(202 days)
Not Found
No
The description focuses on a "treatment algorithm" and "automated dosing guidance based on comparing regularly measured blood glucose data trends to a device specified target range," which suggests a rule-based or algorithmic approach rather than AI/ML. There is no mention of learning, training data, or adaptive models.
No.
The device provides a recommended insulin dose, which aids in optimizing insulin management, but it does not directly administer treatment or alter the body's function. It calculates and recommends a dose, leaving the therapeutic action (insulin administration) to the user.
No
The device is an aid in optimizing insulin management by calculating and recommending the next insulin dose. It does not diagnose a condition or disease; rather, it manages an already diagnosed condition.
Yes
The device is explicitly described as a "software-based" product with "two user-interactive software elements" (Phone App and Website) and a "Get-Dose library". While it interacts with external hardware (cellular phone, blood glucose meter), the core medical device functionality (calculating insulin dose recommendations) is performed by the software components. The description focuses on software verification and validation, not hardware.
Based on the provided information, the d-Nav System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- d-Nav System Function: The d-Nav System's primary function is to calculate and recommend insulin doses based on blood glucose data. While it uses blood glucose data, it does not perform the diagnostic test itself. The blood glucose data is obtained from a separate, cleared Blood Glucose (BG) device.
- Intended Use: The intended use is to "aid in optimizing insulin management" and provide "automated dosing guidance." This is a treatment management function, not a diagnostic function.
- Device Description: The description clearly states it's a "software-based, prescription-only product designed to provide the next insulin dose recommendation."
The d-Nav System is a software-based medical device that utilizes data from an IVD (the blood glucose meter) to provide treatment recommendations. It is not an IVD itself.
N/A
Intended Use / Indications for Use
The d-Nav® System calculates the next dose of insulin to aid in optimizing insulin management.
The d-Nav System contains two user-interactive software elements:
• The patient user interface software is intended for use by adults with Type 2 diabetes as an aid in optimizing insulin management. It resides on a hand-held device, e.g. cellular phone or enabled glucose meter, and is used to enter glucose event data and receive a recommended insulin dose.
• The HCP user interface software tool is intended for use by Health Care Providers (HCPs) to set up the patient software for its intended use. Setup consists of entering the physician-prescribed, patient-specific starting insulin dose instructions (insulin prescription) and sending the patient user software. Insulin instructions include the treatment algorithm (treatment plan), insulin drug, and dose(s).
The d-Nav System also contains the d-Nav Get-Dose Library that provides the next insulin dose.
The System can receive glucose measurement data entered manually into the patient user software or automatically via the cloud from a linked blood glucose meter. The d-Nav Get-Dose Library Recommend Dose function resides locally on the phone while the d-Nav Get-Dose Library Update Insulin Instruction may reside locally on the phone or be hosted in the cloud. Configurations are as follows:
Model 1: Patient user software resides on a hand-held device and uses manual glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides locally within the device.
Model 2: Patient user software resides on a hand-held device and uses manual glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides in the cloud.
Model 3: Patient user software resides on a hand-held device and uses automated glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides locally within the device.
Model 4: Patient user software resides on a hand-held device and uses automated glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides in the cloud.
Use of the d-Nav System is limited to Health Care Providers who have been trained by Hygieia trained person on the use of the d-Nav System, including setup of the patient's Phone App.
Product codes (comma separated list FDA assigned to the subject device)
NDC
Device Description
The d-Nav System is a software-based, prescription-only product designed to provide the next insulin dose recommendation as an aid for personal insulin management. The product integrates the Health Care Provider (HCP) prescribed starting insulin dose instructions with automated dosing quidance to the patient based on comparing reqularly measured blood glucose data trends to a device specified target range. The d-Nav System contains two userinteractive software elements; the d-Nav Phone App and the d-Nav Website.
- . The Phone App is for use by persons with Type 2 diabetes as an aid in optimizing insulin management. The Phone App resides on a cellular phone and is used by the patient to enter qlucose event data and receive a recommended insulin dose. The blood qlucose data is obtained from an over-the-counter, cleared Blood Glucose (BG) device and entered into the software system either through manual BG data entry using the Phone App kevpad or via a cloud-pushed mechanism from a linked blood qlucose meter. The Phone-App allows change in insulin dose recommendations to be sent to the patient without concurrence from the prescriber.
