(88 days)
DermaPik II Skin Test System™ is an allergen skin test device and supporting components designed to apply allergen test extract using the puncture technique.
DermaPik II Skin Test System™ is designed for use by allergy practitioners who are trained in the application and interpretation of the puncture test technique and who are trained in the recognition and treatment of adverse allergic reactions should they occur.
Clinical settings appropriate for use of this system would include professional medical environments such as physician clinics and hospitals.
The target population appropriate for use of this system would include both pediatric and adult patients.
As is common in all allergy skin test procedures, this device is appropriate for use on the forearms or back in accordance with commonly accepted practices of physicians trained in allergy skin testing.
DermaPik II Skin Test System™ is an allergen skin test device and supporting components designed to apply allergen test extract using the puncture technique.
This document is a 510(k) premarket notification letter from the FDA regarding the "Dermapik II Skin Test System". It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The 510(k) letter is an administrative notice of substantial equivalence. It does not typically include detailed performance data or acceptance criteria that would be found in a clinical study report or a summary of safety and effectiveness.
Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on regulatory classification and approval based on substantial equivalence to existing devices.
§ 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).