(247 days)
Not Found
No
The summary describes a software program that uses "logic" to provide recommendations based on blood glucose levels. There is no mention of AI, ML, or related concepts like training data, test data, or specific algorithms typically associated with AI/ML. The description focuses on standard software features and security.
Yes.
The device recommends intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain blood glucose levels, which directly impacts patient health.
No.
The device is a glycemic management software support program that recommends intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain blood glucose levels. It does not diagnose medical conditions.
Yes
The device description explicitly states it is a "software support program" and a "stand-alone program using Microsoft .Net technologies," designed for use on PCs, network servers, and terminal server environments. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, the EndoTool Glucose Management System (EGMS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the EGMS is a "glycemic management software support program" designed to "recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level". It uses existing blood glucose levels as input, but it does not perform the test to measure those levels itself.
- Device Description: The description focuses on software features, security, and technical aspects. There is no mention of reagents, assays, or any components typically associated with performing in vitro tests on biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The EGMS takes pre-existing blood glucose values as input and provides recommendations based on those values. It does not perform the analysis of the blood itself.
In summary, the EGMS is a software tool that assists healthcare professionals in managing blood glucose levels based on existing measurements, rather than a device that performs the measurement itself. This aligns with the definition of a clinical decision support software or a medical device software, but not an IVD.
N/A
Intended Use / 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.
Product codes
NDC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients ages 2 years and above
Intended User / Care Setting
healthcare professionals in all patient care settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical user validation studies demonstrated that the EGMS performs safely and effectively, as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
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: 704-335-1300 Fax: 704-335-1300 Website: www.monarchmedtech.com
Contact Information
Wilson P. Constantine 2815 Coliseum Centre Drive, Suite 250 Charlotte, NC 28217-1361 Phone: 704-323-4055 Facsimile: 704-323-4055 Wilson.Constantine@monarchmedtech.com
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
1
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.
2
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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.
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
4
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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