- The d-Nav Website is for use by Health Care Providers that have been trained by Hygieja or . a Hygieia trained trainer on the use of Phone App and website to set up the patient's Phone App software for its intended use. Setup consists of entering the physician prescribed, patient-specific starting insulin dose instructions and sending the information to the intended patient's Phone App. Insulin instructions include the treatment algorithm (treatment plan), insulin druq, and dose(s).
The d-Nav System also contains the d-Nav Get-Dose library that provides the next insulin dose.
The System can receive glucose measurement data entered manually into the patient user software or automatically via the cloud from a linked blood qlucose meter. The d-Nav Get-Dose Library Recommend Dose function resides locally on the phone while the d-Nav Get-Dose Library Update Insulin Instruction may reside locally on the phone or be hosted in the cloud.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Health Care Providers (HCPs) to set up patient software; patients with Type 2 diabetes for personal insulin management.
Care setting: professional setting (HCP) and at home/mobile (patient).
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)
Risk Management: A risk analysis was conducted in accordance with ISO 14971: 2007 - Medical devices -Application of risk management to medical devices.
Cybersecurity Considerations: A cybersecurity evaluation was conducted to ensure the mitigation of cybersecurity risks according to the FDA guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
d-Nav System Verification and Validation: The software Level of Concern for the d-Nav System is Major. Software System, Integration and Unit level verification and validation was performed on the d-Nay System according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. (May 11, 2005) for software with a major level of concern. Test coverage included load testing of the server to ensure acceptable server performance.
Human Factors testing: Human factors testing was performed on the d-Nav System according to FDA Guidance applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). Testing supported a determination of substantial equivalence.
Comprehensiveness Assessment: The requirements traceability matrix demonstrates that the requirements were fully covered by executing the steps.
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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 4, 2019
Hygieia, Inc Robert J Bard VP Regulatory Affairs 28803 8 Mile Rd. Suite 101 Livonia, Michigan 48152
Re: K181916
Trade/Device Name: d-Nav System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: December 21, 2018 Received: December 26, 2018
Dear Robert J Bard:
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/cdrl/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Alan M.
Stevens -S
for 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) K181916
Device Name d-Nav® System
Indications for Use (Describe)
The d-Nav® System calculates the next dose of insulin to aid in optimizing insulin management.
The d-Nav System contains two user-interactive software elements:
• The patient user interface software is intended for use by adults with Type 2 diabetes as an aid in optimizing insulin management. It resides on a hand-held device, e.g. cellular phone or enabled glucose meter, and is used to enter glucose event data and receive a recommended insulin dose.
· The HCP user interface software tool is intended for use by Health Care Providers (HCPs) to set up the patient software for its intended use. Setup consists of entering the physician-prescribed, patient-specific starting insulin dose instructions (insulin prescription) and sending the patient user software. Insulin instructions include the treatment algorithm (treatment plan), insulin drug, and dose(s).
The d-Nav System also contains the d-Nav Get-Dose Library that provides the next insulin dose.
The System can receive glucose measurement data entered manually into the patient user software or automatically via the cloud from a linked blood glucose meter. The d-Nav Get-Dose Library Recommend Dose function resides locally on the phone while the d-Nav Get-Dose Library Update Insulin Instruction may reside locally on the phone or be hosted in the cloud. Configurations are as follows:
Model 1: Patient user software resides on a hand-held device and uses manual glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides locally within the device.
Model 2: Patient user software resides on a hand-held device and uses manual glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides in the cloud.
Model 3: Patient user software resides on a hand-held device and uses automated glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides locally within the device.
Model 4: Patient user software resides on a hand-held device and uses automated glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides in the cloud.
