(64 days)
The BD VACUTAINER™ Push Button Blood Collection Set is a sterile, multiplesample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of needlestick injury.
The BD VACUTAINER™ Push Button Blood Collection Set is for venous blood collection. The wing set contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks. The retraction of the needle occurs when the user depresses the button.
This 510(k) premarket notification is for the BD VACUTAINER™ Push Button Blood Collection Set.
1. Table of acceptance criteria and the reported device performance:
The document describes the performance evaluation in general terms, stating that "Mechanical and Simulated Use testing was performed to confirm the robustness of the design and reliability of the safety feature function. Clinical use testing was performed to evaluate the function of the safety feature in a blood drawing environment."
Specific quantitative acceptance criteria and corresponding reported device performance values are not explicitly provided in this summary. The document does not detail pass/fail rates, specific metrics, or thresholds for the mechanical, simulated use, or clinical testing. It generally states that the device was found to be "substantially equivalent" to predicate devices, implying that its performance met the necessary criteria for safety and effectiveness.
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample size for the test set in either the mechanical, simulated use, or clinical testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study involved "Clinical use testing... in a blood drawing environment," implying evaluation by healthcare professionals, but the number or qualifications of these individuals, acting as "experts" for ground truth establishment, are not detailed.
4. Adjudication method for the test set:
The document does not describe any specific adjudication method for the test set (e.g., 2+1, 3+1).
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 device is a blood collection set with a safety mechanism, not an AI-powered diagnostic imaging device or a system requiring "human readers" in the sense of image interpretation. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not performed or described for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is a physical medical device, not a software algorithm. Therefore, "standalone" algorithm-only performance is not applicable and was not performed or described. The device's safety feature (needle retraction) is an integral mechanical function intended for user activation during a blood collection procedure (human-in-the-loop).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the mechanical and simulated use testing, the "ground truth" would likely be based on engineering specifications and functional requirements (e.g., successful needle retraction, structural integrity). For the clinical use testing, the "ground truth" would be the observed successful activation of the safety feature and prevention of needlestick injury in a real-world scenario, as assessed by the clinicians performing the venipuncture. However, the specific methodology for defining and confirming this ground truth is not explicitly detailed.
8. The sample size for the training set:
This information is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established:
This information is not applicable as the device is a physical medical device and does not involve AI or machine learning models.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).