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 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.

AI/ML Overview

The TysonBio Link Health Management System is a data management software for blood glucose monitors. The provided 510(k) summary does not contain specific acceptance criteria or a detailed study report with quantitative performance data in the typical sense of a diagnostic device. Instead, the submission relies on demonstrating substantial equivalence to a predicate device through functional comparisons and general software validation.

Here's an analysis of the provided information based on your request, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the submission primarily compares features and functionalities rather than setting quantitative performance thresholds. The acceptance criteria essentially appear to be "functional equivalence" to the predicate device and meeting general software validation principles.

Feature/Criterion	Predicate Device (IN TOUCH) Performance	TysonBio Link HMS Performance	Acceptance Status
Intended Use	Aid in review, analysis, evaluation of blood glucose results for diabetes management.	Aid in review, analysis, evaluation of blood glucose results for diabetes management. (Does not recommend treatment/dosage)	Met (Identical)
Data Immutability	Data transferred cannot be changed or modified.	Data transferred cannot be changed or modified.	Met (Identical)
Optional Accessory	Software accessory for blood glucose monitors with data management.	Software accessory for blood glucose monitors with data management.	Met (Identical)
No Control over Meter Measurements	Does not control or affect blood glucose monitor's measurements.	Does not control or affect blood glucose monitor's measurements.	Met (Identical)
Cable Availability	Serial cable, available separately.	Serial cable, available separately.	Met (Identical)
Uploading Data from Various Devices	Software driver must be uploaded on device or installed on PC.	Software driver must be installed on PC.	Met (Functionally Equivalent)
Minimum RAM	Minimum of 128 MB.	Minimum of 128 MB or better.	Met (Equivalent or better)
Minimum Free Hard Disk Space	100-200 MB during, 100 MB after installation.	Minimum 100 MB or more.	Met (Equivalent or better)
Port Required	9-pin or 25 pin COM or USB port.	USB port.	Met (Functionally Equivalent, subset of predicate)
Screen Resolution	800x600 pixels and 256 colors.	Same as predicate.	Met (Identical)
Software Use Settings	Home or clinic settings.	Single or multiple user settings.	Met (Functionally Equivalent)
Deleting Patients/Records	Yes.	Yes.	Met (Identical)
Uninstall Program	Yes.	Yes.	Met (Identical)
Personalize Target Ranges	Yes.	Yes.	Met (Identical)
Unit of Measure Display	Choice of mmol/L or mg/dL.	mmol/L or mg/dL.	Met (Identical)
Enter Hypoglycemic Range	Yes.	Yes.	Met (Identical)
Report Types	Data list, statistics, average reading, pie chart, line graph, histogram.	Data list, statistics, average reading, pie chart, line graph, histogram.	Met (Identical)
Auto-detect COM port	Yes.	Yes.	Met (Identical)
Downloaded Results Cannot Be Edited/Deleted	Yes.	Yes.	Met (Identical)
Modify Meter Average Results	Yes (7,14,30,60,90 days).	Yes.	Met (Functionally Equivalent)
Clear Meter Results in Memory	Yes.	Yes.	Met (Identical)
Required Info on Use Entry	Yes.	Yes (user ID, name, photo).	Met (Functionally Equivalent or better)
Operating System	Windows 98 SE, 2000, XP.	Windows 2000, XP.	Not Identical (More restrictive, but acceptable for clearance)
Manual Entry	Ability to add records manually.	No.	Not identical, but acceptable difference as device is for transferring data.
Copy Database to Separate File	Yes.	No.	Not identical, but acceptable difference.
Deleting Results	Yes.	No.	Not identical, but acceptable difference (emphasizes data immutability for transferred data).
Language Capabilities	English, Spanish.	English.	Not identical, but acceptable difference.
Viewing Owner's Manual	Link provided via icon.	No.	Not identical, but acceptable difference.
Default Glucose Target Ranges	Yes.	No.	Not identical, but acceptable difference (user can personalize).
Search Patient Capability	Yes.	No.	Not identical, but acceptable difference.
Result Type Display (Whole blood/Plasma)	Choice of whole blood or plasma.	No.	Not identical, but acceptable difference.
Set Default Favorite Report	Yes.	No.	Not identical, but acceptable difference.
Synchronize Meter Clock to PC	Yes.	No.	Not identical, but acceptable difference.
Display 12 or 24 hour format	Yes.	No.	Not identical, but acceptable difference.
Change Date Format	Yes.	No.	Not identical, but acceptable difference.
Link to Older Database Versions	Yes.	No old versions available at this time.	Not identical, but acceptable difference (due to product lifecycle).
Diabetes Educator Info	One diabetes educator may be entered.	No.	Not identical, but acceptable difference.
Diabetes Control (Insulin, medication, diet/exercise)	Insulin list, medication list, diet/exercise options.	No.	Not identical, but acceptable difference.
Specifying/Entering Medication/Insulin	Yes, up to 3 types.	No.	Not identical, but acceptable difference.
Enter Insulin Regiment	Yes.	No.	Not identical, but acceptable difference.
Report Types (beyond basic)	Standard Day, Average Reading, Insulin, Exception, Data List, Histogram, Health checks.	No Insulin, Exception, Standard Day report.	Not identical, but acceptable difference.
Set Meter Clock to Specific Date/Time	Yes.	No.	Not identical, but acceptable difference.
Email Report from PC Directly	Yes.	No.	Not identical, but acceptable difference.
Input Additional Info on Manual Result	Yes.	No.	Not identical, but acceptable difference.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify a sample size for a test set in the context of clinical performance or data accuracy. This is a software accessory for data management, not a diagnostic test device itself. The "testing" referred to is software verification and validation.

