SMARTLOG DIABETES MANAGEMENT SOFTWARE

K133346 · I-Sens, Inc. · NBW · Dec 19, 2013 · Clinical Chemistry

Device Facts

• Record ID: K133346
• Device Name: SMARTLOG DIABETES MANAGEMENT SOFTWARE
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 19, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The SmartLog Diabetes Management Software is PC-based software for use with the i-SENS blood glucose meters. The SmartLog Diabetes Management Software is intended for use in the home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for an effective diabetes management program. The SmartLog Diabetes Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.

Device Story

SmartLog Diabetes Management Software is a PC-based application for managing blood glucose data. It interfaces with i-SENS blood glucose meters via a dedicated USB cable to automatically download test results, including measurement dates and times. The software provides graphic displays, statistical analysis, and logbook features based on user-defined data intervals and target ranges. It is intended for use by patients and healthcare professionals in home and clinical settings. Users interact with the software via a PC or Mac to review trends and changes in blood glucose levels, which supports clinical decision-making for diabetes management programs. The software also supports manual data entry and email reporting.

Clinical Evidence

No clinical data. Evidence consists of software validation and bench testing, including setup, data download accuracy, data management, user profile, manual entry, print, and email functionality tests. Human factors and consumer studies were also conducted.

Technological Characteristics

PC-based software compatible with Windows and Mac OS X. Connectivity via USB cable (2.5mm jack or Mini-USB). System requirements: 300 MHz CPU, 128 MB RAM, 200 MB disk space. Operates as a data management module for i-SENS blood glucose meters.

Indications for Use

Indicated for use by individuals with diabetes and healthcare professionals in home and professional settings to review, analyze, and evaluate blood glucose test results for 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

• PC care Blood Glucose Data Management Software (k100937)

Submission Summary (Full Text)

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K 13346

i-SENS, Inc. 27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea Tel. [phone]

DEC 19 2013

## 510(k) Summary

(As required by 21 CFR 807.92)

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k) | Special 510(k) |
| Submitter<br>Information | i-SENS, Inc.<br>27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea<br>Tel.) [phone]<br>Fax) [phone]<br>e-mail: [e-mail]<br>Contact Person: Hye Young Kang |
| Prepared Date | November 20, 2013 |
| Device Name<br>and<br>Classification | Trade name: SmartLog Diabetes Management Software<br>Common name: Diabetes data management system<br>Classification product code: NBW, JQP<br>Regulation number: 21 CFR 862.1345 Glucose Test System<br>21 CFR 862.2100, calculator/data processing module<br>Classification panel: 75, Chemistry<br>Device class: Class II / Class I, reserved |
| Type of Test | The SmartLog Diabetes Management Software is a software medical device that<br>interfaces with the i-SENS blood glucose monitoring systems using the special<br>USB cable. |
| System<br>Description | 1) Device Description<br>The SmartLog Diabetes Management Software is an optional data management<br>software for use only with the i-SENS brand of Blood Glucose Meters ("i-SENS<br>Blood Glucose Meters") except CareSens POP and CareSens N Mini. The<br>SmartLog Diabetes Management Software allows the transfer of data from the i-<br>SENS Blood Glucose Meters to a personal computer for enhanced data<br>management using graphic displays and analysis tools of the device. Various<br>graphic analysis tools in this software help users of i-SENS BGM system easily |

