DreaMed Advisor Pro

K201476 · DreaMed Diabetes, Ltd. · QCC · Aug 28, 2020 · Clinical Chemistry

Device Facts

• Record ID: K201476
• Device Name: DreaMed Advisor Pro
• Applicant: DreaMed Diabetes, Ltd.
• Product Code: QCC · Clinical Chemistry
• Decision Date: Aug 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1358
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who: · use insulin pumps as their insulin delivery therapy; · monitor their glucose levels using continuous glucose monitoring (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter; • are above the age of 6; and · use rapid acting U-100 insulin analogs in their pump DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing CGM, SMBG and pump data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, Carbohydrate Ratio (CR), and Correction Factor (CF); without considering the full clinical status of a particular patient. DreaMed Advisor Pro does not replace clinical judgement.

Device Story

DreaMed Advisor Pro is a decision-support software for healthcare professionals managing Type 1 diabetes. It ingests glucose readings (CGM/SMBG), insulin dosing logs, and meal data from third-party Diabetes Management Systems (DMS). The software analyzes this data to generate recommendations for insulin pump parameters: basal rates, carbohydrate ratios, correction factors, and active insulin time. It also provides behavioral reminders (e.g., infusion set changes). Recommendations are sent back to the DMS for physician review; the physician may approve, reject, or modify the treatment plan before implementation. By automating data analysis, the device assists clinicians in optimizing insulin therapy, potentially improving glycemic control. It is intended for clinical use by healthcare professionals and is not for direct patient use without physician oversight.

Clinical Evidence

No new clinical trials were conducted. The submission relied on a clinical impact assessment to support the removal of the upper age limit of 65 years, which was reviewed and found acceptable by the FDA.

Technological Characteristics

Software-based decision support system. Operates via algorithmic analysis of patient data. Integrates with third-party Diabetes Management Systems (DMS) for data input/output. Complies with ISO 14971 (risk management), IEC 62304 (software lifecycle), and IEC 62366-1 (usability).

Indications for Use

Indicated for patients >6 years old with Type 1 diabetes using insulin pumps and CGM/SMBG monitoring with rapid-acting U-100 insulin. Contraindicated for patients using automated insulin dosing (AID) systems, non-U-100 insulin, insulin injections/IV insulin, other glucose-lowering therapies, pregnant women, or patients taking medications affecting CGM/SMBG accuracy.

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).

Predicate Devices

• DreaMed Advisor Pro (K191370)

Submission Summary (Full Text)

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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

K201476

B Applicant

DreaMed Diabetes Ltd

C Proprietary and Established Names

DreaMed Advisor Pro

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QCC | Class II | 21 CFR 862.1358 - Insulin Therapy Adjustment Device | Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

Modification to a previously cleared device to update the indications for use allowing patients over 65 years old to use the device.

B Type of Test:

Insulin Therapy Adjustment Device

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) for Use:

DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who:

- use insulin pumps as their insulin delivery therapy;
- monitor their glucose levels using continuous glucose monitoring (CGM) and/or self-monitoring blood glucose (SMBG) meter;
- are above the age of 6; and
- use rapid acting U-100 insulin analogs in their pump

DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing CGM, SMBG and pump data to generate recommendations for optimizing a patient’s insulin pump settings for basal rate, Carbohydrate Ratio (CR), and Correction Factor (CF); without considering the full clinical status of a particular patient. DreaMed Advisor Pro does not replace clinical judgement.

