(217 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on calculation based on patient data and nutritional intake.
No
The device is a software support system that calculates the optimal next dose of insulin; it does not directly administer therapy or produce a therapeutic effect itself.
No
The device is described as a "software support system designed for use by trained healthcare professionals to calculate any individual patient's optimal next dose for insulin," indicating it is a therapeutic dose calculator, not a diagnostic device.
Yes
The device description explicitly states that EndoTool™ Drug Dose Calculator is software that resides on a Microsoft/Intel platform and does not mention any associated hardware components that are part of the medical device itself.
Based on the provided information, the EndoTool™ Drug Dose Calculator 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's Function: The description clearly states that EndoTool™ is a software support system that calculates the optimal insulin dose based on patient data and clinical context. It does not perform any tests on biological samples.
- Intended Use: The intended use is to assist healthcare professionals in managing blood glucose levels through insulin administration, not to diagnose or detect a condition from a sample.
- Device Description: The device is described as software residing on a computer platform, not a device that processes biological samples.
Therefore, based on the provided text, the EndoTool™ Drug Dose Calculator falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This software is to be used by trained nurses with supervision from licensed medical providers with appropriate hospital privileges or directly by licensed medical providers with appropriate hospital privileges in operating rooms, recovery rooms, and intensive care units to calculate the dose of insulin expected to maintain the blood glucose level in a range selected by the attending physician.
The EndoTool™ Drug Dose Calculator is a software support system designed for use by trained healthcare professionals to calculate any individual patient's optimal next dose for insulin administered intravenously to control blood glucose level for critically ill patients without inducing hypoglycemia (low blood glucose levels). EndoTool™ is for use with patients who are receiving a relative constant nutritional intake via intravenous fluids with dextrose, total parental nutrition or continuous gastro-intestinal feedings by any route of delivery.
Product codes
NDC
Device Description
EndoTool™ Drug Dose Calculator is software that resides on a Microsoft/Intel platforms to calculate (see Section 9.2, page 20) the drug dose of insulin to control blood glucose levels for critically ill patients on continuous feeding (IV, TBN, or tube feeding).
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
Not Found
Intended User / Care Setting
trained nurses with supervision from licensed medical providers with appropriate hospital privileges or directly by licensed medical providers with appropriate hospital privileges in operating rooms, recovery rooms, and intensive care units
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TRxF Intelligent Dosing System™ (K011571)
Reference Device(s)
Not Found
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
Page 16
Confidential
JUN 1 4 2006
Section 8 510(k) Summary
510(k) Summary
Prepared October 12, 2005
| Submitted by: | MD Scientific LLC |
|---|---|
| Submitter's Address: | 1214 Wareham Court |
| Charlotte, NC 28207 | |
| Contact Person: | Shade M. Mecum |
| 704-335-1300 | |
| Product Trade Name: | EndoTool™ Glucose Management System |
| Common Name: | Drug Dose Calculator |
| Classification: | Class II (per 21 CFR 868.1890 |
| Predicate Device: | TRxF Intelligent Dosing System™ (K011571) |
| Description of Device: | EndoTool™ Drug Dose Calculator is software that resides on a |
| Microsoft/Intel platforms to calculate (see Section 9.2, page 20) | |
| the drug dose of insulin to control blood glucose levels for | |
| critically ill patients on continuous feeding (IV, TBN, or tube | |
| feeding). | |
| Intended Use: | This software is to be used by trained nurses with supervision |
| from licensed medical providers with appropriate hospital | |
| privileges or directly by licensed medical providers with | |
| appropriate hospital privileges in operating rooms, recovery | |
| rooms, and intensive care units to calculate the dose of insulin | |
| expected to maintain the blood glucose level in a range selected | |
| by the attending physician. |
Comparison with Predicate Devices:
The Submission device and the predicate devices have intended use to calculate any individual's optimum next dose. Both devices are to be used by trained clinicians. The main difference is the patient using this submission device is limited to patients receiving continuous feeding.
The absence of intermittent feeding reduces the complexity of a variety of nutritional sources on blood glucose levels.
MD Scientific LLC Phone: 704-335-1300
1214 Wareham Court www.mdscientific.com Charlotte, NC 28207 Fax: 704-335-1309
1
Safety and Effectiveness Concerns:
This system is compliant to applicable standards ANSVIEEE 1012 (Standards for Software Verification and Validation) and ANSI/IEEE 830 (Guide to Software Requirement Specifications)
Conclusion:
This EndoTool™ Drug Dose Calculator system has the same intended use and characteristics and is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MD Scientific LLC % Mr. Shade M. Mecum President 1214 Wareham Court Charlotte, North Carolina 28207 JUN 1 4 2006
Re: K053137
Trade/Device Name: EndoTool™ Drug Dose Calculator Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulation Class: II Product Code: NDC Dated: May 22, 2006 Received: June 8, 2006
Dear Mr. Mecum:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set
3
Page 2 - Mr. Shade M. Mecum
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Hulut Lemer mos
Mark N. Mellon
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): (Unknown)
Device Name: EndoTool™ Drug Dose Calculator
Indications For Use:
The EndoTool™ Drug Dose Calculator is a software support system designed for use by trained healthcare professionals to calculate any individual patient's optimal next dose for insulin administered intravenously to control blood glucose level for critically ill patients without inducing hypoglycemia (low blood glucose levels). EndoTool™ is for use with patients who are receiving a relative constant nutritional intake via intravenous fluids with dextrose, total parental nutrition or continuous gastro-intestinal feedings by any route of delivery.
| Prescription Use X
| (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |
|---|---|---|
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | ||
| ____________________________________________ | ||
| (Division Sign-Off) | ||
| Division of General, Restorative, | ||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
| and Neurological Devices | ||
| 510(k) Number V05 3137 | Page 1 of ________________ |