(34 days)
The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The VACUETTE® Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The Winged needle is designed with a safety shield, which can be activated to cover the noodle in houleve inmediately following venipuncture to aid in the protection against accreental in accordance with these instructions. The safety feature is easily operated through the release of a latch mechanism whereby the The Salely leature is easily operator and it is removed from the patient. Once the user slides a wingsu ocatety cover locks in place. This mechanism is substantially needie is covered, the oulony ject® Angel Wing Blood Collection Set. The VACUETTE® Safety Blood Collection Set will be available in 80 configurations to include needle gauge (10 gauge sizes), needle length (2 lengths) and tubing length (4 lengths). The devices are packaged as sterile and are labeled for single use only. There is no ability The devices are pookegoe as ses. The results of biocompatibility data support the to clean and rease theose and include sterility, pyrogenicity and systemic injection testing.
The provided text describes a medical device, the VACUETTE® Safety Blood Collection Set, and its 510(k) summary for FDA approval. However, the document does not contain information regarding acceptance criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy), nor does it describe a study to prove the device meets such criteria.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Sherwood Medical Angel Wing™ Safety Blood Collection Set, K912563) based on materials, biocompatibility, and overall performance characteristics.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving performance as it is not present in the provided text. The document primarily addresses regulatory aspects of device approval rather than detailed performance study results against specific metrics.
§ 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).