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IMD's New Fenestrated Nerve Block Needle is a single patient use needle to provide local or regional nerve blocking by the injecting of a local anesthesia. It is to be used only under the direction of a licensed clinician.

The IMD Inc. Fenestrated Nerve Block Needle shares major similarities with the predicate device(s), inasmuch as the configuration, materials, use, labeling and safety issues remain basically unchanged to the IMD predicates. It consists of a plastic hub, and a stainless steel cannula. It has the same pencil point and same side outlet (only more). The addition of fenestrations is similar to predicate anesthesia catheters. The IMD New Fenestrated Peripheral Nerve Block Needle is an anesthetic needle for peripheral nerve blocks using a local anesthetic solution. The distinct advantage offered by IMD's Fenestrated Peripheral Nerve Block Needle is due to the fenestrations. These eliminate the critical locating of the desired nerve to be blocked and only require that the needle be located in the general area for effective use.

The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in a study. The document is a 510(k) summary for a medical device (IMD's Fenestrated Peripheral Nerve Block Needle), which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a clinical effectiveness study with defined acceptance criteria.

The 510(k) summary states that the device's "safety and effectiveness was further tested cli under IDE G040058 and appropriate IRBs." However, it does not provide any results or details of that study.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement based on the information provided in the input text.

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