(66 days)
Not Found
No
The description focuses on data transfer, storage, analysis (logbooks, charts, graphs), and communication. There is no mention of AI or ML algorithms being used for interpretation, prediction, or automated decision-making based on the data. The analysis is presented as standard data visualization and comparison over time.
No
The device is a software system intended for data management, analysis, and communication of blood glucose results and other health statistics to assist in diabetes management. It does not directly treat or diagnose a disease.
No
The device is described as software that assists in managing and analyzing historical blood glucose data and other health statistics to support diabetes management. It does not perform a diagnostic function itself, but rather helps organize and present existing data from other diagnostic devices (blood glucose meters).
No
The summary explicitly mentions "validation of the systems hardware (USB data transfer cable)" in the "Summary of Performance Studies" section, indicating that the device includes a hardware component.
Based on the provided text, the ARKRAY Diabetes Management Software is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The software's intended use is to manage and analyze historical blood glucose data obtained from compatible blood glucose meters. It facilitates data transfer, storage, analysis, and communication. It does not perform any diagnostic testing itself.
- Device Description: The description clearly states that the system serves as an interface between glucose monitoring devices and a database. It helps in the review, analysis, and evaluation of existing blood glucose test results. It is an accessory device to blood glucose monitors, which are the actual IVDs.
- No Diagnostic Function: The software does not perform any chemical, biological, or immunological tests on specimens from the human body. It processes and presents data that has already been generated by a separate diagnostic device (the blood glucose meter).
In essence, the software is a data management and communication tool that supports diabetes management based on data from IVD devices, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The ARKRAY Diabetes Management Software is an optional accessory for use with compatible blood glucose meters, such as ARKRAY Glucocard Vital Blood Glucose Meter with data management capabilities. The ARKRAY Diabetes Management Software transfers data from the meter's memory into a secured sever for enhanced data management. ARKRAY ARK Care™ Diabetes Management System is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating about historical blood glucose test results and other biological statistics to support diabetes management.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW, JQP.
Device Description
ARK Care system serves as an interface between the software in personal glucose monitoring devices and a general purpose health management database to assist in the review, analysis and evaluation of blood glucose test results. The secure system is compliant with HIPAA and HITECH standards.
ARK Care is designed for home use and professional healthcare settings. It is an accessory device to most manufactured model home- use blood glucose monitors, including glucose monitoring devices by ARKRAY, Roche, Bayer, LifeScan, and Abbott. The list of supported devices is located at www.arkcare.net.
The purpose of the electronic diabetes management system is to help users and healthcare teams manage blood glucose information to better regulate diabetes treatments and control blood glucose for better health outcomes. The ARK Care system holds a convenience function, as the user can upload blood glucose data from a variety of currently marketed blood glucose monitors into one location for viewing. After the user transmits and stores blood glucose data to the secure database, the ARK Care system allows family members and/or healthcare professionals to view and monitor the user's data and reports. Family and healthcare team members must receive permission from the primary user and create a password protected login before viewing data. ARK Care provides a safe communication portal for the user, family, and healthcare team to send email-like entries, improving patient care and disease management.
The user and approved healthcare team members can view the blood glucose data in different formats such as logbooks, charts, and graphs. The data can be viewed through selected time intervals and these intervals can be compared over time to track disease management.
The subject can also enter and track other health-related information such as body weight, blood pressure, lab values, and exercise activities. Groups of profiles can be queried for bulk reporting on data related to tracking and trending of outcomes, supporting diabetes disease management in individuals and in managed care organizations.
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
Not Found
Intended User / Care Setting
home and clinical settings
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)
A full array of in-house testing was done consistent with relevant FDA guidance's for blood glucose monitoring systems. Testing included validation of the systems hardware (USB data transfer cable) and software as well as consumer studies that demonstrated the systems ability to be easily operated by in-home users.
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence appears to be "K110709". The characters are written in a simple, somewhat crude style, with varying stroke thicknesses.
MAY 1 9 2011 -
ARK Care™ 510(k) Summary
| Submitter: | ARKRAY Factory USA, Inc.
