(641 days)
BD Vacutainer® EDTA Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing.
BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes are used for testing in hematology including white blood cells (WBC), red blood cells (RBC), red blood cell distribution width (RDW), hemoglobin (HgB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, and 5-part white blood cell (WBC) differential counts (neutrophils, lymphocytes, monocytes, eosinophils, basophils).
BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes are for collecting, transporting and centrifuging blood in a closed tube. The blood collection tube consists of closure assembly, a glass tube and EDTA additive.
The standard closure assembly is a basic rubber stopper. The tube is also available with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are either pink or lavender to indicate the presence of the EDTA additive.
The provided text describes the regulatory submission for BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI/human reader device with acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.
Therefore, many of the requested details about acceptance criteria, study design for AI/human reader performance, sample sizes for training/test sets in machine learning, expert adjudication, MRMC studies, standalone performance, and ground truth establishment in the context of AI are not applicable (N/A) to this document. This submission is for blood collection tubes, not a diagnostic algorithm.
However, I can extract information related to the performance testing of the blood collection tubes themselves.
Here's a breakdown of the relevant information from the document, with an emphasis on why certain requested fields are N/A:
1. A table of acceptance criteria and the reported device performance
Since this is for a medical device (blood collection tubes) and not an AI algorithm, the "acceptance criteria" are related to mechanical and physical performance, and clinical equivalence for blood parameters.
| Test | Acceptance Criteria (Implied by "Pass" result and regulatory context) | Reported Device Performance |
|---|---|---|
| Draw Volume | Must meet defined specifications | Pass |
| X-Value (likely relates to vacuum pressure or fill volume) | Must meet defined specifications | Pass |
| Second Stopper Pullout | Must meet defined specifications for stopper integrity | Pass |
| Stopper/Shield Separation | Must meet defined specifications for closure integrity | Pass |
| Stopper Leakage | Must demonstrate no leakage | Pass |
| Resistance to Breakage during Drop Testing | Must withstand specified drop tests without breakage | Pass |
| Resistance to Breakage During Centrifugation | Must withstand specified centrifugal forces without breakage | Pass |
| Ship Testing for Functional Performance of Packaging Materials | Must maintain integrity and function after simulated shipping | Pass |
| Clinical Equivalence (Method Comparison) | Mean and 95% Confidence Limits of paired sample biases within Clinical Acceptance Limits (CALs) for key hematology parameters (WBC, RBC, RDW, Hgb, HCT, MCV, MCH, MCHC, Platelets, 5-part WBC differential) | Demonstrated for all parameters except Hgb, PLT, and WBC at low medically relevant points on two instruments (mean bias within CAL, but C.I. exceeded; deemed clinically acceptable due to insufficient low-point data) |
| Precision (Lot to Lot Variability) | Non-inferiority for repeatability (within tube) and reproducibility (lot-to-lot and tube-to-tube) when compared to a comparator device for tested hematology parameters | Non-inferiority shown for all tube comparisons and hematology parameters on two instrument platforms. |
| Within-Tube Type Stability | Analytes must demonstrate stability at specified storage conditions and time points (12- and 24-hours Room Temperature, 24 hours Refrigerated, 24 hours Room Temperature followed by 24 hours Refrigerated). | All analytes demonstrated stability. |
| Shelf-Life | Product must maintain performance over proposed shelf life | 11 months for K2EDTA, 10 months for K3EDTA. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact number of samples or subjects for the clinical studies. It mentions "low medically relevant points were insufficient to adequately power the analysis" for Hgb, PLT, and WBC in the method comparison, suggesting a limitation in that specific subgroup analysis.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies involved "testing performed internally and externally," and "clinical samples." There is no mention of prospective or retrospective design, but clinical equivalence and stability studies typically involve prospective collection or use of fresh samples to assess performance over time/conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This device does not rely on expert interpretation for "ground truth" in the way an AI algorithm for image analysis would. The "truth" for blood parameters is established by laboratory analyzers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not relevant. This is not an image interpretation or diagnostic decision-making study that would require adjudication.
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
- N/A. Not an AI-assisted human reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance would be the analytical results obtained from established, calibrated laboratory instruments (e.g., hematology analyzers) using the collected blood samples. Clinical equivalence was demonstrated against "legally marketed comparator tubes," implying that the comparator's performance on these instruments serves as the reference.
8. The sample size for the training set
- N/A. This is not an AI/machine learning device. There are no training sets.
9. How the ground truth for the training set was established
- N/A. Not an AI/machine learning 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.