Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog.

Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetesrelated healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, and evaluation of patient data in order to support effective diabetes management.

Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice.

Insulia Diabetes Management Companion intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols.

Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Device Description

Insulia Diabetes Management Companion is a mobile and web-based diabetes management system for adult type 2 diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components:

A mobile medical application for use by patients on commercially available smartphones (iPhones and Android phones) and tablets.
A web-based application for use by patients in their home on their personal computer and on their mobile device, or by HCPs in professional healthcare settings through a compatible web browser on a personal computer.
A secure database hosted in a private cloud environment and used to securely store patient data.

Insulia Diabetes Management Companion provides secure capture, storage and transmission of blood glucose data and other diabetes-related healthcare information to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management.

Insulia Diabetes Management Companion includes a Basal Calculator intended to provide directions to the patient in response to blood glucose measurements and other diabetesrelated events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments. The guidance is similar to the directions provided to patients as a part of routine clinical practice.

Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values.

Insulia Diabetes Management Companion is only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, insulin degludec (Tresiba® U-100) once daily, and insulin glargine (Basaglar® U-100, Lantus® U-100, Semglee® U-100, Toujeo® U-300) once daily.

Insulia should not be used for:

basal dose recommendations for intermediate-acting insulin (NPH - Neutral Protamine Hagedorn);
premixed insulin

Insulia should not be used in the following populations:

pregnant women;
non-adult patients;
patients that are treated with a basal-plus or a basal-bolus regimen (i.e multiple mealtime insulin injections per day or insulin pump therapy)

AI/ML Overview

The provided text is a 510(k) summary for the Insulia Diabetes Management Companion, specifically addressing a modification to the device (K202596), which is the addition of compatibility with Semglee® (Glargine U-100) insulin. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K172177).

Crucially, the provided text does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria in the typical sense of a performance study with quantitative results (e.g., sensitivity, specificity, accuracy). Instead, it references general design control processes, risk management, and verification/validation testing without providing the numerical results or the specific methodology of such tests.

The information primarily describes the device, its intended use, and argues for its substantial equivalence to a predicate device based on similar intended use and technological characteristics, with the minor modification (Semglee compatibility) not raising new safety or effectiveness concerns.

Therefore, many of the requested points in your prompt cannot be directly answered from the provided text. However, I will extract and infer what information is available:

Device: Insulia Diabetes Management Companion (K202596)

Purpose of the study (as described here): To demonstrate substantial equivalence of the modified device (adding Semglee® compatibility) to the predicate device (K172177). The document implies that the "performance data" refers to verification and validation testing to ensure the modification does not negatively impact the device's functionality.

1. Table of acceptance criteria and the reported device performance:

The document does not provide a quantitative table of acceptance criteria (e.g., target accuracy, sensitivity, specificity for the basal calculator/insulin dose recommendations) or corresponding reported performance metrics. It generally states that "Design verification and validation testing on the modification of Insulia Diabetes Management Companion demonstrated that the device meets the performance requirements for its intended use" and "the data demonstrate that the new device is substantially equivalent to the predicate device."

Without specific numerical criteria or results, a table as requested cannot be constructed from this document. The "performance requirements" are not explicitly defined in terms of metrics.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not explicitly stated. The document refers to "Design verification and validation testing" but does not give details on cohort size, number of cases, or data points used in these tests.
Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to "risk assessment," "risk analysis," and "Failure Mode Effect and Analysis" (FMEA) as part of design control, but these are processes, not data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not specified.
Qualifications of experts: Not specified. The document mentions "a multidisciplinary team" conducting the risk assessment, which implies experts, but their number and specific qualifications (e.g., cardiologists, neurologists, imaging specialists, years of experience) are not detailed.

4. Adjudication method for the test set:

Adjudication method: Not specified. Given the lack of detail on the test set itself, no adjudication method (e.g., 2+1, 3+1) is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC study: Not mentioned or implied. The device is a "basal calculator intended to provide direction to the patient" and a "diabetes management system." It's not an imaging AI device that assists human readers in diagnosis. Therefore, an MRMC study is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The document implies that the "basal calculator" algorithm itself was subject to "verification and validation testing." It states that "The basal insulin calculator is unchanged as compared to the predicate device, i.e. the calculation rules are the same." The modification was only about compatibility with a new insulin type (Semglee®). Therefore, the calculation logic itself would have been tested previously for the predicate device, and the current submission likely focused on verifying its continued correct operation with the new compatible insulin type and ensuring the system as a whole functions as intended. However, specific details of such standalone testing (metrics, results) are not provided in this summary.

