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510(k) Data Aggregation
(446 days)
VivaChek™ Ino Smart Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Smart Blood Glucose Meter (VGM04) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sync Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sync Blood Glucose Meter (VGM05) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sync Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sound Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Blood Glucose Meter (VGM09) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Plus Blood Glucose Meter (VGM22) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™M Ino Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sound Simple Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Simple Blood Glucose Meter (VGM26) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Simple Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sound Bright Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Bright Blood Glucose Meter (VGM27) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Bright Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.
VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05), VivaChek™ Ino Sound Blood Glucose Monitoring System (Model:VGM09), VivaChek™ Ino Plus Blood Glucose Monitoring System (Model:VGM22), VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26), VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27) are designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.
VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04), VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05), VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09) and VivaChek™ Ino Plus Blood Glucose Monitoring System (Model:VGM22) contain Bluetooth, the devices comply with US federal guidelines, Part 15 of the FCC Rules for devices with RF capability. Please refer to the FCC PART 15.247 BLE Test Reports #1803WSU007-U1 for VGM09 and VGM22 systems, and #1803WSU007-U2 for VGM04 and VGM05 systems.
VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09), VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26)and VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27) contain talking functionality, refer to Talking Feature Validation Protocols and Reports, and Meter Robustness Study Protocol and Report.
The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the VivaChek Ino Blood Glucose Monitoring Systems.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various laboratory and clinical tests conducted. While it doesn't present a single consolidated table of acceptance criteria vs. specific quantitative performance for all metrics, it clearly states "Conclusion | Pass" for all listed tests, indicating that the devices met their respective acceptance criteria based on the referenced guidance documents (primarily FDA SMBG Guidance and ISO 15197:2015).
For system accuracy, the key acceptance criteria for glucose monitoring systems are generally based on ISO 15197. The document indirectly confirms adherence to these by stating the "User Evaluation" and "User Evaluation-Accuracy at Extreme Glucose Values" passed per "FDA SMBG Guidance". The FDA SMBG Guidance often references or aligns with ISO 15197. Without explicit performance data tabled, we infer that the devices met the performance criteria outlined in these guidance documents.
Implied Acceptance Criteria (based on FDA SMBG Guidance and ISO 15197:2015, which the device passed):
| Performance Metric | General Acceptance Criteria (per ISO 15197:2015, commonly adopted by FDA) | Reported Device Performance (implied by "Pass") |
|---|---|---|
| System Accuracy (compared to reference method) | For glucose concentrations < 100 mg/dL: At least 95% of results shall fall within ± 15 mg/dL of the reference method. | Met (implied by "Pass" for User Evaluation and Accuracy at Extreme Glucose Values) |
| For glucose concentrations ≥ 100 mg/dL: At least 95% of results shall fall within ± 15% of the reference method. | Met (implied by "Pass" for User Evaluation and Accuracy at Extreme Glucose Values) | |
| Combined Accuracy (Error Grid Analysis) | For professional use, 100% of results in Zone A and B. For self-testing, high percentage in Zone A and B (specific percentages vary but typically >98%). | Met (implied by "Pass" for User Evaluation) |
| Linearity | Demonstrated linearity across the measurement range (20 to 600 mg/dL). | Met ("Pass") |
| Precision (Within-Run & Intermediate) | CV% within specified limits (e.g., < 5% or < 7.5% depending on glucose level). | Met ("Pass" for Intermediate Precision, Within-Run Precision) |
| Hematocrit Effect | Minimal interference across the specified hematocrit range (20-70%). | Met ("Pass") |
| Sample Volume | Correct measurement with specified sample volume (0.8 µL). | Met ("Pass") |
| Interference Agents | Minimal interference from common endogenous and exogenous substances. | Met ("Pass") |
| Operating Conditions (Temperature, Humidity) | Consistent performance across specified operating ranges (e.g., 41-113°F, 10-90% RH). | Met ("Pass" for Operating Conditions Evaluation) |
| Stability (Strip, Control, Open/Closed Vial) | Maintain performance over specified shelf-life and in-use period. | Met ("Pass" for most, "In-process" for some real-time studies) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for the user evaluation (clinical study) or laboratory tests. It generally refers to these studies as being conducted.
- Data Provenance: The studies were conducted as part of the 510(k) submission for regulatory clearance in the United States (FDA submission). They are implicitly prospective studies conducted for the purpose of this clearance. No specific country of origin for the data collection is mentioned beyond the context of the FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For glucose monitoring systems, the ground truth is typically established using a highly accurate reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer) rather than a panel of human experts.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth for glucose measurements is established by a reference laboratory method, not by human expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. Blood glucose monitoring systems measure quantitative values, not interpretations like medical images, thus MRMC studies are not relevant for this device type. The document describes "User Evaluation" studies, which focus on whether lay users can correctly operate the device and obtain accurate readings, not on comparing AI assistance versus unassisted human performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in essence, the "Laboratory Testing" section represents the standalone performance of the device's measurement system. Tests like Linearity, Precision, Hematocrit Effect, Sample Volume, and Interference Agents evaluate the accuracy and reliability of the device's core glucose measurement algorithm and hardware independently of user interaction for specific samples. The "User Evaluation" then adds the human-in-the-loop component for intended use.
7. The Type of Ground Truth Used
The ground truth for the glucose measurements was established using a reference laboratory method, which is considered the gold standard for quantitative glucose assessment. While not explicitly named in the provided text, this typically involves a highly accurate laboratory analyzer (e.g., YSI).
8. The Sample Size for the Training Set
This information is not applicable/provided. Blood glucose meters like these are typically based on electrochemical principles and calibration, not on machine learning algorithms trained on large datasets. Therefore, there isn't a "training set" in the sense of AI/ML models. Any internal calibration or development data would not be labeled as a "training set" in the AI/ML context.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML sense, this question is not applicable. The device's fundamental measurement principle relies on chemistry and electrical current, which are inherently calibrated during manufacturing and design, not "trained" on data.
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