(69 days)
Not Found
No
The description focuses on data transfer and management, with no mention of AI/ML terms or functionalities like prediction, analysis beyond simple review, or learning from data.
No
The device is a software accessory for managing blood glucose data and does not provide any treatment or medical recommendations. Its purpose is to aid in the review, analysis, and evaluation of blood glucose test results, which supports diabetes management but does not constitute therapeutic action itself.
No
The device is described as software that aids in the review, analysis, and evaluation of blood glucose test results for diabetes management. It explicitly states that it "does not recommend any medical treatment or medication dosage level," which indicates it is not used to make a diagnosis or directly determine a patient's medical condition. It's for data management and analysis, not diagnostic assessment.
Yes
The device is described as an "optional software accessory" that transfers data from existing blood glucose meters to a computer for data management. The description focuses solely on the software's function and mentions software verification and validation testing, without any indication of hardware components being part of the device itself.
Based on the provided information, the TysonBio Link Health Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease. This typically involves analyzing biological samples (like blood, urine, etc.) to diagnose, monitor, or screen for conditions.
- TysonBio Link's function: The TysonBio Link Health Management System is described as software that transfers data from blood glucose meters to a computer for enhanced data management. It aids in the review, analysis, and evaluation of blood glucose test results.
- Lack of direct diagnostic function: The software itself does not perform any in vitro testing or analysis of biological samples. It relies on the data generated by the blood glucose meters (which are IVDs).
- Explicit statement: The description explicitly states that the software does not recommend any medical treatment or medication dosage level. This further reinforces that its role is data management and analysis support, not direct diagnostic or treatment guidance.
While it works in conjunction with IVD devices (the blood glucose meters), the software itself is a data management tool and not an IVD.
N/A
Intended Use / 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.
Product codes
NBW, JQP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, 21CFR862.2100 |
| Glucose 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:
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
1
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
Management Software | TysonBio Link Health Management
System |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The IN TOUCH 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 |
| Items | IN TOUCH DIABETES
Management Software | TysonBio Link Health
Management System |
| Cable availability | Serial cable, cable available
separately | Serial cable, cable available separately |
| Capable for uploading
data from various
devices | Software driver must be uploaded on
the device or installed on PC | Software driver must be installed on PC |
| 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 as |
| Software use
indications | Home or clinic settings | Single or multiple user settings |
| Deleting patients and
all accompanying
records | Yes | Yes |
| 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 |
| ltems | 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 |
| Language capabilities | English, Spanish | English |
| Viewing the Owner's
manual | Link provided via icon | 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 |
| Items | IN TOUCH DIABETES
Management Software | TysonBio Link Health
Management System |
| Report types | Standard Day, Average
Reading, Insulin, Exception,
Data List Histogram, Health
checks | No Insulin, Exception,
standard day report. |
| Ability to set meter clock
to a specific date and
time | Yes | No |
| Ability to email report
from PC directly from
program | Yes | No |
| Ability to input additional
information on manual
result | Yes | no |
Similarities
2
:
3
Differences
:
4
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.
5
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:
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