(94 days)
Not Found
No
The description explicitly states the algorithm is based on an "established clinical protocol" and does not mention AI, ML, or any related terms. The performance studies focus on standard software verification and validation, not AI/ML model training or testing.
Yes
This device calculates the dosage of intravenously administered insulin to maintain blood glucose levels, directly impacting the patient's physiological state to treat hyperglycemia.
No
The device is a software program that calculates insulin dosages based on blood glucose levels to maintain them within a target range. It is described as providing information to be used as a tool by medical personnel and explicitly states that "No medical decisions are made by the GlucoCare IGC System software." This indicates that it aids in managing a condition (hyperglycemia) rather than diagnosing one.
Yes
The device description explicitly states "The GlucoCare IGC System is a software program" and describes its functionality solely in terms of software operations and interactions with client computers. There is no mention of accompanying hardware components that are part of the regulated device.
Based on the provided information, the GlucoCare IGC System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic or monitoring purposes.
- GlucoCare IGC System Function: The GlucoCare IGC System is a software program that uses blood glucose levels (which are obtained through an in vitro diagnostic test, likely a blood glucose meter) to calculate insulin dosages. It does not perform the diagnostic test itself. It processes data from an IVD device.
- Intended Use: The intended use is for the management of patient blood glucose levels by calculating insulin dosages based on existing blood glucose data. It is a treatment management tool, not a diagnostic tool.
Therefore, while the GlucoCare IGC System relies on data generated by an IVD device (a blood glucose meter), it is not an IVD device itself. It falls under the category of a clinical decision support system or a treatment management software.
N/A
Intended Use / Indications for Use
The GlucoCare IGC System is a software program indicated for the management of patient blood glucose levels in the hospital setting. The GlucoCare IGC System software, using an algorithm that is based on an established clinical protocol, calculates the dosage of intravenously administered insulin required to maintain the blood glucose level within a target range set by the protocol. No medical decisions are made by the GlucoCare IGC System software. The information provided by the software is intended to be used as a tool by qualified and trained medical personnel. The GlucoCare IGC System software is intended for use in patients over the age of 18 with no known insulin allergies. The device is not intended for use in patients with diabetic ketoacidosis.
Product codes
NDC
Device Description
The GlucoCare IGC System is a software program that implements an insulin infusion protocol intended for the treatment of hyperglycemic adult patients in a healthcare facility. The software directs insulin infusion rates based on the patient's blood glucose level history and target blood glucose level.
Audible and visual alerts remind the medical staff when it is time to take blood glucose readings or change insulin drip rates. The system provides a complete time/date/username-stamped history of all patient activity in text and graphical formats, both on-screen and in a printable form.
The GlucoCare IGC System software resides on the GlucoCare application server. Local client computers interact with the GlucoCare IGC System software using HTTPS.
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
patients over the age of 18
Intended User / Care Setting
qualified and trained medical personnel / hospital setting (healthcare facility)
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
Software verification and validation testing activities were conducted to establish the performance, functionality, and reliability characteristics of the GlucoCare IGC System. Testing included unit testing, integration testing, system testing, and functional testing. The results of the testing confirmed that the GlucoCare IGC System performed as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary for the Pronia Medical Systems, LLC GlucoCare IGC System
1. SUBMITTER/510(K) HOLDER
AUG 21 2008
Pronia Medical Systems, LLC 7527 Beechspring Farm Boulevard Louisville, KY 40241
Contact Person: Brian J. Besterman, M.D. Telephone: (914) 261-6622
May 16, 2008 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | GlucoCare IGC System | |
|---|---|---|
| Common/Usual Name: | Dose Calculation Software | |
| Classification Name: | Drug Dose Calculator | |
| Classification: | Class II (per 21 CFR 868.1890) | |
| Product Code: | NDC |
3. PREDICATE DEVICES
4. DEVICE DESCRIPTION
The GlucoCare IGC System is a software program that implements an insulin infusion protocol intended for the treatment of hyperglycemic adult patients in a healthcare facility. The software directs insulin infusion rates based on the patient's blood glucose level history and target blood glucose level.
