(74 days)
The Clickfine AutoProtect Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin and exenatide.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
The Clickfine AutoProtect Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needle is used by peeling back the peel tab and snapping the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the safety shield glides into the housing enabling the needle to penetrate the skin barrier and into the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism will be activated. The pen-injector delivers the medicinal product through the needle.
After the injection, in order to remove the needle from the skin, the user moves the pen injector away from the skin. As the pen and needle is moved away from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (provide passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect Pen Needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used.
The provided document for K131123 states that no performance and safety data were required because the submission was for an administrative change to revise the Indications for Use. Therefore, the document does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The submission is specifically to align the Indications for Use of the Clickfine AutoProtect Pen Needle with those of the predicate device, the BD AutoShield Pen Needle (K060007), to allow for Over-The-Counter (OTC) marketing for all compatible injection pens. The document explicitly states: "As this was an administrative change, no performance and safety data were required to be submitted in support of the change."
As a result, I cannot provide the requested information.
§ 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).