K Number

Device Name

EndoTool IV System

Manufacturer

Monarch Medical Technologies, LLC

Date Cleared

2020-08-07

(53 days)

Product Code

NDC

Regulation Number

868.1890

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K200443

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software system that uses current and cumulative glucose values to calculate and recommend doses based on "logic," but there is no mention of AI, ML, or any training/testing data sets typically associated with such technologies. The performance studies focus on software verification and validation, not algorithmic performance metrics common in AI/ML evaluations.

Therapeutic

Yes
The device is a glucose management software system that adjusts and maintains glucose levels, which clearly indicates a therapeutic purpose.

Diagnostic

This device is a glucose management software system that recommends insulin or carbohydrate doses to manage blood glucose levels. It does not diagnose a medical condition; instead, it provides guidance for treatment.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "EndoTool IV is a software system for glucose management". The summary focuses on software verification and validation testing, with no mention of hardware components or hardware-specific testing.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
EndoTool IV's function: EndoTool IV is a software system that uses glucose values (which are obtained through in vitro diagnostic tests, like blood glucose meters) but it does not perform the diagnostic test itself. It processes existing glucose data to provide recommendations for treatment (insulin or carbohydrates).

Therefore, EndoTool IV is a clinical decision support software that utilizes data from IVD tests, but it is not an IVD device itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

NDC

Device Description

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, who weigh 12 kgs. or more.

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)

Software verification and validation testing was conducted per IEC 62304 and included the following:

. Requirements-based, module and integration tests
. Endo-Tool regression testing including:
- o Requirements-based testing for risk-related requirements
- o Automated algorithm test cases for the complete application
- o Static analysis of the software code

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K200443

Reference Device(s)

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 7, 2020

Monarch Medical Technologies, LLC Ann Marie Gaitan VP, Regulatory Affairs and Compliance 4400 Stuart Andrew Blvd., Suite N Charlotte, NC 28217

Re: K201619

Trade/Device Name: EndoTool IV System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: NDC Dated: June 15, 2020 Received: June 15, 2020

Dear Ann Marie Gaitan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing 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.

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K201619

Device Name EndoTool IV System

Indications for Use (Describe)

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 turget 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

SUBMITTER -Ann Marie Gaitan VP, Requlatory Affairs and Compliance Monarch Medical Technologies, LLC 4400 Stuart Andrew Blvd., Suite N Charlotte, NC 28217 Tel: +1.704.562.0777 Email: AnnMarie.Gaitan@monarchmedtech.com

Contact Person:	Ann Marie Gaitan
Date Prepared:	June 13, 2020

II. DEVICE
Name of Device:	EndoTool IV System
Classification Name:	Drug Dose Calculator
Regulation:	21 CFR § 868.1890
Regulatory Class:	Class II
Product Classification Code:	NDC

III. PREDICATE DEVICE
Predicate Manufacturer:	Monarch Medical Technologies
Predicate Trade Name:	EndoTool IV 1.10
Predicate 510(k):	K200443

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

Indications for Use The predicate and subject device have equivalent indications for use, ●

with minor updates to add clarification.

. Materials - The predicate and subject device are both software-only devices and therefore do not have any materials.
. Design - The predicate and subject device are equivalent in design. The subject device is an updated version of the predicate software with minor changes to the interface and functionality.
Energy Source – The predicate and subject device are software-only are are both intended to be operated using equivalent computers and operating systems.
Performance Testing The predicate and subject device have both been validated per IEC . 62304 requirements and FDA software validation guidance.

Feature	EndoTool IV System	EndoTool IV 1.10 (K200443)
Indications for 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.	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.
	Prescription Use	Yes
	Product Code	NDC
	Classification	868.1890
	Class	II
	Patient Range	12 kg and 2yr or greater
	Creates patient-specific IV
drug infusion profiles	Yes
		Evaluates current glucose
value	Yes
	Evaluates cumulative
glucose value		Yes
		Calculates next dose of
insulin, glucose, or saline	Yes
	Calculates carbohydrate
intake		Yes
		Calculates nutritional
bolus	Yes
	Calculates meal intake	Yes	Yes
	User Inputs	Yes	Yes
	Weight	Yes	Yes
	Age	Yes	Yes
	Dose titration	Yes	Yes
Calculates infusion rate
calculations	Yes	Yes
Data storage and analysis	Yes	Yes
GUI Interface	Yes	Yes
Alarm advisories	Yes	Yes
Labeling	Yes	Yes
User Manual	Yes	Yes
Warnings	Yes	Yes
	New warning/controls regarding low
potassium added.
Precautions	Yes	Yes
Instructions for Use	Yes	Yes
Intended User	Yes	Yes
Environment of Use	Yes	Yes
Materials	N/A - Standalone Software	N/A - Standalone Software
Design:
Dimensional
Specifications	N/A - Standalone Software	N/A - Standalone Software
Operating Principles	Algorithm B	Algorithm B
Performance
Specifications	N/A - Installed at user facility by
Monarch.	N/A - Installed at user facility
by Monarch.
Ergonomics of
Patient-User Interface	N/A - Standalone Software	N/A - Standalone Software
Packaging
Sterilization Method
Connectivity	On-line web-based application and
off-line, Server-based	On-line web-based application
Energy Source	N/A - Standalone Software	N/A - Standalone Software
Feature Comparison:
Operating System	All	AllInternet Explorer, Microsoft
Browser compatibility	Internet Explorer, Microsoft
Edge, Google Chrome, Mozilla
Firefox	Edge, Google Chrome, Mozilla
Firefox
Hardware
Requirements	server, PC, printer, bar code
scanner (optional)	server, PC, printer, bar code
scanner (optional)
Performance Testing	Validated per IEC 62304 requirements
and FDA software validation guidance.	Validated per IEC 62304 requirements
and FDA software validation guidance.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Sterilization & Shelf-life Testing

Not Applicable (Standalone Software)

Biocompatibility Testing

Not Applicable (Standalone Software)

Electrical safety and electromagnetic compatibility (EMC)

Not Applicable (Passive Device)

Software Verification and Validation Testing

Software verification and validation testing was conducted per IEC 62304 and included the following:

. Requirements-based, module and integration tests
. Endo-Tool regression testing including:
- o Requirements-based testing for risk-related requirements
- o Automated algorithm test cases for the complete application
- o Static analysis of the software code

Mechanical and acoustic Testing

Not Applicable (Standalone Software)

Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of the EndoTool IV. Instead, substantial equivalence is based upon benchtop performance testing.

VIII. CONCLUSIONS

The indications for use and performance of the EndoTool IV is substantially equivalent to that of predicate device (K200443), raising no safety or effectiveness issues, and performing as well as the predicate device.