Audible and visual alerts remind the medical staff when it is time to take blood glucose readings or change insulin drip rates. The system provides a complete time/date/username-stamped history of all patient activity in text and graphical formats, both on-screen and in a printable form.
1
The GlucoCare IGC System software resides on the GlucoCare application server. Local client computers interact with the GlucoCare IGC System software using HTTPS,
5. INTENDED USE
The GlucoCare IGC System is a software program indicated for the management of patient blood glucose levels a healthcare facility setting. The GlucoCare IGC System software, using an algorithm that is based on an established clinical protocol, calculates the dosage of insulin required to maintain the blood glucose level within a target range set by the protocol. No medical decisions are made by the GlucoCare IGC System software. The information provided by the software is intended to be used as a tool by qualified, trained medical personnel. The GlucoCare IGC System software is intended for use in adults over the age of 18 with no known insulin allergies. The device is not intended for use in patients with diabetic ketoacidosis.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Pronia Medical Systems GlucoCare IGC System and the predicate devices are all software programs that dictate insulin dosing instructions based on the patient's blood glucose levels over time. The proposed and predicate software all issue alerts and provide instructions for the timing and frequency of blood glucose testing and the need to infuse glucose to prevent hypoglycemia.
The proposed and predicate devices have the same general intended use and similar indications, technological characteristics, and principles of operation. Any minor technological differences between the GlucoCare IGC System and its predicates do not present any new issues of safety or effectiveness. Thus, the GlucoCare IGC System is substantially equivalent to the EndoTool™ Glucose Management System (K053137) and the MDN-CGS™ Insulin Dosing Calculator (K071713). A comparison of the intended use and technological characteristics of the proposed and predicate devices is provided in Table 5-1.
7. PERFORMANCE TESTING
Software verification and validation testing activities were conducted to establish the performance, functionality, and reliability characteristics of the GlucoCare IGC System. Testing included unit testing, integration testing, system testing, and functional testing. The results of the testing confirmed that the GlucoCare IGC System performed as intended.
2
| Category | GlucoCare IGC System | EndoTool™ Glucose
Management System,
K053137 | MDN-CGSTM Insulin
Dosing Calculator,
K071713 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Intended Use | Intended for use by trained medical personnel for the management of patient blood
glucose levels in the hospital setting | | |
| Patient
Population | Variety of different patient
populations | Critically ill patients on
continuous feeding | Variety of different patient
populations |
| Principle of
Operation | Using blood glucose measurements, software algorithms determine appropriate insulin
dosing in accordance with established treatment protocols | | |
| Hardware | Web based network with
PC running web browser | Web based network with
Windows PC | Standalone Windows PC |
| Features | Provides alerts for
subsequent blood glucose
testing and monitoring | Provides alerts for
subsequent blood glucose
testing and monitoring | Provides alerts for
subsequent blood glucose
testing and monitoring |
Table 5-1. Comparison Table for Determination of Substantial Equivalence
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pronia Medical System, LLC C/O Cynthia J. M. Nolte, Ph.D., RAC Senior Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
AUG 2 1 2008
Re: K081388
Trade/Device Name: Pronia Medical Systems, LLC, GlucoCare Intensive Glycemic Control System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: August 6, 2008 Received: August 7, 2008
Dear Dr. Nolte:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 – Dr. Nolte
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K081388
Pronia Medical Systems, LLC GlucoCare IGC System Device Name:
Indications for Use:
The GlucoCare IGC System is a software program indicated for the management of patient blood glucose levels in the hospital setting. The GlucoCare IGC System software, using an algorithm that is based on an established clinical protocol, calculates the dosage of intravenously administered insulin required to maintain the blood glucose level within a target range set by the protocol. No medical decisions are made by the GlucoCare IGC System software. The information provided by the software is intended to be used as a tool by qualified and trained medical personnel. The GlucoCare IGC System software is intended for use in patients over the age of 18 with no known insulin allergies. The device is not intended for use in patients with diabetic ketoacidosis.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Centum Vm
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K
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81288