Use of the d-Nav System is limited to Health Care Providers who have been trained by Hygieia trained person on the use of the d-Nav System, including setup of the patient's Phone App.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| 510(k) Number: | K181916 |
|---|---|
| Date of Summary: | February 4, 2019 |
| Applicant | Hygieia, Inc. |
| 28803 8 Mile Rd, Suite 101 | |
| Livonia, MI 48152 | |
| Correspondent: Name: | Robert J Bard, JD |
| Hygieia, Inc. | |
| 28803 8 Mile Rd, Suite 101 | |
| Livonia, MI 48152 | |
| 248-573-5040 | |
| rbard@reglaw.net | |
| Trade Name | d-Nav System |
| K181916 | |
| Predicate | My Insulin Doser (MID) |
| K082512 | |
| Device | Calculator, Drug Dose |
| Same | |
| Classification Name: | Predictive pulmonary-function |
| value calculator. | |
| Same | |
| Regulation Number | 21CFR 868.1890 |
| Same | |
| Product Code | NDC |
| Same |
5
1.0 DEVICE DESCRIPTION
The d-Nav System is a software-based, prescription-only product designed to provide the next insulin dose recommendation as an aid for personal insulin management. The product integrates the Health Care Provider (HCP) prescribed starting insulin dose instructions with automated dosing quidance to the patient based on comparing reqularly measured blood glucose data trends to a device specified target range. The d-Nav System contains two userinteractive software elements; the d-Nav Phone App and the d-Nav Website.
- . The Phone App is for use by persons with Type 2 diabetes as an aid in optimizing insulin management. The Phone App resides on a cellular phone and is used by the patient to enter qlucose event data and receive a recommended insulin dose. The blood qlucose data is obtained from an over-the-counter, cleared Blood Glucose (BG) device and entered into the software system either through manual BG data entry using the Phone App kevpad or via a cloud-pushed mechanism from a linked blood qlucose meter. The Phone-App allows change in insulin dose recommendations to be sent to the patient without concurrence from the prescriber.
- The d-Nav Website is for use by Health Care Providers that have been trained by Hygieja or . a Hygieia trained trainer on the use of Phone App and website to set up the patient's Phone App software for its intended use. Setup consists of entering the physician prescribed, patient-specific starting insulin dose instructions and sending the information to the intended patient's Phone App. Insulin instructions include the treatment algorithm (treatment plan), insulin druq, and dose(s).
The d-Nav System also contains the d-Nav Get-Dose library that provides the next insulin dose.
The System can receive glucose measurement data entered manually into the patient user software or automatically via the cloud from a linked blood qlucose meter. The d-Nav Get-Dose Library Recommend Dose function resides locally on the phone while the d-Nav Get-Dose Library Update Insulin Instruction may reside locally on the phone or be hosted in the cloud.
6
System Architecture
The following illustrates the architecture of the d-Nav System. Input into the system is glucose data from a glucose meter, either manual or via cloud. The Get-Dose Library is implemented either in the cloud or on the phone.
Image /page/6/Figure/3 description: The image shows a diagram of the d-Nav System Server, which is a cloud implementation on AWS. The diagram includes components such as the d-Nav Website, BGM Connect Webservice, Communication Webservice, and d-Nav System Database. It also shows the d-Nav Phone App, which includes the Local d-Nav Get-Dose Library, Local Algorithm Integration Library, and Phone App Local Storage.
Figure 1. Distribution of Software Components in the d-Nav System
The d-Nav System consists of the following hardware components:
- . Mobile Phone: An iOS or Android mobile phone
- d-Nav System Server: Cloud implementation deployed on Amazon Web Services (AWS) ●
The d-Nav System consists of the following software components:
- d-Nav Website & Webservices: 1) BGM Connect Webservice, 2) Communication Webservice .
- d-Nav System Database
- d-Nav SAAS Webservices and SAAS Database .
- d-Nav Get-Dose Library
- Algorithm Integration Library ●
- d-Nav Phone App ●
7
Software System Description
The following system context diagram depicts the software components and their interaction within the d-Nav System. This diagram includes illustration of the four (4) d-Nav System Models.
