(53 days)
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.
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.
The provided text describes the 510(k) premarket notification for the EndoTool IV System, a glucose management software. However, it does not include specific acceptance criteria or details of a study proving the device meets those criteria, particularly in the context of clinical performance or human-AI interaction.
The document states that the device is a software-only device and that clinical testing was not required to demonstrate safety and effectiveness. Instead, substantial equivalence to a predicate device (EndoTool IV 1.10, K200443) is based upon benchtop performance testing (Software Verification and Validation Testing).
Therefore, many of the requested details about acceptance criteria, sample sizes for test and training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types are not available in the provided document because the nature of the device and the regulatory pathway chosen (510(k) based on substantial equivalence to a predicate, with bench testing for software verification) did not require them.
Below is a table summarizing the information that is available and explicitly stating what is not available based on the provided text.
Acceptance Criteria and Device Performance (Based on available information for EndoTool IV System)
Given that this is a software-only device and substantial equivalence was determined based on benchtop performance testing (software verification and validation), the "acceptance criteria" discussed are likely related to software quality, functional correctness, and adherence to design specifications, rather than clinical performance metrics in a patient population. The document states that the device performs "as well as the predicate device" in terms of its indications for use and overall performance.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from Software V&V) | Reported Device Performance (Summary from text) |
|---|---|
| Functional Correctness/Accuracy: Calculations and recommendations for IV insulin, carbohydrate doses, and subcutaneous basal transition dosing are accurate. | The device performs "as well as the predicate device (K200443)." It correctly calculates and recommends doses and adjusts/maintains glucose levels within configurable target ranges, evaluating current and cumulative glucose values. The software was validated per IEC 62304. |
| Software Quality/Reliability: Adherence to software development lifecycle standards and risk management. | Software verification and validation testing conducted per IEC 62304 standards, including: - Requirements-based, module, and integration tests - Endo-Tool regression testing (requirements-based for risk-related requirements, automated algorithm test cases for complete application) - Static analysis of the software code. |
| User Interface and Functionality: Interface and functionality are as designed and equivalent to the predicate. | "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." All listed features (e.g., user inputs, alarm advisories, GUI interface) are present and function as intended. |
| Safety Warnings/Precautions: Appropriate warnings and controls are implemented. | New warning/controls regarding low potassium added (compared to predicate). Warnings, precautions, and labeling are present and equivalent to the predicate. |
| Compatibility: Operates on specified systems and browsers. | Compatible with "All" operating systems (as vague as stated) and specific browsers (Internet Explorer, Microsoft Edge, Google Chrome, Mozilla Firefox). Hardware requirements are server, PC, printer, barcode scanner (optional). |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated in terms of patient data or clinical samples. The "test set" likely refers to software test cases and simulated data used for verification and validation.
- Data Provenance: Not applicable in the context of clinical data for this 510(k) submission, as clinical studies were not required. The "data" used would be input data for software testing, derived from theoretical scenarios, and potentially representative patient profiles (though specifics are not provided).
- Retrospective/Prospective: Not applicable as clinical studies were not conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of software verification and validation. The "ground truth" for software functionality is established by its specification and requirements, and verified through testing against those requirements. This does not typically involve a panel of clinical experts adjudicating cases for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As no clinical test set requiring expert interpretation or adjudication was used, this method is not relevant to the data provided.
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, an MRMC study was NOT done. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the EndoTool IV." The device is a "Drug Dose Calculator," which provides recommendations and is an adjunct to clinical reasoning, but the document does not describe it as an AI-powered diagnostic tool requiring human-AI comparative effectiveness studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The entire basis for this 510(k) is the "Software Verification and Validation Testing," which represents the standalone performance of the algorithm against its requirements and specifications. The document states it's "a software system for glucose management which uses the current and cumulative glucose values... to calculate and recommend..." This is the "algorithm only" performance.
