Search Results
Found 3 results
510(k) Data Aggregation
K Number
K211160Device Name
EndoTool SubQ 2.1
Manufacturer
Monarch Medical Technologies, LLC
Date Cleared
2021-10-28
(192 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
Monarch Medical Technologies, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EndoTool SubQ 2.1 is a software application for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with hyperglycemia including adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) and when indicated a carbohydrate dosed on the prescribing healthcare Provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.
EndoTool SubQ 2.1 logic is not a substitute for clinical reasoning but an aid for trained healthcare professionals based on obtained glucose readings and entered clinical data. Final dose recommendations for a patient must be made only after consideration of the full clinical status of the patient. No medical decision should be made based solely upon the results provided by this software program.
Device Description
EndoTool SubQ 2.1 is a software application for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with hyperglycemia including adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) and when indicated a carbohydrate dose based on the prescribing healthcare Provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.
The EndoTool® SubQ 2.1 Glucose Management system includes security, software, and technical support features. Each user has an individual User Identification (ID) and Password to access portions of the application. EndoTool SubQ 2.1 is designed to safeguard the confidentiality, integrity, and availability of electronic protected health information of patients according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rules.
EndoTool SubQ 2.1 is packaged in a user friendly, stand-alone program. The application is installed on Windows Server 2008 R2 or newer. The end-user should access the application using a compatible web browser, such as Internet Explorer 9 and higher, or Google Chrome 58 and higher. The application was developed for use on Personal Computers (PCs), network servers, and terminal server environments. As EndoTool SubQ 2.1 data is time sensitive, it is also imperative that all PCs and servers be set with the correct date and time using UTC.
EndoTool SubQ can utilize barcode scanning in Code 39 format (also known as Alpha39, Code 3 of 9, Code 3/9, Type 39, USS Code 39, or USD-3) for patient identification/verification.
Ask a Question
K Number
K201619Device Name
EndoTool IV System
Manufacturer
Monarch Medical Technologies, LLC
Date Cleared
2020-08-07
(53 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
Monarch Medical Technologies, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EndoTool IV is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool IV logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
Device Description
EndoTool IV is a software system for glucose management which uses the current and cumulative glucose values provided by the user to calculate and recommend intravenous insulin or carbohydrate doses, to adjust and maintain the patient's glucose level within a provider-ordered target range. In addition, the application can recommend a subcutaneous Basal transition insulin therapy is no longer required.
Ask a Question
K Number
K200443Device Name
EndoTool IV 1.10
Manufacturer
Monarch Medical Technologies, LLC
Date Cleared
2020-03-17
(22 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
Monarch Medical Technologies, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
By evaluating current and cumulative blood glucose levels, EndoTool IV 1.10 - a glycemic management software support program - is designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level within a configurable clinician- determined target range. The EndoTool Drug Delivery Calculator is indicated for use in adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more. EndoTool IV 1.10 logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.
Device Description
EndoTool IV is a software device for blood glucose management which evaluates current and cumulative blood glucose values to recommend intravenous insulin or dextrose/carbohydrate dose, to adjust and maintain the blood glucose level within a provider-ordered target range. In addition, the application will recommend a subcutaneous Basal transition insulin dose when IV insulin therapy is no longer required.
Ask a Question
Page 1 of 1