Image /page/7/Figure/3 description: The image shows a system diagram for d-Nav. The diagram includes components such as the d-Nav System Server (1), d-Nav Website (2), d-Nav System Database (3), BGM Connect Webservice (4), Communication Webservice (5), d-Nav SAAS Webservice (6), SAAS Database (7), Algorithm Integration Library (8), Phone App Code (9), and Phone App Local Storage (10). The diagram illustrates the flow of data and interactions between these components within the d-Nav system.
Figure 2. Components in d-Nav System Context
Descriptions for the System Context Diagram Components:
-
- d-Nav System Server: The d-Nav System Server is a cloud server implemented and deployed on the Amazon AWS S3 server. The Server contains the following software components: 1) d-Nav Website (Microsoft IIS), 2) d-Nav System Database (Microsoft SQL Server), 3) BGM (Blood Glucose Meter) Connect Webservice, 4) Communication
8
Webservice and 5) d-Nav SAAS Webservice, and 6) SAAS Database (Microsoft SQL Server).
-
- d-Nav Website (Microsoft IIS): The d-Nav Website is utilized by an authorized Health Care Provider (HCP) to add a new Phone App user to the d-Nav System, set up their physicianprescribed, patient-specific starting insulin dose instructions, and Treatment Plan enable or disable a Phone App, and monitor the Phone App user's insulin and glucose history.
-
- d-Nav System Database: This SQL database is located on the d-Nav System Server. The d-Nav System Database contains information reqarding the system. The database contains 1) website user login information, 2) d-Nav Phone App user information, 3) connected BGM information including the unique relation to users and the records of BG readings sent to the Phone App, 4) records of insulin instructions pushed to the Phone App, 5) records of glucose event data received from the users' Phone App, and 6) insulin instruction updates received from the Phone App (generated by Get-Dose Library).
-
- BGM Connect Webservice: This webservice is used to send a BG reading to the d-Nav Phone App on the user's phone. The BG reading is received by the webservice either directly from a linked meter or from a BGM manufacturer or other's cloud-based infrastructure.
-
- Communication Webservice: This webservice provides an endpoint for the d-Nav Phone App to communicate with the d-Nav System Server.
-
- Algorithm Integration Library/d-Nav SAAS Webservice: In the d-Nav System, there are two instances of the API that enables the d-Nav Get-Dose Library; 1) Algorithm Integration Library in the Phone App and 2) Algorithm Integration Library with the d-Nav SAAS Webservice implementation on the d-Nav System Server. Regardless of the deployment location in the system, the API functions to utilize the otherwise static/stateless d-Nav Get-Dose Library by wrapping it with state and persistence. In the cloud implementation, the d-Nav SAAS Webservice, returns all new data values to the Phone App because the Phone App needs to be in sync with the server.
-
- SAAS Database: This SQL database is located on the d-Nav System Server. The SAAS Database is utilized solely by the d-Nav SAAS Webservice. The database contains information specific to the user's insulin treatment plan but no user personally identifiable information (PII). The information stored in the database is 1) Phone App instance unique identification values, 2) IDF history including the current insulin instructions and containing the selected treatment plan, insulin drug, and dose(s), and 3) the qlucose event records with glucose data, event names, carbs (if applicable), recommended and recorded dose, and timestamp for each record.
-
- d-Nav Get-Dose Library: Upon receiving a request from the Phone App, the library calculates a new recommended insulin dose or updates current insulin instructions based on
9
glucose readings, user's current insulin instructions, and history of events and instructions saved in the SAAS Database or Phone App Local Storage (based on system configuration, cloud or local).
-
- d-Nav Phone App: When the system operation is configured for local usage, the Phone App passes the glucose event data (glucose reading, event type, carb, dose, and timestamp) to the Algorithm Integration Library through a class level function call to request a new recommended dose or update the existing instructions. When the system is configured for cloud server usage, the Phone App call to the d-Nav System Server (to pass a new glucose event data) becomes a REST API¹ request, sent through the internet via a secure SSL connection. This request is received by the d-Nav SAAS Webservice.
-
- Phone App Local Storage: This SQLite database is located on the mobile phone. The Phone App Local Storage is utilized solely by the Algorithm Integration Library in the Phone App. The database contains information specific to the user's insulin treatment plan but no user PII. The information stored in the database is 1) Phone App instance unique identification values, 2) IDF history including the current insulin instructions and containing the selected treatment plan, insulin drug, and dose(s), and 3) the glucose event records with glucose data, event names, carbs (if applicable), recommended and recorded dose, and timestamp for each record.
