endo.digital Platform

K232722 · DreaMed Diabetes, Ltd. · QCC · Oct 3, 2023 · Clinical Chemistry

Device Facts

• Record ID: K232722
• Device Name: endo.digital Platform
• Applicant: DreaMed Diabetes, Ltd.
• Product Code: QCC · Clinical Chemistry
• Decision Date: Oct 3, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1358
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

Indications for Use

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.

Device Story

endo.digital Platform; software-based insulin therapy adjustment device. Inputs: patient glucose data, insulin regimen parameters. Transformation: algorithm processes data to generate insulin therapy adjustments; supports multiple treatment plans including Fixed Meal with sliding scale correction and Meal Estimation with sliding scale correction. Output: recommended insulin therapy adjustments for clinician review. Used in clinical settings; operated by healthcare providers. Assists clinicians in optimizing insulin dosing; improves glycemic management for patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by software design validation testing, including functional testing performed according to a pre-determined test plan. All results met pre-determined specification parameters and acceptance criteria.

Technological Characteristics

Software-based insulin therapy adjustment device; algorithm-driven; cloud-based or networked platform; no physical hardware components described.

Indications for Use

Indicated for patients with Type 1 diabetes >6 years old (using insulin pump or subcutaneous injections) and Type 2 diabetes >10 years old (using subcutaneous injections). Assists healthcare professionals in managing patients using CGM/SMBG and insulin therapy (long-acting, rapid-acting analogs, or regular human insulin).

Regulatory Classification

Identification

An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus.

Special Controls

(b) Classification: Class II (special controls). The special controls for this device are - 1. Design verification and validation must include the following: - (i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations. - (ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated. - (iii)Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations. - (iv)A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification. - (v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures. - (vi)Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device. - (vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level. - 2. The device must not be intended for use in implementing automated insulin dosing. - 3. Your 809.10(b) labeling must include: - (i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device. - (ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations. - (iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device. - (iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following: (i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations; (ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated; (iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations; (iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification; (v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures; (vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and (vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level. (2) The device must not be intended for use in implementing automated insulin dosing. (3) Your 21 CFR 809.10(b) labeling must include: (i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device; (ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations; (iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and (iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).

Predicate Devices

• endo.digital Platform (K232722 - original clearance)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K232722

B Applicant

DreaMed Diabetes Ltd

C Proprietary and Established Names

endo.digital Platform

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QCC | Class II | 21 CFR 862.1358 - Insulin Therapy Adjustment Device | CH - Clinical Chemistry |
| NDC | Class II | 21 CFR 868.1890 - Predictive pulmonary-function value calculator | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device **has not changed**. This change was for the addition of two new treatment plans to the insulin injections algorithm of the device: Fixed Meal with sliding scale correction and Meal Estimation with sliding scale correction.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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