BIONIME DIABETES MANAGEMENT SYSTEM VI.0

K113007 · Bionime Corporation · JQP · Feb 27, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113007
• Device Name: BIONIME DIABETES MANAGEMENT SYSTEM VI.0
• Applicant: Bionime Corporation
• Product Code: JQP · Clinical Chemistry
• Decision Date: Feb 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2100
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest® Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. Bionime Rightest™ GM550 and GM250 meters are compatible with Bionime Diabetes Management System. The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.

Device Story

System transfers blood glucose readings from Rightest GM550/GM250 meters to PC via USB cable and GP550 PC Link Adapter. Software (GP200 Diabetes Assistant) processes data to generate tables, trend charts, and pie charts for periods up to 90 days. Used by patients and healthcare professionals in home or clinical settings. Output allows visualization of glucose trends to assist in diabetes management. Device does not provide treatment decisions or diagnoses; intended as an aid for data review.

Clinical Evidence

Bench testing and consumer study with 29 lay users. Results demonstrated satisfactory performance, ease of use, and understandable output for both lay users and healthcare professionals.

Technological Characteristics

Software-based data management system. Includes GP200 Diabetes Assistant Software and GP550 PC Link Adapter. Connectivity via USB. Utilizes standard statistical and graphical techniques for data visualization.

Indications for Use

Indicated for patients with diabetes and healthcare professionals to manage diabetes by transferring, viewing, analyzing, and printing blood glucose data from compatible Rightest glucose meters.

Regulatory Classification

Identification

A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.

Predicate Devices

• Glucofacts® Deluxe Diabetes Management Software (k091820)

Submission Summary (Full Text)

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# 510(k) SUMMARY Bionime Diabetes Management System

FEB 2 7 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92(C)

The Assigned 510(k) number is: k113007

Date of Summary: October 3rd, 2011

Common Name: Bionime Diabetes Software System; Bionime Diabetes Assistant Software

## Regulatory Information:

| Device Name | Product Code | Classification | Regulation | Panel |
|----------------------------------------------------------|----------------------------------------------------------------|----------------|----------------------|-------------------------------|
| Glucose Test<br>System | NBW: Blood Glucose<br>Test System, Over-the-<br>Counter | Class II | 21 CFR §<br>862.1345 | Clinical<br>Chemistry<br>(75) |
| Calculator/Data<br>Processing Module<br>for Clinical Use | JQP: Calculator/ Data<br>Processing Module for<br>Clinical Use | Class I | 21 CFR §<br>862.2100 | Clinical<br>Chemistry<br>(75) |

## Applicant:

Bionime Corporation No. 694 Renhua Road, Dali District Taichung City, Taiwan 412 Tel.: 886 - 4 - 2495-1268 Fax: 886 - 4 - 2495-2568

#### Contact Persons:

Primary Contact:

Mrs. Feng-Yu Lee Correspondent for this Application Bionime Corporation c/o IVDD Regulatory Consultant 27001 La Paz Road Suite 266B Mission Viejo, CA 92691 Tel: [phone] Fax: [phone] [e-mail]

#### Alternate Only:

Ming-Hung Wu Bionime Corporation No. 694 Renhua Road, Dali District Taichung City, Taiwan 412 Tel.: 886 - 4 - 2495-1268 Fax: 886 - 4 - 2495-2568 Ming-Hung. Wu(@bionime.com

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## 510(k) SUMMARY (Cont.) Bionime Diabetes Management System

## Identification / Product Name:

Bionime Diabetes Management System

## Device Description:

The Bionime Diabetes Management System allows the transfer of blood glucose readings from a compatible Bionime Rightest™ Glucose Meter to a PC via USB cable.

The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal times or time periods up to 90 days. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.

The system includes: 1) Installation CD with setup files for Bionime GP200 Diabetes Assistant Software and Rightest™ PC Link Adapter Driver, 2) GP550 PC Link Adapter.

#### Intended Use:

The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest® Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. Bionime Rightest™ GM550 and GM250 meters are compatible with Bionime Diabetes Management System.

The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.

#### Predicate Kit:

The Bionime Diabetes Management System is substantially equivalent to the predicate device noted below:

Device Name: Glucofacts® Deluxe Diabetes Management Software 510k No.: k091820 Device Company: Bayer Healthcare, LLC

## Technology Characteristics:

The Bionime Diabetes Management System (GP200 Diabetes Assistant Software) is used to capture Rightest " blood glucose meter readings and graphically display the information. It utilizes the standard statistical and graphical techniques to facilitate the review of glucose readings by individual user or health care professionals.

#### Performance:

The product performance characteristics of Bionime Diabetes Management System were assessed through internal and external performance and validation studies, include a consumer study with 29 lay users.

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The results of these studies demonstrate satisfactory performance of Bionime Diabetes Management System (GP 200 Diabetes Assistant Software and GP550 PC Link Adaptor), and it is easy to use and the results are understandable by the users.

## Conclusion:

The results of the verification and validation studies of the Bionime Diabetes Management System demonstrated that the product is safe and effectiveness in the hands of lay users and health care professionals. The product is substantially equivalent to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

10903 New Hampshire Avenue Silver Spring, MD 20993

Bionime Corporation c/o Feng-Yu Lee IVDD Regulatory Consultant 27001 La Paz Road, Suite 266B Mission Viejo. CA 92691

FEB 2 7 2012

Re: k113007

Trade Name: Bionime Diabetes Management System Software Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, JQP Dated: February 13, 2012 Received: February 16, 2012

Dear Mrs. Lee:

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 minted to registration or medical device-related adverse events) (21 007); medical as not reanufacturing 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/Medical

Devices/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 [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

R

Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number (if known): k

# Device Name: Bionime Diabetes Management System (BDMS)

Indication For Use:

The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest® Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the glucose readings, as well as to backup and to recover users' profile and data.

The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.

Prescription Use X (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)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 1< 113007

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