(192 days)
Not Found
No
The summary describes a software application that calculates and recommends insulin doses based on entered clinical data and a defined algorithm, but it does not mention or imply the use of AI or ML technologies. The performance studies focus on standard software verification and validation, not on training or testing of AI/ML models.
No
Explanation: The device is a software application that calculates and recommends insulin doses but does not directly administer treatment. It serves as an aid for healthcare professionals, who make the final medical decisions.
No
This device is designed to calculate and recommend insulin doses for managing blood glucose levels, serving as an aid for healthcare professionals. It explicitly states it is "not a substitute for clinical reasoning" and that "no medical decision should be made based solely upon the results provided." This indicates it does not diagnose a condition but rather provides a treatment recommendation.
Yes
The device description explicitly states that EndoTool SubQ 2.1 is a "software application" and details its installation and access methods (Windows Server, web browser, PCs, network servers, terminal server environments). While it mentions potential use of barcode scanning, this is an input method for data and not a core hardware component of the device itself. The focus of the description and performance studies is on software verification and validation.
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 SubQ 2.1 Function: The description clearly states that EndoTool SubQ 2.1 is a software application that calculates and recommends insulin doses based on patient characteristics, glucose readings (which are obtained externally, likely from a glucose meter), and clinical data. It does not perform any tests on biological samples itself.
- Input Data: The input data for the software is glucose readings and entered clinical data, not the results of in vitro tests performed by the device.
Therefore, EndoTool SubQ 2.1 is a clinical decision support software tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
EndoTool SubQ 2.1 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 hyperglycemia including 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 dosed on the prescribing healthcare Provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.
EndoTool SubQ 2.1 logic is not a substitute for clinical reasoning but an aid for trained healthcare professionals based on obtained glucose readings and entered clinical data. Final dose recommendations 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 upon the results provided by this software program.
Product codes
NDC
Device Description
EndoTool SubQ 2.1 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 hyperglycemia including 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 2.1 Glucose Management system includes security, software, and technical support features. Each user has an individual User Identification (ID) and Password to access portions of the application. EndoTool SubQ 2.1 is designed to safeguard the confidentiality, integrity, and availability of electronic protected health information of patients according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rules.
EndoTool SubQ 2.1 is packaged in a user friendly, stand-alone program. The application is installed on Windows Server 2008 R2 or newer. The end-user should access the application using a compatible web browser, such as Internet Explorer 9 and higher, or Google Chrome 58 and higher. The application was developed for use on Personal Computers (PCs), network servers, and terminal server environments. As EndoTool SubQ 2.1 data is time sensitive, it is also imperative that all PCs and servers be set with the correct date and time using UTC.
EndoTool SubQ can utilize barcode scanning in Code 39 format (also known as Alpha39, Code 3 of 9, Code 3/9, Type 39, USS Code 39, or USD-3) for patient identification/verification.
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
age 2 years and above
Intended User / Care Setting
trained healthcare professionals / Hospital
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 FDA's software validation guidance to demonstrate the performance of the device is substantially equivalent to the predicate. Performance testing included, but is not limited to, the following:
- Requirements-based, module and integration testing
- Data integration testing
- Algorithm test cases (automated and manual)
- Static analysis of the software code
- Regression testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 28, 2021
Monarch Medical Technologies, LLC Christophe Mallard CEO 1924 Cleveland Ave. Ste 201 Charlotte, NC 28203
Re: K211160
Trade/Device Name: EndoTool SubQ 2.1 Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: April 19, 2021 Received: April 19, 2021
Dear Christophe Mallard:
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.
1
542 of the Act); 21 CFR 1000-1050.
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-
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. 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
2
Indications for Use
510(k) Number (if known) K211160
Device Name EndoTool SubQ 2.1
Indications for Use (Describe)
EndoTool SubQ 2.1 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 hyperglycemia including 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 dosed on the prescribing healthcare Provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.
