TYSONBIO LINK HEALTH MANAGEMENT SYSTEM

K081726 · Tyson Bioresearch, Inc. · NBW · Aug 26, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081726
• Device Name: TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
• Applicant: Tyson Bioresearch, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The TysonBio Link Health Management System is an optional software accessory for use with the following models with data management capabilities: a) EZ Smart-608 series meter, b) DIACHEX series Blood Glucose Meter, and c) DIACHEX+ series Blood Glucose Meter. When used with one of these meters, TysonBio Link Health Management System transfers data from the device’s memory into a computer for enhanced data management. TysonBio Link Health Management System is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in the review, analysis and evaluation blood glucose test results to support effective diabetes management. It should be noted that the software does not recommend any medical treatment or medication dosage level.

Device Story

TysonBio Link Health Management System is a Windows-based software accessory for glucose meters (EZ Smart-608, DIACHEX, DIACHEX+ series). It functions by connecting the meter to an Intel-compatible PC via a USB cable. The software extracts stored blood glucose data from the meter's memory; it does not modify or change the data. The system provides data management tools, including statistics, pie charts, line graphs, and histograms for review by patients and healthcare professionals. It is used in home and clinical settings to support diabetes management. The software does not provide medical advice or dosage recommendations. Benefits include improved data visualization and record-keeping for diabetes monitoring.

Clinical Evidence

No clinical data. The device underwent software verification and validation testing in accordance with FDA guidance for software contained in medical devices.

Technological Characteristics

Windows-based software application; requires Intel-compatible PC, Windows 2000/XP or later, 128 MB RAM, 100 MB free hard disk space, and USB port. Connectivity via USB cable. Data management functionality includes export and memory clearing. Does not modify meter measurements.

Indications for Use

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

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

• Lifescan, In Touch Diabetes Management Software (k984527)

Submission Summary (Full Text)

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## 510(k) SUMMARY

#### 1. DATE PREPARED

June16, 2008

K08 1726

#### 2. SPONSOR INFORMATION

#### Address

TYSON BIORESEARCH, INC. 5 F., # 22, KE TUNG RD., SCIENCE BASED INDUSTRIAL PARK CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350

Contact Person: WEN-HAI TSAI

PHONE: [phone] FACSIMILE: 886-37-585996

#### 3. NAME OF DEVICE:

| 1. Trade Name: | TysonBio Link Health Management System |
|--------------------------|------------------------------------------------------------------------------------------------------------------|
| 2. Common Names: | Data Management Software |
| 3. Classification Names: | Calculator/data processing module for clinical use, 21CFR862.2100<br>Glucose Test System, 21 CFR862.1345 |
| 4. Product code: | NBW - System, test, blood glucose, over the counter,<br>JQP - Calculator/data processing module for clinical use |

### 4. DEVICE DESCRIPTION:

The TysonBio Health Management System software is an optional software accessory for use with TysonBio blood glucose monitors with data management capabilities. When use with one of these meters, TysonBio Link Health Management System software transfers data from the devices records into a computer for enhanced data management. It should be noted that the software does not recommend any medical treatment or medication dosage level.

### 5. Principles of Operation

The TysonBio Link Health Management System software provides users the ability to export data from compatible TysonBio meters to a computer via a cable connecting to the computer's required USB port. It is a Microsoft Windows based software application for diabetes data management. TysonBio Link HMS software is designed to operate an Intel compatible PC with Microsoft Windows 2000/XP or later operating system. The export of the data to be viewed only in the TysonBio Link HMS software. Aside from the ability to export the data stored in the meter's memory, the software also allows the ability to clear the meter's memory. Data transferred from the device cannot be changed or modified.

AUG 2 6 2008

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## 6. INTENDED USE:

The TysonBio Link Health Management System is an optional software accessory for use with the following models with data management capabilities: a) EZ Smart-608 series meter, b) DIACHEX series Blood Glucose Meter, and c) DIACHEX+ series Blood Glucose Meter. When used with one of these meters, TysonBio Link Health Management System transfers data from the device's memory into a computer for enhanced data management.

TysonBio Link Health Management System is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in the review, analysis and evaluation blood glucose test results to support effective diabetes management. It should be noted that the software does not recommend any medical treatment or medication dosage level.

## 7. PREDICATE DEVICE:

Predicate device name(s): LifeScan IN TOUCH Diabetes Management System Predicate 510(k) number(s): k984527

## 8. Comparison with predicate:

The TysonBio Link Health Management System software is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Lifescan IN TOUCH Diabetes Management software (k984527). Both management software programs can be described as follows:

- have the same intended use.
- -Data transferred from the device cannot be changed or modified in any way
- -An optional software accessory for use with blood glucose monitors with data management capabilities
- Do not in any way control or affect the blood glucose monitor's measurements -

