(120 days)
No
The description focuses on a rule-based system where a healthcare professional programs patient-specific parameters. There is no mention of the software learning or adapting based on data, which is characteristic of AI/ML.
Yes
The device is indicated for the "management of diabetes" by calculating insulin doses or suggesting carbohydrate intake, which directly addresses a health condition.
No
The device calculates insulin doses or suggests carbohydrate intake based on user-entered data, which is a therapeutic function for managing diabetes, rather than diagnosing a condition. Its function is to manage diabetes, not to identify its presence or severity.
Yes
The device description explicitly states that Insulia Bolus Companion includes three components: a mobile application, a web-based application, and a secure database. All of these components are software-based and there is no mention of any accompanying hardware that is part of the regulated medical device itself. While it runs on commercially available smartphones and computers, these are not considered part of the medical device.
Based on the provided information, the Insulia Bolus Companion is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves analyzing biological samples like blood, urine, or tissue.
- Insulia Bolus Companion's Function: The Insulia Bolus Companion's primary function is to calculate insulin doses or suggest carbohydrate intake based on user-entered data (blood glucose measurements, meals, etc.). It does not perform any analysis on biological specimens in vitro.
- Input Data: The input data for the Insulia Bolus Companion comes from the user entering information, not from the device analyzing a biological sample.
- Intended Use: The intended use is for the management of diabetes by providing dose suggestions and monitoring, not for diagnosing a condition or analyzing a biological sample.
While the device uses blood glucose measurements as input, it doesn't perform the blood glucose measurement itself (which is typically done by a separate IVD device like a blood glucose meter). The Insulia Bolus Companion takes the result of that measurement as input for its calculations.
Therefore, the Insulia Bolus Companion falls under the category of a medical device used for diabetes management, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
NDC
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 is for prescription use and is not for over-the-counter sale.
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 preplanned 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.
An HCP can only start using Insulia Bolus Companion after having been registered by the Manufacturer or the delegate field-support team.
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
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
adults
Intended User / Care Setting
HCPs and their diabetes patients. Home and Professional Healthcare settings.
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)
Design verification and validation testing on Insulia Bolus 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 devices.
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in a way that "FDA" is larger and above the rest of the text.
December 12, 2023
Voluntis SA. Kevin Howard Associate VP, Quality Assurance and Regulatory Affairs, U.S. 22 quai Gallieni Suresnes. 92150 France
Re: K232451
Trade/Device Name: Insulia Bolus Companion Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: July 27, 2023 Received: August 14, 2023
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 (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" (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).
1
Your device is also subject to, among other requirements, the Quality System (OS) 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 QS 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.
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.
For comprehensive regulatory information about mediation-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
2
Indications for Use
510(k) Number (if known)
Device Name Insulia Bolus Companion
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the Voluntis logo. The logo features a blue circle with a white bird-like figure inside, along with a yellow dot. To the right of the circle, the word "VOLUNTIS" is written in a bold, blue font. Below "VOLUNTIS", the words "Connected Therapeutics" are written in a smaller, lighter blue font.
5 510(K) SUMMARY - K232451
[per 21 CFR 807.92]
5.1 Submitter Information
| Name: | Voluntis S.A. |
|---|---|
| Address: | 58, avenue de Wagram |
| 75017 Paris | |
| FRANCE | |
| Phone: | +33 141 383 920 |
| Fax: | +33 141 383 926 |
| Contact Name: | Raffi Krikorian |
Date of summary: December 8, 2023
5.2 Device
| Trade name: | Insulia Bolus Companion |
|---|---|
| Common name: | Diabetes Management Software |
| Classification name: | Predictive pulmonary-function value calculator |
| Product Code: | NDC |
| Regulation number: | 21 CFR 868.1890 |
| Device Class: | II |
5.3 Identification of Predicate Device
- InPen Dose Calculator (K190487) O
- This predicate has not been subject to a design-related recall O
5.4 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 is for prescription use and is not for over-the-counter sale.
