(112 days)
Not Found
No
The description explicitly states "programmed logic" and does not mention any terms associated with AI/ML like "machine learning," "artificial intelligence," "neural network," or "deep learning." The device appears to be based on pre-defined algorithms for calculating insulin/glucose doses.
No.
The device is an insulin dosing calculator, providing calculations and alerts to assist healthcare professionals in determining appropriate insulin drip rates. It does not directly administer therapy.
No
The device is intended to calculate insulin or glucose doses based on blood glucose values to manage and maintain blood glucose levels, not to diagnose a medical condition. It's a dosing calculator, not a diagnostic tool.
Yes
The device description explicitly states it is a "web-based software solution" and the intended use and device description focus solely on the software's calculation and alerting functions, with no mention of accompanying hardware components.
Based on the provided information, the MDN-CGS™ Insulin Dosing Calculator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- MDN-CGS™ Function: The MDN-CGS™ Insulin Dosing Calculator is a software tool that calculates insulin or glucose doses based on existing blood glucose values. It does not perform any tests on patient samples itself. It relies on blood glucose measurements that are presumably obtained through other means (likely an IVD device like a blood glucose meter).
- Intended Use: The intended use clearly states it "evaluate[s] the current patient blood glucose values" and "calculate[s] either a dose of glucose or insulin." It's a calculation tool, not a diagnostic test.
Therefore, while it uses data derived from a potential IVD (the blood glucose measurement), the MDN-CGS™ Insulin Dosing Calculator itself is a medical device software that assists in treatment decisions based on those measurements.
N/A
Intended Use / Indications for Use
The MDN-CGS Insulin Dosing Calculator is intended to evaluate the current patient blood glucose values. Based on the measurements, the software will calculate either a dose of glucose or insulin to drive the blood glucose level up or down toward a predetermined target range. Once that target blood glucose range has been reached, the software program calculates dosing of insulin or glucose for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing calculations of glucose or insulin. The device is intended for use with patients with no known insulin allergies and for patients over the age of 18.
The MDN-CGS Insulin Dosing Calculator programmed logic is a tool and not a substitute for, but rather an assist to, clinical reasoning. The measurements and calculations generated by the MDN-CGS Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel directed by physician order. No medical decisions are to be made solely on the guidance provided by this software program, but are to include consideration of clinical history, symptoms, other diagnostic measurements, and the professional's clinical judgment.
Product codes
NDC
Device Description
The MDN-CGS Insulin Dosing Calculator is a web-based software solution that automates calculations used by healthcare professionals to determine the appropriate intravenous insulin drip rate necessary to manage blood glucose levels across a variety of patient populations. The MDN-CGSTM Insulin Dosing Calculator also provides alerts for subsequent blood glucose testing and monitoring.
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
over the age of 18
Intended User / Care Setting
qualified and trained medical personnel directed by physician order.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for MDN, which stands for Medical Device Network. Next to the logo is the text "510(k) Summary". The text is in a simple, sans-serif font and is aligned to the right of the logo. The image is likely a document header or title page for a medical device summary.
K071713
Medical Decisions Network
5. 510(k) Summary
| Date: | June 21, 2007
OCT 12 2007 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medical Decisions Network, Inc.
2000 Holiday Drive, Suite 200
Charlottesville, VA 22901 |
| Contact: | Medical Decisions Network, Inc.
c/o Mr. Jonathan S. Kahan
Hogan & Hartson LLP
555 Thirteenth Street, NW
Washington, DC 20004 |
| | Phone: (202) 637-5600
Fax: (202) 637-5910
Email: jskahan@hhlaw.com |
| Trade Name: | Clarian Glucose Stabilizer Insulin
Dosing Calculator |
| Common Name: | MDN-CGSTM Insulin Dosing Calculator |
| Classification Name: | Drug Dose Calculator |
| Classification Number: | Class II (per 21 CFR 868.1890) |
| Product Code: | NDC |
| Predicate Device: | EndoTool TM Drug Dose Calculator
(K053137)
Glucommander Plus TM (K061110) |
| Description of Device: | The MDN-CGS TM Insulin Dosing
Calculator is a web-based software
solution that automates calculations used
by healthcare professionals to determine
the appropriate intravenous insulin drip
rate necessary to manage blood glucose
levels across a variety of patient
populations. The MDN-CGSTM Insulin
Dosing Calculator also provides alerts
for subsequent blood glucose testing and
monitoring. |
| Intended Use: | The MDN-CGS TM Insulin Dosing
Calculator is intended to evaluate the |
September 20, 2007
Page of this document of MDN CONFIDENTIAL AND PROPRIETARY
The information in this document is restricted for use by MDN personnel and its Partners and Customers under non-disclosure.
