(454 days)
Not Found
No
The description mentions a "custom algorithm" developed using existing insulin dosing conventions, but there is no mention of AI, ML, or any training/test data sets which are typical indicators of such technologies.
No
The device provides recommendations for insulin dosing but does not directly administer treatment or alter the body, classifying it as a clinical decision support software, not a therapeutic device.
No
The device is a glycemic management software support program that provides insulin dosing recommendations. It is not intended for diagnosis, but rather for managing an already diagnosed condition.
Yes
The device description explicitly states, "The IA System is a software solution." It further details its components as server and client applications, with no mention of accompanying hardware that is part of the medical device itself. While it processes data from glucometers, the glucometer is a separate device, and the IA System's function is purely computational and advisory.
Based on the provided information, this device 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, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- IA System Function: The IA System is a software program that takes existing patient data (blood glucose values, biometric information, insulin dosing information, meal information) and processes it through an algorithm to provide insulin dosing recommendations to a clinician. It does not perform any tests on patient samples in vitro.
- Input Data: The primary input data for the IA System are blood glucose values obtained from a glucometer. While glucometers are IVDs, the IA System itself is not performing the diagnostic test. It is using the results of an IVD test as input.
- Intended Use: The intended use is to provide software support for clinicians to manage insulin dosing based on existing data, not to perform a diagnostic test on a sample.
Therefore, the IA System falls under the category of a medical device software that supports clinical decision-making, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Insulin Algorithms System (IA System) is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. The IA System evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, and gender) and suggests changes (if necessary). The system is designed for use by healthcare professionals. The IA System is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs.
The IA System is not intended to be used to provide insulin dosing recommendations to the clinician in order to adjust insulin treatment for patients hospitalized in an acute care setting. Also, the IA System is not intended to be used to provide insulin dosing recommendations for patients on insulin pump therapy or IV insulin therapy. Nor is IA System intended to provide recommendations for mealtime injections of insulin that are based on carb counting.
The IA System is not a substitute for, but rather an adjunct to clinical reasoning. 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 Insulin Algorithms System (IA System) takes basic biometric information (age, height, weight, gender), insulin dosing information (prescribed insulins, injection times, and amounts), meal information (meal times, before meal glucose targets, after meal glucose targets), along with a collection of glucometer readings and processes this information though a custom algorithm to create a recommendation as to what changes to the patient's insulin regimen should be made. The algorithm was developed using the insulin dosing conventions taught and used in
The IA System is a software solution. It is comprised of two separate software systems: a server application containing all algorithms and mitigations and a client application that serves as an interface to the server. All data are stored and analyzed on the server application. Each user has an individual identification and password to access the application. The IA System is designed to safeguard the confidentiality, integrity, and availability of electronic health information in conformance with the Health Insurance Portability and Accountability Act (HIPAA).
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
adults and pediatric patients ages 7 and above
Intended User / Care Setting
clinician / Not Found
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)
Software verification & validation testing was conducted in accordance with IEC 62304:2006: Medical device software -- Software Life Cycle Processes and with FDA guidances for software development and testing (Guidance for the Content of Premarket Submission for Medical Device Containing Software, FDA-CDRH-CBER, Rockville, MD, 05/2005; Guidance for Off-the-Shelf Software Use in Medical Devices, FDA- CDRH, Rockville, MD, 06/1997; and General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA-CDRH, Rockville, MD, 01/2002). Usability testing indicates that the target group of medical professionals understood the scope and limit of the application and were able to use the program with ease and confidence. All features provided for the IA System have been verified to operate as specified. Testing confirms that the IA System can be used according to its intended use and in an equivalent manner to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2017
INSULIN ALGORITHMS C/O SIGI CARON PRESIDENT MEDTECH CONSULTANTS, INC. 20370 SKYHAWK LANE TOPANGA CA 90290
Re: K160673
Trade/Device Name: Insulin Algorithms System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: II Product Code: NDC Dated: February 2, 2016 Received: February 3, 2016
Dear Sigi Caron:
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.
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 Parts 801 and 809); medical device 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
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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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160673
Device Name Insulin Algorithms System
Indications for Use (Describe)
The Insulin Algorithms System (IA System) is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. The IA System evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, and gender) and suggests changes (if necessary). The system is designed for use by healthcare professionals. The IA System is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs.