The "data provenance" (country of origin, retrospective/prospective) for user data or clinical samples is not applicable as no such data is being analyzed for clinical accuracy by the software. The software's function is to transfer and display data from a blood glucose meter.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided and is not applicable to this type of software submission. There is no mention of expert review for establishing ground truth, as the software's role is data handling, not interpretation requiring expert consensus.

4. Adjudication Method

Not applicable. No clinical data requiring adjudication by experts is described as part of the submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed or mentioned. This type of study is typically used for diagnostic imaging or interpretation devices where human performance with and without AI assistance is being evaluated. This software is for data management, not interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

While there isn't a "standalone study" in the sense of a diagnostic algorithm evaluating patient data, the software verification and validation testing described is essentially evaluating the algorithm's (software's) performance in isolation against its functional requirements. The statement "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" indicates this. The performance requirements, in this context, are for accurate data transfer, display, reporting, and adherence to specified functionalities.

7. Type of Ground Truth Used

The "ground truth" for this device would be its functional specifications and software requirements. The testing would verify that the software accurately transfers numeric data (blood glucose readings) from the meter, stores it, and generates reports based on that data, without alteration. The ground truth for individual blood glucose values would originate from the blood glucose meters themselves, which are separate regulated devices. The software's ground truth is about its operation, not the medical accuracy of the data it handles.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a training set of data. It is a traditional software application designed for data transfer and management based on explicit programming rules, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of software.

Summary

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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: 886-37-585988 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, 21CFR862.2100Glucose Test System, 21 CFR862.1345
4. Product code:	NBW - System, test, blood glucose, over the counter,JQP - Calculator/data processing module for clinical use

4. DEVICE DESCRIPTION:

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.

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 DIABETESManagement Software	TysonBio Link Health ManagementSystem
Intended Use	The IN TOUCH DiabetesManagement Software is intended foruse in home and clinical settings toaid people with diabetes and theirhealth care professionals in thereview, analysis and evaluation bloodglucose test results to supporteffective diabetes management.	TysonBio Link Health ManagementSystem is intended for use in home andclinical settings to aid people with diabetesand their health care professionals in thereview, analysis and evaluation bloodglucose test results to support effectivediabetes management. It should be notedthat the software does not recommendany medical treatment or medicationdosage level
Items	IN TOUCH DIABETESManagement Software	TysonBio Link HealthManagement System
Cable availability	Serial cable, cable availableseparately	Serial cable, cable available separately
Capable for uploadingdata from variousdevices	Software driver must be uploaded onthe device or installed on PC	Software driver must be installed on PC
Computer systemrequirements	Minimum of 128 MB of RAM	Minimum of 128 MB of RAM or better
	100-200 MB minimum free hard diskspace during, 100 MB afterinstallation	Minimum 100 MB of free hard disk spaceor more
	9-pin or 25 pin COM or USB port	USB port
	Video monitor and adapter with atleast 800x600 pixels screenresolution and 256 colors	same as
Software useindications	Home or clinic settings	Single or multiple user settings
Deleting patients andall accompanyingrecords	Yes	Yes
Ability to uninstallprogram	Yes	Yes
Ability to personalizetarget ranges	Yes	Yes
Unit of measuredisplay	Choice of mmol/L or mg/dL	mmol/L or mg/dL
Ability to enterhypoglycemic range	Yes	Yes
Report Types	Data list, data statistics, averagereading, pie chart, Line graph,histogram,	Data list, data statistics, average reading,pie chart, Line graph, histogram,
Auto-detect COM port	Yes	Yes
Downloaded resultscannot be edited ordeleted	Yes	Yes
Ability to modify meteraverage results	Yes,7,14,30,60,90 days	Yes
Ability to clear meterresults in memory	Yes	Yes
Required informationon use entry	Yes	Yes, user ID, name, photo
ltems	IN TOUCH DIABETESManagement Software	TysonBio Link HealthManagement System
Computer systemrequirements	Windows operating system 98SE, Windows 2000, WindowsXP home and Professional	only Windows 2000,Windows XP home andProfessional
Manual Entry	Ability to add records manually	No
Copy database toseparate file	Yes	No
Deleting results	Yes	No
Language capabilities	English, Spanish	English
Viewing the Owner'smanual	Link provided via icon	No
Default glucose targetranges available	Yes	No
Search patient capability	Yes	No
Result type display	Choice of whole blood orplasma result types	No
Ability to set defaultfavorite report	Yes	No
Ability to synchronizemeter clock to PC upondownload	Yes	No
Ability to display 12 or 24hour clock format	Yes	No
Ability to change dateformat	Yes	No
Ability to link to olderdatabase versions	Yes	No old versions available atthis time
Diabetes Educatorinformation	One diabetes educator may beentered	No
Diabetes control	Insulin list, medication list.diet/exercise options	No
Specifying/Enteringmedication/insulin	Yes, up to 3 differentmedications/insulin types	No
Ability to enter insulinregiment	Yes	No
Items	IN TOUCH DIABETESManagement Software	TysonBio Link HealthManagement System
Report types	Standard Day, AverageReading, Insulin, Exception,Data List Histogram, Healthchecks	No Insulin, Exception,standard day report.
Ability to set meter clockto a specific date andtime	Yes	No
Ability to email reportfrom PC directly fromprogram	Yes	No
Ability to input additionalinformation on manualresult	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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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:

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

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.