(105 days)
Not Found
No
The description of the "Basal Calculator" indicates it provides directions "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." This suggests a rule-based or algorithmic approach based on pre-defined clinical guidelines rather than a system that learns and adapts from data, which is characteristic of AI/ML. There is no mention of AI, ML, or training/test data sets.
No
The device aids in data management, displays reports, and provides directions for insulin adjustments, but it is not intended to replace professional care, diagnosis, or treatment. It supports effective diabetes management, rather than directly treating the condition like a therapeutic device would.
No
The device is explicitly stated as "not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment." Its function is to aid in the review and evaluation of patient data and support effective diabetes management, rather than to make a diagnosis itself.
Yes
The device description explicitly states it is a "mobile and web based diabetes management system" with components being a "mobile medical application," a "web-based application," and a "secure database." It runs on "commercially available mobile platforms, personal computers," and uses "generally available networks and communication protocols." There is no mention of proprietary hardware or hardware components included with the device. The performance studies focus on software verification and validation.
Based on the provided text, the Insulia Diabetes Management Companion is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
- Insulia's Function: Insulia's primary functions are:
- Securely capturing, storing, and transmitting diabetes-related healthcare information (like blood glucose data).
- Displaying reports and graphs of this data.
- Providing a basal insulin calculator to guide patients on insulin adjustments based on their blood glucose and health events, within a pre-planned treatment program from an HCP.
- Providing educational coaching messages based on blood glucose values.
Insulia works with data that is already generated by the patient (e.g., blood glucose readings from a separate device). It does not perform any tests or analyses on biological specimens itself. Its purpose is to manage and interpret existing data to support diabetes management and guide insulin adjustments, not to diagnose or monitor conditions through in vitro testing.
N/A
Intended Use / 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, 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.
Product codes
NDC
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 diabetes related 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, and insulin glargine (Lantus® U-100, and Toujeo® U-300) once daily.
Insulia Diabetes Management Companion is not to be used by patients using NPH (Neutral Protamine Hagedorn) insulin and premixed insulin.
Insulia Diabetes Management Companion is not to be used by patients treated with a basal plus or a basal-bolus regimen (i.e. including multiple mealtime regular or rapid-acting insulin injections per day or insulin pump therapy).
Insulia Diabetes Management Companion is not to be used during pregnancy nor by non-adult patients.
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
Adult
Intended User / Care Setting
healthcare professionals (HCPs) and their type 2 adult diabetes patients / in the home or in 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)
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 5-70). A risk assessment was conducted by a multidisciplinary team to assess the impact of the modifications on the device and concluded that only the modification pertaining to the inclusion of Toujeo® in the list of supported insulins may induce possible faulty conditions that might lead to possible hazards for the patients. 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 results of the software verification and validation documented in accordance with FDA's Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005), were provided and demonstrate that the device meets the performance requirements for its intended use, and supports substantial equivalence.
The data demonstrate that the new device is substantially equivalent to the predicate device.
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/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three faces in profile, one behind the other. The seal is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2017
Voluntis S.a. Raffi Krikorian Vice President, Ouality Assurance & Regulatory Affairs 58. Avenue De Wagram Paris. 75017 FR
Re: K170669
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: May 25, 2017 Received: May 26, 2017
Dear Raffi Krikorian:
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. 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 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S6
Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170669
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 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, 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.
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 circular graphic on the left and the word "VOLUNTIS" in blue on the right. Below the word "VOLUNTIS" is the phrase "Connected Therapeutics" in a smaller font size.
ഗ 510(K) SUMMARY
[per 21 CFR 807.92]
K170669
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: June 19, 2017
| 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
| Device | ||
|---|---|---|
| Trade Name: | Insulia Diabetes Management Companion | |
| 510(k) Reference: | K161433, concurrence received on November 9, | |
| 2016 | ||
| 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 |
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Image /page/4/Picture/0 description: The image shows the logo for Voluntis Connected Therapeutics. The logo consists of a blue circle with a white arrow pointing upwards and to the right. The word "VOLUNTIS" is written in blue capital letters to the right of the circle. Below the word "VOLUNTIS" is the phrase "Connected Therapeutics" in a smaller, lighter font.
5.4 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 diabetes related 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, and insulin glargine (Lantus® U-100, and Toujeo® U-300) once daily.
Insulia Diabetes Management Companion is not to be used by patients using NPH (Neutral Protamine Hagedorn) insulin and premixed insulin.
Insulia Diabetes Management Companion is not to be used by patients treated with a basal plus or a basal-bolus regimen (i.e. including multiple mealtime regular or rapid-acting insulin injections per day or insulin pump therapy).
