ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)

K132547 · Monarch Medical Technologies · NDC · Apr 17, 2014 · Anesthesiology

Device Facts

• Record ID: K132547
• Device Name: ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
• Applicant: Monarch Medical Technologies
• Product Code: NDC · Anesthesiology
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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 Story

EndoTool Glucose Management System (EGMS) is a software-based glycemic management support program. It processes current and cumulative blood glucose levels to calculate and recommend intravenous and subcutaneous insulin dosing, as well as dextrose administration. Used by healthcare professionals in all patient care settings, the system operates on PCs, network servers, or terminal server environments. The software provides guidance to help clinicians maintain patient blood glucose within a target range. It functions as an adjunct to clinical reasoning rather than a replacement for professional judgment. By automating complex dosing calculations, the system aims to assist clinicians in achieving glycemic control, potentially improving patient outcomes in hospital or clinical settings.

Clinical Evidence

Clinical user validation studies were conducted to demonstrate safety and effectiveness. No specific performance metrics (e.g., sensitivity, specificity) were provided in the summary. The device conforms to IEC 62304 and ISO 14971 standards.

Technological Characteristics

Stand-alone software application developed using Microsoft .Net technologies. Compatible with Windows XP and Windows 7. Operates on PCs, network servers, and terminal server environments. Includes security features (User ID/Password), data backup, and software upgrade capabilities via a web portal. Compliant with HIPAA privacy rules.

Indications for Use

Indicated for adult and pediatric patients aged 2 years and older weighing 12 kg or more requiring glycemic management via intravenous or subcutaneous insulin and dextrose dosing.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• Glytec LLC, G+ System (K113853)
• MD Scientific Inc., EndoTool Drug Dose Calculator (K053137)

Submission Summary (Full Text)

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#### K132547 510(k) SUMMARY

# Monarch Medical Technologies EndoTool Glucose Management System

#### Date Prepared: April 4, 2014

## Submitter Information

Monarch Medical Technologies 2815 Coliseum Centre Drive, Suite 250 Charlotte, NC 28217-1361 Telephone: [phone] Fax: [phone] Website: www.monarchmedtech.com

### Contact Information

Wilson P. Constantine 2815 Coliseum Centre Drive, Suite 250 Charlotte, NC 28217-1361 Phone: [phone] Facsimile: 704-323-4055 [e-mail]

Proprietary Name: EndoTool Glucose Management System

Common or Usual Name: Drug Dose Calculator

Classification Name: Predictive pulmonary-function value calculator

Device Classification: Class II

Regulation Number: 21 CFR 868.1890

Product Code: NDC

Predicate Devices:

K113853 - Glytec LLC, G+ System K053137 - MD Scientific Inc., EndoTool Drug Dose Calculator

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#### Indications for 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.

#### Technological Characteristics:

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.

#### Performance Data

The EGMS conforms to IEC 62304 Medical Device Software - Software LifeCycle Processes, 2006-05 and ISO 14971 Medical Devices - Risk Management -Application of Risk Management to Medical Devices, 2007-03-01. Clinical user validation studies demonstrated that the EGMS performs safely and effectively, as intended.

#### Substantial Equivalence

The EGMS is as safe and effective as the EndoTool Drug Dose Calculator and the Glytec G+ System. The EGMS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the EGMS and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the EGMS is as safe and effective as the predicate devices, therefore EGMS is substantially equivalent.

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Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2014

Monarch Medical Technologies Mr. Wilson P. Constantine President, CEO 2815 Coliseum Centre Drive, Suite 250 Charlotte, NC 28217

Re: K132547

Trade/Device Name: EndoTool Glucose Management System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: April 9, 2014 Received: April 9, 2014

Dear Mr. Constantine:

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 (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. The general controls provisions of the Act include requirements for annual registration. Iisting 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation. Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K132547

Device Name

EndoTool Glucose Management System, version 8.0 [EGMSv8.0]

# Indications for Use (Describe)

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 EndoToo! 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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THE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR THE LE

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman Date: 2014.04.17 14:19:00 -04'00'

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