(89 days)
The one.click needle is a sterile, single-packed, disposable hypodermic single lumen needle designed for use with a multidose pen injection device, the one.click auto-injector, for the subcutaneous injection of fluid drug products.
The one.click needle is a double-ended needle consisting of a tribeveled tip, hollow steel cannula, needle hub and needle shield. The one.click needle will be available as a 29 Gauge needle, with a patient-end needle length of 12 millimeters.
There is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The pages primarily contain a 510(k) summary and the FDA's clearance letter for the "one.click™ needle."
Therefore, I cannot provide the requested information in a table or answer the specific questions about the study, sample sizes, expert qualifications, or ground truth.
Input Summary:
The provided input describes a 510(k) summary for the "one.click™ needle" by B. Braun Medical Inc. and the FDA's clearance letter for this device. The summary details the device name, common name, classification, predicate device, description, intended use, and substantial equivalence to the predicate. The FDA letter confirms the device's substantial equivalence to a legally marketed predicate. However, neither document includes information about specific acceptance criteria or the details of a study proving the device meets those 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).