(721 days)
Not Found
No
The description focuses on a "software algorithm" and "logic" that evaluates blood glucose values and patient information to recommend dosages. There is no mention of AI, ML, deep learning, or any related concepts. The performance studies rely on non-clinical data and documentation demonstrating substantial equivalence to a predicate device, which is typical for algorithmic devices but not necessarily indicative of AI/ML.
No.
The device recommends dosages of insulin, glucose, or saline, but it does not directly administer treatment or perform a therapeutic action itself; it is a management tool that aids medical personnel in making treatment decisions.
No.
The device is a glycemic management tool that evaluates blood glucose values and patient information to recommend dosages for adjusting and maintaining blood glucose levels. It does not diagnose medical conditions.
Yes
The device description explicitly states "The Glucommander System is a software algorithm device". While it processes patient data (blood glucose values, age, weight, height), the device itself is described solely as a software algorithm. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided text, the Glucommander System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Glucommander's Function: The Glucommander System uses patient blood glucose values (which are obtained from a separate measurement device, likely an IVD itself, like a blood glucose meter or continuous glucose monitor) and patient information (age, weight, height) to recommend dosages of insulin, glucose, or saline. It does not perform the analysis of the biological specimen itself.
- Intended Use: The intended use clearly states it's a "glycemic management tool" and an "adjunct to clinical reasoning" for recommending dosages. It doesn't mention diagnosing or analyzing a biological sample.
The Glucommander System is a software-based clinical decision support tool that utilizes data from other sources (including blood glucose values obtained from IVDs) to provide treatment recommendations.
N/A
Intended Use / Indications for Use
The Glucommander System is a glycemic management tool intended to evaluate current as well as cumulative patient blood glucose values 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 physician-determined target range.
The Glucommander System is indicated for use in adult and pediatric (ages 2 - 17 years) patients.
The G+ 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.
The indications for use are identical to the predicate device.
Product codes (comma separated list FDA assigned to the subject device)
NDC
Device Description
The Glucommander System is a software algorithm device intended to evaluate the current as well as cumulative patient blood glucose values and, based on the aggregate of those measurements, whether one or many, recommend a dosage of insulin, glucose, or saline in order 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.
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
pediatric (ages 2 - 17 years) and adult patients.
Intended User / Care Setting
Not Found
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)
- PERFORMANCE DATA: The 510k submission included software, cybersecurity, and human factors documentation to demonstrate the performance of the device is substantially equivalent to the predicate.
- SUBSTANTIAL EQUIVALENCE: Information presented supports substantial equivalence of the Glucommander System to the predicate device. The proposed enhancements have the same indications for use, are similar in design, have the same fundamental scientific technology, and are tested the same way as the predicate device. As detailed in the submission, the subject device is as safe and as effective as the predicate device.
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.
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
Glytec®
5. TRADITIONAL 510(K) SUMMARY
K152300
| SUMMARY PREPARED ON: | July 31, 2017 |
|---|---|
| SUBMITTED BY: | Glytec, LLC |
| 10 Patewood Drive, Suite 100 | |
| Greenville, SC 29615 | |
| Phone: (864) 263-4180 | |
| CONTACT PERSON: | Julie Glendrange |
| Glytec, LLC | |
| 10 Patewood Drive, Suite 100 | |
| Greenville, SC 29615 | |
| Phone: (864) 263-4180 | |
| DEVICE NAME: | |
| COMMON NAME: | |
| CLASSIFICATION: | |
| PRODUCT CODE: | Glytec Glucommander |
| Calculator, Drug Dose | |
| Class II, 21 CFR 868.1890 Predictive Pulmonary | |
| Function Value Calculator | |
| NDC | |
| SUBSTANTIALLY | |
| EQUIVALENT DEVICE: | Glytec LLC Glucommander System (K113853, |
| May 8, 2012) | |
| DEVICE DESCRIPTION: | The Glucommander System is a software |
| algorithm device intended to evaluate the current | |
| as well as cumulative patient blood glucose | |
| values and, based on the aggregate of those | |
| measurements, whether one or many, | |
| recommend a dosage of insulin, glucose, or | |
| saline in order 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. |
1
INDICATIONS FOR USE:
The Glucommander System is a glycemic management tool intended to evaluate current as well as cumulative patient blood glucose values 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 physician-determined target range.
The Glucommander System is indicated for use in adult and pediatric (ages 2 - 17 years) patients.
The G+ 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.
The indications for use are identical to the predicate device.
Glucommander is a software device. The software includes security features, software upgrades, data backup capabilities and technical support. All users have their own user names and passwords to protect access to the program. All upgrades are performed from Glytec support. Glucommander ensures that it has the latest security features and that it maintains the confidentiality, integrity and availability of all information according to the HIPAA privacy
This 510(k) submission evaluated new functionality as well as modifications to existing
TECHNOLOGICAL CHARACTERISTICS:
Page 2 K152300
2
features including: the Continuous Tube Feeding Module, which is designed to cover patient's receiving enteral nutrition; the Ambulatory Care Module, which is designed to provide recommendations for patients outside the hospital environment; and the Subcutaneous Module, which is designed for non-critical patients in the hospital.
These features do not raise different questions of safety or effectiveness. Non-clinical performance data was used to demonstrate that the device is substantially equivalent to the predicate device.
- PERFORMANCE DATA: The 510k submission included software, cybersecurity, and human factors documentation to demonstrate the performance of the device is substantially equivalent to the predicate.
- SUBSTANTIAL EQUIVALENCE: Information presented supports substantial equivalence of the Glucommander System to the predicate device. The proposed enhancements have the same indications for use, are similar in design, have the same fundamental scientific technology, and are tested the same way as the predicate device. As detailed in the submission, the subject device is as safe and as effective as the predicate device.
3
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2017
Glytec, LLC Julie Glendrange Sr. Director, Product Services and Regulatory Compliance 10 Patewood Drive, Suite 100 Greenville, SC 29615
Re: K152300
Trade/Device Name: Glytec Glucommander Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: February 23, 2017 Received: February 24, 2017
Dear Julie Glendrange:
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.
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 devicerelated 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.
5
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" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure