EndoTool IV 1.10

K200443 · Monarch Medical Technologies, LLC · NDC · Mar 17, 2020 · Anesthesiology

Device Facts

• Record ID: K200443
• Device Name: EndoTool IV 1.10
• Applicant: Monarch Medical Technologies, LLC
• Product Code: NDC · Anesthesiology
• Decision Date: Mar 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric, 3rd-Party Reviewed

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 Story

EndoTool IV 1.10 is a standalone glycemic management software support program. It processes patient-specific inputs, including current and cumulative blood glucose levels, age, and weight. The software utilizes internal logic to calculate and recommend intravenous insulin, dextrose, or carbohydrate doses, as well as subcutaneous basal transition insulin doses. It is intended for use by healthcare professionals in clinical settings to assist in maintaining blood glucose within a clinician-defined target range. The software output serves as an adjunct to clinical decision-making; it does not replace clinical judgment. By providing automated dosing recommendations, the device aims to assist clinicians in achieving glycemic control, potentially improving patient outcomes in inpatient and other care environments.

Clinical Evidence

No clinical data or animal studies were required. Substantial equivalence is supported by benchtop performance testing, including requirements-based module and integration testing, regression testing, and static analysis of software code, all performed per IEC 62304 standards.

Technological Characteristics

Standalone software-only device; no physical materials. Operates on Windows-based servers/PCs. Connectivity includes optional barcode scanner integration. Software validation performed per IEC 62304. No energy source or sterilization required.

Indications for Use

Indicated for adult and pediatric patients ages 2 years and older weighing 12 kg or more requiring glycemic management in all patient care settings.

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

• EndoTool Glucose Management System (K132547)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-.052z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CER 801 Subpart D) </div> | |
| <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M0 2a2 2 0 0 1 2-2h12a2 2 0 0 1 2 2v12a2 2 0 0 1-2 2H2a2 2 0 0 1-2-2V2zm1.5 0a.5.5 0 0 0-.5.5v11a.5.5 0 0 0 .5.5h11a.5.5 0 0 0 .5-.5v-11a.5.5 0 0 0-.5-.5h-11z" fill-rule="evenodd"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

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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: [phone] Email: [e-mail]

| 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

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.

#### V. INDICATIONS FOR 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.

#### 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:<br>EndoTool IV 1.10 | Predicate Device (K132547):<br>EndoTool Glucose Management<br>System |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | By evaluating current and<br>cumulative blood glucose levels,<br>EndoTool IV 1.10 - a glycemic<br>management software support<br>program - is designed for use by<br>healthcare professionals in all<br>patient care settings to<br>recommend intravenous and<br>subcutaneous transition dosing,<br>as well as dextrose, to adjust and<br>maintain the blood glucose level<br>within a configurable clinician-<br>determined target range. The<br>EndoTool Drug Delivery<br>Calculator is indicated for use in<br>adult and pediatric patients ages 2<br>years and above and who weigh<br>12 kgs. or more. EndoTool IV<br>1.10 logic is not a substitute for,<br>but rather an adjunct to clinical<br>reasoning. No medical decision<br>should be based solely on the<br>recommended guidance provided<br>by this software program. | By evaluating current and<br>cumulative blood glucose levels,<br>the Endo-rool Glucose<br>Management Sysstem (EGMS) -<br>a glycemic management software<br>support program is designed for<br>use by healthcare professionals in<br>all patient care settings<br>to recommend intravenous and<br>subcutaneous transition dosing,<br>as well as dextrose, to adjust and<br>maintain the blood<br>glucose level within a<br>configurable clinician-<br>determined target range.<br>The EndoTool Drug Delivery<br>Calculator is indicated for use in<br>adult and pediatric patients ages 2<br>years and above and<br>who weig-h 12 kgs. or more.<br>The EGMS logic is not a<br>substitute for, but rather an<br>adjunct to clinical reasoning. No<br>medical decision should be based<br>solely on the recommended<br>guidance provided by this<br>software 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-specific<br>IV drug infusion profiles | Yes | Yes |
| Evaluates current<br>glucose value | Yes | Yes |
| Evaluates cumulative<br>glucose value | Yes | Yes |
| Calculates next dose of<br>insulin, glucose, or<br>saline | Yes | Yes |
| Calculates carbohydrate<br>intake | Yes | Yes |
| Calculates nutritional<br>bolus | Yes | Yes |
| Calculates meal intake | Yes | Yes |
| User Inputs | Yes | Yes |
| Weight | Yes | Yes |
| Age | Yes | Yes |
| Dose titration | Yes | Yes |
| Calculates infusion rate<br>calculations | Yes | Yes |
| Data storage and<br>analysis | 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<br>• Dimensional Specifications<br>• Operating Principles<br>• Packaging<br>• Sterilization Method | N/A - Standalone Software<br>• Algorithm A<br>• DVD Case<br>• N/A - Standalone Software |
| Energy Source | N/A - Standalone Software | N/A - Standalone Software |
| Feature Comparison: | • Windows<br>• server, PC, printer, bar code scanner (optional) | • Windows<br>• server, PC, printer, bar code scanner (optional) |
| Performance Testing | Validated per IEC 62304<br>requirements and FDA software<br>validation guidance. | Validated per IEC 62304<br>requirements and FDA software<br>validation 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.