(46 days)
Not Found
No
The document describes a system that evaluates blood glucose values and regulates/recommends fluid/insulin titration based on those values. While this involves complex logic and calculations, the description does not use terms like "AI," "ML," "deep learning," or mention training/test sets, which are typical indicators of AI/ML technology in regulatory submissions. The description focuses on "logic" and "calculations" based on aggregate measurements.
Yes
The device actively regulates and recommends titrations of substances (insulin, glucose, and saline) to bring and maintain blood glucose levels within a target range, which constitutes a therapeutic action.
No
The text states that the G+ System evaluates glucose values and regulates infusion to drive blood glucose towards a target range, then recommends titrations to maintain that range. It explicitly mentions that the system's logic is "not a substitute for, but rather an assist to clinical reasoning" and that "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." These functions are focused on active management and therapy, not primarily on identifying a disease or condition. While the system uses patient blood glucose values, its core purpose is treatment and maintenance, not diagnosis. The phrase "evaluating patient conditions" refers to assessing the patient's current state to guide treatment, not to make a diagnosis.
Yes
The device description explicitly states "The Glytec, LLC G+ System is a software device". While it interacts with an I.V. infusion pump, the device itself is described as software.
Based on the provided text, the G+ System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The intended use and device description clearly state that the G+ System evaluates patient blood glucose values and uses this information to regulate the infusion of I.V. fluids and recommend dosing of insulin, glucose, and saline. While it uses blood glucose values as input, it doesn't perform the analysis of the blood itself to determine the glucose level. That analysis is done by a separate device (likely a blood glucose meter or laboratory analyzer).
- The system's primary function is therapeutic and management. It uses the blood glucose data to control and recommend actions related to patient treatment (infusion and dosing), rather than providing diagnostic information about a disease or condition based on the analysis of a specimen.
The G+ System is a software device that acts as a clinical decision support and management tool, using blood glucose data obtained from other sources to guide treatment. This falls outside the typical definition of an IVD.
N/A
Intended Use / Indications for Use
The G+ System is 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, regulate the infusion of I.V. fluids, through and I.V. infusion pump, and drive 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 provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin.
The G+ System logic is not a substitute for, but rather an assist 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.
Product codes (comma separated list FDA assigned to the subject device)
NDC
Device Description
The Glytec, LLC G+ System is a software 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, regulate the infusion of I.V. fluids, through an I.V. infusion pump, and 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 provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin.
The device is available in a Standard Edition or server based Enterprise Edition.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device is not intended for use with patients with known insulin allergies or patients under the age of 18.
Intended User / Care Setting
qualified and trained medical personnel
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
JUN 2 8 2010
K10134Y
Glytec, LLC G+ System (Glucommander Plus System)
Special 510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness
| Proprietary Name: | Glytec LLC, G+ System |
|---|---|
| Common Name: | G+ System™ |
| Product Code/Classification Panel: | NDC – General and Plastic Surgery |
| Classification Name: | Drug Dose Calculator Class II per §868.1890 |
Submitter Information
Submitter's Name and Address:
Glytec, LLC (a wholly owned subsidiary of Glucotec, Inc., formally known as CollaborativeMed, LLC) 665 N. Academy Street Greenville, SC 29601 FDA Establishment Registration Number: 3005853093
Contact Information:
.
William Matthews, Managing Partner BioDevice Solutions, LLC 2607 Woodruff Rd. Simpsonville, SC 29681 Telephone (760) 574-9476 Fax (864) 297-5270
Performance Standards
No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act for Automatic Peritoneal Delivery Systems.
Predicate Device
The predicate device for the GlyTec, LLC G+ System is the following:
- CollaborativeMed, LLC Glucommander Plus (G+) System #K061110 (6/7/2006); .
1
Glytec, LLC G+ System (Glucommander Plus System) Special 510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness
Device Description
The Glytec, LLC G+ System is a software 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, regulate the infusion of I.V. fluids, through an I.V. infusion pump, and 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 provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin.
The device is available in a Standard Edition or server based Enterprise Edition.
Indications for Use/Intended Use
The G+ System is 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, regulate the infusion of I.V. fluids, through and I.V. infusion pump, and drive 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 provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin.
The G+ System logic is not a substitute for, but rather an assist 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.
Statement of Substantial Equivalence
Glytec, LLC believes that, within the meaning of the Medical Device Amendments of 1976, the Glytec, LLC G+ System is substantially equivalent to the following medical device in commercial distribution:
- CollaborativeMed, LLC, Glucommander Plus #K061110 (6/7/2006) .
2
Glytec, LLC G+ System (Glucommander Plus System) Special 510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness
Conclusion
Based upon an analysis of the overall performance characteristics for the Glytec, LLC, G+ System, Glytec, Inc. believes that no significant differences exist between this system and the predicate systems quoted therefore, the Glytec, LLC G+ System does not impose any new safety or effectiveness concerns.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
JUN 2 8 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Glytec, LLC (Formally known as GlucoTec, Incorporated) C/O Mr. William Matthews BioDevice Solutions, LLC 2607 Woodruff Road Simpsonville, South Carolina 29681
Re: K101344
Trade/Device Name: G+ System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary - Function Value Calculator Regulatory Class: II Product Code: NDC Dated: June 17, 2010 Received: June 18, 2010
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.
4
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