(28 days)
Not Found
No
The document describes an "Algorithm" for generating insulin therapy recommendations, but it does not explicitly mention or describe the use of AI or ML techniques in its operation or development. The performance studies focus on functional testing and comparison to a predicate device, not on AI/ML specific metrics or validation.
Yes.
The device provides treatment recommendations for optimizing insulin therapy and includes a bolus calculator, directly assisting in the management of diabetes.
No
Explanation: The device provides "treatment recommendations" and "decision-support software for assisting healthcare professionals in the management of their patients with diabetes," which indicates it is a therapeutic device rather than a diagnostic device that identifies diseases or conditions.
Yes
The device description explicitly states "endo.digital Platform is a software device". While it interacts with data from hardware devices (CGM, SMBG, insulin pumps), the device itself, as described, is solely the software platform and its components (Algorithm, Bolus Calculator).
Based on the provided information, the endo.digital Platform 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, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- endo.digital Platform's Function: The endo.digital Platform is a software device that manages diabetes data, provides treatment recommendations based on glucose readings and insulin delivery data, and facilitates communication. While it uses data from devices that measure biological parameters (CGM and SMBG), the platform itself does not perform the analysis of a biological specimen. It processes and analyzes data already obtained from these devices.
- Intended Use: The intended use clearly states it's for the management of diabetes by people with diabetes and their healthcare providers, and for generating recommendations for optimizing insulin treatment plans. This is a data management and decision support function, not an in vitro diagnostic test.
The platform's function is to process and interpret data from other devices (CGM and SMBG) that do interact with the body or bodily fluids, but the platform itself does not perform the diagnostic test on a specimen.
N/A
Intended Use / Indications for Use
endo.digital Platform is intended for the management of diabetes by people with diabetes and their healthcare providers in order to report, upload, log, track, share, monitor and review their data using web and mobile applications. endo.digital Platform also enables communication between people with diabetes and their healthcare providers as well as among healthcare providers.
endo.digital Platform enables the healthcare provider to use endo.digital Algorithm for treatment recommendations as described below and prescribe endo.digital Bolus Calculator for patient use.
endo.digital Algorithm is a decision-support software intended for assisting healthcare professionals in the management of their patients with diabetes who monitor their glucose levels using continuous ducose monitor (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter: and use any of the following insulin types as their therapy to manage glucose levels via subcutaneous injections or continuous sub-cutaneous insulin infusion (CSII; insulin pump) reported either manually or automatically:
- . Long acting insulins (for injections only)
- . Short acting insulins:
- Rapid acting analogs (for injections and insulin pump according to manufacturer o indications for use)
- Reqular human insulin (for injections only) о
endo.digital Algorithm is intended to be used for patients with:
- . Type 1 diabetes over the age of 6 using an insulin pump or subcutaneous insulin iniections.
- Type 2 diabetes over the age of 10 who use subcutaneous insulin injections. ●
endo.digital Algorithm is indicated for use by healthcare professionals when analyzing CGM, SMBG and/or insulin delivery data to generate recommendations for optimizing a patient's insulin treatment plan for basal therapy and/or bolus therapy and/or glucose targets, without considering the full clinical status of a particular patient. endo.digital Algorithm does not replace clinical judgement.
endo.digital Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood qlucose and/or meal information.
The initial setup of the user's treatment plans, and bolus calculator settings must be performed by a healthcare provider
Product codes (comma separated list FDA assigned to the subject device)
QCC, NDC
Device Description
endo.digital Platform is a software device that is designed to be a diabetes management platform. It includes endo.digital Algorithm that provides insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump or multiple daily injections, a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG). endo.digital Algorithm also provides insulin therapy adjustment recommendations to physicians to assist in the manaqement of diabetes for patients with Type 2 diabetes on basal-bolus therapy via multiple daily injections (MDI), a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG). endo.digital Algorithm gathers and analyzes information inputted through the Diabetes Management Systems (DMS), which collect biological input information from various diabetes devices and data sources including the DreaMed Diary App. Diabetes device information required and used by endo.digital Algorithm includes qlucose 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 endo.digital Algorithm generates results containing summary data and recommendations for adjustments to the patient's insulin therapy parameters, including basal insulin delivery rate(s), insulin to carbohydrate ratio and correction factor (insulin sensitivity) for pump patients, and for MDI patients a daily injection plan including a basal plan and either a sliding scale (which can include Fixed Meal and Meal Estimation plans) or insulin to carbohydrate ratio and correction factor (insulin sensitivity) for bolus injections. endo.digital Algorithm may also advise on personalized diabetes management tips. Results are sent to the Diabetes Management System, which displays results to physicians and a report provided by the algorithm. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient. For MDI patients using rapid acting analogs for insulin bolus dose, the healthcare provider may prescribe endo.digital Bolus Calculator which is integrated in the DreaMed Diary App to aid in calculating their bolus injections.
