Software as a Medical Device, Real-World Evidence, Pediatric
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K210561 · Sep 28, 2021
Advisor Pro Platform
DreaMed Diabetes, Ltd.
Continuous glucose monitoring (CGM) sensor readings; Capillary blood glucose measurements (SMBG); Insulin dosing logs; Meal data collected during daily routine care
The Advisor Pro Algorithm analyzes routine clinical data (glucose, insulin, and meal logs) collected from patients' daily diabetes management to provide insulin therapy adjustment recommendations to healthcare professionals.
Retrospective analysis of routine clinical data; Follow-up/Duration: 21 days of data input
Patients with Type 1 diabetes (age >6) and Type 2 diabetes (age >10) using insulin therapy
Not applicable for this study
Generation of insulin therapy adjustment recommendations (basal, bolus, glucose targets)
AI Performance
Output
Algorithm
Acceptance
Observed
Dev DS
Dev Readers
Test DS
Test Readers
Insulin therapy adjustment recommendations
—
—
Significantly as good as the recommendations of experts in the basal and bolus plan with regards to the overall level of agreement in the direction of change.
—
—
Retrospective clinical study: 17 Type 1 patients and 15 Type 2 patients.
>1 (experts)
Indications for Use
The Advisor Pro Platform is intended for the management of diabetes by people with diabetes and their health care providers in order to report, log, track, share, monitor and review their data using the dedicated computer or mobile software. Advisor Pro Platform also enables communication between people with diabetes and their health care providers as well as among health care providers. The Advisor Pro Platform enables the healthcare provider to use the Advisor Pro Algorithms for treatment recommendations as described below and prescribe the Advisor Pro Bolus Calculator for patient use. Advisor Pro Algorithm is a decision-support software intended for assisting healthcare professionals in the management of their patients with diabetes who monitor their glucose levels using continuous glucose monitor (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter; and use any of the following insulin types as their therapy to manage glucose levels via subcutaneous injections or continuous sub-cutaneous insulin infusion (CSII; insulin pump) reported either manually or automatically: Long Acting insulins (for injections only) Short acting insulins: Rapid acting analogs (for injections and insulin pump according to manufacturer indications for use) Regular human insulin (for injections only) The Advisor Pro algorithm is intended to be used for patients with: Type 1 diabetes over the age of 6 using an insulin pump or subcutaneous insulin injections. Type 2 diabetes over the age of 10 who use subcutaneous insulin injections. Advisor Pro Algorithm is indicated for use by healthcare professionals when analyzing CGM, SMBG and/or insulin delivery data to generate recommendations for optimizing a patient's insulin treatment plan for basal therapy and/or bolus therapy and/or glucose targets; without considering the full clinical status of a particular patient. Advisor Pro Algorithm does not replace clinical judgment. The Advisor Pro Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information. The initial setup of the user's treatment plans, and bolus calculator settings must be performed by a healthcare provider.
Device Story
Software platform for diabetes management; inputs include CGM data, SMBG meter readings, insulin dosing logs, and meal/carb data. Algorithm analyzes historical insulin/glucose data to generate recommendations for basal rates, insulin-to-carb ratios, and correction factors. Healthcare providers review, approve, or modify recommendations via a dashboard. Bolus calculator component (for MDI users) calculates rapid-acting insulin doses based on user-entered blood glucose and meal info. Used in clinical settings by healthcare professionals to optimize treatment plans; patients use the DreaMed Diary App to log data. Benefits include personalized insulin therapy adjustments and improved glycemic management. Not for use with closed-loop systems.
Clinical Evidence
Retrospective clinical study evaluated physician strategies for adjusting basal-bolus therapy versus automated Advisor Pro Algorithm recommendations. Study cohort included 17 Type 1 and 15 Type 2 MDI patients, reviewed by 36 experts. Primary endpoint: level of agreement between expert-to-expert versus algorithm-to-expert. Results demonstrated algorithm recommendations were significantly as good as expert recommendations regarding direction of change.
Technological Characteristics
Software-only device; operates on standard computing platforms. Uses algorithmic analysis of glucose and insulin data. Complies with IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366-1 (usability). Connectivity via Diabetes Management Systems (DMS).