C Special Conditions for Use Statement(s):

- Rx - For Prescription Use Only
- For in vitro diagnostic use only
- This device is not intended to send recommendations directly to patients without initially being reviewed and approved by a healthcare professional (HCP).
- This device is not intended for use with patients who use automated insulin dosing systems. (e.g., "closed-loop", "artificial pancreas", see labeling for a list of the contraindicated devices). Advisor Pro hasn't been tested with these devices. Advisor Pro cannot identify the pump model or operating mode, and although Advisor Pro 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.
- This device is not intended for use with patients who use insulin(s) other than U-100. Advisor Pro hasn't been tested with other types of insulins and is designed to consider the pharmacodynamics and pharmacokinetics of U-100 insulin only. Using Advisor Pro with other types of insulin may lead to potential harm.
- This device is not intended for use with patients treated with insulin injections, intravenous (IV) insulin, or a combination of insulin injections and/or IV insulin and insulin pump therapy. Since Advisor Pro analyzes the insulin dosing history from the insulin pump, it will be blind to insulin delivered by injections and/or IV insulin. This could result to a false conclusion about the changes to the patient's insulin pump settings and may lead to potential harm.
- This device is not intended for patients using other concomitant glucose lowering therapies. Since Advisor Pro analyze the insulin dosing history from the insulin pump, reducing glucose levels by other means will not be taken into consideration by Advisor Pro. This could result

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to a false conclusion about the changes to the patient's insulin pump settings and may lead to potential harm.

- This device is not recommended for pregnant women. Advisor Pro hasn't been tested in this population.
- This device is not recommended for patients who are taking medications that might affect CGM/SMBG values. Please refer to the warnings and contraindications of the patient's CGM/ blood glucose meter to determine whether said medications may falsely raise glucose readings. The level of inaccuracy depends on the amount of said medication active in the patient's body and may be different for each person. Using Advisor Pro in these cases may lead to potential harm.

## IV Device/System Characteristics:

### A Device Description:

DreaMed Advisor Pro is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, and a continuous glucose monitoring (CGM) system and/or self-monitoring blood glucose (SMBG) system.

The DreaMed Advisor Pro gathers and analyzes information inputted through qualified third party Diabetes Management Systems (DMS), which collect biological input information from insulin pumps, glucose meters, and continuous glucose monitoring systems. Diabetes device information required and used by DreaMed Advisor Pro includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during routine care.

Following data collection and analysis, the DreaMed Advisor Pro generates results containing summary data and recommendations for adjustments to a patient's insulin pump therapy parameters, including: basal insulin delivery rate(s), insulin to carbohydrate ratio, correction factor (insulin sensitivity), active insulin time and glucose targets. DreaMed Advisor Pro may also advise behavioral changes, such as reminders to change infusion sets every 2-3 days, to use current blood glucose information when calculating a bolus, and about the timing of meal boluses to avoid hyperglycemia. Results are sent to a qualified third party Diabetes Management System, which displays results to physicians and a report provided by DreaMed Diabetes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient.

### B Instrument Description Information:

1. Instrument Name: DreaMed Advisor Pro
2. Specimen Identification: Not applicable.

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3. Specimen Sampling and Handling: Not applicable.
4. Calibration: Not applicable.
5. Quality Control: Not applicable.

## V Substantial Equivalence Information:

A Predicate Device Name(s): DreaMed Advisor Pro
B Predicate 510(k) Number(s): K191370

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K201476 | K191370 |
| --- | --- | --- |
| Device Trade Name | DreaMed Advisor Pro | 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;
• 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 |

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| Device & Predicate Device(s): | K201476 | K191370 |
| --- | --- | --- |
| Device outputs and insulin therapy adjustment recommendations type | Same | Insulin therapy adjustment recommendations including basal rate, carbohydrate ratio (CR), correction factors (CF), and personal diabetes management tips. |
| Principles of Operation | Same | Algorithmic software device |
| Glucose Data Sources | Same | - Continuous glucose monitor data, or
- Continuous glucose monitor 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 | | |
| Age Range of Intended Users | above the age of 6 | above the age of 6 and under 65 years old |

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

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IEC 62366-1:2015 - Medical Devices - Part 1: Application of Usability Engineering to Medical Devices

ISO 14155 - Clinical Investigation Of Medical Devices For Human Subjects - Good Clinical Practice

## 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.

### B Other Supportive Instrument Performance Characteristics Data:

A Clinical Impact Assessment for removing the upper age limit of 65 years old was provided in the submission and found to be acceptable.

## 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.

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