(269 days)
Not Found
No
The description focuses on data management, reporting, and a "Basal Calculator" that provides directions based on pre-planned treatment programs, similar to routine clinical practice. There is no mention of AI, ML, or any learning algorithms. The "Basal Calculator" appears to be a rule-based system rather than an AI/ML model.
Yes
The device is described as a "Diabetes Management Companion" and includes a basal calculator to provide directions for insulin adjustments, which directly impacts the patient's treatment regimen.
No
The device explicitly states, "Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment." It is designed to aid in the review and evaluation of patient data and support effective diabetes management, rather than to provide a diagnosis itself.
Yes
The device description explicitly states that Insulia Diabetes Management Companion is a "mobile and web-based diabetes management system" consisting of a mobile application, a web-based application, and a secure database. It does not mention any dedicated hardware components included with the device. While it runs on commercially available hardware (smartphones, tablets, personal computers), the device itself is defined by its software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Insulia's Function: Insulia Diabetes Management Companion is a software-based system that manages and analyzes existing patient data (blood glucose readings, health events). It provides guidance for insulin adjustments based on this data and a pre-planned treatment program. It does not perform any tests on biological samples.
- Lack of Mention of Biological Samples or Testing: The description focuses on data capture, storage, transmission, reporting, and providing guidance based on existing data. There is no mention of collecting or analyzing biological samples.
Therefore, Insulia Diabetes Management Companion falls under the category of a diabetes management software or medical device software, but not an In Vitro Diagnostic device.
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 diabetesrelated events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments. The guidance is similar to the directions provided to patients as a part of routine clinical practice.
Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values.
Insulia Diabetes Management Companion is only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, insulin degludec (Tresiba® U-100) once daily, and insulin glargine (Basaglar® U-100, Lantus® U-100, Semglee® U-100, Toujeo® U-300) once daily.
Insulia should not be used for:
- basal dose recommendations for intermediate-acting insulin (NPH - Neutral Protamine Hagedorn);
- premixed insulin
Insulia should not be used in the following populations:
- pregnant women;
- non-adult patients;
- patients that are treated with a basal-plus or a basal-bolus regimen (i.e multiple mealtime insulin injections per day or insulin pump therapy)
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 / 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
Design verification and validation testing on the modification of Insulia Diabetes Management Companion demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the new device is substantially equivalent to the predicate device.
Key Metrics
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
June 4, 2021
Voluntis, S.A. Kevin Howard Director, Quality Assurance and Regulatory Affairs 22 Quai Gallieni Suresnes, 92150 France
Re: K202596
Trade/Device Name: Insulia Diabetes Management Companion Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: November 9, 2020 Received: November 27, 2020
Dear Kevin Howard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202596
Device Name Insulia Diabetes Management Companion
Indications for Use (Describe)
Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog.
Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetesrelated healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, and evaluation of patient data in order to support effective diabetes management.
Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice.
Insulia Diabetes Management Companion intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols.
Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the Voluntis logo. The logo consists of a blue circle with a white bird-like shape inside, and a yellow dot in the upper right corner. To the right of the circle is the word "VOLUNTIS" in blue, and below that is the phrase "Connected Therapeutics" in a smaller, lighter blue font.
510(K) SUMMARY 5
[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: | September 2, 2020 |
| 5.2 | Subject Device | Trade Name: | Insulia Diabetes Management Companion |
|---|---|---|---|
| Common Name: | Diabetes Management Software | ||
| Regulation Number: | 21 CFR 868.1890 | ||
| Regulation Name: | Predictive pulmonary-function value calculator | ||
| Regulatory Class: | II | ||
| Product Code: | NDC | ||
| Classification Panel: | General Hospital |
- 5.3 Predicate Trade Name: Insulia Diabetes Management Companion Device 510(k) Reference: K172177, concurrence received on November 7, 2017 Common Name: Diabetes Management Software Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: II NDC Product Code: Classification Panel: General Hospital
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Image /page/4/Picture/0 description: The image shows the Voluntis logo. The logo consists of a blue circle with a white bird-like shape inside, and a small yellow circle in the upper left corner. To the right of the circle is the word "VOLUNTIS" in blue, and below that is the phrase "Connected Therapeutics" in a smaller, lighter blue font.
5.4 Device Description
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:
- 트 A mobile medical application for use by patients on commercially available smartphones (iPhones and Android phones) and tablets.
- . A web-based application for use by patients in their home on their personal computer and on their mobile device, or by HCPs in professional healthcare settings through a compatible web browser on a personal computer.
- I A secure database hosted in a private cloud environment and used to securely store patient data.
Insulia Diabetes Management Companion provides secure capture, storage and transmission of blood glucose data and other diabetes-related healthcare information to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management.
Insulia Diabetes Management Companion includes a Basal Calculator intended to provide directions to the patient in response to blood glucose measurements and other diabetesrelated events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments. The guidance is similar to the directions provided to patients as a part of routine clinical practice.
Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values.