EndoTool SubQ 2.1 logic is not a substitute for clinical reasoning but an aid for trained healthcare professionals based on obtained glucose readings and entered clinical data. Final dose recommendations 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 upon the results provided by this software program.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image contains the logo for Monarch Medical Technologies. The logo consists of a stylized butterfly icon on the left, followed by the word "Monarch" in a clean, sans-serif font. Below "Monarch" are the words "Medical Technologies" in a smaller font size. The butterfly icon is multicolored, with shades of blue, pink, and yellow.
510(k) Summary
| Submitter: | Monarch Medical Technologies |
|---|---|
| Address: | 1924 Cleveland Ave – Ste 201 |
| Charlotte, NC 28203 | |
| Website: www.monarchmedtech.com | |
| Phone number: | (704) 644-0235 |
| Fax number: | (855) 461-6060 |
| Contact person: | Christophe Mallard |
| Phone number: | (650) 307-7221 |
| Fax number: | (855) 461-6060 |
| Date prepared: | October 21, 2021 |
| Trade name: | EndoTool® SubQ 2.1 |
| Common name: | EndoTool SubQ |
| Product Code: | NDC, Calculator, Drug Dose |
| Regulation: | 21 CFR 868.1890, Predictive pulmonary-function value calculator |
| Substantial Equivalence claimed to: | EndoTool SubQ (K180366) |
Description:
EndoTool SubQ 2.1 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 hyperglycemia including 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 2.1 Glucose Management system includes security, software, and technical support features. Each user has an individual User Identification (ID) and Password to access portions of the application. EndoTool SubQ 2.1 is designed to safeguard the confidentiality, integrity, and availability of electronic protected health information of patients according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rules.
EndoTool SubQ 2.1 is packaged in a user friendly, stand-alone program. The application is installed on Windows Server 2008 R2 or newer. The end-user should access the application using a compatible web browser, such as Internet Explorer 9 and higher, or Google Chrome 58 and higher. The application was developed for use on Personal Computers (PCs), network servers, and terminal server environments. As EndoTool SubQ 2.1 data is time sensitive, it is also imperative that all PCs and servers be set with the correct date and time using UTC.
EndoTool SubQ can utilize barcode scanning in Code 39 format (also known as Alpha39, Code 3 of 9, Code 3/9, Type 39, USS Code 39, or USD-3) for patient identification/verification.
Indications for Use
EndoTool SubQ 2.1 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
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Image /page/4/Picture/0 description: The image contains the logo for Monarch Medical Technologies. The logo features a stylized butterfly with colorful wings on the left. To the right of the butterfly is the company name, "Monarch", in a bold, sans-serif font, with the words "Medical Technologies" in a smaller font size underneath.
blood glucose levels in patients with hyperglycemia including 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.
EndoTool SubQ 2.1 logic is not a substitute for clinical reasoning but an aid for trained healthcare professionals based on obtained glucose readings and entered clinical data. Final dose recommendations 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 upon the results provided by this software program.
Comparison of Technological Characteristics with the Predicate Device
The subject device has the same intended use, technological characteristics, and principles of operation as the previously cleared predicate device. 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. The differences in Indications For Use do not raise new questions of safety or effectiveness.
- 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 enhancements to the user interface, functionality, and data integration.
- Energy Source The predicate and subject device are software-only and 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.
A substantial equivalence chart comparing the subject device, EndoTool SubQ 2.1, to the EndoTool SubQ predicate device is provided below. The change to the indications for use for the subject device removes information about the optional IOB feature for simplicity, and does not raise new questions of safety or efficacy.
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Image /page/5/Picture/0 description: The image shows the logo for Monarch Medical Technologies. The logo features a colorful butterfly on the left, with the word "Monarch" in a bold, sans-serif font to the right of the butterfly. Below the word "Monarch" are the words "Medical Technologies" in a smaller font.
