(169 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 parameters set by the HCP, rather than a system that learns or adapts from data (AI/ML). There are no mentions of AI, ML, or related concepts in the document.
No
The device aids in managing diabetes by providing information, reports, and a basal calculator for insulin adjustments within a pre-planned treatment program. However, it explicitly states it is "not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment." Therefore, it is a management and support tool rather than a therapeutic device that directly treats.
No
The "Intended Use / Indications for Use" section explicitly states that "Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment." This clarifies that its purpose is not to diagnose. While it aids in the review and evaluation of patient data and provides a basal calculator for insulin adjustments, this is to support effective management under a pre-planned treatment program, not to make a diagnosis.
Yes
The device is described as a mobile and web-based system with mobile and web applications and a secure database, explicitly stating it runs on commercially available platforms and uses generally available networks, without mentioning any proprietary hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of Insulia Diabetes Management Companion focuses on managing diabetes through data capture, storage, transmission, reporting, and providing guidance based on blood glucose measurements and other health events. It does not mention analyzing any biological specimens.
- The intended use and device description clearly outline its function as a diabetes management tool. It helps patients and HCPs track data, visualize trends, and provides guidance for insulin adjustments based on a pre-planned treatment program. This is a software-based system for managing existing data and providing support, not for performing diagnostic tests on samples.
- The predicate devices listed (ACCU-CHEK Connect Diabetes Management App and WellDoc BlueStar) are also diabetes management software/systems, not IVDs. This further supports the classification of Insulia as a similar type of device.
Therefore, while Insulia Diabetes Management Companion is a medical device, it falls under the category of diabetes management software/systems and not In Vitro Diagnostics.
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 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 (comma separated list FDA assigned to the subject device)
NDC
Device Description
Insulia Diabetes Management Companion is a mobile and web based diabetes management system for type 2 adult diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components:
- I 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 not to be used in conjunction with a type of long-acting insulin analog different from insulin glargine (Lantus®) or insulin detemir (Levemir®).
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)
Comprehensive performance testing was conducted on the Insulia Diabetes Management Companion to support a determination of substantial equivalence. The results of the performance testing, including the human factors study results and 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 9, 2016
Voluntis S.A. Raffi Krikorian Vice President, Quality Assurance & Regulatory Affairs 2, Rue Des Bourets 92150 Suresnes FRANCE
Re: K161433
Trade/Device Name: Insulia Diabetes Management Companion Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: October 18, 2016 Received: October 19, 2016
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.
1
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 devicerelated 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 yours,
Tina Kiang -S
Tina Kiang, Ph.D. 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) K161433
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 diabetesrelated healthcare information, to enhance data management, to display reports and graphs, and to aid 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 logo for Voluntis Connected Therapeutics. The logo features a blue circle with a white bird-like shape inside, along with a small yellow dot. To the right of the circle, the word "VOLUNTIS" is written in blue, with the words "Connected Therapeutics" in a smaller, lighter font below it.
510(K) SUMMARY 5
[per 21 CFR 807.92]
Submitter Information 5.1
| 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: November 8, 2016
| 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
| Devices | Primary | |
|---|---|---|
| Trade Name: | ACCU-CHEK Connect Diabetes Management App | |
| 510(k) Reference: | K150910 | |
| 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/1 description: The image shows the Voluntis logo. The logo features a blue and white circular design with a yellow dot in the upper left corner. To the right of the design is the word "VOLUNTIS" in blue, with the words "Connected Therapeutics" in a smaller font below.
| Secondary | |
|---|---|
| Trade Name: | WellDoc BlueStar (WellDoc |
| DiabetesManager® System and | |
| DiabetesManager®-Rx System) | |
| 510(k) Reference: | K141273 |
| Common Name: | Medical computers and software |
| Infusion pump accessories | |
| Regulation Number: | 21 CFR 880.5725 |
| Regulation Name: | Infusion Pump |
| Regulatory Class: | II |
| Product Code: | MRZ, LNX |
| Classification Panel: | General Hospital |
Device Description 5.4
Insulia Diabetes Management Companion is a mobile and web based diabetes management system for type 2 adult diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components:
- I 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 not to be used in conjunction with a type of long-acting insulin analog different from insulin glargine (Lantus®) or insulin detemir (Levemir®).
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Image /page/5/Picture/0 description: The image shows the Voluntis logo. The logo consists of a blue and white circular graphic on the left, with a stylized bird in flight. To the right of the graphic is the word "VOLUNTIS" in a bold, blue sans-serif font. Below "VOLUNTIS" is the phrase "Connected Therapeutics" in a smaller, lighter blue font.