1
current patient blood glucose values. Based on the measurements, the software will calculate either a dose of glucose or insulin to drive the blood glucose level up or down toward a predetermined target range. Once that target blood glucose range has been reached, the software program calculates dosing of insulin or glucose for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing calculations of glucose or insulin. The device is intended for use with patients with no known insulin allergies and for patients over the age of 18.
The MDN-CGSTM Insulin Dosing Calculator's programmed logic is a tool and not a substitute for, but rather an assist to, clinical reasoning. The measurements and calculations generated by the MDN-CGSTM Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel directed by physician order. No medical decisions are to be made solely on the guidance provided by this software program, but are to include consideration of clinical history, symptoms, other diagnostic measurements, and the professional's clinical judgment.
The submission device and the predicate devices have the same general intended use and similar indications, technological characteristics, and principles of operation. Each of the devices is intended to be used by trained clinicians. The only technological difference between the MDN-CGSTM Insulin Dosing Calculator and its predicates is that the MDN-CGSTM
Image /page/1/Picture/5 description: The image shows the text "September 20, 2007". The text appears to be a date, indicating the 20th day of September in the year 2007. The text is black and the background is white. The text is slightly blurry.
Image /page/1/Picture/6 description: The image shows a long, narrow object against a white background. The object appears to be a thin rod or stick, possibly made of metal or wood. There is a small, round object attached to the rod near the bottom. The rod is slightly curved and has a rough texture.
Comparison with Predicate Device:
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
Image /page/1/Picture/8 description: The image shows a black and white graphic. The graphic appears to be a partial view of a head or object, with a large, dark, solid area dominating the upper portion. The lower part of the image features a curved line, possibly indicating a chin or the base of the object. The overall impression is that of a silhouette or a close-up of a dark, rounded form against a light background.
MDN CONFIDENTIAL AND PROPRIETARY The information in this document is restricted for use by MDN personnel and its Partners and Customers under non-disclosure.
Page 2 of 3
2
Image /page/2/Picture/0 description: The image shows a long, narrow object that appears to be a metal rod or pole. The object is dark in color and has a smooth, reflective surface. There are some small, round objects attached to the rod at various points. The background is white, which helps to highlight the shape and details of the object.
Conclusion:
Insulin Dosing Calculator is a standalone software device, while the predicate software programs are accessories to automated insulin pumps.
The MDN-CGS™ Insulin Dosing Calculator and the Endotool and Glucommander Plus have the same intended use and similar indications, technological characteristics and principles of operation. The minor technological differences between the MDN-CGS™ and its predicates do not present any new issues of safety or effectiveness. Thus, the MDN-CGSTM Insulin Dosing Calculator is substantially equivalent to the EndoTool™ Drug Dose Calculator (K053137) and the Glucommander Plus™ (K061110).
September 20, 2007
Page 3 of 3 MDN CONFIDENTIAL AND PROPRIETARY The information in this document is restricted for use by MDN personnel and its Partners and Customers under non-disclosure.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
007 1 % 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Decisions Network, Incorporated C/O Mr. Jonathan S. Kahan Partner Hogan & Hartson LLP 555 Thirteenth Street, North West Washington, DC 20004
Re: K071713
Trade/Device Name: Clarian Glucose Stabilizer Insulin Dosing Calculator Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: September 21, 2007 Received: September 21, 2007
Dear Mr. Kahan:
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 - Mr. Kahan
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clues
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
4. Indications for Use
510(k) Number (if known): K071713
Device Name: Clarian Glucose Stabilizer Insulin Dosing Calculator
Indications for Use:
The MDN-CGS™ Insulin Dosing Calculator is intended to evaluate the current patient blood glucose values. Based on the measurements, the software will calculate either a dose of glucose or insulin to drive the blood glucose level up or down toward a predetermined target range. Once that target blood glucose range has been reached, the software program calculates dosing of insulin or glucose for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing calculations of glucose or insulin. The device is intended for use with patients with no known insulin allergies and for patients over the age of 18.
The MDN-CGS™ Insulin Dosing Calculator programmed logic is a tool and not a substitute for, but rather an assist to, clinical reasoning. The measurements and calculations generated by the MDN-CGS™ Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel directed by physician order. No medical decisions are to be made solely on the guidance provided by this software program, but are to include consideration of clinical history, symptoms, other diagnostic measurements, and the professional's clinical judgment.
| 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
| (Division Sigh-Off) | PAGE OF NEEDED) |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| 510(k) Number: | K071713 |
| Page 1 of 1 | September 20, 2007 |
MDN CONFIDENTIAL AND PROPRIETARY The information in this document is restricted for use by MDN personnel and its Partners and Customers under non-disclosure.