(131 days)
The Glucommander System is a glycemic management tool intended to evaluate current and cumulative patient blood glucose values and coupled with patient information including age, weight and height, and, based on the aggregate of these measurement parameters, whether one or many, recommend an IV dosage of insulin, glucose or saline or a subcutaneous basal and bolus insulin dosing recommendation to adjust and maintain the blood glucose level towards a configurable clinician determined target range.
The Glucommander System is indicated for use in adult and pediatric (ages 2 - 17 years) patients.
The Glucommander System logic is not a substitute for, but rather an adjunct to clinical reasoning. The measurements and calculations generated 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 decision should be based solely on the recommended guidance provided by this software program.
The Glytec, LLC Glucommander System is a software device used to evaluate current and cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, recommend an IV dosage of insulin, glucose or saline to direct the blood glucose level towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend a titration of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of insulin for both pediatric (ages 2 - 17 years) and adult patients.
Acceptance Criteria and Study for Glytec LLC, Glucommander™ System (K113853)
This 510(k) submission (K113853) is for a modification to an existing device, the GlyTec, LLC G+ System (K101344). The modification is the addition of a pediatric protocol that considers the weight of the patient. As such, the submission focuses on the performance of the modified software and its substantial equivalence to the predicate device, rather than establishing new acceptance criteria or conducting a comprehensive clinical study to prove general device performance.
Based on the provided document, the following can be inferred regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria or performance metrics for the modified Glucommander™ System (K113853) in a table format.
Instead, the submission relies on demonstrating substantial equivalence to the predicate device (K101344) and emphasizes that the modifications introduced (pediatric protocol) do not raise new safety or effectiveness concerns.
The reported "performance" is qualitative, focusing on functional aspects:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence to predicate device (K101344) for adult patients | "Other user screen labeling such as the function of screen buttons, the ability to add additional patient data and user information, the ability to password protect information and other similar security features, data handling performance, user controlled automatic system shutdown and software update notifications are unchanged." |
| Correct Calculation of Initial Multiplier for pediatric patients based on weight | "An additional input validation on the date of birth field identifies pediatric patients and calculates the patient's initial multiplier based on the patient's weight..." |
| Appropriate User Interface Design for adult/pediatric identification | "Initial starting parameters and the user interface design were modified to allow for the easy identification and calculation of initial multiplier based on a pediatric patient's weight that clearly indicate the order set as either adult or pediatric." |
| Software Functionality as intended | "The results of usability testing of representative users of the device, software testing and performance testing of the device demonstrate the device functions as intended." |
| No New Safety or Effectiveness Concerns compared to predicate device | "Glytec, Inc. believes no differences exist between this system and the predicate system that raise any new safety.or effectiveness concerns." |
2. Sample Size for the Test Set and Data Provenance
The document mentions "usability testing of representative users of the device, software testing and performance testing of the device." However, it does not specify the sample size used for these tests or the data provenance (e.g., country of origin, retrospective/prospective nature of data).
Given the nature of the submission (modification to an existing device for substantial equivalence), it's likely these tests were focused on verifying the correct implementation of the new pediatric protocol and ensuring no regressions in existing functionalities, rather than a large-scale clinical validation study.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" for a test set. The evaluation appears to be based on internal testing (usability, software, performance) to confirm the new features work as designed and that overall functionality remains equivalent to the predicate.
4. Adjudication Method for the Test Set
Since there is no mention of external experts establishing ground truth for a test set, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. The submission focuses on substantial equivalence based on technical modifications rather than a comparative study of human reader performance with and without AI assistance.
6. Standalone Performance Study
A standalone performance study focused on the algorithm only (without human-in-the-loop performance) was implicitly done through "software testing and performance testing of the device." These tests would assess the internal logic and calculations of the Glucommander™ System, including the new pediatric protocol's ability to correctly calculate the initial multiplier. However, the specific metrics and results of such a standalone study are not detailed.
7. Type of Ground Truth Used
For the "software testing and performance testing," the ground truth would likely be based on:
- Engineering specifications and design documents: Verifying that the software calculations and logic conform to the intended design, especially for the new pediatric weight-based multiplier.
- Predetermined correct outputs: For specific test cases, the expected correct IV dosage recommendations or multiplier calculations would be known and used to validate the device's output.
- Clinical rationale: The pediatric protocol's design would be based on clinical understanding of pediatric glycemic management.
The document does not explicitly state that pathology, outcomes data, or expert consensus (external to the development process) were used as "ground truth" in a formal sense for this specific submission.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. As this is a software device for recommending insulin dosages based on blood glucose values and patient parameters, it's likely built on established algorithms and clinical guidelines, rather than relying on a large "training set" in the context of machine learning for image classification, for example. If any machine learning elements were involved, details are not provided.
9. How the Ground Truth for the Training Set Was Established
Given the lack of information on a training set, the method for establishing its ground truth is also not described.