Indications for Use
Indicated for patients with Type 1 diabetes >6 years old (using insulin pump or subcutaneous injections) and Type 2 diabetes >10 years old (using subcutaneous injections). Used by healthcare professionals to analyze CGM, SMBG, and insulin data to generate insulin therapy recommendations. Bolus calculator indicated for patients with Type 1 (>6 years) and Type 2 (>10 years) diabetes using subcutaneous insulin injections.
Regulatory Classification
Identification
An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus.
Special Controls
(b) Classification: Class II (special controls). The special controls for this device are
- 1. Design verification and validation must include the following:
- (i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations.
- (ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated.
- (iii)Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations.
- (iv)A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification.
- (v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures.
- (vi)Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device.
- (vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level.
- 2. The device must not be intended for use in implementing automated insulin dosing.
- 3. Your 809.10(b) labeling must include:
- (i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device.
- (ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations.
- (iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device.
- (iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).
*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations;
(ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated;
(iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations;
(iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification;
(v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures;
(vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and
(vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level.
(2) The device must not be intended for use in implementing automated insulin dosing.
(3) Your 21 CFR 809.10(b) labeling must include:
(i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device;
(ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations;
(iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and
(iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).
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FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
INSTRUMENT ONLY
## I Background Information:
A 510(k) Number
K210561
B Applicant
DreaMed Diabetes Ltd.
C Proprietary and Established Names
Advisor Pro Platform
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QCC | Class II | 21 CFR 862.1358 - Insulin Therapy Adjustment Device | CH - Clinical Chemistry |
| NDC | Class II | 21 CFR 868.1890 - Predictive pulmonary-function value calculator | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modification to a previously cleared device to allow patients on Multiple Daily Injection (MDI) therapy to use the Advisor Pro Algorithm, and to add a bolus dose calculator for users of rapid acting insulin analogs.
B Type of Test:
Insulin Therapy Adjustment Device
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K210561 - Page 2 of 8
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
#### Advisor Pro Platform
The Advisor Pro Platform is intended for the management of diabetes by people with diabetes and their health care providers in order to report, log, track, share, monitor and review their data using the dedicated computer or mobile software. Advisor Pro Platform also enables communication between people with diabetes and their health care providers as well as among health care providers.
The Advisor Pro Platform enables the healthcare provider to use the Advisor Pro Algorithms for treatment recommendations as described below and prescribe the Advisor Pro Bolus Calculator for patient use.
#### Advisor Pro Algorithm
Advisor Pro Algorithm is a decision-support software intended for assisting healthcare professionals in the management of their patients with diabetes who monitor their glucose levels using continuous glucose monitor (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter; and use any of the following insulin types as their therapy to manage glucose levels via subcutaneous injections or continuous sub-cutaneous insulin infusion (CSII; insulin pump) reported either manually or automatically:
- Long Acting insulins (for injections only)
- Short acting insulins:
- Rapid acting analogs (for injections and insulin pump according to manufacturer indications for use)
- Regular human insulin (for injections only)
The Advisor Pro algorithm is intended to be used for patients with:
- Type 1 diabetes over the age of 6 using an insulin pump or subcutaneous insulin injections.
- Type 2 diabetes over the age of 10 who use subcutaneous insulin injections.
Advisor Pro Algorithm is indicated for use by healthcare professionals when analyzing CGM, SMBG and/or insulin delivery data to generate recommendations for optimizing a patient's
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insulin treatment plan for basal therapy and/or bolus therapy and/or glucose targets; without considering the full clinical status of a particular patient. Advisor Pro Algorithm does not replace clinical judgment.
## Advisor Pro Bolus Calculator
The Advisor Pro Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information.
The initial setup of the user's treatment plans, and bolus calculator settings must be performed by a healthcare provider.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
## Advisor Pro Algorithm:
For in vitro diagnostic use only
Advisor Pro algorithm is not intended to send recommendations directly to patients without initially being reviewed and approved by a certified HCP who considers the entire clinical status of the patient.
