(117 days)
The Sol-M Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood.
The Sol-Care Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Sol-Care Safety Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Sol-M Blood Collecting Set is intended to be used with vacuum blood collection tube for the collection of venous blood.
The proposed devices are blood collection devices form a channel between patient's vein and the vacuum blood collection tube intended for collection of blood. The proposed devices are divided into several types, the configuration for each type of proposed device are provided as follows: Blood Collection Needle – one piece, Blood Collection Needle – Direct, Blood Collection Needle – Multi piece, Safety Blood Collection Needle – Direct, Safety Blood Collection Needle – Multi piece, Safety Blood Collection Needle w/Holder – One piece, Safety Blood Collection Needle w/Holder - Direct. In addition, the proposed devices are divided into several types and available in different specifications.
This document is a 510(k) Premarket Notification from Sol-Millennium Medical, Inc. for blood collection needles and sets. It demonstrates substantial equivalence to a predicate device and outlines the non-clinical tests performed. No acceptance criteria, device performance, or study results are provided in the document.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence through comparison of features and adherence to recognized standards, rather than presenting a performance study with acceptance criteria.
§ 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).