(57 days)
Not Found
Unknown
While the device performs complex data analysis and generates recommendations, the summary does not explicitly mention the use of AI or ML algorithms. The description of the performance study comparing the device's recommendations to expert recommendations suggests a rule-based or algorithmic approach rather than a machine learning model trained on data.
No.
A therapeutic device directly treats or cures a disease. This device is a decision-support software that provides recommendations to healthcare professionals, who then make the final judgment and issue the treatment plan. It does not directly provide therapy.
No
The device is a decision-support software that provides recommendations for optimizing insulin pump settings. It does not diagnose any condition itself but assists healthcare professionals in managing patients with existing Type 1 diabetes.
Yes
The device description explicitly states "DreaMed Advisor Pro is a software device". While it interacts with data from hardware devices (insulin pumps, CGM, SMBG), the device itself is the software that processes this data and generates recommendations.
Based on the provided text, DreaMed Advisor Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DreaMed Advisor Pro's Function: DreaMed Advisor Pro analyzes data from other devices (CGM, SMBG, insulin pump) that collect biological information (glucose readings, insulin dosing). It doesn't directly analyze biological specimens itself. Its purpose is to provide decision support to healthcare professionals based on this collected data.
Therefore, while it uses data derived from biological measurements, it is a software device that processes and interprets this data for therapy management, not a device that performs the in vitro diagnostic test itself.
N/A
Intended Use / 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 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.
Product codes
QCC
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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
above the age of 6 and under 65 years old
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Retrospective tests: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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).
- 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
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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.
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.
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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.