2.0 SUBSTANTIALLY EQUIVALENT
The Hygieia d-Nav System is substantially equivalent to the following Dose Calculator device.
| Manufacturer and Product | Cleared Predicate Product Regulatory Information |
|---|---|
| Dimensional Dosing Systems, Inc. | |
| My Insulin Doser (MID)/ Intelligent Dosing | |
| System (IDS) | K Number: K082512 |
| ProCode: NDC | |
| Regulation Number: 21 CFR 868.1890 |
Table 1: Predicate Product
1 Representational State Transfer (REST) Application Program Interface (API)
10
| ATTRIBUTE | PREDICATE | SUBJECT DEVICE | |
|---|---|---|---|
| 1 | Device name | My Insulin Doser (MID)/ | |
| Intelligent Dosing System (IDS) | d-Nav System | ||
| 2 | Device Description | Insulin Dose Calculator | Same |
| 3 | Target population | Health Care Provider (HCP) | |
| • Patients with diabetes | Same | ||
| 4 | Where used | HCP - in professional setting | |
| • Patient - at home or mobile | Same | ||
| 5 | Dose calculator | ||
| algorithm design | |||
| principle | Response-to-dose single dose | Single dose for dose decreases | |
| • Average response to similarly timed | |||
| dose over a 1-week period for both | |||
| increases and decreases | |||
| 6 | UI- containing System | ||
| components | HCP SW: IDS | ||
| • Patient SW: MID | HCP SW: Website | ||
| Patient SW: Phone App | |||
| 7 | Platforms | Web, PC, or Palm Pilot | HCP: Website via PC |
| Patient: iOS, Android Smartphones | |||
| 8 | HCP input process | HCP inputs are entered using the web- | |
| based IDS or PC | HCP inputs are entered using the | ||
| Website through PC | |||
| 9 | HCP inputs | Single Insulin dose | |
| • Desired (Glucose Target) Level | |||
| determine by prescriber | |||
| • Current response (e.g. current | |||
| glucose level) | |||
| • Insulin drug selection | |||
| 12 drugs available: | |||
| ◦ Humalog | |||
| ◦ Humalog mix 75/25 | |||
| ◦ Humulin 50/50 | |||
| ◦ Humulin 70/30 | |||
| ◦ Insulin | |||
| ◦ Lantus | |||
| ◦ Lente | |||
| ◦ Levemir | |||
| ◦ Novolin 70/30 | |||
| ◦ Novolog mix 70/30 | |||
| ◦ NPH | |||
| ◦ Regular (R) | Insulin dose(s) based on Treatment | ||
| Plan | |||
| • Basal | |||
| • Twice daily mixed insulin | |||
| • Basal-bolus | |||
| • Basal-bolus with carbohydrate | |||
| counting | |||
| • Treatment Plan each with fixed target | |||
| glucose | |||
| • Starting insulin sensitivity factor (for | |||
| basal-bolus plans) | |||
| • Starting insulin to carbohydrate ratio | |||
| (for basal-bolus plan with carbohydrate | |||
| counting) | |||
| • Insulin drug selection | |||
| 11 drugs available: | |||
| ◦ Lantus | |||
| ◦ Basaglar | |||
| ◦ Tresiba | |||
| ◦ Toujeo | |||
| ◦ Humalog | |||
| ◦ NovoLog | |||
| ◦ Apidra | |||
| ◦ Humalog Mix 75/25 | |||
| ◦ NovoLog Mix 70/30 | |||
| ◦ Humulin 70/30 | |||
| ◦ Novolin 70/30 | |||
| ATTRIBUTE | PREDICATE | SUBJECT DEVICE | |
| 10 | Patient input process | Patient inputs data by mouse and | |
| keyboard (or keypad) into software | |||
| located either on Web, PC, or Palm Pilot | |||
| Manual inputs | Patient inputs data by keypad into | ||
| software located on smartphone. | |||
| Glucose data can be obtained by manual | |||
| input or transfer from glucose meter via | |||
| cloud | |||
| 11 | Patient inputs | Marker: Fasting Glucose, Current | |
| (Random) Glucose, HgA1c, or Other | |||
| Previous dose administered Insulin drug Last insulin dose Desired response (e.g. Fasting | |||
| Glucose target) | Glucose: Fasting, Current (e.g. Pre-Meal, Bedtime) Dose: record insulin dose to reflect actual dose taken Event Type for current glucose | ||
| reading (e.g. Breakfast) Carbs for Basal-bolus with Carb counting | |||
| 12 | Primary outputs | Next insulin dose recommendation | New insulin dose(s) to be used through |
| the next titration period. | |||
| 13 | Secondary outputs for | ||
| HCP | Patient Dosing Summary | ||
| Log by date of: | |||
| Current Dose Suggested Dose Current Marker (e.g. Fasting Glucose | |||
| reading) Predicted Marker (predicted / | |||
