(111 days)
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.
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. and Toujeo® U-300) once daily.
Insulia Diabetes Management Companion should not be used for:
- basal dose recommendations for intermediate-acting insulin (NPH Neutral Protamine Hagedorn);
- " premixed insulin.
Insulia Diabetes Management Companion 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).
I cannot provide a table of acceptance criteria and reported device performance or information about sample size, expert ground truth, adjudication methods, MRMC studies, standalone studies, or how ground truth was established for this device.
The provided document is an FDA 510(k) clearance letter and associated 510(k) summary for the "Insulia Diabetes Management Companion." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics against acceptance criteria.
Here's why I can't fulfill your request based solely on the provided text:
- No detailed performance data: The document states, "Design verification and validation testing, clinical evidence, and updated Human Factors evaluation on the modification of Insulia Diabetes Management Companion demonstrated that the device meets the performance requirements for its intended use." However, it does not present any specific performance metrics, acceptance criteria, or study results (e.g., accuracy, sensitivity, specificity, or effect size) in numerical form.*
- Focus on Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This often involves demonstrating that technological characteristics are similar and that any differences do not raise new questions of safety or effectiveness. It doesn't typically require a full-scale clinical trial proving net positive clinical benefit from scratch.
- Limited "Clinical Evidence" Description: The document mentions "Clinical evidence provided supported that the addition Tresiba U-100 and Basaglar to the list of insulin analogs compatible with Insulia conforms to the general principles and rules identified in the previous analysis of the standard of care performed for the cleared device." This suggests a review of existing clinical knowledge and principles rather than a new comparative effectiveness study on the device's performance itself against a defined outcome.
Based on the provided text, the device was cleared because it was determined to be substantially equivalent to a previously cleared device (K170669), and the modifications (adding compatibility for two new insulin analogs) were assessed through design verification, validation, and risk management activities, without raising new issues of safety or effectiveness.
To get the information you asked for (acceptance criteria, specific performance metrics, sample sizes, expert details, etc.), you would typically need to refer to more detailed clinical study reports, scientific publications, or internal validation documentation for the device, which are not included in this FDA 510(k) summary.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
November 7, 2017
Voluntis S.A. Kevin Howard Director, Quality Assurance and Regulatory Affairs, U.S. 22 Quai Gallieni Suresnes, 92150 FRANCE
Re: K172177
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: October 2, 2017 Received: October 5, 2017
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. 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.
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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
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Indications for Use
510(k) Number (if known) K172177
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 logo for Voluntis Connected Therapeutics. The logo features a blue circle with a white bird-like shape inside, along with a small yellow circle. To the right of the circle is the word "VOLUNTIS" in blue, with the words "Connected Therapeutics" in a smaller, lighter font below.
5 510(K) SUMMARY
[per 21 CFR 807.92]
Submitter Information 5.1
| Name: | Voluntis S.A. |
|---|---|
| Address: | 58, avenue de Wagram75017 ParisFRANCE |
| Phone: | +33 141 383 920 |
| Fax: | +33 141 383 926 |
| Contact Name: | Raffi Krikorian |
| Date of summary: | July 17, 2017 |
| Subject 510(k) Number: | K172177 |
| 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 |
Predicate 5.3
| Device | Trade Name: | Insulia Diabetes Management Companion |
|---|---|---|
| 510(k) Reference: | K170669, concurrence received on June 19, 2017 | |
| 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 is a logo for Voluntis Connected Therapeutics. The logo features a blue circle with a white silhouette of a person reaching upwards. To the right of the circle, the word "VOLUNTIS" is written in a bold, blue font. Below the word "VOLUNTIS", the words "Connected Therapeutics" are written in a smaller, lighter blue 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 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. and Toujeo® U-300) once daily.
Insulia Diabetes Management Companion should not be used for:
- basal dose recommendations for intermediate-acting insulin (NPH Neutral Protamine Hagedorn);
- " premixed insulin.
Insulia Diabetes Management Companion 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.
ર્સ્ડ 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 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(K170669) | 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 | |
|---|---|
| ------------------------------------------------------------------------------------------------------------- | -- |
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Image /page/6/Picture/0 description: The image is a logo for Voluntis Connected Therapeutics. The logo features a blue circle with a white bird-like figure inside, along with a yellow dot above the bird. To the right of the circle, the word "VOLUNTIS" is written in a bold, blue sans-serif font. Below "VOLUNTIS", the words "Connected Therapeutics" are written in a smaller, light blue sans-serif font.
| PrescriptionUse | Yes | Yes | Same | ||
|---|---|---|---|---|---|
| Technological Characteristics | |||||
| Components | Software only, patientmobile based application,patient and HCP web-based application | Software only, patientmobile based application,patient and HCP web-basedapplication | Same | ||
| TreatmentGuidance | Adjustments to insulindoses within the scope of apre-planned, physician-specified treatmentprogram similar to routineclinical practice | Adjustments to insulindoses within the scope of apre-planned, physician-specified treatmentprogram similar to routineclinical practice | Same | ||
| Type ofCalculatedInsulin | Basal Insulin(long-acting analog) | Basal Insulin(long-acting analog) | Same | ||
| CompatibleLong-ActingInsulinAnalogs | Lantus® (Glargine U-100)Levemir® (Detemir U-100)Toujeo® (Glargine U-300)Basaglar® (Glargine U-100)Tresiba® (Degludec U-100) | Lantus® (glargine U-100)Toujeo® (glargine U-300)Levemir® (detemir U-100) | Modified device iscompatible withBasaglar® (GlargineU-100) and Tresiba®(Degludec U-100) inaddition to the insulinanalogs that arealready compatiblewith the cleareddevice. | ||
| 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 |
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Image /page/7/Picture/0 description: The image shows the Voluntis logo. The logo consists of a circular icon on the left and the word "VOLUNTIS" on the right. The icon contains a stylized image of a bird in flight against a blue background with a yellow dot in the upper left corner. Below the word "VOLUNTIS" is the phrase "Connected Therapeutics" in a smaller font.
| Data Transfer | Public Internet | Public Internet | Same |
|---|---|---|---|
| --------------- | ----------------- | ----------------- | ------ |
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 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 Basaglar (Glargine U-100) and Tresiba (Degludec U-100) does not change the device's intended use nor its technological characteristics.
Therefore, the modified device subject of this Traditional 510(k) submission is substantially equivalent to Insulia Diabetes Management Companion (K170669).
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. 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 an FMEA technique. Where appropriate, adequate mitigation measures related to the risks that cannot be eliminated have been implemented.
Design verification and validation testing, clinical evidence, and updated Human Factors evaluation on the modification of Insulia Diabetes Management Companion demonstrated that the device meets the performance requirements for its intended use. The software verification and validation were 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). Clinical evidence provided supported that the addition Tresiba U-100 and Basaglar to the list of insulin analogs compatible with Insulia conforms to the general principles and rules identified in the previous analysis of the standard of care performed for the cleared device. The submission adequately demonstrates that the device meets the performance requirements for its intended use, and supports substantial equivalence.
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Image /page/8/Picture/0 description: The image shows the logo for Voluntis, a company that specializes in connected therapeutics. The logo features a stylized image of a bird in flight, with a blue circle in the background. The company name, "VOLUNTIS," is written in bold, blue letters, and the tagline "Connected Therapeutics" is written in smaller, light blue letters below the company name. The logo is clean and modern, and it conveys a sense of innovation and progress.
ર્સ્ક 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 (K170669) do not raise any new issues of safety or effectiveness
In conclusion, the subject device is substantially equivalent to Insulia Diabetes Management Companion (K170669).
§ 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).