(118 days)
Not Found
No
The description focuses on "programmed logic" and "automates calculations" based on blood glucose values and patient weight, without mentioning AI or ML techniques.
No
The device is a software solution that calculates and recommends doses of insulin or dextrose; it does not directly administer therapy to the patient. It assists in clinical reasoning and decision-making for managing blood glucose levels.
No
The device is an insulin dosing calculator that uses blood glucose values to recommend insulin or dextrose doses. While it uses measurements (blood glucose values) to make calculations, its primary function is to guide treatment (dosing) rather than to diagnose a condition. It assists in managing a known condition (blood glucose levels) rather than identifying or characterizing a disease. The document states it evaluates "current as well as cumulative patient blood glucose values," but this evaluation is a step towards treatment recommendation, not a diagnostic conclusion about a disease state.
Yes
The device is described as a "Web-based software solution" that automates calculations and provides alerts. There is no mention of any accompanying hardware components or hardware-specific functions.
Based on the provided text, the GlucoStabilizer Insulin Dosing Calculator 3.0 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections.
- GlucoStabilizer's Function: The GlucoStabilizer software takes blood glucose values (which are obtained through an in vitro diagnostic test, but the software itself doesn't perform the test) and uses them to calculate and recommend insulin or dextrose doses. It is a decision support tool based on existing diagnostic data, not a diagnostic test itself.
- Intended Use: The intended use clearly states it's for "evaluat[ing] the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose". It's about managing treatment based on diagnostic results, not performing the diagnosis.
- Device Description: The description focuses on it being a "Web-based software solution that automates calculations used by healthcare professionals to determine the appropriate intravenous insulin drip rate". It's a calculation and management tool.
Therefore, while it relies on data generated by an IVD (blood glucose measurements), the GlucoStabilizer Insulin Dosing Calculator 3.0 itself falls under the category of a clinical decision support software or a medical device software, not an IVD.
N/A
Intended Use / Indications for Use
The GlucoStabilizer Insulin Dosing Calculator 3.0 is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the blood glucose level either up or down towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend dosing of insulin or dextrose for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing calculations of insulin and dextrose for both adult and pediatric (ages 2 to
§ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2014
Medical Decision Network, LLC C/O Jane Keathley, MS Regulatory Project Manager 2220 Ivy Road, Suite 403 Charlottesville, Virginia 22903
Re: K141321
Trade/Device Name: GlucoStabilizer® Insulin Dosing Calculator Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: II Product Code: NDC Dated: August 5, 2014 Received: August 6, 2014
Dear Ms. Keathley:
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. 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.
Image /page/0/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle, there is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141321
Device Name GlucoStabilizer Insulin Dosing Calculator
Indications for Use (Describe)
The GlucoStabilizer Insulin Dosing Calculator 3.0 is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the either up or down towards a predetermined target range.
Once that target blood glucose range has been reached, the system's function is to recommend dosing of insulin or dextrose for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing calculations of insulin and dextrose for both adult and pediatric (ages 2 to Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for MDN, which stands for "Sullivan Street O'Sullivan Network, LLC". The logo is in bold, dark blue letters. The text "Sullivan Street O'Sullivan Network, LLC" is in a smaller font size and is located below the MDN letters.
September 10, 2014
5. 510(k) Summary
| Date: | Sep-10-2014 | |
|---|---|---|
| Owner/Submitter: | Greg Menke | |
| 2220 Ivy Road, Suite 403 | ||
| Charlottesville, VA 22903 | Medical Decision Network, LLC | |
| Phone: 866-791-6108 | ||
| Fax: 434-202-7282 | ||
| Contact: | Jane Keathley, MS | |
| Regulatory Project Manager | ||
| 2220 Ivy Road, Suite 403 | ||
| Charlottesville, VA 22903 | Medical Decision Network, LLC | |
| Phone: (434) 409-3535 | Email: jane.keathley@mdnllc.net | |
| Type of 510(k) Submission: | Traditional 510(k) | |
| Trade Name: | GlucoStabilizer® Insulin Dosing | |
| Calculator | ||
| (Formerly Clarian Glucose Stabilizer | ||
| Insulin Dosing Calculator) | ||
| Common Name: | GlucoStabilizer | |
| (Formerly MDN-CGSTM Insulin Dosing | ||
| Calculator) | ||
| Establishment Registration Number: | 3010817588 | |
| Review Panel/Medical Specialty: | ||
| Product Code: | ||
| Classification Name: | ||
| Classification Number: | ||
| Class: | Anesthesiology | |
| NDC | ||
| Drug Dose Calculator | ||
| 21 CFR 868.1890 | ||
| 2 | ||
| Predicate Device: | MDN-CGS™ Insulin Dosing Calculator (K071713) | |
| Glytec LLC, Glucommander™ System (K113853) |
5
Description of Device: The GlucoStabilizer Insulin Dosing Calculator 3.0 is a Web-based software solution that automates calculations used by healthcare professionals to determine the appropriate intravenous insulin drip rate necessary to manage blood glucose levels across a variety of patient populations. GlucoStabilizer also provides alerts for subsequent blood glucose testing and monitoring. The GlucoStabilizer software release described in this 510(k) submission contains a modification that allows its use for pediatric patients. The pediatric protocol considers patient weight in insulin calculations for patients under the age of 18 years and provides a 3-digit multiplier for more granular calculation results. In addition, this release of GlucoStabilizer provides an optional 'multi-view'screen that allows healthcare personnel to more easily manage multiple, on-going patient treatment programs. Other features and technological characteristics of GlucoStabilizer are unchanged. Intended Use: The GlucoStabilizer Insulin Dosing Calculator 3.0 is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the blood glucose level either up or down towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend dosing of insulin or dextrose for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing calculations of insulin and dextrose for both adult and pediatric (ages 2-