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510(k) Data Aggregation
(202 days)
IMPROVACUTER Gel & Clot Activator Tube is a single used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healthcare worker. For in vitro diagnostic use.
The IMPROVACUTER® Gel & Clot Activator Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, (3) a Barrier Gel and (4) a plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
The provided text describes a 510(k) submission for the IMPROVACUTER® Gel & Clot Activator Tube, a medical device for blood collection, and focuses on demonstrating its substantial equivalence to a predicate device, the BD Vacutainer® Gel & Clot Activator Tube. The study outlined is a method comparison study, which is a common approach for demonstrating equivalence for in vitro diagnostic (IVD) devices.
Here's an breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text doesn't explicitly state quantitative acceptance criteria in a dedicated table. Instead, it describes the acceptance as demonstrating "no major differences" or "clinically equivalent" results compared to the predicate device. The performance is summarized qualitatively.
| Criterion Type | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Clinical Equivalence | The IMPROVACUTER® Gel & Clot Activator Tube should provide clinically equivalent chemistry and immunology analyte results compared to the predicate BD Vacutainer® tubes. | "The clinical evaluation demonstrated that the IMPROVACUTER® Gel & Clot Activator Tube provide clinically equivalent chemistry analyte results when compared to the BD Vacutainer® tubes." |
| "All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes." (This statement is repeated for Method Comparison, Stability, Shelf-life, Same-Lot Repeatability, and Lot-to-Lot Reproducibility studies) | ||
| Analyte Stability (Refrigerated) | Analytes should be stable for 24 hours at 2-8°C. | Demonstrated for all analytes. "All results showed no significant different from BD Vacutainer® stored under the same condition." and "Stability for 24 hours at room temperature and refrigerated temperature has been demonstrated for all the analytes except TBIL." |
| Analyte Stability (Room Temperature) | Analytes should be stable for 24 hours at 22-25°C. | Demonstrated for most analytes. "TBIL is stable at room temperature for up to 20 hours." and "All results showed no significant different from BD Vacutainer® stored under the same condition." |
| Shelf-life | The device should not show significant differences from newly manufactured devices over its shelf life. | "All results showed no significant different from these [newly manufactured devices]." |
| Same-Lot Repeatability | No major differences from the method comparison study results within the same lot. | "All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes." (Implies meeting the criterion by finding no major differences compared to the predicate, which serves as the reference for acceptable performance). |
| Lot-to-Lot Reproducibility | No major differences from the method comparison study results across different lots. | "All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes." (Implies meeting the criterion by finding no major differences compared to the predicate, which serves as the reference for acceptable performance). |
The document refers to CLSI Guideline, EP9-A2: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline Second edition, which would contain the specific statistical methods and criteria (e.g., allowable total error, bias, correlation coefficients) used to determine "no major differences" or "clinically equivalent." However, these specific numerical criteria are not detailed in the provided summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The exact number of individual patient samples (N) for the "clinical evaluations" (method comparison studies) is not explicitly stated in the provided text. It mentions comparing devices "in total 28 chemistry assays and 13 Immunology assays," but this refers to the number of analytes tested, not the number of samples.
- Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "Clinical evaluations were performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the context of this device and study. The "ground truth" for these types of studies (blood collection tubes for chemistry and immunology assays) is based on the analytical measurements from a legally marketed and accepted predicate device, rather than expert judgment or interpretation of images/clinical findings. The "truth" is the measured analyte concentration.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication typically refers to resolving discrepancies between multiple human readers or between human readers and an AI system, especially in image interpretation tasks. For a method comparison study of blood collection tubes, the "readings" are objective laboratory measurements, so there is no human interpretation or adjudication process in the same way.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the impact of a diagnostic aid (often AI) on human reader performance, usually in image-based diagnostics. This submission is for a blood collection device, which is an in vitro diagnostic (IVD) rather than an AI-powered diagnostic imaging tool. The study compares the performance of the device itself to a predicate device, not the performance of human readers using or not using the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, effectively. The "clinical evaluations were performed to determine the safety and efficiency of the IMPROVACUTER® Gel & Clot Activator Tube" by comparing its analytical results directly to those obtained from the predicate device. This is a standalone performance assessment of the device (or the "algorithm" in the context of a non-AI device, meaning its functional performance) without human interpretation influencing the primary outcome measures (i.e., analyte concentrations). The device itself is the "algorithm" being evaluated.
7. The Type of Ground Truth Used
The "ground truth," in this context, is the analyte concentration obtained from the legally marketed predicate device (BD Vacutainer® tubes). The study design is a method comparison where the predicate device serves as the reference standard. The results from the IMPROVACUTER® tubes are compared against the results from the BD Vacutainer® tubes to demonstrate "no major differences" or "clinical equivalence."
8. The Sample Size for the Training Set
Not applicable. This submission is for a traditional medical device (blood collection tube), not an AI algorithm. Therefore, there is no "training set" in the machine learning sense. The device's performance is inherent to its design and materials, not learned from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.
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