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510(k) Data Aggregation
K Number
K241088Device Name
EndoTool IV (3.1)
Manufacturer
Monarch Medical Technologies
Date Cleared
2024-12-11
(236 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
Monarch Medical Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EndoTool IV 3.1 is a glucose management software system used by healthcare professionals in all inpatient care settings for adult and pediatric patients aged two years and above who weigh 12 kgs. or more. EndoTool adjusts and maintains a patient's glucose level within a configurable clinician-determined target range by recommending patient-specific intravenous insulin dosing, carbohydrate dosing for recovery or supplementation, and subcutaneous dosing for the transition from IV dosing.
EndoTool IV 3.1 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 3.1 is a software system for glucose management which uses the current and cumulative qlucose 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 dose when IV insulin therapy is no longer required.
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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.
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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.
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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.
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K Number
K142918Device Name
EndoTool SubQ
Manufacturer
MONARCH MEDICAL TECHNOLOGIES
Date Cleared
2015-04-24
(199 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
MONARCH MEDICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EndoTool SubQ 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 Diabetes Mellitus in both 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 is not a substitute for clinical reasoning, but is an aid for trained healthcare professionals to manage patients. The System is based on obtained glucose readings and clinical data entered by the medical staff. Final dose decisions 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 on the recommendations provided by this software program.
Device Description
Monarch Medical Technology's EndoTool SubQ Glucose Management System is a glucose management software solution for healthcare institutions. This system uses proprietary control technology to provide patient-specific glycemic control across a broad population of adult and pediatric patients using basal/bolus insulin therapy. This system is designed to correctly dose subcutaneous insulin (and amount of carbohydrates if and when indicated to treat hypoglycemia) to achieve patient-specific, sustained control with different nutritional and insulin regimens, selected by the patient's physician responsible for glycemic control.
EndoTool SubQ Glucose Management System is designed to be used following a physician order with physician set optional diet, insulin regimen, basal/bolus distribution, initial total daily dose of insulin, and glucose target range. The primary user of the EndoTool SubQ Glucose Management System is the bedside caregiver (e.g. nurse) who will use the system to enter clinical data (e.g. food intake and scheduled blood glucose readings). With confirmation of previous data entered, the system makes the next dose calculation of subcutaneous insulin and the next time for a scheduled glucose determination.
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K Number
K132547Device Name
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
Manufacturer
MONARCH MEDICAL TECHNOLOGIES
Date Cleared
2014-04-17
(247 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
MONARCH MEDICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
By evaluating current and cumulative blood glucose levels, the EndoTool Glucose Management Sysstem (EGMS) - 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.
The EGMS 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
The EGMS includes: security features, software upgrades, data backup capabilities, and technical support. Each user has an individual User ldentification (ID) and Password in order to access portions of the application. Software upgrades are accessible through the EndoTool Portal website and the technical support is made easier by the use of Microsoft .Net technologies. EndoTool 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 is packaged in a user friendly, stand-alone program using Microsoft .Net technologies. The application requires Windows XP or Windows 7. The application was developed for use on Personal Computers (PCs), network servers, and terminal server environments.
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