(99 days)
AutoSafe Safety Needles are indicated to be used to inject fluids into or withdraw fluid from the body. They are compatible for use with standard luer slip and luer lock syringes. Additionally, the passive needle safety shield is designed to help prevent needlestick injuries by shielding the needle before use, between steps and after use.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding the "AutoSafe-Reflex® Safety Needle" and "AutoSafe Advantage Safety Needle." This letter grants market clearance based on substantial equivalence to predicate devices.
However, the document does NOT contain information about:
- Acceptance criteria and reported device performance.
- Any specific study data, sample sizes, data provenance, expert qualifications, or ground truth establishment.
- Any details regarding AI/ML powered devices, MRMC studies, or standalone algorithm performance.
Therefore, I cannot provide the requested table or answer the questions related to studies and acceptance criteria from the given text. The document is solely a regulatory clearance letter.
§ 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).