EndoTool IV System

K201619 · Monarch Medical Technologies, LLC · NDC · Aug 7, 2020 · Anesthesiology

Device Facts

• Record ID: K201619
• Device Name: EndoTool IV System
• Applicant: Monarch Medical Technologies, LLC
• Product Code: NDC · Anesthesiology
• Decision Date: Aug 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

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 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.

Device Story

EndoTool IV is a glucose management software system for healthcare professionals; used in all patient care settings. Inputs: current and cumulative glucose values provided by user. Processing: software calculates and recommends intravenous insulin or carbohydrate doses; adjusts and maintains glucose levels within clinician-determined target range; can recommend subcutaneous basal transition insulin therapy. Output: dosing recommendations for insulin, carbohydrates, or saline. Clinical impact: assists clinicians in glycemic control; logic serves as adjunct to clinical reasoning; not a substitute for professional judgment. Benefits: helps maintain patient glucose levels within target range.

Clinical Evidence

No clinical data. Substantial equivalence is based on benchtop performance testing, including requirements-based module and integration testing, regression testing, and static analysis of software code.

Technological Characteristics

Standalone software; no physical materials. Operates on standard server/PC hardware. Connectivity: online web-based and offline server-based. Software validation per IEC 62304. Uses 'Algorithm B' for glucose management calculations.

Indications for Use

Indicated for adult and pediatric patients ages 2 years and older, weighing 12 kg or more, requiring glucose management in any patient care setting.

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 IV 1.10 (K200443)

Submission Summary (Full Text)

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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

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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 ([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) 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) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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: [phone] Email: [e-mail]

| 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

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.

#### V. 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.

#### 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, ●

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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<br>management software system,<br>designed for use by healthcare<br>professionals in all patient care<br>settings to recommend intravenous<br>and subcutaneous transition dosing, as<br>well as carbohydrates. Evaluating<br>current and cumulative glucose levels,<br>the software adjusts and maintains the<br>glucose level within a configurable<br>clinician-determined target range. The<br>system is indicated for use in adult<br>and pediatric patients ages 2 years and<br>above, who weigh 12 kgs. or more.<br>EndoTool IV logic is not a substitute<br>for, but rather an adjunct to clinical<br>reasoning. No medical decision<br>should be based solely on the<br>recommended guidance provided by<br>this software system. | 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 recommend<br>intravenous and subcutaneous<br>transition dosing, as well as<br>dextrose, to adjust and maintain the<br>blood glucose level within a<br>configurable clinician- determined<br>target range. The EndoTool Drug<br>Delivery Calculator is indicated for<br>use in adult and pediatric patients<br>ages 2 years and above and who<br>weigh 12 kgs. or more. EndoTool<br>IV 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. | |
| | Prescription Use | Yes | |
| | Product Code | NDC | |
| | Classification | 868.1890 | |
| | Class | II | |
| | Patient Range | 12 kg and 2yr or greater | |
| | Creates patient-specific IV<br>drug infusion profiles | Yes | |
| | | Evaluates current glucose<br>value | Yes |
| | Evaluates cumulative<br>glucose value | | Yes |
| | | Calculates next dose of<br>insulin, glucose, or saline | Yes |
| | Calculates carbohydrate<br>intake | | Yes |
| | | Calculates nutritional<br>bolus | 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 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<br>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<br>Specifications | N/A - Standalone Software | N/A - Standalone Software | |
| Operating Principles | Algorithm B | Algorithm B | |
| Performance<br>Specifications | N/A - Installed at user facility by<br>Monarch. | N/A - Installed at user facility<br>by Monarch. | |
| Ergonomics of<br>Patient-User Interface | N/A - Standalone Software | N/A - Standalone Software | |
| Packaging | | | |
| Sterilization Method | | | |
| Connectivity | On-line web-based application and<br>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<br>Edge, Google Chrome, Mozilla<br>Firefox…