4
Image /page/4/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 text "VOLUNTIS" in blue, and the text "Connected Therapeutics" in a smaller, lighter font below it. The logo is clean and modern, suggesting a company focused on innovation and technology in the healthcare sector.
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 preplanned 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.
An HCP can only start using Insulia Bolus Companion after having been registered by the Manufacturer or the delegate field-support team.
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
Indications for Use ર્સ્ડ
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.
5.6 Comparison to Predicate Device
A comparison of Insulia Bolus Companion to the predicate device is provided in Table 5.1. This table lists the key similarities and differences between Insulia Bolus Companion and the predicate device.
5
Image /page/5/Picture/0 description: The image shows the logo for Voluntis Connected Therapeutics. The logo consists of a blue circle with a white figure inside, and the text "VOLUNTIS" in blue, with the words "Connected Therapeutics" in gray underneath. The logo is simple and modern, and it conveys a sense of connection and innovation.
| Feature | Insulia Bolus Companion | InPen Dose Calculator (K190487) |
|---|---|---|
| Regulation No. | 21 CFR 868.1890 | 21 CFR 868.1890 |
| Device Class | Class II | Class II |
| Product Code | NDC | NDC |
| Environment of | ||
| Use | Home and Professional Healthcare | |
| settings | Not specified | |
| Intended User | HCPs and their diabetes patients | People with diabetes and their HCP |
| when providing patient-specific fixed | ||
| doses/meal sizes to be programmed | ||
| into the software prior to use | ||
| Prescription Use | Yes | Yes |
| Components | Software only, patient mobile-based | |
| application, HCP web-based | ||
| application | Software only, patient mobile-based | |
| application | ||
| Treatment | ||
| Guidance | Adjustments to insulin doses based | |
| on physician-specified, patient- | ||
| specific treatment parameters to | ||
| be programmed into the software | Adjustments to insulin doses based | |
| on physician-specified, patient- | ||
| specific treatment parameters to be | ||
| programmed into the software | ||
| Type of Calculated | ||
| Insulin | Bolus Insulin | Bolus Insulin |
| Supported Insulins | Rapid acting or short acting insulin | |
| products | NovoLog® U-100 | |
| Humalog® U-100 | ||
| Fiasp® U-100 | ||
| Manual Data Entry | Yes | Yes |
| Digital Logbook | Yes | Yes |
| Trends & Statistics | Yes | Yes |
Table 5.1: List of the key similarities and differences between Insulia Bolus Companion and the predicate device
Insulia Bolus Companion has the same intended use as the predicate device in that both devices are software applications intended for patients as an aid in the management of diabetes through automated self-management, based on a provider pre-planned treatment program. Furthermore, the proposed indications for use for the subject device are similar to
6
and consistent with those of the predicate devices, and do not raise different questions of safety or effectiveness.
Insulia Bolus Companion's technological characteristics are similar to and consistent with those of the predicate device, i.e., both are software applications that provide data collection, storage, transmission, analysis and reporting of self-management data to help patients and their healthcare providers manage the patient's condition. Both devices include an advisor function that computes bolus insulin dose suggestions for consideration by the patient in response to user-entered measurements and relevant health events. In both devices, recommendations are made within the scope of a regimen prescribed by the physician using rules that are part of routine clinical practice and are based on evidence-based standards of care.
Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Therefore, Insulia Bolus Companion is substantially equivalent to the predicate device.
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: 2019 (FDA recognition number 5-125). 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 Insulia Bolus 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 devices.
5.8 Conclusion
Insulia Bolus Companion has similar indications for use, the same intended use, and substantially equivalent technological characteristics as those of the predicate device. The differences in technological characteristics have been analyzed and addressed through performance testing, which demonstrate that Insulia Bolus Companion meets its intended use. Any technological differences between Insulia Bolus Companion and the predicate devices do not raise any new issues of safety or effectiveness. Furthermore, performance testing has demonstrated that Insulia Bolus Companion performs as intended and is substantially equivalent to the predicate device.
In summary, Insulia Bolus Companion is substantially equivalent to the predicate device.