(57 days)
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.
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.
The DreaMed Advisor Pro is a decision-support software for healthcare professionals managing Type 1 diabetes patients. It generates recommendations for optimizing insulin pump settings based on continuous glucose monitoring (CGM), self-monitoring blood glucose (SMBG), and pump data.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative performance table but discusses equivalence to a predicate device and clinical validity compared to expert recommendations.
| Feature / Characteristic | Acceptance Criteria (Implied / Compared to Predicate) | Reported Device Performance and Assessment |
|---|---|---|
| Agreement with Predicate Device (Retrospective Test) | - High level of agreement with DEN170043 when comparing recommendations over similar datasets. | - Retrospective tests showed a "high level of agreement" with the predicate device (DEN170043) for recommendations on similar data sets. - When sufficient data was available with simulated-SMBG, DreaMed Advisor Pro made similar recommendations to the predicate. - When insufficient data, DreaMed Advisor Pro did not recommend changes, mirroring the predicate's behavior without enough CGM data. |
| Clinical Validity vs. Experts (SMBG data alone) | - Recommendations in basal, CR, and CF plan (regarding direction of change) should be significantly as good as experts. | - An additional retrospective clinical study found that DreaMed Advisor Pro's recommendations (when 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." - This suggests the Advisor Pro's recommendations are similar to those from experienced healthcare professionals. |
| Minimum Data Points for Analysis (Subject Device) | - Minimum of 12 valid days. | - Achieved: Minimum of 12 valid days required. A valid day consists of: - Minimum glucose data: At least 67% of CGM sensor readings per day (e.g., 192 samples for 5-minute interval sensor, 64 samples for 15-minute interval sensor), OR - At least 4 BG measurements a day separated by at least 160 minutes. - Minimum insulin pump data: At least 1 basal rate record and 1 bolus record. - Insulin pump settings at analysis within acceptable ranges: Basal rate (0.025-3 u/h), CR (3-70gr/u), CF (10-280gr/u), Bolus calculator targets (≤ 150 mg/dl). |
| Input Data Specifications (Accuracy) | - CGM sensors with regulatory approval demonstrating accuracy below MARD of 15%. | - Achieved: Uses CGM with regulatory approval showing accuracy below MARD of 15%. |
| Non-clinical tests (Design Validation, Human Factors, Software) | - Performs according to stated intended use. - Human Factors validation documented per FDA Guidance. - All software test results fall within pre-determined specifications and acceptance criteria. - Special controls implemented and validated. | - Achieved: Design validation testing and human factors study results confirmed performance per intended use. - Human Factors validation documented according to FDA Guidance (February 3, 2016). - Software evaluation included functional testing; all results within pre-determined specification parameters and acceptance criteria. - Special controls implemented and validated per DreaMed's software test plan. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Clinical Study: 15 patients.
- Data Provenance: Retrospective clinical study. The document does not explicitly state the country of origin of the data.
3. Number of Experts and Qualifications
- Number of Experts: 17 experts.
- Qualifications of Experts: They are described as "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." No specific number of years of experience or physician titles (e.g., radiologist) are provided, as this is for diabetes management.
4. Adjudication Method
- Adjudication Method: The clinical study compared recommendations 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)." This implies a comparison against individual expert opinions, rather than a formal consensus-based adjudication method like 2+1 or 3+1. Each expert's recommendation was likely treated as a reference point for comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document describes a comparative study where the device's recommendations were compared against experts. It's a "retrospective clinical study" involving 17 experts reviewing data for 15 patients. While it involves multiple readers (experts) and multiple cases (patients), it focuses on the agreement between the AI and human experts, and experts among themselves, rather than a direct MRMC study to quantify how much human readers improve with AI assistance vs. without AI assistance. The study concluded that the Advisor Pro's recommendations were "significantly as good as the recommendations of expert," implying equivalence, but not necessarily an "improvement effect size" in a human-in-the-loop scenario.
6. Standalone Performance
- Yes, a standalone performance assessment was done. The "Additional retrospective clinical study" evaluated the DreaMed Advisor Pro's recommendations based on SMBG data alone and compared these recommendations directly to those of human experts. This demonstrates the algorithm's performance in generating recommendations without real-time human input or modification.
7. Type of Ground Truth Used
- Ground Truth: Expert consensus (or rather, expert recommendations serving as a reference) was used. The study compared the device's recommendations against the recommendations made by the 17 human experts.
8. Sample Size for the Training Set
- The document does not explicitly state the sample size used for the training set. It focuses on the validation of the device.
