EndoTool SubQ

K142918 · Monarch Medical Technologies · NDC · Apr 24, 2015 · Anesthesiology

Device Facts

• Record ID: K142918
• Device Name: EndoTool SubQ
• Applicant: Monarch Medical Technologies
• Product Code: NDC · Anesthesiology
• Decision Date: Apr 24, 2015
• 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 SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with Diabetes Mellitus in both adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) (and when indicated a carbohydrate dose) based on the prescribing healthcare provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics. The EndoTool SubQ is not a substitute for clinical reasoning, but is an aid for trained healthcare professionals to manage patients. The System is based on obtained glucose readings and clinical data entered by the medical staff. Final dose decisions for a patient must be made only after consideration of the full clinical status of the patient. No medical decision should be made based solely on the recommendations provided by this software program.

Device Story

EndoTool SubQ is a hospital-based software application for glycemic management. It accepts inputs including physician-prescribed nutritional regimens, insulin regimens, target glucose ranges, patient characteristics, and bedside-entered blood glucose readings and food intake. The system utilizes proprietary feedback mathematics and a nonlinear dosing equation to calculate and recommend subcutaneous insulin doses and carbohydrate doses for hypoglycemia. It is operated by bedside caregivers (e.g., nurses) via an internal hospital website. The output is presented to the clinician as a dose recommendation; the clinician must review the patient's full clinical status before making final administration decisions. The device aims to achieve sustained, patient-specific glycemic control, assisting healthcare professionals in managing insulin therapy.

Clinical Evidence

Bench testing only. Evidence includes requirements-based testing for all functionality and risk-related requirements, integration testing for database data flow, and automated execution of algorithm test cases. Off-the-shelf (OTS) software components were verified for intended function.

Technological Characteristics

Software-based glucose management system deployed via internal hospital server/website. Uses feedback mathematics and nonlinear dosing equations for insulin/carbohydrate calculation. Features include configurable therapy goals, audit trails, and visual/audible alerts. Operates on patient-specific data inputs to optimize dosing models over time.

Indications for Use

Indicated for adult and pediatric patients (age 2+ years, weight 12kg+) with Diabetes Mellitus to manage blood glucose levels via subcutaneous insulin dose recommendations.

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 Glucose Management System (EGMS8) (K132547)
• Glucommander G+ Enterprise System (K113853)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2015

Monarch Medical Technologies Mr. Al Pacheco Certified Compliance Solutions 11665 Avena Place, Suite #203 San Diego, CA 92128

Re: K142918

Trade/Device Name: EndoTool SubQTM Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: II Product Code: NDC Dated: March 23, 2015 Received: March 24, 2015

### Dear Mr. Pacheco:

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, 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.

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Page 2 - Mr. Al Pacheco

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K142918

Device Name EndoTool SubQ

#### Indications for Use (Describe)

EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with Diabetes Mellitus in both adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) (and when indicated a carbohydrate dose) based on the prescribing healthcare provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.

The EndoTool SubQ is not a substitute for clinical reasoning, but is an aid for trained healthcare professionals to manage patients. The System is based on obtained glucose readings and clinical data entered by the medical staff. Final dose decisions for a patient must be made only after consideration of the full clinical status of the patient. No medical decision should be made based solely on the recommendations provided by this software program.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

| Submitter: | Monarch Medical Technologies |
|------------------------|--------------------------------------------------------------------------------------|
| Address: | 2137 South Blvd, Suite 300<br>Charlotte, NC 28217<br>Website: www.monarchmedtech.com |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Contact person: | Al Pacheco |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Date prepared: | March 23, 2015 |
| Trade name: | EndoTool SubQ™ |
| Common name: | EndoTool SubQ |
| Product Code, Primary: | NDC, Calculator, Drug Dose |
| Regulation: | 21 CFR 868.1890, Predictive pulmonary-function value calculator |

Substantial equivalence claimed to: EndoTool IV Glucose Management System (EGMS8) - K132547 Glytec LLC, Glucommander G+ Enterprise System - K113853

#### Description:

Monarch Medical Technology's EndoTool SubQ Glucose Management System is a glucose management software solution for healthcare institutions. This system uses proprietary control technology to provide patient-specific glycemic control across a broad population of adult and pediatric patients using basal/bolus insulin therapy. This system is designed to correctly dose subcutaneous insulin (and amount of carbohydrates if and when indicated to treat hypoglycemia) to achieve patient-specific, sustained control with different nutritional and insulin regimens, selected by the patient's physician responsible for glycemic control.