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
Type 1 diabetes over the age of 6
Type 2 diabetes over the age of 10
Intended User / Care Setting
healthcare providers, people with diabetes
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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 in blue, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font, also in blue. The logo is simple and professional, and it is easily recognizable.
October 3, 2023
DreaMed Diabetes Ltd. Eran Atlas, CEO 14 Kaplan St, POB 3271 Petah Tikva, 4952701 Israel
Re: K232722
Trade/Device Name: endo.digital Platform Regulation Number: 21 CFR 862.1358 Regulation Name: Insulin Therapy Adjustment Device Regulatory Class: Class II Product Code: QCC, NDC Dated: September 5, 2023 Received: September 5, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232722
Device Name endo.digital Platform
Indications for Use (Describe)
endo.digital Platform
endo.digital Platform is intended for the management of diabetes and their healthcare providers in order to report, upload, log, track, share, monitor and review their data using web and mobile applications. endo.digital Platform also enables communication between people with diabetes and their healthcare providers as well as among healthcare providers.
endo.digital Platform enables the healthcare provider to use endo.digital Algorithm for
treatment recommendations as described below and prescribe endo.digital Bolus Calculator for patient use.
endo.digital Algorithm
endo. digital Algorithm is a decision-support software intended for assisting healthcare professionals in the management of their patients with diabetes who monitor their glucose levels using continuous glucose monitor (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter; and use any of the following insulin types as their therapy to manage glucose levels via subcutaneous injections or continuous sub-cutaneous insulin infusion (CSII; insulin pump) reported either manually or automatically:
- Long acting insulins (for injections only)
- Short acting insulins:
- · Rapid acting analogs (for injections and insulin pump according to manufacturer indications for use)
- · Regular human insulin (for injections only)
endo.digital Algorithm is intended to be used for patients with:
- Type 1 diabetes over the age of 6 using an insulin pump or subcutaneous insulin injections.
- Type 2 diabetes over the age of 10 who use subcutaneous insulin injections.
endo.digital Algorithm is indicated for use by healthcare professionals when analyzing CGM, SMBG and/or insulin delivery data to generate recommendations for optimizing a patient's insulin treatment plan for bolus therapy and/or glucose targets, without considering the full clinical status of a particular patient. Algorithm does not replace clinical judgement.
endo.digital Bolus Calculator
endo.digital Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on userentered blood glucose and/or meal information. The initial setup of the user's treatment plans, and bolus calculator settings must be performed by a healthcare provider.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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."
4
510(k) SUMMARY endo.digital Platform
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
DreaMed Diabetes Ltd. 14 Kaplan St. Petah Tikva 4952701 Israel
Contact Person: eran.atlas Email: eran.atlas@dreamed.ai Phone: +972-52-3166684 Date Prepared: August 29,2023
510(k) Number
K232722
Name of Device and Name/Address of Sponsor
endo.digital Platform (combined with endo.digital Algorithm for insulin injections version 02.05.xx, endo.digital Algorithm for insulin pumps version 01.09.xx, endo.digital Algorithm Server version 02.01.xx) DreaMed Diabetes Ltd. 14 Kaplan St Petah Tikva 4952701 Israel
Common or Usual Name
Insulin Therapy Adjustment Device
Calculator, Drug Dose
Classification
Class II, 21 CFR 862.1358, Product Code: QCC,
Class II, 21 CFR 868.1890, Product Code: NDC.