| expected response) Patient Dosing with Chart: | |||
| Log by date/time of: | Patient Dosing History | ||
| Log by date/time of: Patient Insulin Instruction history Patient Glucose Event data history Data Export available | |||
| Unit Dose (current insulin dose) Current Level (Marker level) Desired Level (of Marker) | |||
| 14 | Primary output for | ||
| Patient | Next insulin dose recommendation | Same | |
| 15 | Secondary outputs for | ||
| Patient (Reports) | Dose Summary Report, a log by date of: Current Marker (e.g. Fasting Glucose | ||
| readings) Current Dose Suggested Dose Predicted Marker (predicted / | |||
| expected response) Patient Dosage with Chart Report: | |||
| Log by date of: Unit Dose (current insulin dose) Current Level (Marker level) Desired Level (of Marker) Chart plotting by date: various parameters | Patient Dosing History | ||
| Log by date/time of: Glucose event data history Current insulin instructions Each Glucose Event record shows date, | |||
| time, event type, blood glucose | |||
| reading, carbs if applicable, and | |||
| insulin dose, if applicable. | |||
| Algorithm | |||
| 16 | Glucose Target | Adjustable target value | Fixed target range (e.g. glucose 80 - 130 |
| mg/dL) Fixed range based on the | |||
| Treatment Plan chosen | |||
| ATTRIBUTE | PREDICATE | SUBJECT DEVICE | |
| 17 | Magnitude of insulin | ||
| adjustment as a | |||
| function of target | Proportional to distance from target value | Same | |
| 18 | Limits on insulin | ||
| adjustment | ≤ ±20% | ≤ ±20% but not to exceed pre-determined | |
| max. number of units of insulin, except | |||
| +30% for increases in Basal-Bolus plans | |||
| 19 | Frequency of insulin | ||
| adjustment (increase) | Daily increase allowed | Increase occur no greater than weekly | |
| 20 | Frequency of insulin | ||
| adjustment (decrease) | Daily decrease allowed | Same |
Table 2: Comparison of device under review and its predicates
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| Table 3: Intended/indications for Use Comparison of Subject Device and its Predicates | ||
|---|---|---|
| -- | -- | --------------------------------------------------------------------------------------- |
| ATTRIBUTES | PREDICATE | SUBJECT DEVICE |
|---|---|---|
| Intended / | ||
| indications for use | My Insulin Doser/IDS calculates the next dose of | |
| insulin to optimize a diabetic patient's individual | ||
| insulin management. | The d-Nav® System calculates the next dose of insulin to aid in optimizing insulin management. | |
| The d-Nav System contains two user-interactive software elements: | ||
| • The patient user interface software is intended for use by adults with Type 2 diabetes as an aid in | ||
| optimizing insulin management. It resides on a hand-held device, e.g. cellular phone or enabled | ||
| glucose meter, and is used to enter glucose event data and receive a recommended insulin dose. | ||
| • The HCP user interface software tool is intended for use by Health Care Providers (HCPs) to set | ||
| up the patient software for its intended use. Setup consists of entering the physician-prescribed, | ||
| patient-specific starting insulin dose instructions (insulin prescription) and sending the information | ||
| to the patient user software. Insulin instructions include the treatment algorithm (treatment plan), | ||
| insulin drug, and dose(s). | ||
| The d-Nav System also contains the d-Nav Get-Dose Library that provides the next insulin dose. | ||
| The System can receive glucose measurement data entered manually into the patient user | ||
| software or automatically via the cloud from a linked blood glucose meter. The d-Nav Get-Dose | ||
| Library Recommend Dose function resides locally on the phone while the d-Nav Get-Dose Library | ||
| Update Insulin Instruction function may reside locally on the phone or be hosted in the cloud. | ||
| Configurations are as follows: | ||
| Model 1: Patient user software resides on a hand-held device and uses manual glucose | ||
