Who is the manufacturer of DreaMed Advisor Pro?

DreaMed Diabetes, Ltd. filed the 510(k) submission for DreaMed Advisor Pro (K191370).

What is the FDA product code for DreaMed Advisor Pro?

QCC. It is classified under 21 CFR 862.1358 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for DreaMed Advisor Pro?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DreaMed Advisor Pro?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DreaMed Advisor Pro

K191370 · DreaMed Diabetes, Ltd. · QCC · Jul 18, 2019 · Clinical Chemistry

Device Facts

Record ID	K191370
Device Name	DreaMed Advisor Pro
Applicant	DreaMed Diabetes, Ltd.
Product Code	QCC · Clinical Chemistry
Decision Date	Jul 18, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1358
Device Class	Class 2
Attributes	Software as a Medical Device, Pediatric

Intended 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 CGM and/or self-management blood glucose meter; · are above the age of 6 and under 65 years old; and · use rapid acting U-100 insulin analogs in their pump. DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing continuous glucose monitoring (CGM), self-monitoring blood glucose (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 data (CGM/SMBG), insulin dosing logs, and meal data from Diabetes Management Systems (DMS). The device analyzes this data to generate recommendations for optimizing insulin pump settings: basal rates, carbohydrate ratios (CR), and correction factors (CF). It may also suggest behavioral changes. The physician reviews, approves, rejects, or modifies these recommendations before issuing an updated treatment plan. The device operates by filtering non-physiological inputs and applying safety limits to output magnitude. It is intended for clinical use to assist in therapy optimization, potentially improving patient outcomes by providing data-driven adjustments while maintaining physician oversight.

Clinical Evidence

Retrospective clinical study involving 17 experts reviewing 15 patient datasets (136 expert-to-expert pairs vs. 17 Advisor-to-expert pairs). Results showed Advisor Pro recommendations based on SMBG data alone were significantly as good as expert recommendations regarding the direction of change for basal, CR, and CF plans. Bench testing and human factors validation confirmed performance according to specifications.

Technological Characteristics

Algorithmic software device; processes CGM, SMBG, and insulin pump data. Connectivity via DMS using SSL and JSON. Implements protective measures including non-physiological input filtering and output magnitude limiting. Validated for Major Level of Concern. No hardware components.

Indications for Use

Indicated for healthcare professionals managing Type 1 diabetes patients aged 6-65 years using insulin pumps with rapid-acting U-100 insulin analogs and monitoring glucose via CGM and/or SMBG.

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 (DEN170043)

