(259 days)
The BD Vacutainer® Citrate Blood Collection Tube (0.109M buffered sodium citrate) is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain plasma for in vitro diagnostic testing. It is used in settings where a venous blood sample is collected by a trained healthcare worker. The BD Vacutainer® Citrate Blood Collection Tube is used for clinical laboratory testing in coagulation.
BD Vacutainer® Citrate Blood Collection Tubes (BD Citrate Tubes) are available in plastic configurations and contain a liquid additive. Tubes include a color-coded BD Hemogard™ Closure and are comprised of an inner and outer tube to maintain the draw volume and liquid additive. Refer to Table 1 for unique product configurations. Tube stoppers are lubricated with silicone to facilitate stopper insertion. The buffered sodium citrate solution provides an anticoagulated specimen when used in accordance with the instructions for use. The tubes are compatible with the BD Vacutainer® Blood Collection Needles, Blood Collection Sets, Transfer Devices. Holders and Adaptors.
The information provided in the document describes the substantial equivalence of the "BD Vacutainer Citrate Blood Collection Tubes" to a predicate device, focusing on physical and chemical characteristics, rather than the performance of an AI or software device. As such, many of the requested categories for AI/software device evaluation (e.g., sample size of test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, how ground truth for training set was established) are not applicable to this submission.
However, I can extract information related to the device's performance testing and acceptance criteria as described for the medical device itself.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Non-Clinical Performance Testing Results" in Table 3, which can be interpreted as demonstrating the device's adherence to its design specifications or performance criteria. The acceptance criteria themselves are not explicitly detailed in the provided text (e.g., what constitutes a "Pass" for "Draw Volume" or "Resistance to Breakage"). However, the results consistently report "Pass."
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Draw Volume | Met specifications (e.g., 2.7 ± 10% mL or 1.8 ± 10% mL) | Pass |
| X-Value | Met specified requirements | Pass |
| Second Stopper Pullout | Met specified requirements for stopper integrity | Pass |
| Stopper/Shield Separation | Met specified requirements for separation integrity | Pass |
| Stopper Leakage | Met specified requirements for preventing leakage | Pass |
| Resistance to Breakage during Drop Testing | Met specified requirements for impact resistance | Pass |
| Resistance to Breakage During Centrifugation | Met specified requirements for integrity during centrifugation | Pass |
| Moisture Lost | Met specified limits for moisture loss over time | Pass |
| Ship Testing for Functional Performance of Packaging Materials | Met specified requirements for packaging integrity during transport | Pass |
Clinical Performance Studies and Acceptance Criteria (as described):
The clinical studies aimed to demonstrate "Clinical Equivalence" and evaluated specific parameters. The acceptance criteria for these (e.g., non-inferiority margins) are not explicitly stated but are implied by the "demonstrated clinical equivalence" and "passed non-inferiority criterion" statements.
| Study | Key Objective / Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clinical Equivalence | Evaluate clinical equivalence of BD Citrate Tubes compared to a similar comparator citrate tube for PT, aPTT, INR, D-Dimer, Anti-Factor Xa. (Implied acceptance: demonstrating equivalence, likely within predefined statistical margins). | Clinical equivalence was demonstrated for all tube comparisons for representative selected plasma coagulation test parameters (PT, aPTT, INR, D-Dimer, Anti-Factor Xa). |
| Within-Tube Stability (WTS) | Demonstrate within-tube stability for PT, aPTT, INR, D-Dimer, Anti-Factor Xa with BD Citrate Tubes. (Implied acceptance: stability within predefined limits over a specified time). | Demonstrated Within-Tube Stability (WTS) for representative selected plasma coagulation test parameters (PT, aPTT, INR, D-Dimer, Anti-Factor Xa). |
| Shelf-Life Performance | Evaluate performance of BD Citrate Tubes at end-of-shelf-life (EOSL) compared to recently manufactured tubes for PT, aPTT, INR, D-Dimer, Anti-Factor Xa. (Implied acceptance: performance at EOSL is comparable to fresh tubes, supporting the proposed shelf-life). | The results support the proposed shelf-life for the selected plasma coagulation test parameters (PT, aPTT, INR, D-Dimer, Anti-Factor Xa). |
| Repeatability/Reproducibility | Evaluate within-tube repeatability (duplicate testing), tube-to-tube reproducibility (two tubes/lot), and lot-to-lot reproducibility (three lots) for PT, aPTT, INR, D-Dimer, Anti-Factor Xa, compared to a similar comparator. (Implied acceptance: meeting non-inferiority criterion based on ratios appropriate to data structure). | The evaluation passed the non-inferiority criterion for all tube comparisons, based on the ratios appropriate to the data structure for the selected coagulation analytes when compared with a similar comparator citrate anticoagulant tube (PT, aPTT, INR, D-Dimer, Anti-Factor Xa). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the clinical test sets. It mentions "whole blood collected," but the number of subjects or samples is not specified.
Data Provenance: "Clinical testing was conducted on whole blood collected in the subject device, BD Citrate Tubes, and a similar comparator tube." This implies the data were collected from human subjects, likely in a clinical setting. The country of origin is not specified, and it's a prospective collection for these studies as they were performed to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a blood collection tube, not an AI diagnostic system requiring expert interpretation of primary data (like medical images). The "ground truth" for clinical performance likely refers to the analytical results obtained from the blood samples, which are objectively measured by laboratory instruments.
4. Adjudication Method for the Test Set
This information is not applicable for a device of this nature. Adjudication methods are typically relevant for subjective interpretations (e.g., by human readers in medical imaging studies).
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
This is not applicable as the device is a blood collection tube, not an AI or software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a blood collection tube, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the clinical studies, the "ground truth" refers to the analytical measurements of coagulation parameters (Prothrombin Time [PT], Activated Partial Thromboplastin Time [aPTT], International Normalized Ratio [INR], D-Dimer, Anti-Factor Xa) obtained from the blood plasma after collection and processing. These are objective laboratory measurements, not expert consensus, pathology, or outcomes data in the typical sense for AI devices.
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is not an AI/machine learning device that requires a training set.
§ 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.