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510(k) Data Aggregation
(132 days)
The ACCU-CHEK® Aviva system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring blood glucose in the home or health care facility. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
The ACCU-CHEK Aviva system utilizes reagent test strips stored within a desiccated vial. A test strip is removed from the vial and inserted into the meter. Upon insertion, the meter is activated. Blood is applied to the end of the test strip, and a glucose result is reported. The test principle is: Blood from the test site works with the chemicals in the test strip to make a small electrical current in the test strip. The meter reads the current and gives the blood glucose result.
Acceptance Criteria and Device Performance Study for ACCU-CHEK® Aviva System
This document describes the acceptance criteria and the study that demonstrates the ACCU-CHEK® Aviva System meets these criteria, based on the provided FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in the typical "pass/fail" format often seen for performance studies. Instead, it focuses on demonstrating substantial equivalence to a predicate device (ACCU-CHEK Advantage system, K010362 and K032552) through similarities and highlighted differences which represent technological advancements and improved features. The "reported device performance" is inferred from the described benefits and technological improvements that are inherently tied to performance.
| Aspect | Acceptance Criteria (Inferred from Predicate Equivalence and Benefits) | Reported Device Performance (ACCU-CHEK Aviva) |
|---|---|---|
| Intended Use | Quantitatively measure glucose in capillary whole blood for persons with diabetes or healthcare professionals for home/facility monitoring. | Meets this criterion; indicated for professional use and over-the-counter sale. Professionals can test capillary and venous blood, lay users are limited to capillary whole blood. Testing sites include fingertip, palm, forearm, upper arm, thigh, and calf. |
| Sample Type | Utilize whole blood samples (capillary or venous). | Utilizes whole blood samples (capillary or venous for professionals, capillary only for lay users). |
| Operating Environment | Suitable for home and professional use. | Intended for use in the home or healthcare facilities. |
| Closed System | Test strips and controls designed for use only with the specific system. | Test strips and controls are designed to be used only with the ACCU-CHEK Aviva system. |
| Test Strip Storage | Store at room temperature, less than 90°F. Do not freeze. | Same storage conditions: room temperature, less than 90°F. Do not freeze. |
| Quality Control Procedure | Defined procedure for when to test quality controls. | Same quality control procedure: when cap is left off vial, new vial opened, meter dropped, result doesn't agree with user's feeling, or to check system performance. |
| Reportable Range | 10 – 600 mg/dL. | Same reportable range: 10 – 600 mg/dL. |
| Warnings and Precautions | For in vitro diagnostic use only. | For in vitro diagnostic use only. |
| Monitor Coding Process | Use a code key, included in test strip vial, inserted into the meter. | Uses a code key, included in the test strip vial, inserted into the meter. |
| Test Strip Packaging | Provide test strips in a desiccated vial. | Provides test strips in a desiccated vial. |
| Identification of Control | Implicitly, a reliable method for distinguishing controls from blood samples. (Predicate: Manual flagging) | Automatically distinguishes control solutions from whole blood samples, improving usability and reducing user error compared to the predicate. |
| Test Sample Volume | Implicitly, a practical and sufficient volume. (Predicate: 4.0 uL) | Requires 0.6 uL, a significant reduction from the predicate's 4.0 uL, indicating improved efficiency and potentially less discomfort for the user. |
| Test Time | Implicitly, a reasonable time for results. (Predicate: 26 seconds) | Provides results in 5 seconds, a substantial reduction from the predicate's 26 seconds, enhancing user convenience. |
| Test Strip Expiration | Implicitly, clear information regarding expiration. (Predicate: Labeling only) | Code key contains expiration date, and the system informs the user when the code key has expired, providing an additional fail-safe against using expired strips, an improvement over the predicate's labeling-only notification. |
| Test Strip Technology | Implicitly, a robust and accurate measurement principle. (Predicate: Electrical biamperometry) | Utilizes both AC/DC electrical impedance information, which is described as a new technology allowing for several fail-safes. This implies improved accuracy and reliability compared to the predicate's electrical biamperometry. |
| Blood Glucose Range Labeling | Provide appropriate guidance on normal blood glucose ranges. | Provides updated labeling instructions for normal fasting (74-106 mg/dL) and post-meal (<140 mg/dL) blood glucose ranges for non-diabetics, and advises consultation with a doctor for diabetic ranges. This is a subtle update to the predicate's ranges (70-105 mg/dL fasting) but aligns with current understanding at the time. |
| Test Strip Integrity | Implicitly, reliable performance even under varying conditions; protection against compromised strips. (Predicate: Not explicitly detailed fail-safes) | Performs more than 150 checks on the integrity of each test strip prior to use. Strips exposed to excessive heat or humidity are not used to generate results, ensuring result accuracy. |
| Environmental Compensation | Implicitly, accurate results across physiological variations like temperature and hematocrit. (Predicate: Not explicitly detailed compensation) | Automatically compensates for some variation in temperature and hematocrit through the AC electrical information channel, indicating improved accuracy and robustness across different user conditions compared to the predicate. |
| User Lockout (Expiration) | Implicitly, prevention of using inoperable or expired components. | Automatically locks out the user after the test strip expiration date has been exceeded, preventing potentially inaccurate results from expired strips, a significant safety and reliability improvement. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for a specific "test set" or a detailed performance validation study with specific number of participants. It rather focuses on demonstrating substantial equivalence based on features and technological differences. Therefore, details regarding the country of origin of the data or whether it was retrospective or prospective are also not available in the provided text.
3. Number of Experts and Their Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set. This type of detail is typically found in clinical performance studies where expert review is necessary, which is not fully detailed here.
4. Adjudication Method
As no explicit "test set" and ground truth establishment by experts is detailed, no adjudication method (e.g., 2+1, 3+1, none) is mentioned or applicable based on the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not mentioned in the provided document. The device is a glucose meter, intended for direct measurement rather than interpretation of images or signals by multiple human readers, so such a study would generally not be relevant.
6. Standalone Performance Study
While a detailed study with specific performance metrics (e.g., accuracy against a laboratory reference method with a defined sample size) is not provided in a summary table within this document, the fact that the device automatically provides a glucose result implies a standalone performance was conducted/demonstrated as part of the overall regulatory submission. The document states "Blood is applied to the end of the test strip, and a glucose result is reported," and describes how the meter reads the current and gives the blood glucose result, confirming its independent operational capability. However, the exact methodology and results of such a standalone study (e.g., accuracy, precision) are not detailed in this summary.
7. Type of Ground Truth Used
For a glucose meter, the "ground truth" for evaluating accuracy typically involves comparison against a laboratory reference method (e.g., YSI analyzer, hexokinase method). While the document does not explicitly state the ground truth method used, it is standard practice for glucose meters to be validated against such methods. "Expert consensus," "pathology," or "outcomes data" would generally not be the primary ground truth for glucose measurements.
8. Sample Size for the Training Set
The document does not explicitly mention a training set sample size. Glucose meters typically do not involve machine learning models that require a distinct "training set" in the same way AI-powered image analysis systems do. The development and calibration of such devices usually involve extensive testing with various blood samples to ensure accuracy and robustness across different physiological conditions, which could be considered an iterative development and testing process.
9. How the Ground Truth for the Training Set Was Established
Since a distinct "training set" in the context of machine learning is not implied or detailed, the document does not describe how ground truth for a training set was established. The development likely involved calibrating the electrical response of the test strip technology against known glucose concentrations, derived from laboratory reference methods on blood samples.
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