(69 days)
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.
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.
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.
§ 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.