| measurement entry. The Get-Dose Library Update Insulin Instruction function resides locally within | ||
| the device. | ||
| Model 2: Patient user software resides on a hand-held device and uses manual glucose | ||
| measurement entry. The Get-Dose Library Update Insulin Instruction function resides in the cloud. | ||
| Model 3: Patient user software resides on a hand-held device and uses automated glucose | ||
| measurement entry. The Get-Dose Library Update Insulin Instruction function resides locally within | ||
| the device. | ||
| Model 4: Patient user software resides on a hand-held device and uses automated glucose | ||
| measurement entry. The Get-Dose Library Update Insulin Instruction function resides in the cloud. | ||
| Use of the d-Nav System is limited to Health Care Providers who have been trained by Hygieia or a | ||
| Hygieia trained person on the use of the d-Nav System, including setup of the patient's Phone App. |
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SE Discussion of Intended Use
Both devices require a prescription from the treating clinician and both are set up by Health Care Providers in a professional setting and used by persons with diabetes in a home setting.
The devices are both intended for use by healthcare professionals and their patients with Type 2 diabetes for calculating insulin dose.
The intended use of the d-Nav System is similar to that of the predicate, as both are software devices that calculate the next dose of insulin to aid in optimizing insulin management.
Both devices calculate the insulin dose based on previous response to aid in optimizing insulin management. The predicate uses a single dose to calculate a dose response. The subject device uses both a single dose to calculate dose reductions and a weekly average based on the relative time point for that insulin dose (i.e. breakfast, or bedtime) to calculate both dose increases and decreases.
Neither device is intended to be a substitute for clinical reasoning.
Substantial Equivalence Discussion of Technological Characteristics
Hygieia has referred to FDA's document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff (July 28, 2014)" while drafting this evaluation of substantial equivalence with the predicate device.
Technological Characteristics
In terms of technological characteristics, the subject and predicate devices have many similarities. We list the key similarities below. They both:
- Are insulin dose calculator software systems ●
- . Include separate software components for usage by the Health Care Provider (in the professional setting) and for the patient (in the home)
- . Use a response-to-dose calculator algorithm that relies on current responses (e.g. blood glucose readings), current insulin instruction dose components, and a target response (e.g. blood glucose level) to calculate the next insulin dose recommendation
- . Support usage of a variety of insulin drugs, including basal insulin (e.g. Lantus), premixed insulin (e.q. Humulin 70/30), and bolus insulin drugs (e.g. Humaloq, Regular (R))
- Provide a history of responses (e.g. glucose readings) and insulin doses to both Health Care ● Providers and patients
- Limit the maximum change in the next insulin dose recommendation
- . Instruct the patient to alter the next dose recommendation to reflect actual insulin dose taken so that such changes by the patient are recorded in the device memory for review by the Health Care Provider and patient
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In terms of technological characteristics, the d-Nav System and predicate devices differ in several details. However, none of these differences rises to the level of being significant as per the previously mentioned FDA Guidance. See Table 2 for Comparison of the two devices.
Discussion of Safety and Efficacy for Certain Differences
The new technology of the d-Nav System does not raise any new issues of safety and/or efficacy when compare to the predicate.
