(22 days)
No reference devices were used in this submission.
No
The summary describes a software program that uses "logic" and evaluates "current and cumulative blood glucose values" to make recommendations. There is no mention of AI, ML, training data, or complex algorithms typically associated with AI/ML. The performance studies focus on software verification and validation, not AI/ML model performance.
Yes
The device is designed to recommend insulin and dextrose dosages to adjust and maintain blood glucose levels, which constitutes a therapeutic intervention.
No
The device is a glycemic management software support program that recommends intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain blood glucose levels. It does not diagnose conditions.
Yes
The device description explicitly states "EndoTool IV is a software device for blood glucose management". The performance studies focus on software verification and validation, with no mention of hardware components or testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- EndoTool IV's function: EndoTool IV is a software program that evaluates blood glucose levels (which are obtained from in vitro testing) but its primary function is to recommend insulin and dextrose dosing and transition strategies. It is a decision support tool for healthcare professionals, not a device that performs the in vitro test itself or directly provides diagnostic information about a physiological state based on the specimen.
- Intended Use: The intended use clearly states it's a "glycemic management software support program" designed to "recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level." This focuses on therapeutic management based on existing data, not on the diagnostic analysis of a specimen.
- Device Description: The description reinforces this by stating it "evaluates current and cumulative blood glucose values to recommend intravenous insulin or dextrose/carbohydrate dose."
While it uses data from in vitro diagnostic tests (blood glucose measurements), the software itself is not performing the in vitro diagnostic function. It's a tool for managing treatment based on those results.
N/A
Intended Use / Indications for Use
By evaluating current and cumulative blood glucose levels, EndoTool IV 1.10 - a glycemic management software support program - is designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level within a configurable clinician- determined target range. The EndoTool Drug Delivery Calculator is indicated for use in adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more. EndoTool IV 1.10 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 program.
Product codes (comma separated list FDA assigned to the subject device)
NDC
Device Description
EndoTool IV is a software device for blood glucose management which evaluates current and cumulative blood glucose values to recommend intravenous insulin or dextrose/carbohydrate dose, to adjust and maintain the blood glucose level within a provider-ordered target range. In addition, the application will recommend a subcutaneous Basal transition insulin dose when IV insulin therapy is no longer required.
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
adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more
Intended User / Care Setting
healthcare professionals in all patient care settings
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:
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:
- Requirements-based testing for risk-related requirements
- Automated algorithm test cases for the complete application
- Static analysis of the software code
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 17, 2020
Monarch Medical Technologies, LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K200443
Trade/Device Name: EndoTool IV 1.10 Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: NDC Dated: February 22, 2020 Received: February 24, 2020
Dear Prithul Bom:
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
1
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 531-542 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 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. 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
2
Indications for Use
510(k) Number (if known) K200443
Device Name EndoTool IV 1.10
Indications for Use (Describe)
By evaluating current and cumulative blood glucose levels, EndoTool IV 1.10 - a glycemic management software support program - is designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level within a configurable clinician- determined target range. The EndoTool Drug Delivery Calculator is indicated for use in adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more. EndoTool IV 1.10 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 program.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 Monarch Medical Technologies, LLC 2137 South Blvd. Ste 300 Charlotte, NC 28203 Tel: +1.704.562.0777 Email: AnnMarie.Gaitan@monarchmedtech.com
| Contact Person: | Ann Marie Gaitan |
|---|---|
| Date Prepared: | November 12, 2019 |
| II. DEVICE | |
|---|---|
| Name of Device: | EndoTool IV 1.10 |
| 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 Glucose Management System |
| Predicate 510(k): | K132547 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
EndoTool IV is a software device for blood glucose management which evaluates current and cumulative blood glucose values to recommend intravenous insulin or dextrose/carbohydrate dose, to adjust and maintain the blood glucose level within a provider-ordered target range. In addition, the application will recommend a subcutaneous Basal transition insulin dose when IV insulin therapy is no longer required.
V. INDICATIONS FOR USE
By evaluating current and cumulative blood glucose levels, EndoTool IV 1.10 - a glycemic management software support program - is designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level within a configurable clinician- determined target range. The EndoTool Drug Delivery Calculator is indicated for use in adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more. EndoTool IV 1.10 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 program.
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 identical indications for use, ●
4
with the exception of the updated name of the device.
- . 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 | Subject Device:
EndoTool IV 1.10 | Predicate Device (K132547):
EndoTool Glucose Management
System |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | By evaluating current and
cumulative blood glucose levels,
EndoTool IV 1.10 - a glycemic
management software support
program - is designed for use by
healthcare professionals in all
patient care settings to
recommend intravenous and
subcutaneous transition dosing,
as well as dextrose, to adjust and
maintain the blood glucose level
within a configurable clinician-
determined target range. The
EndoTool Drug Delivery
Calculator is indicated for use in
adult and pediatric patients ages 2
years and above and who weigh
12 kgs. or more. EndoTool IV
1.10 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 program. | By evaluating current and
cumulative blood glucose levels,
the Endo-rool Glucose
Management Sysstem (EGMS) -
a glycemic management software
support program is designed for
use by healthcare professionals in
all patient care settings
to recommend intravenous and
subcutaneous transition dosing,
as well as dextrose, to adjust and
maintain the blood
glucose level within a
configurable clinician-
determined target range.
The EndoTool Drug Delivery
Calculator is indicated for use in
adult and pediatric patients ages 2
years and above and
who weig-h 12 kgs. or more.
The EGMS 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 program. |
| 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-specific
IV drug infusion profiles | Yes | Yes |
| Evaluates current
glucose value | Yes | Yes |
| Evaluates cumulative
glucose value | Yes | Yes |
| Calculates next dose of
insulin, glucose, or
saline | Yes | Yes |
| Calculates carbohydrate
intake | Yes | Yes |
| Calculates nutritional
bolus | Yes | Yes |
| Calculates meal intake | Yes | Yes |
| User Inputs | Yes | Yes |
| Weight | Yes | Yes |
| Age | Yes | Yes |
| Dose titration | Yes | Yes |
| Calculates infusion rate
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 |
| 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: | N/A - Standalone Software
• Dimensional Specifications
• Operating Principles
• Packaging
• Sterilization Method | N/A - Standalone Software
• Algorithm A
• DVD Case
• N/A - Standalone Software |
| Energy Source | N/A - Standalone Software | N/A - Standalone Software |
| Feature Comparison: | • Windows
• server, PC, printer, bar code scanner (optional) | • Windows
• 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. |
5
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
Not Applicable (Standalone Software)
6
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: ●
- о Requirements-based testing for risk-related requirements
- Automated algorithm test cases for the complete application o
- Static analysis of the software code o
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 (K132547), raising no safety or effectiveness issues, and performing as well as the predicate device.