Insulia Diabetes Management Companion is only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, insulin degludec (Tresiba® U-100) once daily, and insulin glargine (Basaglar® U-100, Lantus® U-100, Semglee® U-100, Toujeo® U-300) once daily.
Insulia should not be used for:
- . basal dose recommendations for intermediate-acting insulin (NPH - Neutral Protamine Hagedorn);
- premixed insulin ●
Insulia should not be used in the following populations:
- pregnant women;
- non-adult patients;
- patients that are treated with a basal-plus or a basal-bolus regimen (i.e multiple mealtime insulin injections per day or insulin pump therapy)
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Image /page/5/Picture/0 description: The image is a company logo for Voluntis Connected Therapeutics. The logo features a blue circle with a white bird-like shape inside, along with the company name in blue text. Below the company name, the words "Connected Therapeutics" are written in a smaller, lighter blue font.
ર.ર Indications for Use
Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog.
Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes-related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management.
Insulia Diabetes Management Companion includes 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 Device
Insulia Diabetes
Management Companion | Cleared Predicate Device
Insulia Diabetes
Management Companion
(K172177) | 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 |
| Table 5.1: List of the key similarities and differences between the subject device and the predicate device | |||
|---|---|---|---|
| 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 | Basal Insulin | |
| (long-acting analog) | |||
| Compatible | |||
| Long-Acting | |||
| Insulin | |||
| Analogs | Lantus® (Glargine U-100) | ||
| Levemir® (Detemir U-100) | |||
| Toujeo® (Glargine U-300) | |||
| Basaglar® (Glargine U-100) | |||
| Tresiba® (Degludec U-100) | |||
| Semglee® (Glargine U-100) | Lantus® (glargine U-100) | ||
| Toujeo® (glargine U-300) | |||
| Levemir® (detemir U-100) | |||
| Basaglar® (Glargine U-100) | |||
| Tresiba® (Degludec U-100) | Modified device is | ||
| compatible with | |||
| Semglee® (Glargine | |||
| U-100) in addition | |||
| to the insulin | |||
| analogs that are | |||
| 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 |
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Image /page/6/Picture/0 description: The image shows the Voluntis logo. The logo consists of a blue circle with a white bird-like shape inside, along with the company name "VOLUNTIS" in blue, and the tagline "Connected Therapeutics" in a smaller, lighter blue font. The logo is clean and modern, suggesting a focus on innovation and technology in the healthcare sector.
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Image /page/7/Picture/1 description: The image shows the Voluntis logo. The logo consists of a blue circle with a white bird and a yellow dot inside. To the right of the circle is the word "VOLUNTIS" in blue, with the words "Connected Therapeutics" in a smaller font below.
Insulia Diabetes Management Companion has the same intended use and the same indications for use statement as the predicate device.
The subject device's technological characteristics are identical to those of the predicate device, i.e. both include software applications that provide secure capture, storage, transmission and display of blood glucose data as well as other diabetes related healthcare information.
Insulia Diabetes Management Companion and the predicate device provide directions which are similar to directions that physicians provide to patients as part of routine clinical practice. Both devices provide directions within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions provide to patients as part of routine clinical practice. The basal insulin calculator is unchanged as compared to the predicate device, i.e. the calculation rules are the same. The modification of the Insulia Diabetes Management Companion effecting compatibility with Semglee® (Glargine U-100) does not change the device's intended use nor its technological characteristics.
Therefore, the modified device subject of this Special 510(k) submission is substantially equivalent to Insulia Diabetes Management Companion (K172177).
5.7 Performance Data Demonstrating Substantial Equivalence
All product development activities were performed in compliance with the Design Control requirements per 21 CFR 820.30.
The risk management activities were conducted in accordance with FDA recognized consensus standard ISO 14971 (FDA recognition number 5-40). A risk assessment was conducted by a multidisciplinary team to assess the impact of the modifications on the device. A risk analysis according to the "Risk Reduction Principle" laid down in ISO 14971 was carried out for the subject device. Possible hazards and consequences were systematically identified and evaluated by using a "Failure Mode Effect and Analysis" technique. Where appropriate, adequate mitigation measures related to the risks that cannot be eliminated have been implemented.
Design verification and validation testing on the modification of Insulia Diabetes Management Companion demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the new device is substantially equivalent to the predicate device.
5.8 Conclusion
Insulia Diabetes Management Companion has the same indications for use, the same intended use, and similar technological characteristics as those of the predicate device. The modifications brought to the device have been analyzed in terms of risks and addressed through performance testing, which demonstrates that Insulia Diabetes Management Companion meets its intended use. Any technological differences between Insulia Diabetes Management Companion and the predicate device (K172177) do not raise any new issues of safety or effectiveness.
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Image /page/8/Picture/0 description: The image shows the Voluntis logo. The logo features a blue circle with a white bird-like shape inside, along with the company name "VOLUNTIS" in blue, bold letters. Below the company name, the tagline "Connected Therapeutics" is written in a smaller, lighter font.
In conclusion, the subject device is substantially equivalent to Insulia Diabetes Management Companion (K172177).