7. The type of ground truth used:

For a basal insulin calculator, ground truth would typically refer to physiologically correct insulin dose recommendations or patient outcomes based on those recommendations. The document states the device provides "directions...similar to the directions provided to patients as a part of routine clinical practice" based on a "pre-planned treatment program from a healthcare professional." This suggests the ground truth for evaluating the calculator's outputs would be adherence to established medical guidelines or physician-prescribed treatment plans, potentially validated by clinical experts or simulation models. However, the specific method for establishing this "ground truth" for testing is not detailed.

8. The sample size for the training set:

Given that the device uses a "basal calculator" with "calculation rules," it's more likely based on deterministic algorithms derived from medical guidelines and pharmacokinetics rather than a machine learning model that requires a training set in the typical sense. The document does not mention any "training set." If any part of the device involved machine learning (unlikely for a basal calculator of this description), no information on a training set size is provided.

9. How the ground truth for the training set was established:

As no training set is mentioned (see point 8), this question is not applicable based on the provided text. The "ground truth" for the basal calculator's logic would be established by clinical consensus, medical literature, and expert input that defined the "pre-planned treatment program" and "calculation rules."

Summary

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June 4, 2021

Voluntis, S.A. Kevin Howard Director, Quality Assurance and Regulatory Affairs 22 Quai Gallieni Suresnes, 92150 France

Re: K202596

Trade/Device Name: Insulia Diabetes Management Companion Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: November 9, 2020 Received: November 27, 2020

Dear Kevin Howard:

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 (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 located 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.

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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

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,

Kellie Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202596

Device Name Insulia Diabetes Management Companion

Indications for Use (Describe)

Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog.

Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

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)

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Image /page/3/Picture/0 description: The image shows the Voluntis logo. The logo consists of a blue circle with a white bird-like shape inside, and a yellow dot in the upper right corner. To the right of the circle is the word "VOLUNTIS" in blue, and below that is the phrase "Connected Therapeutics" in a smaller, lighter blue font.

510(K) SUMMARY 5

K202596

[per 21 CFR 807.92]

Submitter Information 5.1

Name:	Voluntis S.A.
Address:	58, avenue de Wagram75017 Paris, France
Phone:	+33 141 383 920
Fax:	+33 141 383 926
Contact Name:	Raffi Krikorian
Date of summary:	September 2, 2020

5.2	Subject Device	Trade Name:	Insulia Diabetes Management Companion
		Common Name:	Diabetes Management Software
		Regulation Number:	21 CFR 868.1890
		Regulation Name:	Predictive pulmonary-function value calculator
		Regulatory Class:	II
		Product Code:	NDC
		Classification Panel:	General Hospital

5.3 Predicate Trade Name: Insulia Diabetes Management Companion Device 510(k) Reference: K172177, concurrence received on November 7, 2017 Common Name: Diabetes Management Software Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: II NDC Product Code: Classification Panel: General Hospital

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Image /page/4/Picture/0 description: The image shows the Voluntis logo. The logo consists of a blue circle with a white bird-like shape inside, and a small yellow circle in the upper left corner. To the right of the circle is the word "VOLUNTIS" in blue, and below that is the phrase "Connected Therapeutics" in a smaller, lighter blue font.

5.4 Device Description

트 A mobile medical application for use by patients on commercially available smartphones (iPhones and Android phones) and tablets.
. A web-based application for use by patients in their home on their personal computer and on their mobile device, or by HCPs in professional healthcare settings through a compatible web browser on a personal computer.
I A secure database hosted in a private cloud environment and used to securely store patient data.

Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values.

Insulia should not be used for:

. basal dose recommendations for intermediate-acting insulin (NPH - Neutral Protamine Hagedorn);
premixed insulin ●

Insulia should not be used in the following populations:

pregnant women;
non-adult patients;
patients that are treated with a basal-plus or a basal-bolus regimen (i.e multiple mealtime insulin injections per day or insulin pump therapy)

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Image /page/5/Picture/0 description: The image is a company logo for Voluntis Connected Therapeutics. The logo features a blue circle with a white bird-like shape inside, along with the company name in blue text. Below the company name, the words "Connected Therapeutics" are written in a smaller, lighter blue font.

ર.ર Indications for Use

Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog.

Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes-related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management.

Insulia Diabetes Management Companion includes software intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols.

Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

5.6 Comparison to the Predicate Device

The subject device is a modified version of the already cleared predicate device Insulia Diabetes Management Companion. A comparison of key similarities and differences between the subject device and the predicate device is provided in Table 5.1.

