ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)

K093819 · Arkray Factory USA, Inc. · NBW · Jun 9, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093819
• Device Name: ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
• Applicant: Arkray Factory USA, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

ARKRAY Diabetes Data Management Software (SMBG Viewer) is an accessory for ARKRAY blood glucose meters. System includes a USB data transfer cable and software. Device downloads blood glucose results from meter memory to a computer; converts data into graphs, charts, and reports. Used in home and clinical settings by patients and healthcare professionals. Software does not recommend medical treatment or medication dosage. Output allows users and clinicians to review historical glucose trends to support diabetes management.

Clinical Evidence

No clinical data. Bench testing included validation of hardware (USB cable) and software functionality. Consumer studies were conducted to demonstrate the system's ability to be easily operated by in-home users.

Technological Characteristics

System consists of a USB data transfer cable and software application. Operates on a computer platform. Software is used for data management, visualization, and reporting of blood glucose results. No specific materials or energy sources beyond standard USB connectivity and PC hardware.

Indications for Use

Indicated for people with diabetes and their healthcare professionals in home and clinical settings to review, analyze, and evaluate historical blood glucose test results to support diabetes management.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• GlucoBalance Data Management Software (K022545)

Submission Summary (Full Text)

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K093819

JUN - 9`2010 - 1.

## 7 510(k) Summary

| Submitter: | ARKRAY Factory USA, Inc.<br>5182 W. 76th Street<br>Minneapolis, MN 55439 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tom Speikers<br>Director, Quality Systems and Regulatory Affairs<br>ARKRAY Factory USA, Inc.<br>5182 W. 76th Street<br>Minneapolis, MN 55439<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| 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<br>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<br>accessory for use with ARKRAY blood glucose meters with data<br>management capabilities. The subject device consists of a USB data<br>transfer cable and software. The system allows the user to download<br>blood glucose results from their glucose meter to their computer,<br>maintain a history of their glucose test results, and convert them into<br>graphs, charts and reports. The software does not recommend any<br>medical treatment or medication dosage level. |
| Intended Use: | The ARKRAY Diabetes Data Management Software (SMBG Viewer) is<br>an optional accessory for use with ARKRAY blood glucose meters with<br>data management capabilities. The ARKRAY Diabetes Data<br>Management Software transfers data from the meter's memory into a<br>computer for enhanced data management. The ARKRAY Diabetes<br>Data Management Software is intended for use in home and clinical<br>settings to assist people with diabetes and their health care<br>professionals in review, analysis and evaluation of historical blood<br>glucose test results to support diabetes management. |
| Functional and<br>Safety Testing: | A full array of in-house testing was done consistent with relevant FDA<br>guidance's for blood glucose monitoring systems. Testing included<br>validation of the systems hardware (USB data transfer cable) and<br>software as well as consumer studies that demonstrated the systems<br>ability to be easily operated by in-home users. |
| Conclusion: | Labeling, validation testing results and consumer studies results<br>support the Indications for Use and the claim of substantial<br>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).

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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 [phone]. 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 [phone]. 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 [phone] 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