(46 days)
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.
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.
This 510(k) summary does not contain the detailed information required to fill out all the sections of your request regarding acceptance criteria and a study proving those criteria are met. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a new, comprehensive performance study that establishes and validates new acceptance criteria.
Here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance:
This document does not provide explicit acceptance criteria or detailed performance metrics. The core of this 510(k) is a declaration of substantial equivalence to a predicate device (CollaborativeMed, LLC, Glucommander Plus #K061110). Studies demonstrating new performance would have been required for a device that wasn't substantially equivalent to a predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No information is provided regarding a test set sample size or data provenance for a performance study. Since this is a Special 510(k) and focuses on substantial equivalence, it's likely they are relying on the predicate device's established performance without conducting new, extensive performance trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
No information is provided regarding experts or ground truth establishment for a test set. This would be relevant if a new performance study were conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No information is provided on an adjudication method, as there's no mention of a performance study with a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No information is provided about an MRMC study or the effect size of human improvement with AI assistance. This document describes a software device for dose calculation, not an AI for image interpretation or diagnosis where MRMC studies are common.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device description explicitly states: "The G+ System logic is not a substitute for, but rather an assist to clinical reasoning... No medical decision should be based solely on the recommended guidance provided by this software program." This indicates it's designed for use with human-in-the-loop. Therefore, a standalone performance study in the sense of a fully autonomous algorithm acting without human oversight would contradict its intended use. However, no specific standalone performance study results are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
No information is provided regarding the type of ground truth used, as there's no mention of a new performance study requiring ground truth establishment.
8. The sample size for the training set:
No information is provided regarding a training set sample size. This document focuses on a "Special 510(k)" for modifications to an existing predicate device, implying that the core algorithms and their validation likely happened with the original device and are not being re-evaluated with a new training set.
9. How the ground truth for the training set was established:
No information is provided on how ground truth was established for a training set.
In summary:
This document is a Special 510(k), which is typically used for modifications to an existing device where the changes do not significantly affect the safety or effectiveness. The primary claim for regulatory clearance is substantial equivalence to the predicate device (CollaborativeMed, LLC, Glucommander Plus #K061110) based on an analysis of "overall performance characteristics." This type of submission generally does not require a new, comprehensive clinical or performance study with new acceptance criteria and detailed data as would be found in a Traditional 510(k) for a novel device or a device with significant changes in technology or indications. The assumption is that the predicate device already demonstrated adequate performance.
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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); .
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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) .
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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.
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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.
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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,
Swor Ranns
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): K011344
Device Name: G+™ System
Indications For Use:
The Glucommander 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, calculate and recommend a dose of saline, glucose, and insulin 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, 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 not intended for use with patients with known insulin allergies or patients under the age of 18.
The Glucommander's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GBGDS 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 he recommended guidance provided by this software program.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
Ris C. Cla
Division of Anesthesiology, Genera Infection Control, Dental Devices
510(k) Number: -
§ 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).