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 basalplus 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 nonadult patients.
ર્સ્ટ ર્ 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 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 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.
ર્ડ.6 Comparison to Predicate Devices
A comparison of Insulia Diabetes Management Companion to the predicate devices is provided in Table 5.1. This table lists the key similarities and differences between Insulia Diabetes Management Companion and the predicate devices.
| Feature | Insulia Diabetes
Management
Companion | ACCU-CHEK Connect
Diabetes Management
App (K150910) | WellDoc BlueStar
DiabetesManager-Rx
System (K141273) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Regulation
No. | 21 CFR 868.1890 | 21 CFR 868.1890 | 21 CFR 880.5725 |
| Device Class | Class II | Class II | Class II |
| Product Code | NDC | NDC, JQP, LFR, LZG | MRZ, LNX |
| Environment
of Use | Home and Professional
Healthcare settings | Home and Professional
Healthcare settings | Home and Professional
Healthcare settings |
| Intended User | HCPs and their adult type
2 diabetes patients | HCPs and their patients
with diabetes | HCPs and their adult type
2 diabetes patients |
| Prescription
Use | Yes | OTC distribution of the
app, but the bolus
calculator function can be
activated only upon
prescription by a
physician | Yes |
| 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 when
used in conjunction with
ACCU-CHEK Connect
Online | Software only, patient
mobile based application,
patient and HCP web-
based application |
| 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 and calculation
of carbohydrate intake | Insulin dose reminder
and schedule |
| Type of
Calculated
Insulin | Basal Insulin | Bolus Insulin | N/A |
| Manual Data
Entry | Yes | Yes | Yes |
| Logbook | Yes | Yes | Yes |
| Personal
Health Record | Yes | Yes | Yes |
| Reports &
Statistics | Yes | Yes | Yes |
| Coaching
Messages | Yes | No | Yes |
| Secure
Database | On computer media | On computer media | On computer media |
| Data Transfer | Public Internet | Public Internet | Public Internet |
Table 5.1: List of the key similarities and differences between Insulia Diabetes Management Companion and the predicate devices
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Image /page/6/Picture/0 description: The image contains the logo for Voluntis, a company focused on connected therapeutics. The logo features a stylized circular icon with a white bird-like shape against a blue background. To the right of the icon, the company name "VOLUNTIS" is displayed in a bold, sans-serif font, with the tagline "Connected Therapeutics" written in a smaller, lighter font beneath it.
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Image /page/7/Picture/0 description: The image shows the logo for Voluntis Connected Therapeutics. 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 words "Connected Therapeutics" are written in a smaller, lighter blue font.
Insulia Diabetes Management Companion has the same intended use as the predicate devices. Indeed, all are software applications intended for use by healthcare professionals and their diabetes patients as an aid in the management of diabetes. Furthermore, the proposed indications for use for the subject device are similar to and consistent with those of the predicate devices, and do not raise different questions of safety or effectiveness.
Insulia Diabetes Management Companion's technological characteristics are similar to and consistent with those of the predicate devices, i.e. all 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 devices provide directions which are similar to directions that physicians provide to patients as part of routine clinical practice. In addition, Insulia Diabetes Management Companion and ACCU-CHEK Bolus Advisor (which is a component of the ACCU-CHEK Connect Diabetes Management App) both 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 a part of routine clinical practice.
Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Therefore, Insulia Diabetes Management Companion is substantially equivalent to the predicate devices.
5.7 Performance Data Demonstrating Substantial Equivalence
Comprehensive performance testing was conducted on the Insulia Diabetes Management Companion to support a determination of substantial equivalence.
The results of the performance testing, including the human factors study results and 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.
5.8 Conclusion
Insulia Diabetes Management Companion has similar indications for use, the same intended use, and similar technological characteristics as those of the predicate devices. The
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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 abstract design inside, along with the word "VOLUNTIS" in blue, and the words "Connected Therapeutics" in a smaller font below.
differences in technological characteristics have been analysed and addressed through performance testing, which demonstrate that Insulia Diabetes Management Companion meets its intended use. Any technological differences between Insulia Diabetes Management Companion and the predicate devices do not raise any new issues of safety or effectiveness. Furthermore, performance testing has demonstrated that the Insulia Diabetes Management Companion performs as intended and is substantially equivalent to the predicate devices.
In summary, Insulia Diabetes Management Companion is substantially equivalent to the predicate devices.