Feature	Modified Subject DeviceInsulia DiabetesManagement Companion	Cleared Predicate DeviceInsulia DiabetesManagement Companion(K172177)	Comparison
General Characteristics
RegulationNo.	21 CFR 868.1890	21 CFR 868.1890	Same
Device Class	Class II	Class II	Same
Product Code	NDC	NDC	Same
Environmentof Use	Home and ProfessionalHealthcare settings	Home and ProfessionalHealthcare settings	Same
Intended User	HCPs and their adult type 2diabetes patients	HCPs and their adult type 2diabetes patients	Same

Table 5.1: List of the key similarities and differences between the subject device and the predicate device

PrescriptionUse	Yes	Yes	Same
Technological Characteristics
Components	Software only, patientmobile based application,patient and HCP web-basedapplication	Software only, patientmobile based application,patient and HCP web-basedapplication	Same
TreatmentGuidance	Adjustments to insulin doseswithin the scope of a pre-planned, physician-specifiedtreatment program similar toroutine clinical practice	Adjustments to insulin doseswithin the scope of a pre-planned, physician-specifiedtreatment program similar toroutine clinical practice	Same
Type ofCalculatedInsulin	Basal Insulin	Basal Insulin(long-acting analog)
CompatibleLong-ActingInsulinAnalogs	Lantus® (Glargine U-100)Levemir® (Detemir U-100)Toujeo® (Glargine U-300)Basaglar® (Glargine U-100)Tresiba® (Degludec U-100)Semglee® (Glargine U-100)	Lantus® (glargine U-100)Toujeo® (glargine U-300)Levemir® (detemir U-100)Basaglar® (Glargine U-100)Tresiba® (Degludec U-100)	Modified device iscompatible withSemglee® (GlargineU-100) in additionto the insulinanalogs that arecompatible withthe cleared device
Manual DataEntry	Yes	Yes	Same
Logbook	Yes	Yes	Same
PersonalHealth Record	Yes	Yes	Same
Reports &Statistics	Yes	Yes	Same
CoachingMessages	Yes	Yes	Same
SecureDatabase	On computer media	On computer media	Same
Data Transfer	Public Internet	Public Internet	Same

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Image /page/6/Picture/0 description: The image shows the Voluntis logo. The logo consists of a blue circle with a white bird-like shape inside, along with the company name "VOLUNTIS" in blue, and the tagline "Connected Therapeutics" in a smaller, lighter blue font. The logo is clean and modern, suggesting a focus on innovation and technology in the healthcare sector.

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Image /page/7/Picture/1 description: The image shows the Voluntis logo. The logo consists of a blue circle with a white bird and a yellow dot inside. To the right of the circle is the word "VOLUNTIS" in blue, with the words "Connected Therapeutics" in a smaller font below.

Insulia Diabetes Management Companion has the same intended use and the same indications for use statement as the predicate device.

The subject device's technological characteristics are identical to those of the predicate device, i.e. both include software applications that provide secure capture, storage, transmission and display of blood glucose data as well as other diabetes related healthcare information.

Insulia Diabetes Management Companion and the predicate device provide directions which are similar to directions that physicians provide to patients as part of routine clinical practice. Both devices provide directions within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions provide to patients as part of routine clinical practice. The basal insulin calculator is unchanged as compared to the predicate device, i.e. the calculation rules are the same. The modification of the Insulia Diabetes Management Companion effecting compatibility with Semglee® (Glargine U-100) does not change the device's intended use nor its technological characteristics.

Therefore, the modified device subject of this Special 510(k) submission is substantially equivalent to Insulia Diabetes Management Companion (K172177).

5.7 Performance Data Demonstrating Substantial Equivalence

All product development activities were performed in compliance with the Design Control requirements per 21 CFR 820.30.

The risk management activities were conducted in accordance with FDA recognized consensus standard ISO 14971 (FDA recognition number 5-40). A risk assessment was conducted by a multidisciplinary team to assess the impact of the modifications on the device. A risk analysis according to the "Risk Reduction Principle" laid down in ISO 14971 was carried out for the subject device. Possible hazards and consequences were systematically identified and evaluated by using a "Failure Mode Effect and Analysis" technique. Where appropriate, adequate mitigation measures related to the risks that cannot be eliminated have been implemented.

Design verification and validation testing on the modification of Insulia Diabetes Management Companion demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the new device is substantially equivalent to the predicate device.

5.8 Conclusion

Insulia Diabetes Management Companion has the same indications for use, the same intended use, and similar technological characteristics as those of the predicate device. The modifications brought to the device have been analyzed in terms of risks and addressed through performance testing, which demonstrates that Insulia Diabetes Management Companion meets its intended use. Any technological differences between Insulia Diabetes Management Companion and the predicate device (K172177) do not raise any new issues of safety or effectiveness.

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Image /page/8/Picture/0 description: The image shows the Voluntis logo. The logo features a blue circle with a white bird-like shape inside, along with the company name "VOLUNTIS" in blue, bold letters. Below the company name, the tagline "Connected Therapeutics" is written in a smaller, lighter font.

In conclusion, the subject device is substantially equivalent to Insulia Diabetes Management Companion (K172177).

Regulation Number and Section

§ 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).