9. How the Ground Truth for the Training Set was Established
- The document does not describe how the ground truth for any potential training set was established. The clinical study mentioned is a validation study comparing the device's output to expert recommendations, not a description of the training data or its ground truth establishment.
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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.
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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
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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)
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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) | SubmitterAddress: | DreaMed Diabetes Ltd.5 Mota Gur StreetPetah Tikva4952701Israel |
|---|---|---|
| 1. (b) | ManufacturerAddress: | DreaMed Diabetes Ltd.5 Mota Gur StreetPetah Tikva4952701Israel |
| 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 AdjustmentCalculator For Healthcare Professionals classified as Class 2 QCC, RegulationNumber 21 CFR 862.1358 |
| 3. | Predicate Device: | Trade/Device Name: DreaMed Advisor ProRegulation Number: 21 CFR 862.1358Regulation Name: Insulin Therapy Adjustment DeviceRegulatory Class: Class IIProduct Code: QCCDEN170043 |
| 4. | Description: | DreaMed Advisor Pro is a software device that is designed to provide insulintherapy adjustment recommendations to physicians to assist in the managementof diabetes for patients with Type 1 diabetes using an insulin pump, a continuousglucose monitoring (CGM) system and self-management blood glucose meter(SMBG).The DreaMed Advisor Pro gathers and analyzes information inputted throughqualified Diabetes Management Systems (DMS), which collects biological inputinformation from various diabetes devices. Diabetes device information requiredand used by DreaMed Advisor Pro includes glucose readings (either CGM sensorreadings and/or capillary blood glucose measurements), insulin dosing logs, andmeal data during daily routine care. |
| Following data collection and analysis, the DreaMed Advisor Pro generates resultscontaining summary data and recommendations for adjustments to the patient'sinsulin therapy parameters, including basal insulin delivery rate(s), insulin tocarbohydrate ratio and correction factor (insulin sensitivity). DreaMed Advisor Promay also advise behavioral changes. Results are sent to a qualified DiabetesManagement Systems, which displays results to physicians and a report providedby DreaMed Diabetes. The physician can approve, reject or change therecommendations and issue the updated treatment plan to the patient. | ||
| 5. | Environment of Use: | None |
| 6. | Intended Use andIndication for use: | DreaMed Advisor Pro is a decision-support software intended for assistinghealthcare 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 whenanalyzing 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 theindication for use | With respect to the indication for use we conclude that the differences in theindication 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 ofTechnologicalCharacteristics: | With respect to technology characteristics the new version of DreaMed Advisor Prois substantially equivalent to its predicate device. DreaMed Diabetes believes thattheir 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 Concernrequirements. Design validation testing and human factors study resultsconfirmed that the DreaMed Advisor Pro performs according to the statedintended use. The Human Factors validation was documented according to FDAGuidance - Applying Human Factors and Usability Engineering to Medical Devices(February 3, 2016). Software evaluation consisted of functional testingperformed pursuant to DreaMed's software test plan. All test results fell withinthe pre-determined specification parameters and acceptance criteria. |
| Special controls were implemented and validated according to DreaMed softwaretest plan. |
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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.
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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).
- 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
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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 DeviceDreaMed Advisor Pro(subject device) | Predicate DeviceDreaMed Advisor Pro(DEN 170043) | Assessment ofdifference |
|---|---|---|---|
| Product Code | QCC | QCC | Same |
| Intended use (thegeneral purpose of thedevice or its function) | An Insulin pump therapyadjustment calculator forhealthcare professionals,intended to recommendinsulin pump therapyparameters adjustments(e.g. basal rates, insulinto carbohydrate ratios,insulin sensitivity factors)based on data fromexternal devices,including continuousglucose monitors | An Insulin pump therapyadjustment calculatorfor healthcareprofessionals, intendedto recommend insulinpump therapyparameters adjustments(e.g. basal rates, insulinto carbohydrate ratios,insulin sensitivityfactors) based on datafrom external devices,including continuousglucose monitors | Same |
