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

Indications 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.

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) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
k081726

B. Purpose for Submission:
New submission for an accessory data management software application for glucose meters

C. Manufacturer and Instrument Name:
Tyson Bioresearch, Tysonbio Link Health Management System

D. Type of Test or Tests performed:
Tysonbio Link Health Management System is a software-only medical device which serves as an internet-based accessory which interfaces between the software in personal glucose monitoring devices and the Tysonbio Link Health Management System.

E. System Descriptions:

1. Device Description:
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. The TysonBio Link HMS 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 allows 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.

2. Principles of Operation:
The TysonBio Link Health Management System is an accessory to compatible meters: EZ Smart-608 series meter (k062829), DIACHEX series Blood Glucose Meter (k072854), and DIACHEX+ series Blood Glucose Meter (k073492)

3. Modes of Operation:
TysonBio Link HMS is compatible with Microsoft® Windows® 2000/XP version 2

Hardware specifications:
☐ Intel® Pentium® III 850 MHz processor or better
☐ Minimum 128MB of RAM or better
☐ Minimum 100 MB of free hard disk space or more
☐ USB port
☐ TysonBio Link PC link Cable
☐ Mouse and keyboard
☐ Printer for printing reports

4. Specimen Identification:

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Meter controlled

5. Specimen Sampling and Handling:
Not Applicable

6. Calibration:
Not Applicable

7. Quality Control:
Not Applicable

8. Software:
FDA has reviewed the applicant’s Hazard Analysis and software
Documentation: Yes ☐ X or No ☐

F. Regulatory Information:

1. Regulation Section:
21CFR §862.1345 -Glucose test system.
21CFR Sec.-862.2100 - Calculator/data processing module for clinical use.

2. Classification:
Class 2 and 1 respectively

3. Product Code:
NBW - System, Test, Blood Glucose, Over The Counter
JQP-Calculator/Data Processing Module, For Clinical Use

4. Panel:
Chemistry (75)

G. Intended Use:

1. Indication(s) 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.

2. Special Condition for use Statement(s):
Not Applicable

H. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) numbers:
Lifescan, In Touch Diabetes Management Software (k984527)

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2. Comparison with Predicate Device:
Similarities

| Items | IN TOUCH DIABETES Management Software | TysonBio Link Health Management System |
| --- | --- | --- |
| Intended Use | The IN TOUTCH Diabetes Management Software 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. | 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 |
| Cable availability | Serial cable, cable available separately | Serial cable, cable available separately |
| Capable of uploading data from various devices | Software driver must be uploaded on the device or install PC | Same |
| Computer system requirements | Minimum of 128 MB of RAM | Minimum of 128 MB of RAM or better |
| | 100-200 MB minimum free hard disk space during, 100 MB after installation | Minimum 100 MB of free hard disk space or more |
| | 9-pin or 25 pin COM or USB port | USB port |
| | Video monitor and adapter with at least 800x600 pixels screen resolution and 256 colors | Same |
| Software use indications | Home or clinic settings | Single or multiple user settings |
| Deleting patients and all accompanying records | Yes | Yes |

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| Items | IN TOUCH DIABETES Management Software | TysonBio Link Health Management System |
| --- | --- | --- |
| Ability to uninstall program | Yes | Yes |
| Ability to personalize target ranges | Yes | Yes |
| Unit of measure display | Choice of mmol/L or mg/dL | mmol/L or mg/dL |
| Ability to enter hypoglycemic range | Yes | Yes |
| Report Types | Data list, data statistics, average reading, pie chart, Line graph, histogram, | Data list, data statistics, average reading, pie chart, Line graph, histogram, |
| Auto-detect COM port | Yes | Yes |
| Downloaded results cannot be edited or deleted | Yes | Yes |
| Ability to modify meter average results | Yes,7,14,30,60,90 days | Yes |
| Ability to clear meter results in memory | Yes | Yes |
| Required information on use entry | Yes | Yes, user ID, name, photo |

Differences

| Items | IN TOUCH DIABETES Management Software | TysonBio Link Health Management System |
| --- | --- | --- |
| Computer system requirements | Windows operating system 98 SE, Windows 2000, Windows XP home and Professional | only Windows 2000, Windows XP home and Professional |
| Manual Entry | Ability to add records manually | No |
| Copy database to separate file | Yes | No |
| Deleting results | Yes | No |

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| Items | IN TOUCH DIABETES Management Software | TysonBio Link Health Management System |
| --- | --- | --- |
| Language capabilities | English, Spanish | English |
| Viewing the Owner's manual | Link provided via icom | No |
| Default glucose target ranges available | Yes | No |
| Search patient capability | Yes | No |
| Result type display | Choice of whole blood or plasma result types | No |
| Ability to set default favorite report | Yes | No |
| Ability to synchronize meter clock to PC upon download | Yes | No |
| Ability to display 12 or 24 hour clock format | Yes | No |
| Ability to change date format | Yes | No |
| Ability to link to older database versions | Yes | No old versions available at this time |
| Diabetes Educator information | One diabetes educator may be entered | No |
| Diabetes control | Insulin list, medication list, diet/exercise options | No |
| Specifying/Entering medication/insulin | Yes, up to 3 different medications/insulin types | No |
| Ability to enter insulin regiment | Yes | No |
| Report types | Standard Day, Average Reading, Insulin, Exception, Data List Histogram, Health checks | No Insulin, Exception, standard day report. |
| Ability to set meter | Yes | No |

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| Items | IN TOUCH DIABETES Management Software | TysonBio Link Health Management System |
| --- | --- | --- |
| clock to a specific date and time | | |
| Ability to email report from PC directly from program | Yes | No |
| Ability to input additional information on manual result | Yes | No |

I. Standard/Guidance Document Referenced (if applicable):
None

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:
see above associated devices k062829, k072854 and k073492

The accuracy of PC download feature was investigated in k073492. There is a 300 test memory capacity in DIACHEX+ INFINITY Blood Glucose Meter. The PC download feature was validated by installing the TysonBio Link Health Management System software, setting meter in PC transfer data mode and connecting to computer through RS 232 port. The accuracy of transfer data was validated by comparison to the original data in DICHEX+ INFINITY device.

b. Precision/Reproducibility:
see above associated devices k062829, k072854 and k073492

c. Linearity:
see above associated devices k062829, k072854 and k073492

d. Carryover:
Not Applicable

e. Interfering Substances:
see above associated devices k062829, k072854 and k073492

2. Other Supportive Instrument Performance Data Not Covered Above:

125 typical diabetic users ranging in age, education and about equally divided between males and females were included in the user study. Participants were first provided with a DIACHEX Basic or DIACHEX Superb glucose meter (with previously stored test data), cable and both the meter and software User's manuals. They were asked to read the user's

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manual and follow the instructions to install the software to transfer the data from meter to PC and use all the software application functions. The statistical analysis of study participants' response to consumer questionnaire indicated the software is easy to use and met the expectation of end users.

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K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.