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The SPROTTE® NRFit™, Quincke NRFit™ needles are anesthesia conduction needles which are used to administer anesthetic agent to the subarachnoid space.

The device is intended for adult and pediatric patients.

The SPROTTE® NRFit™ and Quincke NRFit™ needles are anesthesia conduction needles for spinal anaesthesia. The device is disposable and supplied sterile to the end user, or non-sterile intended to be sterilized prior to use to repackagers/medical device manufacturers. The needles consist of a needle/cannula, hub, optional glue, introducer (tubing, hub, optional glue), stylet (tubing, knob, optional glue), retaining plate, and for Quincke needles, a fixation clip and haemostylet. The materials used are Stainless Steel 1.4301 (X5CrNi18-10), AISI 304 (V2A) for tubing and stylet, Polycarbonate PC for hubs, knobs, retaining plate, and fixation clip, and Epoxy resin for optional glue. The primary difference from the predicate devices is the design of the hub to comply with ISO 80369-6.

I am unable to answer this question. The document is a 510(k) premarket notification for an anesthesia conduction needle. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical descriptions and performance testing summarized from international standards. It does not contain information about acceptance criteria and studies related to AI or algorithm performance, human reader studies, ground truth establishment, or training set details as requested in your prompt. This type of information would typically be found in the context of an AI/ML medical device submission, which this document is not.

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