Insulia Diabetes Management Companion is not to be used during pregnancy nor by non-adult patients.
ર.5 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.
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Image /page/5/Picture/1 description: The image shows the logo for Voluntis Connected Therapeutics. The logo consists of a blue circle with a white arrow pointing upwards and to the right. The word "VOLUNTIS" is written in blue capital letters to the right of the circle. Below the word "VOLUNTIS" is the phrase "Connected Therapeutics" in a smaller, lighter blue font.
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 a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a preplanned 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 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 Cleared 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 Device
Insulia Diabetes
Management Companion | Cleared Predicate Device
Insulia Diabetes
Management Companion
(K161433) | Comparison |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Regulation
No. | 21 CFR 868.1890 | 21 CFR 868.1890 | Same |
| Device Class | Class II | Class II | Same |
| Product Code | NDC | NDC | Same |
| Environment
of Use | Home and Professional
Healthcare settings | Home and Professional
Healthcare settings | Same |
| Intended User | HCPs and their adult type 2
diabetes patients | HCPs and their adult type 2
diabetes patients | Same |
| Prescription
Use | Yes | Yes | Same |
| Technological Characteristics | | | |
| Components | Software only, patient
mobile based application,
patient and HCP web-
based application | Software only, patient
mobile based application,
patient and HCP web-based
application | Same |
| Treatment
Guidance | Adjustments to insulin
doses within the scope of a
pre-planned, physician-
specified treatment
program similar to routine
clinical practice | Adjustments to insulin
doses within the scope of a
pre-planned, physician-
specified treatment
program similar to routine
clinical practice | Same |
| Type of
Calculated
Insulin | Basal Insulin
(long-acting analog) | Basal Insulin
(long-acting analog) | Same |
| Compatible
Long-Acting
Insulin
Analogs | Lantus® (glargine U-100)
Toujeo® (glargine U-300)
Levemir® (detemir U-100) | Lantus® (glargine U-100)
Levemir® (detemir U-100) | Modified device is
compatible with
Toujeo® (insulin
glargine U-300) in
addition to the insulin
analogs that are
already compatible
with the cleared
device. |
| Manual Data
Entry | Yes | Yes | Same |
| Logbook | Yes | Yes | Same |
| Personal
Health Record | Yes | Yes | Same |
| Reports &
Statistics | Yes | Yes | Same |
| Coaching
Messages | Yes | Yes | Same |
| Secure
Database | On computer media | On computer media | Same |
| Data Transfer | Public Internet | Public Internet | Same |
Table 5.1: List of the key similarities and differences between the subject device and the predicate device
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Image /page/6/Picture/0 description: The image shows the logo for Voluntis, a company that specializes in connected therapeutics. The logo features a stylized blue and white graphic on the left, resembling a bird in flight or an abstract medical symbol. To the right of the graphic is the company name, "VOLUNTIS," in bold, blue sans-serif letters, with the tagline "Connected Therapeutics" in a smaller font size underneath.
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Image /page/7/Picture/1 description: The image shows the logo for Voluntis, a company that specializes in connected therapeutics. The logo consists of a blue circular graphic with a white arrow pointing upwards and to the right, along with the company name "VOLUNTIS" in blue, bold letters. Below the company name, the words "Connected Therapeutics" are written in a smaller, lighter font.
Insulia Diabetes Management Companion has the same intended use and the same indications for use statement as the predicate device.
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 physicians 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 Toujeo® does not change the device's intended use, and this modified technical characteristic does not raise different questions of safety and effectiveness.
Therefore, the modified device subject of this Traditional 510(k) submission is substantially equivalent to Insulia Diabetes Management Companion (K161433).
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 5-70). A risk assessment was conducted by a multidisciplinary team to assess the impact of the modifications on the device and concluded that only the modification pertaining to the inclusion of Toujeo® in the list of supported insulins may induce possible faulty conditions that might lead to possible hazards for the patients. 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 results of the software verification and validation documented in accordance with FDA's Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005), were provided and demonstrate that the device meets the performance requirements for its intended use, and supports substantial equivalence.
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
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Image /page/8/Picture/0 description: The image shows the Voluntis logo. The logo consists of a blue circle with a white arrow inside, followed by the word "VOLUNTIS" in blue, and the words "Connected Therapeutics" in a smaller font below. The logo is clean and modern, and the colors are simple and professional.
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 (K161433) do not raise any new issues of safety or effectiveness.
In summary, the subject device is substantially equivalent to Insulia Diabetes Management Companion (K161433).