| Functionality | EndoTool SubQ 2.1
(Subject Device) | EndoTool SubQ
(Predicate Device)
K180366 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | EndoTool SubQ 2.1 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 hyperglycemia
including 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. | EndoTool SubQ is a software
management system for use by
trained healthcare professionals
to calculate and recommend an
individual patient's next dose of
insulin to be administered
subcutaneously to manage
elevated blood glucose levels in
both adult and pediatric patients
(age 2 and above and 12 kg or
more). The software is designed
to recommend the insulin dose(s)
(and on occasion a carbohydrate
dose for the treatment of
hypoglycemia) based on the
prescribing healthcare provider's
insulin regimen, target glucose
level range, and nutritional
regimen. The software provides
an optional insulin-on-board
(IOB) calculation that estimates
the sum of the remaining insulin
activity from previously
administered subcutaneous
insulin(s). This IOB adjustment
reduces the prescribed Bolus
dose and, if appropriate,
recommends a supplemental
carbohydrate dose to the trained
healthcare professional. |
| EndoTool SubQ 2.1 logic is not a
substitute for clinical
reasoning but an aid for
trained healthcare
professionals based on
obtained glucose readings and
entered clinical data. Final
dose recommendations 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 upon the
results provided by this
software program. | | EndoTool SubQ is not a substitute
for clinical reasoning, but rather
an aid for trained healthcare
professionals based on timely,
accurately obtained glucose
readings and timely, accurately
entered clinical data. Final dose
recommendations for a patient
must be accepted only after |
| | | |
| | | consideration of the full clinical
status of the patient. No medical
decision should be made based
solely upon the
recommendations provided by
this software program. |
| Prescription Use | Yes | Yes |
| Intended User | Clinician | Clinician |
| Patient Range | 12 kg and 2yr or greater | 12 kg and 2yr or greater |
| Environment of Use | Hospital | Hospital |
| EMR launch | Yes | Yes |
| Design:
• Operating Principles
• Performance Specifications
• Ergonomics of User
Interface | • Algorithm
• Data inputs, algorithm, parameters
• Nursing workflow, simplicity, feedback, messaging, information icon | • Algorithm
• Data inputs, algorithm, parameters
• Nursing workflow, simplicity, feedback, messaging, information icon |
| Patient setup (demographics, clinical, protocol) –
• directed via physician orders | Yes | Yes |
| • Option for integration with facility's Computer Physician Order Entry (CPOE). | Yes | No |
| Creates patient-specific drug administration profiles | Yes | Yes |
| Evaluates current glucose value | Yes | Yes |
| Evaluates cumulative glucose value | Yes | Yes |
| Calculates carbohydrate intake | Yes | Yes |
| Calculates nutritional bolus | Yes | Yes |
| Calculates meal intake | Yes | Yes |
| Dose titration | Yes | Yes |
| Calculates insulin total daily dose (TDD) and/or carbohydrate dose | Yes | Yes |
| • Option for integration with
facility's Medication
Administration Record
(MAR) | Yes | No |
| Data storage and analysis | Yes | Yes |
| Blood glucose entry | Yes | Yes |
| Feature Comparison:
• Operating System
• Browser compatibility
• Hardware Requirements | • Windows
• Internet Explorer, Microsoft Edge, Google Chrome, Mozilla Firefox
• server, PC, printer, bar code scanner (optional) | • Windows
• Internet Explorer, Microsoft Edge, Google Chrome, Mozilla Firefox
• 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. |
Comparison Summary Between the Subject Device and Predicates
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Image /page/6/Picture/0 description: The image shows the logo for Monarch Medical Technologies. The logo features a colorful butterfly on the left side. To the right of the butterfly is the word "Monarch" in a dark, sans-serif font. Below "Monarch" are the words "Medical Technologies" in a smaller, lighter font.
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Image /page/7/Picture/0 description: The image contains the logo for Monarch Medical Technologies. The logo features a colorful butterfly on the left side, with the word "Monarch" in a bold, sans-serif font to the right of the butterfly. Below the word "Monarch" are the words "Medical Technologies" in a smaller font size.
Performance Data
Software verification and validation testing was conducted per IEC 62304 and FDA's software validation guidance to demonstrate the performance of the device is substantially equivalent to the predicate. Performance testing included, but is not limited to, the following:
- Requirements-based, module and integration testing
- Data integration testing
- Algorithm test cases (automated and manual) ●
- Static analysis of the software code
- Regression testing
Conclusions
The subject device has the same intended uses, functionalities, technological characteristics, principles of operation, and is tested in the same way as the predicate device. As detailed in the submission, the subject device is as safe and effective as the predicate device.