(112 days)
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.
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.
The provided document, a 510(k) summary for the Clarian Glucose Stabilizer Insulin Dosing Calculator (MDN-CGS™ Insulin Dosing Calculator), does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study particulars. Medical Device Network (MDN) is stated as the submitter.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance metrics. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting the results of a performance study against predefined criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not included in the provided text. The document does not describe any specific test set or data used for validation.
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)
This information is not available. As there is no described test set or ground truth establishment process, details about experts are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. No adjudication method is mentioned.
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
There is no indication of an MRMC comparative effectiveness study being performed or whether human readers improve with AI assistance. The device is a "Drug Dose Calculator" and not an imaging AI system that would typically involve human readers. The document states it is "a tool and not a substitute for, but rather an assist to, clinical reasoning."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the MDN-CGS™ Insulin Dosing Calculator as a "standalone software device". However, it explicitly states its calculations are "intended to be used by qualified and trained medical personnel directed by physician order" and "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." This implies it does not operate fully in a standalone capacity for patient care decisions, but rather as an aid. The study details to confirm standalone performance (e.g., accuracy of calculations in a simulated environment) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided. The document describes the device's logic, but not how it was developed or trained.
9. How the ground truth for the training set was established
This information is not provided.
Summary of available information:
The provided document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices (EndoTool™ Drug Dose Calculator and Glucommander Plus™) for regulatory clearance. It describes the device's intended use and functionality, stating it is a web-based software that automates calculations for intravenous insulin/glucose dosing and provides alerts. It emphasizes that the device is an "assist to, clinical reasoning" and not a substitute, requiring use by qualified medical personnel. The key argument for substantial equivalence rests on similar intended use, indications, technological characteristics, and principles of operation, with the main difference being the MDN-CGS™ is a standalone software device, unlike its accessories-to-pump predicates. However, it does not contain the detailed performance validation study information typically found when describing acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
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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, 2007OCT 12 2007 |
|---|---|
| Submitter: | Medical Decisions Network, Inc.2000 Holiday Drive, Suite 200Charlottesville, VA 22901 |
| Contact: | Medical Decisions Network, Inc.c/o Mr. Jonathan S. KahanHogan & Hartson LLP555 Thirteenth Street, NWWashington, DC 20004 |
| Phone: (202) 637-5600Fax: (202) 637-5910Email: jskahan@hhlaw.com | |
| Trade Name: | Clarian Glucose Stabilizer InsulinDosing 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 DosingCalculator is a web-based softwaresolution that automates calculations usedby healthcare professionals to determinethe appropriate intravenous insulin driprate necessary to manage blood glucoselevels across a variety of patientpopulations. The MDN-CGSTM InsulinDosing Calculator also provides alertsfor subsequent blood glucose testing andmonitoring. |
| Intended Use: | The MDN-CGS TM Insulin DosingCalculator 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.
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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
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Comparison with Predicate Device:
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
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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
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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.
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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.
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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
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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.
§ 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).