Predicate Devices
Advisor Pro Platform, K210561
Intended Use / Indications for Use
endo.digital Platform
endo.digital Platform is intended for the management of diabetes by people with diabetes and their healthcare providers in order to report, upload, log, track, share, monitor and review their data using web and mobile applications. endo.digital Platform also enables communication
5
dream
between people with diabetes and their healthcare providers as well as among healthcare providers
endo.digital Platform enables the healthcare provider to use endo.digital Algorithm for treatment recommendations as described below and prescribe endo.digital Bolus Calculator for patient use.
endo.digital Algorithm
endo.digital Algorithm is a decision-support software intended for assisting healthcare professionals in the management of their patients with diabetes who monitor their glucose levels using continuous ducose monitor (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter: and use any of the following insulin types as their therapy to manage glucose levels via subcutaneous injections or continuous sub-cutaneous insulin infusion (CSII; insulin pump) reported either manually or automatically:
- . Long acting insulins (for injections only)
- . Short acting insulins:
- Rapid acting analogs (for injections and insulin pump according to manufacturer o indications for use)
- Reqular human insulin (for injections only) о
endo.digital Algorithm is intended to be used for patients with:
- . Type 1 diabetes over the age of 6 using an insulin pump or subcutaneous insulin iniections.
- Type 2 diabetes over the age of 10 who use subcutaneous insulin injections. ●
endo.digital Algorithm is indicated for use by healthcare professionals when analyzing CGM, SMBG and/or insulin delivery data to generate recommendations for optimizing a patient's insulin treatment plan for basal therapy and/or bolus therapy and/or glucose targets, without considering the full clinical status of a particular patient. endo.digital Algorithm does not replace clinical judgement.
endo.digital Bolus Calculator
endo.digital Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood qlucose and/or meal information.
The initial setup of the user's treatment plans, and bolus calculator settings must be performed by a healthcare provider
Device Description
endo.digital Platform is a software device that is designed to be a diabetes management platform. It includes endo.digital Algorithm that provides insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump or multiple daily injections, a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG). endo.digital Algorithm also provides insulin therapy adjustment recommendations to physicians to assist in the manaqement of diabetes for patients with Type 2 diabetes on basal-bolus therapy via multiple daily injections (MDI), a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG). endo.digital Algorithm gathers and analyzes information inputted
6
dreamed
through the Diabetes Management Systems (DMS), which collect biological input information from various diabetes devices and data sources including the DreaMed Diary App. Diabetes device information required and used by endo.digital Algorithm includes qlucose 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 endo.digital Algorithm generates results containing summary data and recommendations for adjustments to the patient's insulin therapy parameters, including basal insulin delivery rate(s), insulin to carbohydrate ratio and correction factor (insulin sensitivity) for pump patients, and for MDI patients a daily injection plan including a basal plan and either a sliding scale (which can include Fixed Meal and Meal Estimation plans) or insulin to carbohydrate ratio and correction factor (insulin sensitivity) for bolus injections. endo.digital Algorithm may also advise on personalized diabetes management tips. Results are sent to the Diabetes Management System, which displays results to physicians and a report provided by the algorithm. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient. For MDI patients using rapid acting analogs for insulin bolus dose, the healthcare provider may prescribe endo.digital Bolus Calculator which is integrated in the DreaMed Diary App to aid in calculating their bolus injections.
Substantial Equivalence
endo.digital Platform has the same intended use as the previously cleared DreaMed Advisor Pro. In addition, endo.digital Platform has very similar indications, technological characteristics, and principles of operation as its predicate. The indications for use difference between the subject device and its predicate device, which consists of the additional device capability wherein data can be uploaded directly to the device, raises no new issues of safety or effectiveness. Similarly, the only difference in the device's output are the additional options for insulin therapy adjustment recommendations, which now include plans for Fixed Meal with sliding scale correction and for Meal Estimation with sliding scale correction. As the cleared predicate device already implemented the technological characteristics of analyzing insulin bolus plans that include separate settings for the meal portion of the bolus and the correction portion of the bolus in some treatment plans, the addition of these new treatment plans does not raise any new risks.
Therefore, although there are minor differences between endo.digital Platform and its predicate. those differences do not raise new questions of safety or efficacy. Furthermore, software performance data demonstrates that endo.digital Platform is as safe and effective as the predicate device. Thus, endo.digital Platform is substantially equivalent.
Software
endo.digital Platform was validated pursuant to the Major Level of Concern requirements. Design validation testing results confirmed that endo.digital Platform performs according to the stated intended use. 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.
Conclusions
DreaMed Diabetes believes that the changes as described in this 510(k) submission do not present additional safety or effectiveness concerns for endo.digital Platform including endo.digital Algorithm as well as endo.digital Bolus Calculator and is substantially equivalent to the predicate cited.