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K113853
MAY - 8 2012
Section 3 510(k) Summary of Safety and Effectiveness
April 30, 2012
| Proprietary Name: | Glytec LLC, Glucommander™ System |
|---|---|
| Common Name: | G+ System, Enterprise Edition |
| Product Code/Classification Panel: | NDC - General and Plastic Surgery |
| Classification Name: | Predictive Pulmonary Function Value Calculator, Class II per §868.1890 |
Submitter Information
Submitter's Name and Address:
Glytec, LLC (a wholly owned subsidiary of Glucotec, Inc.) 770 Pelham Rd., Ste 210 Greenville, SC 29615 FDA Establishment Registration Number: 3005853093
Contact Information:
William Matthews, Executive VP, Operations Glytec, LLC 770 Pelham Rd., Ste 210 Greenville, SC 29615 Phone 864-263-4180 Fax 864-233-7828
Performance Standards
No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act for a Predictive Pulmonary Function Value Calculator ട്ട868.1890.
Predicate Device
The predicate device for the GlyTec, LLC G+ System is the following:
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Section 3 510(k) Summary of Safety and Effectiveness
April 30, 2012
GlyTec, LLC G+ System - #K101344 (6/28/2010) .
Device Description
The Glytec, LLC Glucommander System is a software device used to evaluate current and cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, recommend an IV dosage of insulin, glucose or saline to direct the blood glucose level towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend a titration of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of insulin for both pediatric (ages 2 - 17 years) and adult patients.
Indications for Use/Intended Use
The Glucommander System is a glycemic management tool intended to evaluate current and cumulative patient blood glucose values and coupled with patient information including age, weight and height, and, based on the aggregate of these measurement parameters, whether one or many, recommend an IV dosage of insulin, glucose or saline or a subcutaneous basal and bolus insulin dosing recommendation to adjust and maintain the blood glucose level towards a configurable clinician determined target range.
The Glucommander System is indicated for use in adult and pediatric (ages 2 - 17 years) patients.
The Glucommander System logic is not a substitute for, but rather an adjunct to clinical reasoning. The measurements and calculations generated 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 decision should be based solely on the recommended guidance provided by this software program.
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Section 3 510(k) Summary of Safety and Effectiveness
April 30, 2012
Summary of Technological Characteristics
The Glytec, LLC Glucommander System described by this submission, contains a modification to the software. This modification is the addition of a pediatric protocol that considers the weight of the patient. Initial starting parameters and the user interface design were modified to allow for the easy identification and calculation of initial multiplier based on a pediatric patient's weight that clearly indicate the order set as either adult or pediatric. An additional input validation on the date of birth field identifies pediatric patients and calculates the patient's initial multiplier based on the patient's weight whereas the multiplier for the adult patients is still selected manually. In the adult protocol, the coefficient selection is unchanged.
Other user screen labeling such as the function of screen buttons, the ability to add additional patient data and user information, the ability to password protect information and other similar security features, data handling performance, user controlled automatic system shutdown and software update notifications are unchanged.
Statement of Substantial Equivalence
Glytec, LLC believes that, within the meaning of the Medical Device Amendments of 1976, the Glytec, LLC Glucommander System is substantially equivalent to the following medical device in commercial distribution:
GlyTec. LLC. G+ System #K101344 (6/28/2010) .
Summary of Non Clinical Performance Data and Conclusions
The results of usability testing of representative users of the device, software testing and performance testing of the device demonstrate the device functions as intended.
Conclusion
Based upon an analysis of the performance characteristics of the Glytec, LLC, Glucommander System, Glytec, Inc. believes no differences exist between this system
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Section 3 510(k) Summary of Safety and Effectiveness
April 30, 2012
and the predicate system that raise any new safety.or effectiveness concerns.
Page 4 of 4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. William Matthews Executive Vice President, Operations Glytec, LLC 770 Pelham Road, Suite 210 Greenville, South Carolina 29615
MAY - 8 2012
Re: K113853
Trade/Device Name: Glucommander™ System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: April 24, 2012 Received: April 26, 2012
Dear Mr. Matthews:
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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Page 2 - Mr. Matthews
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A.
Director Division of Anesthesiology, General Hospital, 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): K113853
Device Name: Glucommander™ System
Indications For Use:
The Glucommander System is a glycemic management tool intended to evaluate current and cumulative patient blood glucose values and coupled with patient information including age, weight and height, and, based on the aggregate of these measurement parameters, whether one or many, recommend an IV dosage of insulin, glucose or saline or a subcutaneous basal and bolus insulin dosing recommendation to adjust and maintain the blood glucose level towards a configurable clinician determined target range.
The Glucommander System is indicated for use in adult and pediatric (ages 2 - 17 years) patients.
The Glucommander System logic is not a substitute for, but rather an adjunct to clinical reasoning. The measurements and calculations generated 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 decision should be based solely on the recommended quidance provided by this software program.
AND/OR 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 ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K11385
§ 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).