Sa.
• Product Code: NDC · Anesthesiology
• Decision Date: Jun 4, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

Indications for Use

The Insulia Diabetes Management Companion is a prescription-only software intended for use by healthcare professionals and their adult patients with type 2 diabetes. The device is intended to provide insulin dose recommendations for patients treated with basal insulin. The device is intended to be used as an aid in the management of type 2 diabetes.

Device Story

Mobile and web-based diabetes management system; supports adult type 2 diabetes patients and HCPs. Inputs: blood glucose measurements and diabetes-related health events. Processing: basal calculator provides insulin dose adjustment guidance based on pre-planned, physician-specified treatment programs; provides educational coaching messages. Outputs: insulin dose directions, reports, graphs, and statistics. Used in home or professional settings via smartphones, tablets, or PCs. Data stored in secure private cloud. HCPs review data to support diabetes management; patients use guidance for routine insulin adjustments. Benefits: facilitates adherence to physician-prescribed treatment plans and improves data management.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of the software modification to include compatibility with insulin glargine Semglee.

Technological Characteristics

Software-only system; mobile app (iOS/Android) and web-based application. Connectivity via public internet to private cloud database. Basal calculator uses rule-based logic derived from physician-specified treatment programs. Compatible with long-acting insulin analogs (Glargine, Detemir, Degludec).

Indications for Use

Indicated for type 2 adult diabetes patients treated with long-acting insulin analogs (Lantus, Levemir, Toujeo, Basaglar, Tresiba, Semglee). Contraindicated for pregnant women, non-adults, and patients on basal-plus, basal-bolus, or insulin pump therapy.

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

• Insulia Diabetes Management Companion (K172177)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K202596

B Applicant

Voluntis, S.A.

C Proprietary and Established Names

Insulia Diabetes Management 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 |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: Insulia Diabetes Management Companion (K172177).
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was for:

- The addition of insulin glargine Semglee® to the list of long-acting insulin analogs compatible with the device.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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