Advisor Pro algorithm is not recommended for patients that change their concomitant glucose-lowering therapies or alter their current therapy dose while using the Advisor Pro Algorithm. Since Advisor Pro algorithm only analyzes the insulin dosing history data and assumes all other elements that affect glucose levels are stable, the effect of changing or altering the dose of other glucose-lowering therapies will not be taken into consideration by Advisor Pro algorithm. This could result in a false conclusion about the changes to the patient's insulin treatment plan and may lead to potential harm. Advisor Pro algorithm is not recommended for pregnant women. Advisor Pro has not been tested in this population.
Advisor Pro algorithm is not intended for use with patients who use automated insulin dosing (AID) systems (e.g., "closed-loop", "artificial pancreas"). Advisor Pro algorithm hasn't been tested with these devices. Advisor Pro algorithm cannot identify the pump model or operating mode, and although Advisor Pro algorithm has some design mitigations to help detect when AID systems are used in closed loop mode and will usually prevent the system from providing recommendations for pump parameter changes, it cannot detect closed loop insulin delivery 100% of the time. Therefore, pay attention to pump information and the pump's operating mode and do not accept Advisor Pro recommendations if the user was using the AID system in closed loop mode.
Advisor Pro algorithm is not intended for use with patients who use insulin(s) other than the types indicated above. Advisor Pro algorithm hasn't been tested with other types of insulins. Using Advisor Pro algorithm with other types of insulin may lead to potential harm.
Advisor Pro algorithm is not recommended for patients who have changed their insulin type within the last 21 days. Since Advisor Pro algorithm only analyzes the current plan, the effect of changing the insulin type during period for analysis is not taken into consideration. This could
K210561 - Page 3 of 8
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result in a false conclusion about the changes to the patient’s insulin treatment plan and may lead to potential harm.
Advisor Pro algorithm is not intended for use with patients treated with intravenous (IV) insulin injections, or a combination of insulin injections and/or IV insulin and insulin pump therapy. Since Advisor Pro algorithm analyzes the insulin dosing history, it assumes a certain insulin delivery methodology as per the physician settings of the patient profile. Using Advisor Pro algorithm in the above manner could result in a false conclusion about the changes to the patient's insulin treatment plan and may lead to potential harm.
IV Device/System Characteristics:
A Device Description:
The Advisor Pro Platform is a software device that is designed to be a diabetes management platform. It includes the Advisor Pro Algorithm, the Advisor Pro Bolus Calculator and the DreaMed Diary App. The Advisor Pro Algorithm provides insulin therapy adjustment recommendations to healthcare professionals for the management of their patients with diabetes (Type 1 or Type 2) who monitor their glucose levels using continuous glucose monitor (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter and use insulin to manage glucose levels via subcutaneous injections (multiple daily injections (MDI)) or continuous sub-cutaneous insulin infusion (CSII, insulin pump) with dosing data reported either manually or automatically. The DreaMed Diary App allows those people with diabetes who administer Multiple Daily Injections (MDIs) of insulin to easily log and track blood glucose levels, insulin delivery and physical activity, as well as carb and meal information, providing that information as input to the DreaMed Advisor Pro Platform used by their HCP. The Advisor Bolus Calculator is hosted within the Diary App.
The Advisor Pro Algorithm gathers and analyzes information inputted through the Diabetes Management Systems (DMS), which collects information from various diabetes devices and data sources including the DreaMed Diary App. Diabetes device information required and used by Advisor Pro Algorithm includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care.
Following data collection and analysis, the Advisor Pro Algorithm generates results containing summary data and recommendations for adjustments to the patient’s insulin therapy parameters, including basal insulin delivery rate(s), insulin to carbohydrate ratio and correction factor (insulin sensitivity) for pump patients; and a daily injection plan for MDI patients including a basal plan as well as either a sliding scale or insulin to carbohydrate ratio and correction factor (insulin sensitivity) for bolus injections. Advisor Pro Algorithm may also advise on personalized diabetes management tips. Results are sent to the Diabetes Management System, which displays results to physicians and a report provided by the algorithm. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient.
