(73 days)
An evacuated tube which provides a means of collecting, transporting, separating and processing venous blood in a closed system. Blood collected in these tubes is primarily used for clinical laboratory chemistry assays using patient serum but may be used for other serum specimens as determined by the laboratory.
VACUTAINER® Brand PLUS (plastic) Serum and SST® Serum Separator Tubes ("Full Draw" Tubes Only)
This document describes a 510(k) summary for Becton Dickinson VACUTAINER® Brand PLUS Serum and SST® Serum Separator Tubes, specifically focusing on a proposed modification involving a reduction in the amount of silicone tube coating in "full draw" tubes. The core of the submission is to demonstrate that this modification does not impact the safety or effectiveness of the product.
Acceptance Criteria and Device Performance:
The acceptance criteria are implicitly performance characteristics of the modified tubes being equivalent to or better than the predicate devices, or demonstrating acceptable safety improvements. The document outlines several studies to support these claims.
| Acceptance Criteria Category | Specific Criteria / Target | Reported Device Performance |
|---|---|---|
| Breakage Reduction | Improved breakage resistance compared to current plastic tubes. | "Breakage reduction is demonstrated in a study consisting of drop testing and centrifugation testing." (Details of "improvement" or specific metrics are not provided in this summary.) |
| Waste Disposal Improvement | Improved environmental profile regarding incineration by-products. | "Waste disposal improvement is demonstrated in a study of the by products of incineration for the components separately and the product as a whole." (Details of "improvement" or specific metrics are not provided in this summary.) |
| Reduced Blood Exposure | Reduced blood exposure compared to conventional rubber stopper tubes and competitive tubes. | "Reduced blood exposure is demonstrated in a study comparing VACUTAINER® Brand Tubes with the HEMOGARD™ closure to both VACUTAINER® Brand Tubes with the conventional rubber stopper and competitive tubes." (Details of "reduction" or specific metrics are not provided in this summary.) |
| Equivalent Clinical Performance (Analytes) | Equivalent levels for a panel of 18 analytes: albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (initial time only), blood urea nitrogen (BUN), calcium, chloride, cholesterol, creatinine, glucose, gammaglutamyl transferase (GGT), iron, phosphorus, potassium, sodium, protein, triglycerides, and uric acid, when compared to the current VACUTAINER® Brand PLUS SST® Serum Separator Tube. | "The results demonstrated equivalent functional performance" for all listed analytes, except for a noted difference in lactate dehydrogenase (LD) levels. |
| Equivalent Clinical Performance (Gel Barrier) | Equivalent performance characteristics of the gel barrier (e.g., proper separation) and absence of clinically significant fibrin, red cells, and hemolysis, when assessed visually, compared to the current VACUTAINER® Brand PLUS SST® Serum Separator Tube. The partial draw evaluation tubes exhibited a film of red blood cells on the tube wall above the barrier; therefore, these tubes will not be modified (note: all 13 X 100 size tubes used in clinical studies were partial draw tubes). | "The performance characteristics of the gel barrier and the presence of fibrin, red cells and hemolysis were assessed visually. The partial draw evaluation tubes exhibited a film of red blood cells on the tube wall above the barrier; therefore, these tubes will not be modified." |
| Minimization of Interference (Vitamins) | Minimization of the possibility of obtaining elevated levels of vitamin B12 and folate when used with the CIBA Corning ACS:180® Analyzer, compared to the current glass VACUTAINER® Brand Serum Tube without silicone (control). | "The results demonstrated a minimization of the interference." |
Study Details:
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Sample size used for the test set and the data provenance:
- Breakage reduction study: No specific sample size is provided for drop testing and centrifugation testing. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
- Waste disposal improvement study: No specific sample size (number of products/components) is provided. Data provenance is not specified.
- Reduced blood exposure study: No specific sample size (number of tubes tested) is provided. Data provenance is not specified.
- Equivalent clinical performance (analytes & gel barrier) study: No specific sample size (e.g., number of patient samples, number of tubes) is provided. The document states, "Note: All 13 X 100 size tubes used in clinical studies were partial draw tubes," but doesn't give the total number of tubes or patients. Data provenance is not specified.
- Minimization of interference (vitamins) study: No specific sample size (e.g., number of patient samples, number of tubes) is provided. Data provenance is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for any of the studies described. The "ground truth" appears to be established via direct laboratory measurements and visual assessments rather than expert consensus on a diagnostic outcome.
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Adjudication method for the test set:
- No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for any of the studies.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or AI-related study was mentioned. This document pertains to a medical device (blood collection tubes), not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This document pertains to a medical device (blood collection tubes), not an AI diagnostic tool.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Breakage reduction: Engineering test results (drop testing, centrifugation testing).
- Waste disposal improvement: Analytical measurements of incineration by-products.
- Reduced blood exposure: Performance comparison of closure mechanisms (implied direct measurement or observation of exposure).
- Equivalent clinical performance (analytes): Laboratory assay results for specific analytes, measured directly in the serum collected from the tubes. The "ground truth" for equivalence is a statistical comparison to results from predicate devices.
- Equivalent clinical performance (gel barrier): Visual assessment of gel barrier integrity, presence of fibrin, red cells, and hemolysis.
- Minimization of interference (vitamins): Laboratory assay results for vitamin B12 and folate using the CIBA Corning ACS:180® Analyzer, compared against a control tube known to have no coatings.
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The sample size for the training set:
- There is no mention of a "training set" as these studies are performance evaluations of a physical medical device, not a machine learning model.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device evaluation.
§ 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.