5182 W. 76th Street
Minneapolis, MN 55439 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tyler Foutch
Regulatory Affairs Project Manager
ARKRAY Factory USA, Inc.
5182 W. 76th Street
Minneapolis, MN 55439
Phone: 952-646-3171
Fax: 952-646-3110
fbutcht@ARKRAYusa.com |
| Date Prepared: | March 8, 2010 |
| Trade Name: | ARKRAY ARK Care Diabetes Management System™ |
| Classification: | Glucose test system, 21 CFR 862.1345; Class II |
| | Calculator/data processing module for clinical use, 21 CFR 862.2100;
Class I |
| Product Codes: | CGA, NBW, JQP. |
| Predicate Device: | MCT Diabetes™ (K073699). |
| Device Description: | ARK Care system serves as an interface between the software in
personal glucose monitoring devices and a general purpose health
management database to assist in the review, analysis and evaluation
of blood glucose test results. The secure system is compliant with
HIPAA and HITECH standards.
ARK Care is designed for home use and professional healthcare
settings. It is an accessory device to most manufactured model home-
use blood glucose monitors, including glucose monitoring devices by
ARKRAY, Roche, Bayer, LifeScan, and Abbott. The list of supported
devices is located at www.arkcare.net.
The purpose of the electronic diabetes management system is to help
users and healthcare teams manage blood glucose information to
better regulate diabetes treatments and control blood glucose for
better health outcomes. The ARK Care system holds a convenience
function, as the user can upload blood glucose data from a variety of
currently marketed blood glucose monitors into one location for
viewing. After the user transmits and stores blood glucose data to the
secure database, the ARK Care system allows family members and/or
healthcare professionals to view and monitor the user's data and
reports. Family and healthcare team members must receive
permission from the primary user and create a password protected
login before viewing data. ARK Care provides a safe communication
portal for the user, family, and healthcare team to send email-like |
| | entries, improving patient care and disease management. |
| | The user and approved healthcare team members can view the blood
glucose data in different formats such as logbooks, charts, and graphs.
The data can be viewed through selected time intervals and these
intervals can be compared over time to track disease management. |
| | The subject can also enter and track other health-related information
such as body weight, blood pressure, lab values, and exercise
activities. Groups of profiles can be queried for bulk reporting on data
related to tracking and trending of outcomes, supporting diabetes
disease management in individuals and in managed care
organizations. |
| Intended Use: | ARKRAY ARK Care Diabetes Management System™ is intended for
use in home and clinical settings via the internet to assist people with
diabetes and their healthcare professionals in uploading, storing,
analyzing, and communicating about historical blood glucose test
results and other biological statistics to support diabetes management. |
| Functional and
Safety Testing: | A full array of in-house testing was done consistent with relevant FDA
guidance's for blood glucose monitoring systems. Testing included
validation of the systems hardware (USB data transfer cable) and
software as well as consumer studies that demonstrated the systems
ability to be easily operated by in-home users. |
| Conclusion: | Labeling, validation testing results and consumer studies results
support the Indications for Use and the claim of substantial
equivalence to the predicate (K073699). |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized emblem consisting of a series of curved lines, possibly representing a stylized caduceus or a similar symbol associated with health and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Arkray Factory Usa, Inc. c/o Tyler Foutch Project Manager Regulatory Affairs 5182 West 76th St., Minneapolis. MN 55439
MAY 1 9 2011
Re: K110709
Trade/Device Name: ARK Care™ Diabetes Management System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, CGA, JQP Dated: March 11, 2011 Received: March 14,2011
Dear: Mr. Foutch:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
:
Enclosure
4
Indication for Use
510(k) Number (if known): K110709
Device Name: ARK CARE™ DIABETES MANAGEMENT SYSTEM
Indication For Use:
The ARKRAY Diabetes Management Software is an optional accessory for use with compatible blood glucose meters, such as ARKRAY Glucocard Vital Blood Glucose Meter with data management capabilities. The ARKRAY Diabetes Management Software transfers data from the meter's memory into a secured sever for enhanced data management. ARKRAY ARK Care™ Diabetes Management System is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating about historical blood glucose test results and other biological statistics to support diabetes management.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use X . (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Diving Officer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) = K110709