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This device is used to inject legally marketed injectable therapeutic agents into the lower urinary tract through the working channel of a cystoscope.

This device is a flexible, sheath covered injection needle The device consists of a device handle, flexible outer sheath, and needle assembly. The device has an outer diameter of 6Fr, a working length of 70 cm and a 23 ga needle for injection of legally marketed therapeutic agents into the lower urinary tract through the working channel of a cystoscope.

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the "Injekt™ Cysto Flexible Injection Needle," primarily focused on establishing substantial equivalence to a legally marketed predicate device (Cook Injection Needles, K022484) and outlining the device's indications for use.

Therefore, I cannot populate the requested table or answer the specific questions about a study, sample sizes, ground truth, or expert involvement. The document explicitly states:

"Performance standards under Section 514 of the Federal ~Food, Drug and Cosmetic Act applicable to Injekt™ Cysto Flexible Injection Needle have not been established by the Food and Drug Administration."

This indicates that formal performance standards or acceptance criteria, as typically defined by the FDA for certain device types, were not established for this device at the time of this 510(k) submission. The substantial equivalence argument relies on comparison of characteristics and addressing risks through their Design Control Process.

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