Cloud Feature: The d-Nav Phone App allows for the Get-Dose Library Update Insulin Instruction function to reside in the cloud, which means that, unlike the predicate device, titration may require cloud connectivity. The effect of dose titration is only applicable for the next time a similar dose will be qiven. For instance, if a breakfast dose resulted in a low qlucose reading, then once connected to the Get-Dose Library Update Insulin Instruction function will reduce the breakfast dose component. The user will not act upon the new recommendation until the next time they have breakfast which is expected to be in ~24 hours. Hygieia believes that in almost all cases, the user's Phone App will be able to connect to the cloud sometime during that 24 hour period. The labeling advises the prescriber that if the patient is unlikely to have reliable cloud connectivity, the Get-Dose Library should reside on the phone (Model 1 or 3). Conclusion: this new feature of having the titration functionality in the cloud does not raise any new safety or efficacy issues when compared to the predicate device.
Manual vs Connected: The d-Nav Phone App allows the user an option to connect a thirdparty blood glucose meter via a cloud-to-cloud integration in addition to always allowing the manual entry of glucose if needed. The predicate device does not allow cloud or bluetooth connect and requires manual entry of glucose. Conclusion: the convenience feature in the d-Nav Phone App for blood glucose entry does not raise a new safety concern compared to the predicate device.
Treatments: The d-Nav Phone App and the predicate device support several insulin products (see Table 4 below). Both devices require the prescriber to set the patients' starting insulin dose and have a limit to the next dose titration recommendation. The differences are that the predicate device provides a single titration recommendation at a time and the d-Nav provides four (4) different treatment regimens (basal, twice daily pre-mixed, basal-bolus, and basal-bolus with carbohydrate counting). The d-Nav Phone App includes some safety-check conditions; stops titrations if the patient exceeds an allowable percent deviation from the recommended dose, or if the total daily dose exceeds the prescribers set threshold.
The only other difference is that the d-Nav Phone App supports fast-acting insulin analogs rather than the bolus human insulin Regular (R) for bolus dosing supported by the predicate. Fast-acting insulin analogs have a shorter peak-time and a shorter duration compared to Regular insulin.
Conclusion: the types of regimens and insulins supported by the d-Nav Phone App compared to the predicate device do not raise any new safety or efficacy concerns.
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| Treatment plan | Predicate device | d-Nav Phone App |
|---|---|---|
| Long acting (Basal) insulin | • Lantus | |
| • Levemir | ||
| • Lente | ||
| • NPH | • Lantus | |
| • Tresiba | ||
| • Basaglar | ||
| • Toujeo | ||
| Pre-mixed insulin | • Humalog mix 75/25 | |
| • Humulin 70/30 | ||
| • Novolog Mix 70/30 | ||
| • Novolin 70/30 | • Humalog mix 75/25 | |
| • Humulin 70/30 | ||
| • Novolog Mix 70/30 | ||
| • Novolin 70/30 | ||
| Bolus insulin | • Regular (R) | • Humalog |
| • Novolog | ||
| • Apidra |
Table 4: Supported Insulin Products
3.0 PERFORMANCE DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE
Risk Management
A risk analysis was conducted in accordance with ISO 14971: 2007 - Medical devices -Application of risk management to medical devices.
Cybersecurity Considerations
A cybersecurity evaluation was conducted to ensure the mitigation of cybersecurity risks according to the FDA guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
d-Nav System Verification and Validation
The software Level of Concern for the d-Nav System is Major. Software System, Integration and Unit level verification and validation was performed on the d-Nay System according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. (May 11, 2005) for software with a major level of concern. Test coverage included load testing of the server to ensure acceptable server performance.
Human Factors testing
Human factors testing was performed on the d-Nav System according to FDA Guidance applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). Testing supported a determination of substantial equivalence.
Comprehensiveness Assessment
The requirements traceability matrix demonstrates that the requirements were fully covered by executing the steps.
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4.0 CONCLUSION
The intended use of the d-Nav System is equivalent to that of the predicate, as both are software devices that calculate the next dose of insulin to aid in optimizing insulin management.
Where there are differences between the detailed functionality of the d-Nav System and the predicate, the differences do not raise different questions of safety and effectiveness (see Discussion of Safety and Efficacy for Certain Differences above).
We conclude that the d-Nav System is substantially equivalent to the predicate.