For MDI patients using insulin to carbohydrate ratio and correction factor (insulin sensitivity) for bolus injections the healthcare provider may prescribe the Advisor Bolus Calculator which is integrated in the DreaMed Diary App to aid in calculating their bolus injections.
K210561 - Page 4 of 8
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K210561 - Page 5 of 8
# B Instrument Description Information:
1. Instrument Name:
Advisor Pro Platform
2. Specimen Identification:
Not applicable.
3. Specimen Sampling and Handling:
Not applicable.
4. Calibration:
Not applicable.
5. Quality Control:
Not applicable.
This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.
# V Substantial Equivalence Information:
A Predicate Device Name(s):
DreaMed Advisor Pro
B Predicate 510(k) Number(s):
K201476
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K210561 | K201476 |
| --- | --- | --- |
| Device Trade Name | Advisor Pro Platform | DreaMed Advisor Pro |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Same | Decision-support for assisting healthcare professionals in the management of insulin pump therapy for patients with Type 1 diabetes who:
• use insulin pumps as their insulin delivery therapy; |
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K210561 - Page 6 of 8
| | | • monitor their glucose levels using CGM and/or Self-Management Blood Glucose (SMBG) meter; and
• use rapid acting U-100 insulin analogs in their pump |
| --- | --- | --- |
| Timeframe over which data inputs must be collected | Same | 21 days |
| Principles of Operation | Algorithmic software device (Advisor Pro Algorithm) and insulin dose calculator based on user-entered data (Advisor Pro Bolus Calculator). | Algorithmic software device |
| Glucose Data Sources | Algorithm:
- Continuous glucose monitoring system data, or
- Continuous glucose monitoring system data and self-monitoring blood glucose meter values, or
- Self-monitoring blood glucose meter values (at least three per day, spaced at least 210 minutes apart)
Bolus Dose Calculator:
- user-entered blood glucose | Algorithm:
- Continuous glucose monitoring data, or
- Continuous glucose monitoring data and self-monitoring blood glucose meter values, or
- Self-monitoring blood glucose meter values (at least four per day, spaced at least 160 minutes apart) |
| Contraindications for Automated Insulin Dosing Systems | same | - This device is not intended for use with patients who use automated insulin dosing systems. |
| **General Device Characteristic Differences** | | |
| Insulin Therapy Adjustment Recommendation Types | Same outputs. For pump and MDI users. | Insulin therapy adjustment recommendations including basal rate, carbohydrate ratio (CR), correction factors (CF), and personal diabetes management tips.
For pump users only. |
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| Bolus Calculator | Yes, for MDI users only | Not available |
| --- | --- | --- |
| Age Range of Intended Users | Intended to be used for patients with:
- Type 1 diabetes over the age of 6
- Type 2 diabetes over the age of 10 | Intended to be used for patients with Type 1 diabetes above the age of 6 |
VI Standards/Guidance Documents Referenced:
21 CFR 862.1358 (Special controls established under DEN170043)
ISO 14971:2007; Medical Devices – Application of Risk Management to Medical Devices
ISO 15223-1:2016; Medical Devices – Symbols to be Used with Medical Device Labels, Labeling and Information to be Supplied – Part 1: General Requirements
IEC 62304:2006 – Medical Devices Software – Software Lifecycle Processes
IEC 62366-1:2015 - Medical Devices - Part 1: Application of Usability Engineering to Medical Devices
IEC 60601-1-6:2010; Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility: Not Applicable.
2. Linearity: Not Applicable.
3. Analytical Specificity/Interference: Not Applicable.
4. Accuracy (Instrument): Not Applicable.
5. Carry-Over: Not Applicable.
K210561 - Page 7 of 8
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B Other Supportive Instrument Performance Characteristics Data:
The sponsor assessed the clinical impact of the design modifications compared to the predicate, and performed a non-interventional expert survey to evaluate the use of the Advisor Pro algorithm for MDI users with Type 1 and Type 2 diabetes. Results from these assessments support that the Advisor Pro Platform, with the modified Advisor Pro Algorithm and the new Advisor Pro Bolus Calculator, is substantially equivalent to the predicate.
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K210561 - Page 8 of 8
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