(56 days)
The function of the Safe T Retractable Blood Collection Device is to provide a safe and reliable method for facilitating blood withdrawal from a patient into evacuated blood collection tubes without exposing the phlebotomist to an accidental needle stick injury.
The Safe T Retractable Blood Collection Device is comprised of three components, a body, plunger and hub. The thread in the hub component matches that of all regular tube holders. The space within the holder is sufficient to fit all regular multi-sample needles after retraction. The device is supplied fully assembled, primed and ready for use, bulk packaged in polyethylene bags of 10 units. The device is non patient contacting and thus is sold non sterile.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Safe T Retractable Blood Collection Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing acceptance criteria and conducting studies to prove a device meets those criteria in the same way a novel device might.
Therefore, the document does not contain the specific information requested regarding acceptance criteria, reported device performance against those criteria, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or details on training sets.
Instead, the submission for the Safe T Retractable Blood Collection Device relies on the following for its substantial equivalence claim:
- Comparison of Design and Technological Characteristics: The document states that the Safe T Retractable Blood Collection Device is substantially equivalent to the Retractable Technologies Vanish Point Tube Holder (predicate device K971763) based on "Design similarities between the proposed device and the currently marketed device," and "Technological Characteristics. The proposed Safe T Retractable Blood Collection Device and currently marketed Retractable Technologies Vanish Point Tube Holder - K971763 are similar in terms of materials of construction, performance characteristics, and basic design."
- Intended Use: The device has "the same intended use and indication statement as the predicate device."
- Operating Principle: The device "uses the same operating principle as that of its predicate."
- Performance Testing: The document briefly states, "Bench Testing and Simulated Use testing were performed." However, it does not provide any details about the acceptance criteria used for these tests, the results, sample sizes, or how they specifically demonstrate substantial equivalence beyond a general statement.
In summary, the provided text does not offer the detailed information required by your request for acceptance criteria and specific study results. The 510(k) process for this device focused on showing its similarity to an existing device rather than providing quantitative performance metrics against pre-defined acceptance criteria as would be expected for a novel device.
§ 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).