Related Devices

K201476 — DreaMed Advisor Pro · DreaMed Diabetes, Ltd. · Aug 28, 2020
DEN170043 — DreaMed Advisor Pro · DreaMed Diabetes, Ltd. · Jun 12, 2018
K210561 — Advisor Pro Platform · DreaMed Diabetes, Ltd. · Sep 28, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 18, 2019 DreaMed Diabetes Ltd. Eran Atlas Co-Founder & CEO 5 Mota Gur Street Petah Tikva, 4952701 Israel Re: K191370 Trade/Device Name: DreaMed Advisor Pro Regulation Number: 21 CFR 862.1358 Regulation Name: Insulin therapy adjustment device Regulatory Class: Class II Product Code: QCC Dated: May 20, 2019 Received: May 22, 2019 Dear Eran Atlas: 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. {1}------------------------------------------------ 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 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 B. Kelm, Ph.D. Acting 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) k191370 Device Name DreaMed Advisor Pro ### Indications for Use (Describe) 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 CGM and/or self-management blood glucose meter; · are above the age of 6 and under 65 years old; and · use rapid acting U-100 insulin analogs in their pump. DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing continuous glucose monitoring (CGM), self-monitoring blood glucose (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. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Dreamed Diabetes. The logo features the letters "dm" in a circular design on the left, with the word "dreamed" in a sans-serif font to the right. Below "dreamed" is the word "DIABETES" in smaller, all-caps letters. The color scheme is primarily gray and blue. # 510k submission DreaMed Diabetes, Ltd. 510(k) Summary Pursuant to CFR 807.92, the following 510(k) Summary is provided: | 1. (a) | Submitter Address: | DreaMed Diabetes Ltd. 5 Mota Gur Street Petah Tikva 4952701 Israel | |--------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. (b) | Manufacturer Address: | DreaMed Diabetes Ltd. 5 Mota Gur Street Petah Tikva 4952701 Israel | | | Mfg. Phone: | Tel .: +972-52-3166684 | | | Contact Person: | Mr. Eran Atlas | | | Date: | May 20th, 2019 | | 2. | Device & Classification Name: | DreaMed Advisor Pro, which is an Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals classified as Class 2 QCC, Regulation Number 21 CFR 862.1358 | | 3. | Predicate Device: | Trade/Device Name: DreaMed Advisor Pro Regulation Number: 21 CFR 862.1358 Regulation Name: Insulin Therapy Adjustment Device Regulatory Class: Class II Product Code: QCC DEN170043 | | 4. | 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, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG). The DreaMed Advisor Pro gathers and analyzes information inputted through qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. 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 daily routine care. | | | | Following data collection and analysis, the DreaMed Advisor Pro 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). DreaMed Advisor Pro may also advise behavioral changes. Results are sent to a qualified Diabetes Management Systems, 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. | | 5. | Environment of Use: | None | | 6. | Intended Use and Indication 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 CGM and/or self-management blood glucose meter; • are above the age of 6 and under 65 years old; and | | | | • use rapid acting U-100 insulin analogs in their pump. DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing continuous glucose monitoring (CGM), self-monitoring blood glucose (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. | | 7. | Comparison of the indication for use | With respect to the indication for use we conclude that the differences in the indication for use of new version of DreaMed Advisor Pro do not affect the safety and effectiveness of the device and do not alter the intended the use of the devices. | | 8. | Comparison of Technological Characteristics: | With respect to technology characteristics the new version of DreaMed Advisor Pro is substantially equivalent to its predicate device. DreaMed Diabetes believes that their device does not raise additional safety of efficacy concerns. At the end of this | | 9. | Non-clinical tests | DreaMed Advisor Pro was validated pursuant to the Major Level of Concern requirements. Design validation testing and human factors study results confirmed that the DreaMed Advisor Pro performs according to the stated intended use. The Human Factors validation was documented according to FDA Guidance - Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). Software evaluation consisted of functional testing performed pursuant to DreaMed's software test plan. All test results fell within the pre-determined specification parameters and acceptance criteria. | | | | Special controls were implemented and validated according to DreaMed software test plan. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Dreamed Diabetes. The logo consists of the letters 'dm' in a circular design on the left, followed by the word 'dreamed' in a smaller font. Below the word 'dreamed' is the word 'DIABETES' in an even smaller font. The color scheme is primarily blue and gray. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Dreamed Diabetes. The logo consists of the letters "dm" in a circle with an arrow pointing to the right. To the right of the circle is the word "dreamed" in a sans-serif font. Below the word "dreamed" is the word "DIABETES" in a smaller font. In addition, DreaMed has performed retrospective tests between the predicate device and the subject device. Results show that the two devices present high level of agreement when comparing the recommendations of each version over similar data sets of patients. Thus, from the high rate of level of agreement we can conclude that if there is enough data with simulated-SMBG DreaMed Advisor Pro is making similar recommendations to pump settings as DreaMed Advisor Pro (DEN170043) would do. When there is not data enough data DreaMed Advisor Pro doesn't recommend to changes the pump settings. This is exactly the characteristics of DreaMed Advisor Pro (DEN170043) when there is not enough CGM data to make certain recommendation. Therefore, it can be concluded that DreaMed Advisor Pro is substantially equivalent to DreaMed Advisor Pro (DEN170043). 