EndoTool SubQ Glucose Management System is designed to be used following a physician order with physician set optional diet, insulin regimen, basal/bolus distribution, initial total daily dose of insulin, and glucose target range. The primary user of the EndoTool SubQ Glucose Management System is the bedside caregiver (e.g. nurse) who will use the system to enter clinical data (e.g. food intake and scheduled blood glucose readings). With confirmation of previous data entered, the system makes the next dose calculation of subcutaneous insulin and the next time for a scheduled glucose determination.

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#### Indications for Use:

EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with Diabetes Mellitus in both and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) (and when indicated a carbohydrate dose) based on the prescribing healthcare provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.

EndoTool SubQ is not a substitute for clinical reasoning, but is an aid for trained healthcare professionals to manage patients. The System is based on obtained glucose readings and clinical data entered by the medical staff. Final dose decisions for a patient must be made only after consideration of the full clinical status of the patient. No medical decision should be made based solely on the recommendations provided by this software program.

### Technological Characteristics

The EndoTool SubQ Glucose Management System uses feedback mathematics to individualize insulin dosing by calculating limited proportional incremental changes in the insulin dosing model (total daily dose and the physician set basal/bolus distribution) or carbohydrate recommendations based on a patient's previous blood glucose readings in response to prior insulin doses. These calculations are repeated by the software when new data is entered into the system, constantly seeking the optimal, patient specific insulin dose for the targets set by the physician.

The software provides three main functions: set-up or initial mathematical model of a patient, physician confirmed or altered daily update of patient's mathematical model through time as new blood glucose values and carbohydrate intake is entered and calculated doses of insulin or carbohydrates based on the physician confirmed total daily dose, basal/bolus distribution, and insulin regimen.

The system is installed on a server and deployed via an internal website on the hospital's infrastructure. Insulin and carbohydrate therapy are managed using blood glucose measurements, available patient information and a set of algorithms that includes a nonlinear dosing equation that is individualized and optimized through time based on blood glucose response to previous doses administered. Therapy goals and limits are configurable by the patient's physician.

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#### Substantial Equivalence

The EndoTool SubQ Glucose Management System is substantially equivalent to other FDA cleared, marketed drug dosage calculators. Specifically, the EndoTool SubQ Glucose Management System is substantially equivalent to the Glytec Glucommander G+ Enterprise System (K113853) and EndoTool IV Glucose Management System (K132547). Minor differences in the technological characteristics between these devices do not raise new questions of safety or efficacy.

| Functionality | This<br>device | EndoTool IV<br>(Predicate 1) | Glucommander<br>(Predicate 2) |
|-------------------------------------------------------------------------------------|----------------|------------------------------|-------------------------------|
| Patient selection and initiation | Yes | Yes | Yes |
| Patient setup (demographics, clinical, protocol) -<br>directed via physician orders | Yes | Yes | Yes |
| Carbohydrate intake (meals and continuous nutrition) | Yes | Yes | Yes |
| Blood glucose entry | Yes | Yes | Yes |
| Display of advisories/guardrails | Yes | Yes | Yes |
| Display of calculated insulin dose or carbohydrate dose | Yes | Yes | Yes |
| Reports | Yes | Yes | Yes |
| User Security | Yes | Yes | Yes |
| Visual and audible alerts | Yes | Yes | Yes |
| Audit trails | Yes | Yes | Unknown |
| Data storage | Yes | Yes | Yes |

#### Functionality Comparison Between the Subject Device and Predicates

#### Substantial Equivalence Conclusion

The EndoTool SubQ Glucose Management System has the same intended use and similar indications, technological characteristics, principles of operation as the previously cleared Glytec Glucommander G+ Enterprise System and EndoTool IV Glucose Management System, thus establishing substantial equivalence.

#### Test Summary

Testing included the following:

- Requirements-based testing for all functionality. 1)
- 2) Requirements-based testing for all risk-related requirements.
- 3) Integration testing to ensure that data flows correctly into and out of the database.
- Automated algorithm test case execution. 4)
- 5) Off The Shelf (OTS) software embedded in the application was included in the technical verification protocols. Each OTS component was tested to ensure that it functioned as intended.

#### Test Summary Conclusion:

The performance of the EndoTool SubQ Glucose Management System is substantially equivalent to that of the Glytec Glucommander G+ Enterprise System (K113853) and EndoTool IV Glucose Management System (K132547) and raises no new safety or effectiveness issues and performs as well as the predicate.