(18 days)
The BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc).
Plastic tube (13x100, 6ml)
Tube closure: Royal blue Hemogard™ closure
Additive: Silica Clot Activator or K2EDTA
The provided submission K041071 is for a medical device (BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube), not an AI/ML diagnostic system. Therefore, most of the requested information regarding acceptance criteria and study design for an AI/ML device is not applicable.
However, I can extract the general information about the device and the nature of its performance evaluation as described in the document.
Here's a breakdown of the relevant information from the provided text, noting where specific AI/ML-related questions cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in a table format for performance metrics like sensitivity, specificity, or AUC, as would be expected for an AI/ML diagnostic. Instead, it states that "Extensive mechanical and functional testing was performed to demonstrate the devices' safety and effectiveness."
The "performance" of this device is related to its ability to collect, transport, and process blood for trace element testing without interfering with the integrity of the sample or the accuracy of the subsequent trace element analysis. The substantial equivalence argument relies on comparison to predicate devices, implying that if the new device performs similarly in these functional aspects, it is acceptable.
Reported Device Performance (Implicit):
The submission implies that the device meets its intended use, which is to collect, transport, and process blood for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc) in a closed tube. The performance is deemed acceptable because it is "substantially equivalent" to predicate devices, meaning it functions similarly and has comparable safety and effectiveness for its intended purpose.
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for "test sets" in the context of an AI/ML model, nor does it mention data provenance (e.g., country of origin, retrospective/prospective). The "extesive mechanical and functional testing" would have involved physical samples (e.g., blood) but the number of such samples is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. "Ground truth" in the context of AI/ML diagnostics (e.g., expert consensus on image pathology) is not relevant for this device. The 'ground truth' here would be the accurate measurement of trace elements, which is performed by laboratory analytical methods, not human visual assessment or consensus.
4. Adjudication Method (for the test set)
Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI/ML model ground truth establishment. This is not relevant for a blood collection tube.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are used to assess the effectiveness of AI assistance on human reader performance. This device is a blood collection tube, not an AI system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is not an algorithm, so a standalone algorithm performance study is irrelevant.
7. Type of Ground Truth Used
The 'ground truth' for evaluating a blood collection tube's performance would be the accurate and precise measurement of trace elements from blood samples collected in the device and compared to a reference method or samples collected in predicate devices. This would typically involve laboratory analytical results from validated assays, ensuring that the tube does not contaminate the sample or interfere with the measurement of the trace elements.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model.
Summary of the Device's "Study" and Evidence for Substantial Equivalence:
The submission highlights that the safety and effectiveness of the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube were demonstrated through:
- Extensive mechanical and functional testing: This refers to physical tests conducted on the tubes to ensure they perform their basic functions (e.g., maintaining vacuum, not leaking, material compatibility).
- Comparison to predicate devices: The core of the justification for approval is showing "substantial equivalence" to existing, legally marketed Becton, Dickinson and Company products: the BD Vacutainer® Trace Element Serum Glass Tube and the BD Vacutainer® Trace Element Na2EDTA Glass Tube. This comparison covers device features, materials, intended use, and performance. The implication is that if the new plastic tubes perform as well as the older glass tubes for trace element collection, they are effective.
In essence, the "study" for this type of device is a series of engineering, chemical, and functional tests that confirm the device performs its basic role (blood collection and preservation for specific tests) without introducing contaminants or compromising sample integrity, and that it is comparable to already approved devices. It does not involve AI/ML performance metrics or study designs.
§ 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.