(115 days)
The BD Vacutainer® Multiple Sample Luer Adapter is a sterile, single-use, non-invasive medical device intended to be connected with BD Vacutainer® brand needle holders, to enable blood collection from venous access devices, such as needles and blood collection sets or catheters with female luer connectors into blood collection tubes or blood culture bottles for the purpose of in vitro diagnostic testing. These devices are intended to be used by healthcare professionals.
The BD Vacutainer® Multiple Sample Luer Adapter consists of a luer-slip fitting (male) which mates with the female Luer connector of venous access devices, and an NP (non-patient) cannula, which punctures the stopper of the evacuated tube(s), or the septum of a blood culture bottle(s) to collect blood.
The NP cannula of the device is lubricated and has a sleeve that recovers over the cannula to prevent leakage during blood collection in-between tubes and/or bottles.
Each end of the device is enclosed in a plastic shield, which join together to fully protect the device. A tamper evident label secures the two shields together and allows identification of whether the sterile barrier has been compromised.
The device consists of the following components:
- Non-patient (NP) Cannula
- Sleeve
- Luer Hub
- NP Shield
- IV Shield
- Epoxy
Note: the IV Shield is intended for maintaining sterility of the luer-slip of the device; there is no IV needle component.
This document is a 510(k) premarket notification for a medical device, the BD Vacutainer® Multiple Sample Luer Adapter (K243649). It details the device's characteristics, intended use, and a comparison to a predicate device (K991088) to establish substantial equivalence.
Based on the provided text, the device in question is a physical medical device (a luer adapter) used for blood collection, not an AI/software-based medical device that would typically involve acceptance criteria related to algorithmic performance metrics like sensitivity, specificity, or image analysis. Therefore, much of the requested information (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of device submission.
Instead, the "acceptance criteria" for a physical device like this are met through a series of non-clinical performance tests, biocompatibility testing, and sterilization validation. The "study that proves the device meets the acceptance criteria" refers to the entire battery of these tests.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values for each test. Instead, it states that the tests were conducted to "verify that the subject device met all design specifications and performance standards" and "demonstrates acceptable performance." The acceptance criteria are implicitly defined by the relevant standards and internal design specifications, and the "reported device performance" is summarized as having met these.
However, we can list the types of tests performed, which serve as the basis for the performance evaluation:
| Acceptance Criterion (Type of Test) | Reported Device Performance (Summary from Document) |
|---|---|
| Non-clinical Performance Testing | "met all design specifications and performance standards" |
| Torque to Break | "demonstrates acceptable performance" |
| NP Cannula Pull Test | "continues to perform as expected" |
| Spinout Test | |
| IV Shield Pull Force Test | |
| NP Sleeve Pull-off Force Test | |
| Tube Push Off Test | |
| Leakage by Pressure Decay Test | |
| Sub-Atmospheric Pressure Air Leakage Test | |
| Stress Cracking Test | |
| Resistance to Axial Separation Test | |
| Sterile Barrier Microbial Challenge Test | |
| Biocompatibility Testing | "demonstrates acceptable performance" |
| Cytotoxicity | |
| Sensitization | |
| Intracutaneous Reactivity or Irritation | |
| Material-mediated Pyrogenicity | |
| Acute Systemic Toxicity | |
| Hemocompatibility | |
| Leachables/Extractables | |
| Sterilization Testing | "demonstrates conformity to the following sterilization standards" |
| Sterility (EN 556-1) | Sterility Assurance Level (SAL) of 10^-6 achieved |
| Radiation Sterilization (EN ISO 11137-1/2) | |
| Microbiological Methods (EN ISO 11737-1/2) | |
| Packaging Validation | "demonstrates conformity to the following standards" |
| Packaging for Terminally Sterilized Medical Devices (ISO 11607-1/2) |
2. Sample sized used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each of the non-clinical performance tests. These types of tests often follow specific ISO or ASTM standards that prescribe minimum sample sizes for statistical confidence, but the exact numbers are not detailed in this summary.
- Data Provenance: The tests were conducted internally by Becton Dickinson and Company. The provenance would be the manufacturer's own testing facilities. No information regarding country of origin of data or retrospective/prospective status is relevant, as this concerns bench testing of physical prototypes/production samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical, mechanical medical device. "Ground truth" in this context is established through engineering and scientific measurements and adherence to recognized performance standards (e.g., ISO, EN standards), not through expert consensus on interpretation of data like medical images.
4. Adjudication method for the test set
This question is not applicable for the same reasons as point 3. No adjudication of expert opinions or subjective interpretations is involved.
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 question is not applicable. The device is a physical blood collection adapter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical blood collection adapter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a physical device, the "ground truth" is based on:
- Engineering specifications and tolerances: The physical dimensions, material properties, and functional capabilities must meet predefined engineering standards.
- Regulatory standards: Adherence to international standards (e.g., ISO, EN) for medical devices, manufacturing quality, biocompatibility, and sterilization.
- Predicate device performance: The new device must perform comparably to the predicate device in relevant tests.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is a physical device, not an AI algorithm that undergoes machine learning training.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as point 8.
§ 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.