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T

| analyze the trends and changes in their blood glucose. | |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| 2) Optional principle | |
| The SmartLog Diabetes Management Software downloads all blood glucose test | |
| results along with their measurement dates and times from the i-SENS Blood | |
| Glucose Meters through the USB port connected to the PC with the special cable. | |
| The SmartLog Diabetes Management Software operates under a Microsoft | |
| Windows based OS or Apple Mac based OS and provides reports containing | |
| variety of graphs and statistics based on User-selectable data interval and blood | |
| glucose target ranges. | |
| | |
| 3) System Requirements | |
| · | CPU: 300 MHz Intel Pentium II or higher |
| · | RAM: 128 MB or higher |
| | Minimum free hard disk space: 200 MB |
| | Windows® XP Home, Professional (SP2 or above), Windows® Vista (32-bit |
| | /64-bit), Windows® 7 (32-bit/64-bit) or Windows® 8 (32bit/64bit), |
| | MAC OS X 10.7.0 or later |
| · | USB port |
| · | USB cable (Cable type: 2.5 mm jack cable or Mini-USB plug cable) |
| | Mouse and Keyboard for data entry and menu selection |
| | Video monitor and adapter with at least 1024x768 pixel screen resolution and |
| | 256 colors |
| | Printer to print report |
| | Internet connection to send email |
| Intended Use | The SmartLog Diabetes Management Software is PC-based software for use with |
| | the i-SENS blood glucose meters. The SmartLog Diabetes Management Software |
| | is intended for use in the home and professional settings to help people with |
| | diabetes and their healthcare professionals in the review, analysis and evaluation |
| | of glucose test results for an effective diabetes management program. The |
| | SmartLog Diabetes Management Software allows the user to download Blood |
| | glucose readings automatically from the meter to the PC. |
| | |

·

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Image /page/2/Picture/0 description: The image shows a logo with the text "i-sens" in bold, black font. A small, solid black circle is positioned above the "i" in "i-sens." The logo is partially encircled by a dashed line, creating a circular shape around the text and the dot above the "i."

| Substantial<br>Equivalence<br>Information | 1) Predicate Device Information<br>Device name: PC care Blood Glucose Data Management Software<br>510(k) number: k100937 | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| 2) Comparison to the Predicate Device | | |
| Item | PC care Blood Glucose Data<br>Management Software<br>(Predicate Device) | SmartLog Diabetes<br>Management Software<br>(Candidate Device) |
| Intended Use | The Diabetes Management Software is<br>intended for use in the home and<br>professional settings to help people<br>with diabetes and their healthcare<br>professionals in the review, analysis<br>and evaluation of glucose test results<br>for an effective diabetes management<br>program. The Diabetes Management<br>Software allows the user to download<br>Blood glucose readings automatically<br>from the meter to the PC. | Same |
| Over-the Counter | Yes | Same |
| Accessory to<br>Glucose meter | Yes | Same |
| Intended user | Home users, Healthcare Professional | Same |
| Use on | PC | PC / Mac |
| Setting Reminders | Yes | Same |
| Connectivity to<br>Meter | USB cable | Same |
| Manual Data Entry | Yes | Same |
| Logbook | Yes | Same |
| Massaging | Yes | Same |
| Test Principle | Not Applicable | |

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Image /page/3/Picture/0 description: The image shows a logo for i-sens. The logo features the lowercase letters 'i-sens' in a bold, sans-serif font. A dotted circle surrounds the letters, adding a visual element to the design. The logo is simple and modern.

.

| Validation<br>Activities | We conducted software validation and bench testing to demonstrate data accuracy transmission for each meter. The following test reports are included in this submission.<br>Setup Test, End Test Download Reading Test, Data Management Test User Profile Test, Manual Entry Test Print Test, Email Test Consumer Study, Human Factors Study |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based on the submitted information in this premarket notification, the candidate device is substantially equivalent to the predicate device. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's official name and national scope. The logo is in black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

December 19, 2013

I-SENS, INC. HYE YOUNG KANG 27-36 GWANGUN-RO, NOWON-GU SEOUL 139-845 KOREA

Re: K133346

Trade/Device Name: SmartLog Diabetes Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JOP Dated: October 28, 2013 Received: October 30, 2013

Dear Mr. Kang:

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. Ilsting 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 (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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Kang

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

:

K13346

Device Name SmartLog Diabetes Management Software

Indications for Use (Describe)

The Smartl of Diabetes Management Software is PC-based software for use with the i-SENS blood glucose meters. The SmartLog Diabetes Management Software is intended for use in the home and professional settings to belp people with diabetes and their healthcare professionals in the review, and evaluation of glucose test results for an effective diabetes management program. The Smarti of Diabetes Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

.. FOR FDA USE ONLY . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Stayce Beck

FORM FDA 3881 (9/13)