(57 days)
The VACUTAINER® Brand PLUS (plastic) Tube with EDTA is an evacuated blood collection tube which provide a means of collecting, transporting, separating and processing blood in a plastic tube. When the tube is used together with VACUTAINER® Brand Needles and Holders, it is a closed system for the collection of venous blood with the same indications as described herein.
Blood collected in a tube containing EDTA Anticoagulant is primarily used for clinical laboratory testing-hematology study using whole blood but may be used for other studies including such studies as testing for lead and FEP analyses, requiring whole blood as determined by the laboratory.
The VACUTAINER® Brand PLUS Tube with EDTA is an evacuated plastic tube for collecting, transmitting and processing blood in a closed plastic tube. The blood collection tube consists of closure assembly, a plastic tube and EDTA coating (dipotassium, K2). The plastic tube is manufactured from PET (Polyethylene terepthalate Plastic and enhances user safety and disposal because of the reduced risk of tube breakage and incineration as a method of disposal. The standard closure assembly is a basic rubber stopper. The tube is also available with VACUTAINER Systems Hemogard™ Closure assembly which is designed to reduce user exposure to blood. The EDTA anticoagulant tube coating is spray coated in a dipotassium (K2) form. The EDTA prevents specimen coagulation.
The provided text describes a 510(k) premarket notification for the VACUTAINER® Brand PLUS Tube with EDTA Anticoagulant. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Equivalence for FEP (Free Erythrocyte Protoporphyrin) Analysis (compared to VACUTAINER® Brand Glass Tube with EDTA) | Demonstrated analytically and statistically equivalent results and sample stability at initial time and extended tube storage. |
| Equivalence for Blood Lead Analysis (compared to VACUTAINER® Brand Glass Tube with EDTA) | Demonstrated analytically and statistically equivalent results and sample stability at initial time and extended tube storage. |
| Lead Level in Tubes (Maximum limit is 2.5 ug/L (ppb) as per draft product labeling for the Becton Dickinson VACUTAINER Systems Plus Plastic Tube with EDTA) | All tubes from three different lots tested had lead levels below 2 ug/L. |
| Reduced Risk of Tube Breakage | Achieved, as described in prior 510(k) K901449/A. |
| Enhanced Disposal (Incineration as method) | Achieved, as described in prior 510(k) K901449/A. |
2. Sample Size Used for the Test Set and Data Provenance:
- For FEP and Blood Lead Analysis: The specific sample size for the clinical evaluation comparing the Plus Tube to the Glass Tube is not explicitly stated.
- For Tube Lead Levels: "Twenty tubes from each of the three lots" were tested, totaling 60 tubes (20 tubes/lot * 3 lots).
- Data Provenance: The document does not specify the country of origin for the clinical evaluation data. It is a prospective comparison study for FEP and Blood Lead, and an analytical/bench study for tube lead levels.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document describes analytical and statistical equivalence based on laboratory measurements (FEP, Blood Lead, Atomic Absorption for lead). It does not mention the use of human experts to establish "ground truth" in the typical sense of expert consensus for diagnostic interpretation.
- The "ground truth" for FEP and Blood Lead would be the quantitative measurements themselves, and for lead levels, it would be the results from Atomic Absorption.
4. Adjudication Method for the Test Set:
- Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies involving human interpretation of diagnostic images or clinical assessments where there might be inter-reader variability.
- Given the nature of the tests (quantitative analyte measurements and material analysis), no adjudication method was mentioned or appears to be applicable in this context. The determination of equivalence and lead levels relies on direct analytical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. The study design involved comparing a new medical device (plastic tube) to an existing device (glass tube) for its ability to preserve sample integrity for specific laboratory tests (FEP and Blood Lead) and for its material properties (lead levels in the tube). This is not equivalent to an MRMC study which typically assesses the impact of AI on human reader performance in diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- This device is a blood collection tube, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's performance is driven by its material properties and manufacturing, assessed through analytical and clinical laboratory testing.
7. The Type of Ground Truth Used:
- Quantitative Analytical Measurements:
- For FEP and Blood Lead analyses: The "ground truth" was established by quantitative measurements of FEP and blood lead levels from blood samples collected in both the test (plastic) and predicate (glass) tubes. The comparison was based on the numerical results and their statistical equivalence.
- For tube lead levels: The "ground truth" was established by Atomic Absorption (AA) measurements of lead levels within the tubes.
8. The Sample Size for the Training Set:
- This device is a physical medical device (blood collection tube), not an AI model that requires a "training set." Therefore, the concept of a training set does not apply to this submission.
9. How the Ground Truth for the Training Set was Established:
- As concluded in point 8, there is no training set for this device.
§ 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.