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IMD's specialty / anesthesia needles – Tuohy, Quincke and Pencil Point Needles – are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Anesthesia conduction needles consist of a luer hub, a stainless steel cannula with various tip types, and a stainless steel stylet. These needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needles fit into an introducer needle. This is a simple hypodermic needle to make the initial puncture through the skin to aid in the placement of the anesthesia conduction needle. The later can facilitate the placement of an epidural catheter for continuous infusion of local anesthetics into the epidural space for longer pain relief.

The IMD anesthesia conduction needles - Tuohy, Quincke, and Pencil Point - are single use, sterile and latex-free medical devices for transient delivery of anesthetics during regional anesthesia. The cannula is stabilized during puncture with use of an inner stylet. This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for regional anesthesia. Then the anesthetics can be applied transiently (i.e., within minutes) by the professional anesthetist. Alternatively or additionally, an epidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.

The provided text is a 510(k) summary for IMD's Anesthesia Needles (Tuohy, Quincke, and Pencil Point). It declares substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria, device performance metrics, or a study design to measure these metrics.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and equivalence to existing devices rather than a detailed performance study against predefined acceptance criteria.

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