(118 days)
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 <18 years) patients with no known insulin allergies.
The GlucoStabilizer Insulin Dosing Calculator's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GlucoStabilizer Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decisions should be based solely on the recommended guidance provided by this software program.
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.
The provided document describes the GlucoStabilizer® Insulin Dosing Calculator, a software solution, and its substantial equivalence to predicate devices, particularly in the context of expanding its use to pediatric patients. However, the document does NOT contain explicit acceptance criteria (performance metrics with pass/fail thresholds) or a detailed study description with specific data on device performance against such criteria. The FDA letter is a 510(k) clearance based on substantial equivalence, not an approval based on meeting pre-defined performance metrics from a de novo clinical trial.
Based on the provided text, here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided document. The 510(k) clearance is based on substantial equivalence to predicate devices (MDN-CGS™ Insulin Dosing Calculator (K071713) and Glytec LLC, Glucommander™ System (K113853)), rather than a direct demonstration against specific numerical acceptance criteria for this new version.
The document states: "The GlucoStabilizer Insulin Dosing Calculator 3.0 has the same technological characteristics and principles of operation as the MDN-CGSTM Insulin Dosing Calculator and Glytec LLC, Glucommander™ System. GlucoStabilizer 3.0 has the same intended use and similar indications as the Glucommander System. The minor technological differences between the GlucoStabilizer 3.0 and its predicates do not present any new issues of safety or effectiveness."
This implies that the device "meets" its criteria by being sufficiently similar to devices already recognized as safe and effective. No specific performance metrics (e.g., accuracy of insulin dose calculation to within X%, percentage of patients reaching target glucose within Y hours) or their corresponding results are reported for the GlucoStabilizer 3.0 itself in this document.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The 510(k) summary focuses on the comparison to predicate devices and the new features (pediatric use, multi-view screen). It does not detail a specific test set or data provenance used to evaluate the GlucoStabilizer 3.0's expanded functionality.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. As no specific test set evaluation is detailed, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The clearance is based on substantial equivalence to existing devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
The document does not describe a standalone study. The device is explicitly an "assist to clinical reasoning" and requires "qualified and trained medical personnel" for its use. Therefore, any evaluation would likely involve human-in-the-loop given its nature. However, no specific performance study is detailed, standalone or otherwise.
7. The Type of Ground Truth Used
Given the lack of a detailed performance study, the type of ground truth used for this specific 510(k) submission is not specified. For a device like an insulin dosing calculator, ground truth in a clinical study would typically involve a comparison of the device's recommendations against clinically optimal dosing determined by a panel of endocrinologists or an established gold-standard protocol, and ultimately, patient outcomes (blood glucose control, adverse events). However, such a study is not described here.
8. The Sample Size for the Training Set
This information is not provided in the document.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document, as no training set is described.
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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.
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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
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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 <18 years) patients with no known insulin allergies.
The GlucoStabilizer Insulin Dosing Calculator's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GlucoStabilizer Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decisions should be based solely on the recommended guidance provided by this software program.
Contraindications:
The device is not intended for use with patients with known insulin allergies or patients under the age of 2 years.
Warnings and Precautions:
The GlucoStabilizer Insulin Dosing Calculator's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GlucoStabilizer Insulin Dosing Calculator are intended to be used by qualified and trained medical persomel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decisions should be based solely on the recommended guidance provided by this software program.
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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September 10, 2014
5. 510(k) Summary
| Date: | Sep-10-2014 | |
|---|---|---|
| Owner/Submitter: | Greg Menke2220 Ivy Road, Suite 403Charlottesville, VA 22903 | Medical Decision Network, LLC |
| Phone: 866-791-6108Fax: 434-202-7282 | ||
| Contact: | Jane Keathley, MSRegulatory Project Manager2220 Ivy Road, Suite 403Charlottesville, 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 DosingCalculator(Formerly Clarian Glucose StabilizerInsulin Dosing Calculator) | |
| Common Name: | GlucoStabilizer(Formerly MDN-CGSTM Insulin DosingCalculator) | |
| Establishment Registration Number: | 3010817588 | |
| Review Panel/Medical Specialty:Product Code:Classification Name:Classification Number:Class: | AnesthesiologyNDCDrug Dose Calculator21 CFR 868.18902 | |
| Predicate Device: | MDN-CGS™ Insulin Dosing Calculator (K071713)Glytec LLC, Glucommander™ System (K113853) |
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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-<18) patients with no known insulin allergies. The GlucoStabilizer Insulin Dosing Calculator's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GlucoStabilizer Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel in evaluating patient
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| conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decisions should be based solely on the recommended guidance provided by this software program. | |
|---|---|
| Comparison withPredicate Device: | The submission device and the predicate devices have the same general intended use and similar indications, technological characteristics, and principles of operation. Each of the devices is intended to be used by trained clinicians. |
| This release of GlucoStabilizer includes support for use with pediatric patients, similar to Glytec LLC, Glucommander™ System. | |
| Conclusion: | GlucoStabilizer Insulin Dosing Calculator 3.0 has the same technological characteristics and principles of operation as the MDN-CGSTM Insulin Dosing Calculator and Glytec LLC, Glucommander™ System. GlucoStabilizer 3.0 has the same intended use and similar indications as the Glucommander System. The minor technological differences between the GlucoStabilizer 3.0 and its predicates do not present any new issues of safety or effectiveness. Thus, the GlucoStabilizer Insulin Dosing Calculator 3.0 is substantially equivalent to the MDN-CGS™ Insulin Dosing Calculator (K0717130) and the Glytec LLC, GlucommanderTM System (K113853). |
September 10, 2014
§ 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).