(266 days)
BD Vacutainer® K2 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® K2 EDTA Blood Collection Tubes are used for Hemoglobin A1c (HbA1c) testing.
BD Vacutainer® K2EDTA Blood Collection Tubes are used for collection, containment, preservation, and transport of human venous blood specimens in a closed tube. The evacuated blood collection tube consists of a Vacutainer® Hemogard™ Closure Assembly, a plastic tube and EDTA additive. The EDTA anticoagulant is spray coated in the dipotassium (K2) form. The EDTA additive prevents specimen coagulation.
The plastic tubes are closed with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield. The Hemogard™ Closure Assembly, introduced in 1995, is intended to help reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are lavender to indicate the presence of the EDTA additive.
The plastic tube is manufactured from Polyethylene terephthalate (PET). These plastic tubes were introduced in 1990. Plastic tubes enhance user safety and disposal because of the reduced risk of tube breakage and the availability of incineration as a method of disposal.
This is a 510(k) summary for a medical device (BD Vacutainer® K2 EDTA Blood Collection Tubes), which focuses on demonstrating substantial equivalence to a predicate device rather than providing device performance against specific acceptance criteria for a novel device. Therefore, a direct table of acceptance criteria and reported device performance isn't entirely applicable in the way it would be for a new diagnostic algorithm.
However, based on the provided text, we can infer the types of performance evaluations conducted and their outcomes.
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
| Characteristic Measured | Inferred Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Draw Volume | Product meets labeled draw volume. | Met the predetermined acceptance criteria (implicitly, as all bench testing met acceptance criteria). |
| X-Value | (Not specified, but likely relates to tube manufacturing tolerance/performance). | Met the predetermined acceptance criteria (implicitly, as all bench testing met acceptance criteria). |
| Second Stopper Pullout | Acceptable force/mechanism for stopper removal. | Met the predetermined acceptance criteria (implicitly, as all bench testing met acceptance criteria). |
| Stopper/Shield Separation | Acceptable separation/integrity of stopper and shield. | Met the predetermined acceptance criteria (implicitly, as all bench testing met acceptance criteria). |
| Stopper Leakage | No leakage. | Met the predetermined acceptance criteria (implicitly, as all bench testing met acceptance criteria). |
| Tube Leakage | No leakage. | Met the predetermined acceptance criteria (implicitly, as all bench testing met acceptance criteria). |
| Resistance to Breakage during Drop Testing | Acceptable resistance to damage upon dropping. | Met the predetermined acceptance criteria (implicitly, as all bench testing met acceptance criteria). |
| Ship Testing (Packaging Materials) | Functional performance of packaging maintained. | Met the predetermined acceptance criteria (implicitly, as all bench testing met acceptance criteria). |
| Clinical Testing (HbA1c) | ||
| Clinical Equivalence to Comparator | Performance for HbA1c testing is clinically equivalent to legally marketed comparator devices. | Results based on pre-determined acceptance criteria demonstrated the BD Vacutainer® K2 EDTA Blood Collection Tubes are suitable for use in HbA1C testing. This implies equivalence. |
| Within-Tube Stability for HbA1c | HbA1c values remain stable within the tube over the specified duration. | Results based on pre-determined acceptance criteria demonstrated the BD Vacutainer® K2 EDTA Blood Collection Tubes are suitable for use in HbA1C testing. This implies stability criteria were met. |
| Shelf-Life Performance for HbA1c | Device performance for HbA1c testing maintained over the entire shelf life. | Results based on pre-determined acceptance criteria demonstrated the BD Vacutainer® K2 EDTA Blood Collection Tubes are suitable for use in HbA1C testing. Both accelerated and real-time aging studies met predetermined acceptance criteria. |
| Repeatability/Reproducibility for HbA1c | Consistent and reliable HbA1c measurements. | Results based on pre-determined acceptance criteria demonstrated the BD Vacutainer® K2 EDTA Blood Collection Tubes are suitable for use in HbA1C testing. This implies repeatability/reproducibility criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: A "minimum of three unique lots of product" was used for testing.
- Clinical Testing: The text mentions "the distribution of subjects selected to be approximately representative of the general US population." No specific number of subjects or samples is provided for the clinical test set.
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. It is a 510(k) submission to the US FDA, so studies would likely be relevant to or conducted in the US market. The studies are prospective in nature, as they involve collecting blood samples in the subject device and comparing them to a legally marketed comparator, and conducting stability and repeatability tests on these samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The "ground truth" for a blood collection tube isn't established by experts in the same way as, for example, image interpretation for an AI diagnostic device. Instead, the "ground truth" for a blood collection tube is the accurate and stable measurement of an analyte (like HbA1c) using standard laboratory methods, assuming the comparator device performs correctly. The study aims to demonstrate that the subject device allows for these accurate measurements.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment of results requiring an adjudication method. The outcome measures are quantitative (e.g., HbA1c levels, physical properties).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a blood collection tube, not an AI diagnostic algorithm or a device requiring human interpretation of results.
6. Standalone Performance
Not applicable. This device is a blood collection tube, not an algorithm. Its "performance" is inherently tied to its physical characteristics and its ability to preserve blood samples for subsequent in vitro diagnostic testing.
7. Type of Ground Truth Used
For the clinical study, the "ground truth" for HbA1c measurements would be the results obtained from established, validated laboratory analyzers using samples collected in the comparator device. The subject device's performance is gauged by showing that the HbA1c measurements from samples collected in it are equivalent to those from the comparator.
For bench testing, the ground truth is based on engineering specifications and validated test methods (e.g., measuring draw volume against a specified volume, testing for leakage against a pass/fail criterion).
8. Sample Size for the Training Set
Not applicable. This device is a physical blood collection tube, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.