| Items | IN TOUCH DIABETES<br>Management Software | TysonBio Link Health Management<br>System |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The IN TOUCH Diabetes<br>Management Software is intended for<br>use in home and clinical settings to<br>aid people with diabetes and their<br>health care professionals in the<br>review, analysis and evaluation blood<br>glucose test results to support<br>effective diabetes management. | TysonBio Link Health Management<br>System is intended for use in home and<br>clinical settings to aid people with diabetes<br>and their health care professionals in the<br>review, analysis and evaluation blood<br>glucose test results to support effective<br>diabetes management. It should be noted<br>that the software does not recommend<br>any medical treatment or medication<br>dosage level |
| Items | IN TOUCH DIABETES<br>Management Software | TysonBio Link Health<br>Management System |
| Cable availability | Serial cable, cable available<br>separately | Serial cable, cable available separately |
| Capable for uploading<br>data from various<br>devices | Software driver must be uploaded on<br>the device or installed on PC | Software driver must be installed on PC |
| Computer system<br>requirements | Minimum of 128 MB of RAM | Minimum of 128 MB of RAM or better |
| | 100-200 MB minimum free hard disk<br>space during, 100 MB after<br>installation | Minimum 100 MB of free hard disk space<br>or more |
| | 9-pin or 25 pin COM or USB port | USB port |
| | Video monitor and adapter with at<br>least 800x600 pixels screen<br>resolution and 256 colors | same as |
| Software use<br>indications | Home or clinic settings | Single or multiple user settings |
| Deleting patients and<br>all accompanying<br>records | Yes | Yes |
| Ability to uninstall<br>program | Yes | Yes |
| Ability to personalize<br>target ranges | Yes | Yes |
| Unit of measure<br>display | Choice of mmol/L or mg/dL | mmol/L or mg/dL |
| Ability to enter<br>hypoglycemic range | Yes | Yes |
| Report Types | Data list, data statistics, average<br>reading, pie chart, Line graph,<br>histogram, | Data list, data statistics, average reading,<br>pie chart, Line graph, histogram, |
| Auto-detect COM port | Yes | Yes |
| Downloaded results<br>cannot be edited or<br>deleted | Yes | Yes |
| Ability to modify meter<br>average results | Yes,7,14,30,60,90 days | Yes |
| Ability to clear meter<br>results in memory | Yes | Yes |
| Required information<br>on use entry | Yes | Yes, user ID, name, photo |
| ltems | IN TOUCH DIABETES<br>Management Software | TysonBio Link Health<br>Management System |
| Computer system<br>requirements | Windows operating system 98<br>SE, Windows 2000, Windows<br>XP home and Professional | only Windows 2000,<br>Windows XP home and<br>Professional |
| Manual Entry | Ability to add records manually | No |
| Copy database to<br>separate file | Yes | No |
| Deleting results | Yes | No |
| Language capabilities | English, Spanish | English |
| Viewing the Owner's<br>manual | Link provided via icon | No |
| Default glucose target<br>ranges available | Yes | No |
| Search patient capability | Yes | No |
| Result type display | Choice of whole blood or<br>plasma result types | No |
| Ability to set default<br>favorite report | Yes | No |
| Ability to synchronize<br>meter clock to PC upon<br>download | Yes | No |
| Ability to display 12 or 24<br>hour clock format | Yes | No |
| Ability to change date<br>format | Yes | No |
| Ability to link to older<br>database versions | Yes | No old versions available at<br>this time |
| Diabetes Educator<br>information | One diabetes educator may be<br>entered | No |
| Diabetes control | Insulin list, medication list.<br>diet/exercise options | No |
| Specifying/Entering<br>medication/insulin | Yes, up to 3 different<br>medications/insulin types | No |
| Ability to enter insulin<br>regiment | Yes | No |
| Items | IN TOUCH DIABETES<br>Management Software | TysonBio Link Health<br>Management System |
| Report types | Standard Day, Average<br>Reading, Insulin, Exception,<br>Data List Histogram, Health<br>checks | No Insulin, Exception,<br>standard day report. |
| Ability to set meter clock<br>to a specific date and<br>time | Yes | No |
| Ability to email report<br>from PC directly from<br>program | Yes | No |
| Ability to input additional<br>information on manual<br>result | Yes | no |

#### Similarities

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# Differences

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## 9. Performance Data

The TysonBio Health Management System software has been developed in accordance with the FDA's Guidance for Content of Premarket Submission for Software Contained in Medical Devices(May 11,2005) and general Principles of Software Validation 1/11/2002 : Final Guidance for Industry and FDA Staff, where applicable and appropriate. Software verification and validation testing demonstrated that the TysonBio Health Management System meets the performance requirements for the intended use of the optional accessory device.

### 10. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Software verification and validation testing demonstrated that the TysonBio Health Management System meets the performance requirements for the intended use of the optional accessory device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## AUG 2 6 2008

Tyson Bioresearch, Inc. c/o Mr. Wen-Hai Tsai 5 F., # 22, Ke Tung Rd. Science Based Industrial Park Chun-Nan, Miao-Li County China (Taiwan) 350

Re: k081726 Trade/Device Name: Tysonbio Link Health Management System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JOP Dated: June 16, 2008 Received: June 18, 2008

Dear Mr. Tsai:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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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# Indication for Use

510(k) Number (if known): K081726

TysonBio Link Health Management System Device Name:

Indication For Use:

The TysonBio Link Health Management System is an optional software accessory for use with the following models with data management capabilities: a) EZ Smart-608 series meter, b) DIACHEX Series Blood Glucose Meter, and c) DIACHEX+ Series Blood Glucose Meter. When used with one of these meters, TysonBio Link Health Management System transfers data from the device's memory into a computer for enhanced data management.

TysonBio Link Health Management System is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in the review, analysis and evaluation blood glucose test results to support effective diabetes management. It should be noted that the software does not recommend any medical treatment or medication dosage level.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (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

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

510(k) k081726