The IA System is not intended to be used to provide insulin dosing recommendations to the clinician in order to adjust insulin treatment for patients hospitalized in an acute care setting. Also, the IA System is not intended to be used to provide insulin dosing recommendations for patients on insulin pump therapy or IV insulin therapy. Nor is IA System intended to provide recommendations for mealtime injections of insulin that are based on carb counting.
The IA System is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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1. 510(K) SUMMARY - K160673
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| DATE PREPARED | June 7, 2017 |
|---|---|
| APPLICANT | Insulin Algorithms |
| 269 S. Beverly Dr. #613 | |
| Beverly Hills, CA 90212 | |
| www.insulinalgorithms.com | |
| Tel: (310) 606-2055 | |
| OFFICIAL | |
| CORRESPONDENT | Sigi Caron |
| MedTech Consultants, Inc. | |
| 20370 Skyhawk Lane | |
| Topanga, CA 90290 | |
| sigi@medtechconsultants.com | |
| Tel: (310) 455-3473 | |
| Fax: (888) 295-1535 | |
| TRADE NAME | IA System |
| COMMON NAME | Drug Dose Calculator |
| DEVICE CLASSIFICATION | Name: Predictive pulmonary-function value calculator |
| Regulation No: §868.1890 | |
| Product Code: NDC | |
| Class: II | |
| Panel: Anesthesiology | |
| PREDICATE DEVICE | • Glucommander System – K113853 |
| • EndoTool Glucose Management System – K132547 |
SUBSTANTIALLY EQUIVALENT TO:
The IA System device is substantially equivalent in intended use and technological features to the Glucommander System - K113853 and to the EndoTool Glucose Management System -K132547.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Insulin Algorithms System (IA System) takes basic biometric information (age, height, weight, gender), insulin dosing information (prescribed insulins, injection times, and amounts), meal information (meal times, before meal glucose targets, after meal glucose targets), along with a collection of glucometer readings and processes this information though a custom algorithm to create a recommendation as to what changes to the patient's insulin regimen should be made. The algorithm was developed using the insulin dosing conventions taught and used in
4
INDICATIONS FOR USE:
The IA System is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. The IA System evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and gender) and suggests changes (if necessary). The system is designed for use by healthcare professionals. The IA System is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs.
The IA System is not intended to be used to provide insulin dosing recommendations to the clinician in order to adjust insulin treatment for patients hospitalized in an acute care setting. Also, the IA System is not intended to be used to provide insulin dosing recommendations for patients on insulin pump therapy or IV insulin therapy. Nor is IA System intended to provide recommendations for mealtime injections of insulin that are based on carb counting.
The IA System is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.
TECHNICAL CHARACTERISTICS:
The IA System is a software solution. It is comprised of two separate software systems: a server application containing all algorithms and mitigations and a client application that serves as an interface to the server. All data are stored and analyzed on the server application. Each user has an individual identification and password to access the application. The IA System is designed to safeguard the confidentiality, integrity, and availability of electronic health information in conformance with the Health Insurance Portability and Accountability Act (HIPAA).
PERFORMANCE STANDARDS:
No applicable performance standards have been issued under 514 of the Food, Drug and Cosmetic Act for a predictive Pulmonary Function Value Calculator §868.1890.
SUMMARY OF NONCLINICAL TESTING:
Software verification & validation testing was conducted in accordance with IEC 62304:2006: Medical device software -- Software Life Cycle Processes and with FDA guidances for software development and testing (Guidance for the Content of Premarket Submission for Medical Device Containing Software, FDA-CDRH-CBER, Rockville, MD, 05/2005; Guidance for Off-the-Shelf Software Use in Medical Devices, FDA- CDRH, Rockville, MD, 06/1997; and General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA-CDRH, Rockville, MD, 01/2002). Usability testing indicates that the target group of medical
5
professionals understood the scope and limit of the application and were able to use the program with ease and confidence. All features provided for the IA System have been verified to operate as specified. Testing confirms that the IA System can be used according to its intended use and in an equivalent manner to the predicate devices.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The IA System is substantially equivalent to the listed predicate devices with respect to their indications for use (intended use) and technical characteristics. The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues.
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