(231 days)
THIS DEVICE IS USED FOR INJECTIONOF INSULIN VIA PEN NEEDLE/DEVICE FOR USE BY DIABETIC PATIENTS .
Not Found
The provided text is a US FDA 510(k) clearance letter for the Exel Comfortpoint Insulin Pen Needle. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth, or any of the other specific details requested in your prompt.
The letter is a regulatory approval document and focuses on:
- Confirmation of substantial equivalence.
- Instructions regarding general controls provisions of the Act (registration, listing, GMP, labeling, etc.).
- Contact information for various FDA offices.
- The "Indications for Use" for the device.
Therefore, I cannot fulfill your request for information about acceptance criteria and the study proving the device meets those criteria based on the provided text. This type of information would typically be found in the 510(k) submission itself, or in supporting technical documentation, which is not included here.
§ 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).