(188 days)
The Greiner Vacuette™ blood collection tube with EDTA K, is an evacuated blood collection device containing EDTA K, anticoagulant additive and intended for use in evaluations of whole blood specimens.
The Greiner Vacuette™ blood collection tube with EDTA K, is an evacuated blood collection device containing EDTA K, anticoagulant additive. The tube material for the Greiner product is clear plastic.
Here's an analysis of the provided 510(k) summary for the Greiner Vacuette™ blood collection tube with EDTA K3, addressing your requested information points.
Important Note: This document describes a medical device (blood collection tube), not a software-based AI device. Therefore, many of your requested criteria, which are standard for AI/ML medical devices, are not applicable in this context. I will address each point, clarifying why certain information is missing or not relevant for this type of device.
Acceptance Criteria and Device Performance (Greiner Vacuette™ blood collection tube with EDTA K3)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Becton Dickinson Vacutainer® EDTA K3 tube - K940905) | Good correlation observed in test results for 15 hematology parameters when comparing paired samples collected in Greiner Vacuette™ tubes and Becton Dickinson Vacutainer® tubes. |
| Same Intended Use as Predicate Device | Confirmed: Both tubes are intended for use in evaluations of whole blood specimens with EDTA K3 anticoagulant. |
| Same Stopper Material and Additive as Predicate Device | Confirmed: Both tubes use the same stopper material and contain the same EDTA K3 additive. |
| Material Difference (Plastic vs. Glass) does not impact performance negatively | Implied by "good correlation observed" across hematology parameters despite the material difference. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the number of patients or samples used in the equivalency study. It only mentions "paired samples."
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a physical medical device (blood collection tube) for which "ground truth" is established by laboratory analytical methods, not by expert interpretation of images or clinical data. The accuracy of the hematology parameters is the "ground truth" in this context, measured by standard laboratory assays.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is not a device requiring human experts to establish ground truth or adjudicate results in the way an AI/ML device would. The "adjudication" is essentially the comparison of quantitative laboratory results between the two tube types.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This type of study is designed for diagnostic imaging devices where human readers provide interpretations (e.g., radiologists reading images). This is a blood collection tube; there are no "readers" in the context of its primary function.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable. This is a physical device, not an algorithm or software. There is no "algorithm only" performance to evaluate. The device's performance is its ability to collect and preserve blood for accurate analysis.
7. Type of Ground Truth Used
- Laboratory Assay Results: The "ground truth" is established by the results of standard hematology assays performed on the collected blood samples. The comparison is between the assay results obtained from samples collected in the predicate device vs. the new device.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set. The "study" here is a comparative bench/clinical equivalency study, not a machine learning model's development.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8).
Summary of the Study:
The study conducted was a direct comparative equivalency study. Paired blood samples were collected from an unspecified number of subjects. One sample from each pair was collected in the predicate device (Becton Dickinson Vacutainer® EDTA K3 tube, K940905) and the other in the new Greiner Vacuette™ EDTA K3 tube. These samples were then analyzed for 15 hematology parameters using standard laboratory methods. The "good correlation" observed between the results from the two tube types demonstrated that the Greiner tube performed equivalently to the predicate device, despite the difference in tube material (plastic vs. glass). This equivalency supports the claim of substantial equivalence for regulatory purposes.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.