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510(k) Data Aggregation
K Number
K210561Device Name
Advisor Pro Platform
Manufacturer
DreaMed Diabetes Ltd.
Date Cleared
2021-09-28
(215 days)
Product Code
QCC, NDC
Regulation Number
862.1358Why did this record match?
Applicant Name (Manufacturer) :
DreaMed Diabetes Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Advisor Pro Platform is intended for the management of diabetes by people with diabetes and their health care providers in order to report, log, track, share, monitor and review their data using the dedicated computer or mobile software. Advisor Pro Platform also enables communication between people with diabetes and their health care providers as well as among health care providers.
The Advisor Pro Platform enables the healthcare provider to use the Advisor Pro Algorithms for treatment recommendations as described below and prescribe the Advisor Pro Bolus Calculator for patient use.
Advisor Pro 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)
The Advisor Pro 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.
Advisor Pro 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. Advisor Pro Algorithm does not replace clinical judgment.
The Advisor Pro 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 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.
Device Description
The Advisor Pro Platform is a software device that is designed to be a diabetes management platform. It includes the Advisor Pro 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). The Advisor Pro Algorithm also provides insulin therapy adjustment recommendations to physicians to assist in the management 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).
The Advisor Pro Algorithm gathers and analyzes information inputted through the Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices and data sources including the DreaMed Diary App. Diabetes device information required and used by Advisor Pro Algorithm 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 Advisor Pro 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 or insulin to carbohydrate ratio and correction factor (insulin sensitivity) for bolus injections. Advisor Pro 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 the Advisor Pro Bolus Calculator which is integrated in the DreaMed Diary App to aid in calculating their bolus injections.
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