| Indication for use(the disease orcondition the device willdiagnose, treat,prevent, cure ormitigate, including adescription of thepatient population forwhich the device isintended) | DreaMed Advisor Pro is adecision-supportsoftware intended forassisting healthcareprofessionalsin the management ofpatients with Type 1diabetes who:• use insulin pumps astheir insulin deliverytherapy;• monitor their glucoselevels using CGM and/orself-management bloodglucose meter• are above the age of 6and under 65 years old;and• use rapid acting U-100insulin analogs in theirpumpDreaMed Advisor Pro isindicated for use byhealthcare professionalswhen analyzingcontinuousglucose monitoring(CGM) self-monitoring | DreaMed Advisor Pro is adecision-supportsoftware intended forassisting healthcareprofessionalsin the management ofpatients with Type 1diabetes who:• use insulin pumps astheir insulin deliverytherapy;• monitor their glucoselevels using either of thefollowing:o CGM, oro CGM and self-management bloodglucose meter• are above the age of 6and under 65 years old;and• use rapid acting U-100insulin analogs in theirpumpDreaMed Advisor Pro isindicated for use byhealthcare professionalswhen analyzing | Different(markedwithBOLD ) |
| Feature /Characteristic | Subject DeviceDreaMed Advisor Pro(subject device) | Predicate DeviceDreaMed Advisor Pro(DEN 170043) | Assessment ofdifference |
| blood glucose (SMBG)and pump data togeneraterecommendations foroptimizing a patient'sinsulin pump settings forbasal rate, carbohydrateratio(CR), and correctionfactor (CF); withoutconsidering the fullclinical status of aparticular patient.DreaMed Advisor Prodoes not replace clinicaljudgment. | continuousglucose monitoring(CGM), self-monitoringblood glucose (SMBG)and pump data togeneraterecommendations foroptimizing a patient'sinsulin pump settings forbasal rate, carbohydrateratio(CR), and correctionfactor (CF); withoutconsidering the fullclinical status of aparticular patient.DreaMed Advisor Prodoes not replace clinicaljudgment. | ||
| Data inputs types | Continuous glucosemonitoring (CGM), self-monitoring blood glucose(SMBG) and pump data | Continuous glucosemonitoring (CGM), self-monitoring bloodglucose (SMBG) andpump data | Same |
| Timeframe overwhich data inputsmust be collected | 21 days | 21 days | Same |
| Minimum numberof data pointsrequired foraccuraterecommendations | Minimum of 12 validdays in order to performanalysis, where a validday is defined as a daythe consisted of:Minimum glucose dataper valid day:At least 67% of CGMsensor readings perday according to thesensor's sample rate(i.e., for a sensor thatpresents glucosereadings every 5minutes at least 192samples are requiredand for that presentsglucose readings | Minimum of 12 validdays in order to performanalysis, where a validday is defined as a daythe consisted of:Minimum glucose dataper valid day:At least 67% of CGMsensor readings perday according to thesensor's sample rate(i.e., for a sensor thatpresents glucosereadings every 5minutes at least 192samples are requiredand for that presentsglucose readings | Different(markedwithBOLD ) |
| Feature /Characteristic | Subject DeviceDreaMed Advisor Pro(subject device) | Predicate DeviceDreaMed Advisor Pro(DEN 170043) | Assessment ofdifference |
| every 15 minutes atleast 64 samples), OR• At least 4 BGmeasurements a daythat are separatedfrom each other by aleast 160 minutes.Minimum insulin pump dataper valid day:• At least 1 basal raterecord• At least 1 bolus recordIn addition, insulin pumpsettings at analysis must bewithin the following acceptablerange:• Basal rate - Each ratein the basal plan iswithin 0.025-3 u/h• Carbohydrate ratio -Each value in the CRplan is within 3-70gr/u• Correction Factor -Each value in the CFplan is within 10-280gr/u• Bolus calculatortargets - Equal to orbelow 150 mg/dl | every 15 minutes atleast 64 samples)Minimum insulin pump dataper valid day:• At least 1 basal raterecord• At least 1 bolus recordIn addition, insulin pumpsettings at analysis must bewithin the following acceptablerange:• Basal rate - Each ratein the basal plan iswithin 0.025-3 u/h• Carbohydrate ratio -Each value in the CRplan is within 3-70gr/u• Correction Factor -Each value in the CFplan is within 10-280gr/u• Bolus calculatortargets - Equal to orbelow 150 mg/dl | ||
| Input dataspecifications,includingaccuracyrequirements forcontinuousglucose monitorsand other devicesgenerating datainputs | • Blood glucosemeters - Allmeters withregulatoryapproval(dependent onlocation: EU /US/ Rest of theWorld [ROW])• Insulin pump -All insulinpumps withregulatoryapproval(dependent on | • Blood glucosemeters - Allmeters withregulatoryapproval(dependent onlocation: EU /US/ Rest of theWorld [ROW])• Insulin pump -All insulinpumps withregulatoryapproval(dependent on | Same |
| Feature /Characteristic | Subject DeviceDreaMed Advisor Pro(subject device) | Predicate DeviceDreaMed Advisor Pro(DEN 170043) | Assessment ofdifference |
