(177 days)
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.
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.
The provided document describes the ARKRAY Diabetes Data Management Software (SMBG Viewer), an accessory for ARKRAY blood glucose meters. This software facilitates the transfer, historical tracking, and analysis of blood glucose results.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the software itself, beyond its functional capabilities. The summary focuses on the software's role in data management and its substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to download blood glucose results from ARKRAY meters. | Device allows user to download blood glucose results from their glucose meter to their computer. |
| Ability to maintain a history of glucose test results. | Device maintains a history of their glucose test results. |
| Ability to convert data into graphs, charts, and reports. | Device converts data into graphs, charts, and reports. |
| Ease of operation by in-home users. | Consumer studies demonstrated the systems ability to be easily operated by in-home users. |
| Functionality of USB data transfer cable. | Validation of the system's hardware (USB data transfer cable) was performed. |
| Functionality of software. | Validation of the software was performed. |
| Does not recommend medical treatment or medication dosage. | The software does not recommend any medical treatment or medication dosage level. (This is a safety/limitation statement rather than a performance metric but is crucial for its intended use). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "consumer studies that demonstrated the systems ability to be easily operated by in-home users." However, it does not specify the sample size for these consumer studies or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given that the device is data management software for blood glucose meters, the "ground truth" for its primary function (transferring and displaying data accurately) would likely be the data produced by the blood glucose meters themselves, and its accurate visual representation. The consumer studies likely evaluated usability rather than clinical diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are typically relevant for studies where expert interpretation or consensus is required (e.g., image analysis). For data management software, the "adjudication" would likely involve verifying that the software accurately displays the data it receives from the meter.
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
No MRMC comparative effectiveness study was done or mentioned. This type of study is usually conducted for diagnostic aids where human readers interpret medical images or complex data, and the AI is designed to assist in that interpretation. This device is a data management tool, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A "standalone" performance evaluation, in the context of diagnostic algorithms, typically refers to the algorithm's performance in isolation. For this device, the "standalone" performance would be its ability to correctly download, store, and display blood glucose data. The document states that "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..." This implies that the software's functional performance (without human interaction for its core data handling tasks) was evaluated. However, specific metrics for this standalone performance aren't detailed, beyond successful validation.
7. The Type of Ground Truth Used
For the functional aspects of the software (data transfer, storage, display), the "ground truth" would be the raw data from the blood glucose meters themselves. The validation would verify that the software accurately receives, stores, and presents that exact data. For the "consumer studies," the ground truth was likely subjective user feedback regarding ease of use and satisfaction.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The ARKRAY Diabetes Data Management Software is described as a data management tool, not a machine learning or AI algorithm that requires a training set. Its functionality is based on programmed logic for data transfer and display.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided as the device does not appear to utilize a machine learning model requiring a training set.
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JUN - 9`2010 - 1.
7 510(k) Summary
| Submitter: | ARKRAY Factory USA, Inc.5182 W. 76th StreetMinneapolis, MN 55439 |
|---|---|
| Contact Person: | Tom SpeikersDirector, Quality Systems and Regulatory AffairsARKRAY Factory USA, Inc.5182 W. 76th StreetMinneapolis, MN 55439Phone: 952-646-3168Fax: 952-646-3110speikerst@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 CFR862.2100, Class I. |
| Product Codes: | CGA, NBW, JQP. |
| Predicate Device: | GlucoBalance Data Management Software (K022545). |
| Device Description: | The ARKRAY Diabetes Data Management Software is an optionalaccessory for use with ARKRAY blood glucose meters with datamanagement capabilities. The subject device consists of a USB datatransfer cable and software. The system allows the user to downloadblood glucose results from their glucose meter to their computer,maintain a history of their glucose test results, and convert them intographs, charts and reports. The software does not recommend anymedical treatment or medication dosage level. |
| Intended Use: | The ARKRAY Diabetes Data Management Software (SMBG Viewer) isan optional accessory for use with ARKRAY blood glucose meters withdata management capabilities. The ARKRAY Diabetes DataManagement Software transfers data from the meter's memory into acomputer for enhanced data management. The ARKRAY DiabetesData Management Software is intended for use in home and clinicalsettings to assist people with diabetes and their health careprofessionals in review, analysis and evaluation of historical bloodglucose test results to support diabetes management. |
| Functional andSafety Testing: | A full array of in-house testing was done consistent with relevant FDAguidance's for blood glucose monitoring systems. Testing includedvalidation of the systems hardware (USB data transfer cable) andsoftware as well as consumer studies that demonstrated the systemsability to be easily operated by in-home users. |
| Conclusion: | Labeling, validation testing results and consumer studies resultssupport the Indications for Use and the claim of substantialequivalence 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).
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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
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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
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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
§ 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.