(236 days)
EndoTool IV 3.1 is a glucose management software system used by healthcare professionals in all inpatient care settings for adult and pediatric patients aged two years and above who weigh 12 kgs. or more. EndoTool adjusts and maintains a patient's glucose level within a configurable clinician-determined target range by recommending patient-specific intravenous insulin dosing, carbohydrate dosing for recovery or supplementation, and subcutaneous dosing for the transition from IV dosing.
EndoTool IV 3.1 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 3.1 is a software system for glucose management which uses the current and cumulative qlucose 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 dose when IV insulin therapy is no longer required.
The provided text is a 510(k) summary from the FDA, detailing the premarket notification for the "EndoTool IV 3.1" device. While it outlines the device's purpose, comparison to a predicate device, and general statements about software verification and validation, it does not contain the specific information required to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.
The document states:
- "Software verification and validation testing was conducted per IEC 62304."
- "Clinical testing was not required to demonstrate the safety and effectiveness of the EndoTool IV 3.1. Instead, substantial equivalence is based upon benchtop performance testing."
This indicates that the validation was primarily software-focused and benchtop (likely simulated data or internal testing against predefined rules) rather than clinical. It does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, its provenance, or whether it was retrospective/prospective.
- Information on experts used for ground truth, their qualifications, or adjudication methods.
- Details of a Multi-Reader Multi-Case (MRMC) study or its effect size.
- Results from a standalone algorithm performance study.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set or how its ground truth was established.
Therefore, based solely on the provided document, I cannot fulfill your request as the essential information about specific performance data, test methodologies, and ground truth establishment is not present. The document focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and conformance to a general software standard (IEC 62304).
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December 11, 2024
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Monarch Medical Technologies Tara Burnett Senior Vice President of Regulatory Affairs and Compliance 112 S. Tryon Street. Ste. 800 Charlotte, North Carolina 28284
Re: K241088
Trade/Device Name: EndoTool IV 3.1 Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: October 29, 2024 Received: October 29, 2024
Dear Tara Burnett:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) K241088
Device Name EndoTool IV 3.1
Indications for Use (Describe)
EndoTool IV 3.1 is a glucose management software system used by healthcare professionals in all inpatient care settings for adult and pediatric patients aged two years and above who weigh 12 kgs. or more. Endo Tool adjusts and maintains a patient's glucose level within a configurable clinician-determined target range by recommending patient-specific intravenous insulin dosing, carbohydrate dosing for recovery or supplementation, and subcutaneous dosing for the transition from IV dosing.
EndoTool IV 3.1 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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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:
l. SUBMITTER
Monarch Medical Technologies, LLC 112 S. Tryon Street, Ste. 800 Charlotte, NC 28284 Tel: +1.303.913.4822 Email: tara.burnett@monarchmedtech.com
| Contact Person: | Tara Burnett |
|---|---|
| Date Prepared: | December 10, 2024 |
DEVICE ll.
| Name of Device: | EndoTool IV 3.1 |
|---|---|
| Classification Name: | Drug Dose Calculator |
| Regulation: | 21 CFR § 868.1890 |
| Regulatory Class: | Class II |
| Product Classification Code: | NDC |
| 510(k) Submission Number: | K241088 |
PREDICATE DEVICE lll.
| Predicate Manufacturer: | Monarch Medical Technologies |
|---|---|
| Predicate Trade Name: | EndoTool IV System |
| Predicate 510(k): | K201619 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
EndoTool IV 3.1 is a software system for glucose management which uses the current and cumulative qlucose 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 dose when IV insulin therapy is no longer required.
V. INDICATIONS FOR USE
EndoTool IV 3.1 is a glucose management software system used by healthcare professionals in all inpatient care settings for adult and pediatric patients aged two years and above who weigh 12 kgs. or more. EndoTool adjusts and maintains a patient's glucose level within a configurable cliniciandetermined target range by recommending patient-specific intravenous insulin dosing,
carbohydrate dosing for recovery or supplementation, and subcutaneous dosing for the transition from IV dosing.
EndoTool IV 3.1 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 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, .
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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 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.
| Feature | EndoTool IV 3.1 System | EndoTool IV System |
|---|---|---|
| Indications for Use | EndoTool IV 3.1 is a glucosemanagement software systemused by healthcare professionalsin all inpatient care settings foradult and pediatric patients agedtwo years and above who weigh12 kgs. or more. EndoTooladjusts and maintains a patient'sglucose level within a configurableclinician-determined target rangeby recommending patient-specificintravenous insulin dosing,carbohydrate dosing for recoveryor supplementation, andsubcutaneous dosing for thetransition from IV dosing.EndoTool IV 3.1 logic is not asubstitute for but rather an adjunctto clinical reasoning. No medicaldecision should be based solelyon the recommended guidanceprovided by this software system. | EndoTool IV is a glucosemanagement software system,designed for use by healthcareprofessionals in all patient caresettings to recommendintravenous and subcutaneoustransition dosing, as well ascarbohydrates. Evaluatingcurrent and cumulative glucoselevels, the software adjusts andmaintains the glucose level withina configurable clinician-determined target range. Thesystem is indicated for use inadult and pediatric patients ages2 years and above, who weigh 12kgs. or more. EndoTool IV logic isnot a substitute for, but rather anadjunct to clinical reasoning. Nomedical decision should bebased solely on therecommended guidance providedby this software system. |
| 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-specificIV drug infusion profiles | Yes | Yes |
| Evaluates current glucosevalue | Yes | Yes |
| Evaluates cumulativeglucose value | Yes | Yes |
| Calculates next dose ofinsulin, glucose, or saline | Yes | Yes |
| Calculates carbohydrateintake | Yes | Yes |
| Calculates nutritionalbolus | Yes | 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 |
| Precautions | Yes | Yes |
| Instructions for Use | Yes | Yes |
| Intended User | Healthcare Professionals | Healthcare Professionals |
| Environment of Use | Windows hosting environmentincludes physical or virtual webapplication server and databaseserver. These may be hosted onclient premises or in a privatevirtual network in Monarch's Azurehosting environment. | Windows Hosting Environmenton Client's Servers. |
| 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 facilityor in Azure private virtualnetwork by Monarch. | • N/A – Installed at user facilityby Monarch. |
| • Ergonomics ofPatient-User Interface | • N/A – Standalone Software | • N/A – Standalone Software |
| • Packaging | • N/A – Standalone Software | • N/A – Standalone Software |
| • Sterilization Method | • N/A – Standalone Software | • N/A – Standalone Software |
| Connectivity | On-line web-based application | On-line web-based applicationand off-line, Server-based |
| Energy Source | N/A – Standalone Software | N/A – Standalone Software |
| Feature Comparison: | ||
| • Operating System | • All | • All |
| • Browser compatibility | • Microsoft Edge, GoogleChrome | • Internet Explorer, MicrosoftEdge, Google Chrome,Mozilla Firefox |
| • HardwareRequirements | server, PC, printer, bar codescanner (optional) | server, PC, printer, bar codescanner (optional) |
| Performance Testing | Validated per IEC 62304requirements and FDA softwarevalidation guidance. | Validated per IEC 62304requirements and FDA softwarevalidation 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)
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.
Mechanical and acoustic Testing
Not Applicable (Standalone Software)
Animal Studv
Animal performance testing was not required to demonstrate the safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the EndoTool IV 3.1. Instead, substantial equivalence is based upon benchtop performance testing.
VIII. CONCLUSIONS
The indications for use and performance of the EndoTool IV 3.1 are substantially equivalent to that of the predicate device (K201619), 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).