| US/ ROW),including thosewith lowglucosesuspend orpredicted lowglucosesuspendfeatures. ContinuousGlucosesensors – CGMwhich hasreceivedregulatoryapproval fromauthorities,where as partof this approvalsafety andefficacy datawas shown toverify accuracyof the CGMbelow MARD of15%. | US/ ROW),including thosewith lowglucosesuspend orpredicted lowglucosesuspendfeatures. ContinuousGlucosesensors – CGMwhich hasreceivedregulatoryapproval fromauthorities,where as partof this approvalsafety andefficacy datawas shown toverify accuracyof the CGMbelow MARD of15%. | ||
| Device outputsand insulintherapyadjustmentrecommendationstype | Insulin therapyadjustmentrecommendations includebasal rate,carbohydrateratio (CR), andcorrectionfactor (CF);withoutconsidering thefull clinicalstatus of aparticularpatient Personaldiabetesmanagementtips | Insulin therapyadjustmentrecommendations includebasal rate,carbohydrateratio (CR), andcorrectionfactor (CF);withoutconsidering thefull clinicalstatus of aparticularpatient Personaldiabetesmanagementtips | Same |
| Table 2: Technological Characteristics Comparison | |||
| Feature /Characteristic | Subject DeviceDreaMed Advisor Pro(subject device) | Predicate DeviceDreaMed Advisor Pro(DEN 170043) | Assessment ofdifference |
| Clinical validity ofthe deviceoutputs andinsulin therapyrecommendations | The clinical validity ofthe device output wasevaluated in aretrospective studyversus experts in thefield of diabetes | The clinical validity ofthe device output wasevaluated in aretrospective studyversus experts in thefield of diabetes | Same |
| Means of datatransmission toand from thedevice, includingdata integritychecks, accuracychecks, reliabilitychecks, andsecurity measures | Data is transmitted fromDMS to Advisor deviceusing SSL mechanism,JSON data structure.Integrity checks,accuracy checks,reliability checks areperformed throughoutthe data transmissionfrom the data system, tothe algorithm and fromthe algorithm back tothe data system | Data is transmitted fromDMS to Advisor deviceusing SSL mechanism,JSON data structure.Integrity checks,accuracy checks,reliability checks areperformed throughoutthe data transmissionfrom the data system, tothe algorithm and fromthe algorithm back tothe data system | Same |
| Usabilitycharacteristics | The device has agraphical user interfacewhich presents to thehealthcare professionalthe report of theAdvisor. The healthcareprofessional can review,edit and share therecommendations withthe patient. Thehealthcare professionalcan review theglucose/insulin datathat was used togenerate the Advisorrecommendations. Thegraphical user interfacewas evaluated in HF/UEstudies to ensure safety | The device has agraphical user interfacewhich presents to thehealthcare professionalthe report of theAdvisor. The healthcareprofessional can review,edit and share therecommendations withthe patient. Thehealthcare professionalcan review theglucose/insulin datathat was used togenerate the Advisorrecommendations. Thegraphical user interfacewas evaluated in HF/UEstudies to ensure safety | Same |
| Means tominimize theoccurrence ofdosingrecommendationerrors | • Advisorimplementsprotectivemeasures toensure thereliability of the | • Advisorimplementsprotectivemeasures toensure thereliability of the | Same |
| Feature /Characteristic | Subject DeviceDreaMed Advisor Pro(subject device) | Predicate DeviceDreaMed Advisor Pro(DEN 170043) | Assessment ofdifference |
| as filtering non-physiologicalglucose inputs,not consideringrises in glucosewhich areattributed tospecificbehavior,correctingerrors in clockshift betweendevices.• Advisor haslimitations tothe magnitudeof the outputto ensuresafety | as filtering non-physiologicalglucose inputs,not consideringrises in glucosewhich areattributed tospecificbehavior,correctingerrors in clockshift betweendevices.• Advisor haslimitations tothe magnitudeof the outputto ensuresafety | ||
| Use of automatedinsulin dosingsystem with thedevice | Not allowed - part of thecontraindicationdevices. | Not allowed - part of thecontraindicationdevices. | Same |
| Identification ofspecific insulinformulations thathave beendemonstrated tobe compatiblewith use of thedevice | Rapid acting U-100insulin analogs | Rapid acting U-100insulin analogs | Same |
| Principles ofOperation | Algorithmicsoftware device | Algorithmicsoftware device | Same |
Table 2: Technological Cha -+ c rictics C
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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.
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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.
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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.
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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.
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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.
§ 862.1358 Insulin therapy adjustment device.
(a)
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.(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; 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).