(177 days)
Not Found
No
The description focuses on data transfer, storage, and visualization (graphs, charts, reports) of blood glucose data. There is no mention of AI/ML terms, image processing, or any analysis beyond basic data presentation. The software explicitly states it does not recommend medical treatment or medication dosage, which is a common application area for AI/ML in diabetes management.
No
The device is a data management software that assists in reviewing and analyzing blood glucose test results, but it does not directly treat or diagnose a disease. The description explicitly states, "The software does not recommend any medical treatment or medication dosage level," indicating it is not a therapeutic device.
No
The device is a data management software that analyzes and presents historical blood glucose data. It does not perform a diagnostic function itself, but rather assists in the management of a pre-existing condition, diabetes, by providing tools for review, analysis, and evaluation of data from a separate diagnostic device (blood glucose meter). The description explicitly states that "The software does not recommend any medical treatment or medication dosage level."
No
The device description explicitly states that the system consists of a USB data transfer cable and software, and the performance studies include validation of the system's hardware (USB data transfer cable).
Based on the provided information, the ARKRAY Diabetes Data Management Software (SMBG Viewer) is an IVD (In Vitro Diagnostic) accessory.
Here's why:
- Intended Use: The intended use explicitly states it's for "review, analysis and evaluation of historical blood glucose test results to support diabetes management." Blood glucose testing is an in vitro diagnostic procedure.
- Accessory to an IVD: The software is described as an "optional accessory for use with ARKRAY blood glucose meters." Blood glucose meters are IVD devices used to measure glucose in a biological sample (blood). Accessories that are intended to be used with an IVD and contribute to the overall diagnostic process are also considered IVDs or IVD accessories.
- Data Management of IVD Results: The primary function is to manage data generated by an IVD device (the blood glucose meter). This data is used to support clinical decision-making related to diabetes management.
While the software itself doesn't perform the initial diagnostic test (that's done by the meter), its function of managing and presenting the results of that IVD test for clinical evaluation makes it an integral part of the overall in vitro diagnostic process for diabetes management.
N/A
Intended Use / Indications for Use
The ARKRAY Diabetes Data Management Software (SMBG Viewer) is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The ARKRAY Diabetes Data Management Software transfers data from the meter's memory into a computer for enhanced data management. The ARKRAY Diabetes Data Management Software is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW, JQP
Device Description
The ARKRAY Diabetes Data Management Software is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The subject device consists of a USB data transfer cable and software. The system allows the user to download blood glucose results from their glucose meter to their computer, maintain a history of their glucose test results, and convert them into graphs, charts and reports. The software does not recommend any medical treatment or medication dosage level.
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.
0
JUN - 9`2010 - 1.
7 510(k) Summary
| Submitter: | ARKRAY Factory USA, Inc.
5182 W. 76th Street
Minneapolis, MN 55439 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tom Speikers
Director, Quality Systems and Regulatory Affairs
ARKRAY Factory USA, Inc.
5182 W. 76th Street
Minneapolis, MN 55439
Phone: 952-646-3168
Fax: 952-646-3110
speikerst@ARKRAYusa.com |
| Date Prepared: | December 11, 2009 |
| Trade Name: | ARKRAY Diabetes Data Management Software (SMBG Viewer) |
| Classification: | Glucose test system, 21 CFR 862.1345; Class II, and 21 CFR
862.2100, Class I. |
| Product Codes: | CGA, NBW, JQP. |
| Predicate Device: | GlucoBalance Data Management Software (K022545). |
| Device Description: | The ARKRAY Diabetes Data Management Software is an optional
accessory for use with ARKRAY blood glucose meters with data
management capabilities. The subject device consists of a USB data
transfer cable and software. The system allows the user to download
blood glucose results from their glucose meter to their computer,
maintain a history of their glucose test results, and convert them into
graphs, charts and reports. The software does not recommend any
medical treatment or medication dosage level. |
| Intended Use: | The ARKRAY Diabetes Data Management Software (SMBG Viewer) is
an optional accessory for use with ARKRAY blood glucose meters with
data management capabilities. The ARKRAY Diabetes Data
Management Software transfers data from the meter's memory into a
computer for enhanced data management. The ARKRAY Diabetes
Data Management Software is intended for use in home and clinical
settings to assist people with diabetes and their health care
professionals in review, analysis and evaluation of historical blood
glucose test results 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 (K022545). |
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three stripes forming its wings, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. The text is in all caps and is evenly spaced around the circle.
ARKRAY Factory USA, Inc c/o Tom Speikers Director, Quality Systems and Regulatory Affairs 5182 West 76th St., Minneapolis, MN 55439
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
JUN 0 9 2019
Re: K093819
Trade/Device Name: ARKRAY Diabetes Data Management Software (SMBG Viewer) Regulation Number: 21 CFR 862.1345 Regulation Name:Glucose test system. Regulatory Class: II Product Code: NBW, CGA, JQP Dated: April 8, 2010 Received: April 27, 2010
Dear: Mr. Speikers:
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).
2
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. 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
3
Indications for Use Statement ರಿ
1093819 510(k) Number (if known):
Device Name: ARKRAY Diabetes Data Management Software Indications For Use:
ARKRAY Diabetes Data Management Software:
The ARKRAY Diabetes Data Management Software (SMBG Viewer) is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The ARKRAY Diabetes Data Management Software transfers data from the meter's memory into a computer for enhanced data management. The ARKRAY Diabetes Data Management Software is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.
Prescription Use Over-The-Counter Use Prescription Use =============================================================================================================================================================
×
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division
Office of In Vitro Disgnostic Device Evaluation and Subty
51000/1093819
4
Indications for Use Statement 6
510(k) Number (if known): K093819
Device Name: ARKRAY Diabetes Data Management Software
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Indications For Use:
ARKRAY Diabetes Data Management Software:
The ARKRAY Diabetes Data Management Software (SMBG Viewer) is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The ARKRAY Diabetes Data Management Software transfers data from the meter's memory into a computer for enhanced data management. The ARKRAY Diabetes Data Management Software is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.
Prescription Use 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 PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Of
Office of In Vitro Diagnos
510(k) K093819