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.

AI/ML Overview

The provided document is a 510(k) summary for the EndoTool IV 1.10 device, a glycemic management software support program. It states that the device is substantially equivalent to a predicate device (EndoTool Glucose Management System, K132547).

Based on the provided text, the device is a software-only device that calculates blood glucose management recommendations. The 510(k) summary explicitly states that clinical studies and animal studies were not required, and performance testing was limited to software verification and validation testing in accordance with IEC 62304 and FDA software validation guidance. Therefore, much of the requested information regarding acceptance criteria for a clinical study, human reader performance, types of ground truth for training/test sets, and sample sizes for training/test sets, is not available in this document as such studies were not conducted for the clearance of this specific iteration of the device.

Here's what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria tied to quantitative device performance metrics (e.g., accuracy, precision) in the way one might expect for a diagnostic or therapeutic device that undergoes clinical trials. Instead, the acceptance criteria are implicit in the software verification and validation testing objectives: ensuring the software meets its requirements and functions correctly as intended.

Acceptance Criteria (Implicit)	Reported Device Performance
Software meets requirements as defined by IEC 62304 and FDA software validation guidance.	"Software verification and validation testing was conducted per IEC 62304 and included the following:Requirements-based, module and integration testsEndo-Tool regression testing including:Requirements-based testing for risk-related requirementsAutomated algorithm test cases for the complete applicationStatic analysis of the software code"
The device performs as well as the predicate device (K132547) and raises no new safety or effectiveness issues.	"The indications for use and performance of the EndoTool IV is substantially equivalent to that of predicate device (K132547), raising no safety or effectiveness issues, and performing as well as the predicate device."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable/not specified. The testing described is software verification and validation, not a clinical study with a patient test set.
Data Provenance: Not applicable. No clinical data was used for performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical test set was used, no human experts were involved in establishing ground truth for performance evaluation of the algorithm against patient data. Software testing relies on defined requirements and expected computational outputs as its "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the EndoTool IV." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in the sense that the software's internal logic and calculations were verified through "Automated algorithm test cases" and "Static analysis of the software code." However, this is against predetermined computational correctness, not against clinical outcomes or human performance. The device is intended to provide "recommended guidance" and is "not a substitute for, but rather an adjunct to clinical reasoning," implying it's always intended to be used with a human in the loop. The "standalone" performance here refers to its computational correctness rather than its diagnostic or therapeutic performance in isolation from clinical context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the software verification and validation, the "ground truth" is defined by the software requirements and expected computational outputs based on those requirements. It is a mathematical/logic-based ground truth, not a clinical one derived from patient outcomes or expert consensus on clinical data.

8. The sample size for the training set

Not applicable/not specified. This device is described as a software program that calculates doses based on input data, not as a machine learning model that undergoes a "training" phase on a dataset of patient outcomes. Its logic is presumably rule-based or uses established physiological models.

9. How the ground truth for the training set was established

Not applicable. No training set described.

Summary

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March 17, 2020

Monarch Medical Technologies, LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K200443

Trade/Device Name: EndoTool IV 1.10 Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: NDC Dated: February 22, 2020 Received: February 24, 2020

Dear Prithul Bom:

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

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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 medical devices and radiation-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

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Indications for Use

510(k) Number (if known) K200443

Device Name EndoTool IV 1.10

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CER 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 Monarch Medical Technologies, LLC 2137 South Blvd. Ste 300 Charlotte, NC 28203 Tel: +1.704.562.0777 Email: AnnMarie.Gaitan@monarchmedtech.com

Contact Person:	Ann Marie Gaitan
Date Prepared:	November 12, 2019

II. DEVICE
Name of Device:	EndoTool IV 1.10
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 Glucose Management System
Predicate 510(k):	K132547

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 identical indications for use, ●

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with the exception of the updated name of the device.

. 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	Subject Device:EndoTool IV 1.10	Predicate Device (K132547):EndoTool Glucose ManagementSystem
Indications for Use	By evaluating current andcumulative blood glucose levels,EndoTool IV 1.10 - a glycemicmanagement software supportprogram - is designed for use byhealthcare professionals in allpatient care settings torecommend intravenous andsubcutaneous transition dosing,as well as dextrose, to adjust andmaintain the blood glucose levelwithin a configurable clinician-determined target range. TheEndoTool Drug DeliveryCalculator is indicated for use inadult and pediatric patients ages 2years and above and who weigh12 kgs. or more. EndoTool IV1.10 logic is not a substitute for,but rather an adjunct to clinicalreasoning. No medical decisionshould be based solely on therecommended guidance providedby this software program.	By evaluating current andcumulative blood glucose levels,the Endo-rool GlucoseManagement Sysstem (EGMS) -a glycemic management softwaresupport program is designed foruse by healthcare professionals inall patient care settingsto recommend intravenous andsubcutaneous transition dosing,as well as dextrose, to adjust andmaintain the bloodglucose level within aconfigurable clinician-determined target range.The EndoTool Drug DeliveryCalculator is indicated for use inadult and pediatric patients ages 2years and above andwho weig-h 12 kgs. or more.The EGMS logic is not asubstitute for, but rather anadjunct to clinical reasoning. Nomedical decision should be basedsolely on the recommendedguidance provided by thissoftware program.
Prescription Use	Yes	Yes
Product Code	NDC	NDC
Classification	868.1890	868.1890
Class	II	II
Patient Range	12 kg and 2yr or greater	12 kg and 2yr or greater
Creates patient-specificIV drug infusion profiles	Yes	Yes
Evaluates currentglucose value	Yes	Yes
Evaluates cumulativeglucose value	Yes	Yes
Calculates next dose ofinsulin, glucose, orsaline	Yes	Yes
Calculates carbohydrateintake	Yes	Yes
Calculates nutritionalbolus	Yes	Yes
Calculates meal intake	Yes	Yes
User Inputs	Yes	Yes
Weight	Yes	Yes
Age	Yes	Yes
Dose titration	Yes	Yes
Calculates infusion ratecalculations	Yes	Yes
Data storage andanalysis	Yes	Yes
GUI Interface	Yes	Yes
Alarm advisories	Yes	Yes
Labeling	Yes	Yes
User Manual	Yes	Yes
Warnings	Yes	Yes
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:	N/A - Standalone Software• Dimensional Specifications• Operating Principles• Packaging• Sterilization Method	N/A - Standalone Software• Algorithm A• DVD Case• N/A - Standalone Software
Energy Source	N/A - Standalone Software	N/A - Standalone Software
Feature Comparison:	• Windows• server, PC, printer, bar code scanner (optional)	• Windows• server, PC, printer, bar code scanner (optional)
Performance Testing	Validated per IEC 62304requirements and FDA softwarevalidation guidance.	Validated per IEC 62304requirements and FDA softwarevalidation guidance.

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VII. PERFORMANCE DATA

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

Sterilization & Shelf-life Testing

Not Applicable (Standalone Software)

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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: ●
- о Requirements-based testing for risk-related requirements
- Automated algorithm test cases for the complete application o
- Static analysis of the software code o

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 (K132547), raising no safety or effectiveness issues, and performing as well as the predicate device.

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).