(60 days)
The BD Vacutainer™ Safety Coagulation tube is a plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. The benefits of a safety plastic coagulation tube with Hemogard Safety Closure Assembly are:
- reduced risk of specimen tube breakage .
- reduced exposure to blood by laboratory personnel and to minimize blood . splatter during stopper removal
These benefits lead to increased safety of laboratory personnel and reduced necessity of repeat specimen collection.
The BD Vacutainer™ Safety Coagulation tubes are sterile, plastic, evacuated blood collection tubes. The tubes contain 0.109M or 0.129M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. The specimen is centrifuged and the plasma portion is analyzed for coagulation parameters to detect clotting time disorders and to monitor patients undergoing anticoagulation therapy. The benefits of a plastic tube decrease the occurrence of accidental breakage, increases the safety of laboratory personnel and reduces the necessity of repeat specimens.
The provided text describes the 510(k) summary for the BD Vacutainer™ Safety Coagulation tube, which is a blood collection device, not an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone performance, number of experts, training set details) are not applicable.
However, I can extract the relevant information regarding acceptance criteria and the study that demonstrates the device meets these criteria based on the provided text.
Here's the breakdown of the information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly stated through the claim of "substantially equivalent results" in comparison to the predicate device. The performance is reported as meeting this equivalence.
| Aspect of Performance | Acceptance Criteria Implied | Reported Device Performance |
|---|---|---|
| Coagulation Assay Results | Provides "substantially equivalent results" to the predicate glass tube for various patient types. | "The clinical evaluation demonstrated that the BD Vacutainer™ Safety Coagulation tube provides clinically equivalent results when compared to the VACUTAINER™ Brand Sodium Citrate Tube for Normal, Warfarin, Heparin and other patient donors." |
| Reduced Breakage Risk | Implied: Reduce the occurrence of accidental breakage compared to glass tubes. | Stated as a benefit: "reduced risk of specimen tube breakage." |
| Reduced Blood Exposure | Implied: Reduce exposure of lab personnel to blood. | Stated as a benefit: "reduced exposure to blood by laboratory personnel and to minimize blood splatter during stopper removal." |
| Reduced Repeat Specimens | Implied: Reduce the necessity of repeat specimens. | Stated as a benefit: "reduced necessity of repeat specimen collection." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. The text mentions "Clinical evaluations were performed" for "Normal, Warfarin, Heparin and other patient donors" but does not give specific numbers of patients or samples.
- Data Provenance: The study was a "Clinical evaluation," suggesting it involved real human blood samples. No specific country of origin is mentioned, but the submission is to the U.S. FDA. The text implies a prospective collection for the purpose of the evaluation, as the device was compared to a "currently marketed" product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a blood collection device, and the "ground truth" would be the coagulation assay results themselves, typically performed by laboratory instruments and interpreted by clinical laboratory personnel, rather than subjective expert consensus on image interpretation, for example.
4. Adjudication method for the test set
Not applicable. This concept is typically relevant for subjective assessments (e.g., image interpretation where multiple readers' opinions might differ). For laboratory assay results, the measurements are objective.
5. 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
Not applicable. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used
The ground truth used was coagulation assay results obtained from the blood samples collected in both the test device (plastic tube) and the predicate device (glass tube). The comparison was based on these objective measurements.
8. The sample size for the training set
Not applicable. This device does not use an AI/ML algorithm that requires a training set. The "training" in this context would be the manufacturing and quality control processes for the physical device.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML powered 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.