- No specific performance metrics (e.g., accuracy, precision relative to a ground truth clinical outcome) are provided because clinical studies were not performed. The performance is deemed "as well as the predicate device" based on software verification.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the clinical sense. The "ground truth" for software validation testing is typically the expected output based on the defined algorithms and inputs, derived from mathematical models, clinical guidelines incorporated into the algorithm, or predefined correct outputs for specific test cases. This is not derived from expert consensus on patient cases, pathology, or outcomes data in the way a diagnostic AI would require for clinical validation.
8. The sample size for the training set:
- Not applicable/Not stated. This device is presented as an update to a predicate software system, and the filing focuses on demonstrating substantial equivalence based on engineering and software validation. There is no mention of a machine learning component requiring a "training set" of data in the common AI/ML sense. It is a rule-based or algorithm-based system ("Algorithm B" is mentioned).
9. How the ground truth for the training set was established:
- Not applicable. As there is no mention of an ML training set, the establishment of its ground truth is not relevant here. The "ground truth" for the core algorithms would be embedded in established medical principals for glucose management.
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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 (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) 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) | |
|---|---|
| Prescription Use (Part 21 CFR 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 -Ann Marie Gaitan VP, Requlatory Affairs and Compliance Monarch Medical Technologies, LLC 4400 Stuart Andrew Blvd., Suite N Charlotte, NC 28217 Tel: +1.704.562.0777 Email: AnnMarie.Gaitan@monarchmedtech.com
| 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 glucosemanagement software system,designed for use by healthcareprofessionals in all patient caresettings to recommend intravenousand subcutaneous transition dosing, aswell as carbohydrates. Evaluatingcurrent and cumulative glucose levels,the software adjusts and maintains theglucose level within a configurableclinician-determined target range. Thesystem is indicated for use in adultand pediatric patients ages 2 years andabove, who weigh 12 kgs. or more.EndoTool IV logic is not a substitutefor, but rather an adjunct to clinicalreasoning. No medical decisionshould be based solely on therecommended guidance provided bythis software system. | 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 to recommendintravenous and subcutaneoustransition dosing, as well asdextrose, to adjust and maintain theblood glucose level within aconfigurable clinician- determinedtarget range. The EndoTool DrugDelivery Calculator is indicated foruse in adult and pediatric patientsages 2 years and above and whoweigh 12 kgs. or more. EndoToolIV 1.10 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. | |
| Prescription Use | Yes | ||
| Product Code | NDC | ||
| Classification | 868.1890 | ||
| Class | II | ||
| Patient Range | 12 kg and 2yr or greater | ||
| Creates patient-specific IVdrug infusion profiles | Yes | ||
| Evaluates current glucosevalue | Yes | ||
| Evaluates cumulativeglucose value | Yes | ||
| Calculates next dose ofinsulin, glucose, or saline | Yes | ||
| Calculates carbohydrateintake | Yes | ||
| Calculates nutritionalbolus | 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 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 lowpotassium 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: | |||
| DimensionalSpecifications | N/A - Standalone Software | N/A - Standalone Software | |
| Operating Principles | Algorithm B | Algorithm B | |
| PerformanceSpecifications | N/A - Installed at user facility byMonarch. | N/A - Installed at user facilityby Monarch. | |
| Ergonomics ofPatient-User Interface | N/A - Standalone Software | N/A - Standalone Software | |
| Packaging | |||
| Sterilization Method | |||
| Connectivity | On-line web-based application andoff-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, MicrosoftEdge, Google Chrome, MozillaFirefox | Edge, Google Chrome, MozillaFirefox | |
| HardwareRequirements | server, PC, printer, bar codescanner (optional) | server, PC, printer, bar codescanner (optional) | |
| Performance Testing | Validated per IEC 62304 requirementsand FDA software validation guidance. | Validated per IEC 62304 requirementsand FDA software validation guidance. |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
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Sterilization & Shelf-life Testing
Not Applicable (Standalone Software)
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:
- o Requirements-based testing for risk-related requirements
- o Automated algorithm test cases for the complete application
- o Static analysis of the software code
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 (K200443), raising no safety or effectiveness issues, and performing as well as the predicate device.
§ 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).