10. Clinical Tests: Additional retrospective clinical study were performed to evaluate physicians' strategies of adjustment of insulin pump settings based on glucometer and pump data alone for patients with type 1 diabetes and to compare results to automated recommendations given by the DreaMed Advisor Pro. The study involved 17 experts which reviewed data set of 15 patients. Recommendations were compared to examine the level of agreement between one expert to his colleague (total of 136 pairs) versus the level of agreement between DreaMed Advisor Pro recommendations and experts (total of 17 pairs). The study results show that the recommendations of the DreaMed Advisor Pro when is based on SMBG data alone were significantly as good as the recommendations of expert in the basal, CR and in the CF plan with regards to the direction of change. Therefore, the Advisor Pro recommendations could be considered similar to those given by Healthcare Professional who work at leading centers with a wealth of experience in the field of diabetes and who are especially familiar with diabetes technology devices {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Dreamed Diabetes. The logo consists of the letters "dm" in a circle with an arrow pointing to the right. To the right of the circle is the word "dreamed" in a sans-serif font. Below the word "dreamed" is the word "DIABETES" in a smaller font. The following table compares these features and characteristics: | Feature / Characteristic | Subject Device DreaMed Advisor Pro (subject device) | Predicate Device DreaMed Advisor Pro (DEN 170043) | Assessment of difference | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Product Code | QCC | QCC | Same | | Intended use (the general purpose of the device or its function) | An Insulin pump therapy adjustment calculator for healthcare professionals, intended to recommend insulin pump therapy parameters adjustments (e.g. basal rates, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors | An Insulin pump therapy adjustment calculator for healthcare professionals, intended to recommend insulin pump therapy parameters adjustments (e.g. basal rates, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors | Same | | Indication for use (the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended) | 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 CGM and/or self-management blood glucose meter • are above the age of 6 and under 65 years old; and • use rapid acting U-100 insulin analogs in their pump DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing continuous glucose monitoring (CGM) self-monitoring | 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 either of the following: o CGM, or o CGM and self- management blood glucose meter • are above the age of 6 and under 65 years old; and • use rapid acting U-100 insulin analogs in their pump DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing | Different (marked with BOLD ) | | Feature / Characteristic | Subject Device DreaMed Advisor Pro (subject device) | Predicate Device DreaMed Advisor Pro (DEN 170043) | Assessment of difference | | | blood glucose (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 judgment. | continuous glucose monitoring (CGM), self-monitoring blood glucose (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 judgment. | | | Data inputs types | Continuous glucose monitoring (CGM), self- monitoring blood glucose (SMBG) and pump data | Continuous glucose monitoring (CGM), self- monitoring blood glucose (SMBG) and pump data | Same | | Timeframe over which data inputs must be collected | 21 days | 21 days | Same | | Minimum number of data points required for accurate recommendations | Minimum of 12 valid days in order to perform analysis, where a valid day is defined as a day the consisted of: Minimum glucose data per valid day: At least 67% of CGM sensor readings per day according to the sensor's sample rate (i.e., for a sensor that presents glucose readings every 5 minutes at least 192 samples are required and for that presents glucose readings | Minimum of 12 valid days in order to perform analysis, where a valid day is defined as a day the consisted of: Minimum glucose data per valid day: At least 67% of CGM sensor readings per day according to the sensor's sample rate (i.e., for a sensor that presents glucose readings every 5 minutes at least 192 samples are required and for that presents glucose readings | Different (marked with BOLD ) | | Feature / Characteristic | Subject Device DreaMed Advisor Pro (subject device) | Predicate Device DreaMed Advisor Pro (DEN 170043) | Assessment of difference | | | every 15 minutes at least 64 samples), OR • At least 4 BG measurements a day that are separated from each other by a least 160 minutes. Minimum insulin pump data per valid day: • At least 1 basal rate record • At least 1 bolus record In addition, insulin pump settings at analysis must be within the following acceptable range: • Basal rate - Each rate in the basal plan is within 0.025-3 u/h • Carbohydrate ratio - Each value in the CR plan is within 3-70gr/u • Correction Factor - Each value in the CF plan is within 10- 280gr/u • Bolus calculator targets - Equal to or below 150 mg/dl | every 15 minutes at least 64 samples) Minimum insulin pump data per valid day: • At least 1 basal rate record • At least 1 bolus record In addition, insulin pump settings at analysis must be within the following acceptable range: • Basal rate - Each rate in the basal plan is within 0.025-3 u/h • Carbohydrate ratio - Each value in the CR plan is within 3-70gr/u • Correction Factor - Each value in the CF plan is within 10- 280gr/u • Bolus calculator targets - Equal to or below 150 mg/dl | | | Input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs | • Blood glucose meters - All meters with regulatory approval (dependent on location: EU / US/ Rest of the World [ROW]) • Insulin pump - All insulin pumps with regulatory approval (dependent on | • Blood glucose meters - All meters with regulatory approval (dependent on location: EU / US/ Rest of the World [ROW]) • Insulin pump - All insulin pumps with regulatory approval (dependent on | Same | | Feature / Characteristic | Subject Device DreaMed Advisor Pro (subject device) | Predicate Device DreaMed Advisor Pro (DEN 170043) | Assessment of difference | | | US/ ROW), including those with low glucose suspend or predicted low glucose suspend features. Continuous Glucose sensors – CGM which has received regulatory approval from authorities, where as part of this approval safety and efficacy data was shown to verify accuracy of the CGM below MARD of 15%. | US/ ROW), including those with low glucose suspend or predicted low glucose suspend features. Continuous Glucose sensors – CGM which has received regulatory approval from authorities, where as part of this approval safety and efficacy data was shown to verify accuracy of the CGM below MARD of 15%. | | | Device outputs and insulin therapy adjustment recommendations type | Insulin therapy adjustment recommendati ons include basal rate, carbohydrate ratio (CR), and correction factor (CF); without considering the full clinical status of a particular patient Personal diabetes management tips | Insulin therapy adjustment recommendati ons include basal rate, carbohydrate ratio (CR), and correction factor (CF); without considering the full clinical status of a particular patient Personal diabetes management tips | Same | | Table 2: Technological Characteristics Comparison | | | | | Feature / Characteristic | Subject Device DreaMed Advisor Pro (subject device) | Predicate Device DreaMed Advisor Pro (DEN 170043) | Assessment of difference | | Clinical validity of the device outputs and insulin therapy recommendations | The clinical validity of the device output was evaluated in a retrospective study versus experts in the field of diabetes | The clinical validity of the device output was evaluated in a retrospective study versus experts in the field of diabetes | Same | | Means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures | Data is transmitted from DMS to Advisor device using SSL mechanism, JSON data structure. Integrity checks, accuracy checks, reliability checks are performed throughout the data transmission from the data system, to the algorithm and from the algorithm back to the data system | Data is transmitted from DMS to Advisor device using SSL mechanism, JSON data structure. Integrity checks, accuracy checks, reliability checks are performed throughout the data transmission from the data system, to the algorithm and from the algorithm back to the data system | Same | | Usability characteristics | The device has a graphical user interface which presents to the healthcare professional the report of the Advisor. The healthcare professional can review, edit and share the recommendations with the patient. The healthcare professional can review the glucose/insulin data that was used to generate the Advisor recommendations. The graphical user interface was evaluated in HF/UE studies to ensure safety | The device has a graphical user interface which presents to the healthcare professional the report of the Advisor. The healthcare professional can review, edit and share the recommendations with the patient. The healthcare professional can review the glucose/insulin data that was used to generate the Advisor recommendations. The graphical user interface was evaluated in HF/UE studies to ensure safety | Same | | Means to minimize the occurrence of dosing recommendation errors | • Advisor implements protective measures to ensure the reliability of the | • Advisor implements protective measures to ensure the reliability of the | Same | | Feature / Characteristic | Subject Device DreaMed Advisor Pro (subject device) | Predicate Device DreaMed Advisor Pro (DEN 170043) | Assessment of difference | | | as filtering non- physiological glucose inputs, not considering rises in glucose which are attributed to specific behavior, correcting errors in clock shift between devices. • Advisor has limitations to the magnitude of the output to ensure safety | as filtering non- physiological glucose inputs, not considering rises in glucose which are attributed to specific behavior, correcting errors in clock shift between devices. • Advisor has limitations to the magnitude of the output to ensure safety | | | Use of automated insulin dosing system with the device | Not allowed - part of the contraindication devices. | Not allowed - part of the contraindication devices. | Same | | Identification of specific insulin formulations that have been demonstrated to be compatible with use of the device | Rapid acting U-100 insulin analogs | Rapid acting U-100 insulin analogs | Same | | Principles of Operation | Algorithmic software device | Algorithmic software device | Same | ### Table 2: Technological Cha -+ c rictics C {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Dreamed Diabetes. The logo consists of the letters "dm" in a blue circle with an arrow pointing to the right. To the right of the circle is the word "dreamed" in a sans-serif font, with the word "DIABETES" in smaller letters below it. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Dreamed Diabetes. The logo consists of the letters "dm" in a circular shape on the left, followed by the word "dreamed" in blue. Below the word "dreamed" is the word "DIABETES" in a smaller font size. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Dreamed Diabetes. The logo consists of the letters "dm" in a blue circle with an arrow pointing to the right. To the right of the circle is the word "dreamed" in a sans-serif font, with the word "DIABETES" in smaller letters below it. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for Dreamed Diabetes. The logo consists of the letters "dm" in a circular design on the left, followed by the word "dreamed" in a sans-serif font. Below "dreamed" is the word "DIABETES" in a smaller font size. The logo is primarily blue and gray. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the logo for Dreamed Diabetes. The logo features the letters "dm" in a circular design on the left, followed by the word "dreamed" in a sans-serif font. Below "dreamed" is the word "DIABETES" in smaller letters. The color scheme is primarily blue and gray. ## Conclusion DreaMed Diabetes believes that the changes as described in this 510(k) submission, do not present additional safety or effectiveness concerns for the DreaMed Advisor Pro, which is a modification of the legally marketed DreaMed Advisor Pro (DEN170043). This is based upon the testing and validation data provided in this 510(k) notification. Accordingly, this should be sufficient for the FDA to determine the DreaMed Advisor Pro to be substantially equivalent to its predicate device because it has the same intended use and the same fundamental technology.