(108 days)
The Manan™ Seldinger Needle is intended for use for atraumatic percutaneous arterial pressure monitoring.
This needle is made in various gauges from 15 to 22 ga, and in various lengths from 2 to 3 ins. It is a two piece assembly made up of an outer cannula with a truncated pencil tip which is matched to the inner solid stylet. The inner stylet has a modified chisel bevel which extends past the outer cannula.
This document is a 510(k) summary for the Manan™ Seldinger Needle, a medical device. It describes the device and its intended use, and states that it has been found substantially equivalent to a predicate device already on the market. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) process for medical devices focuses on demonstrating "substantial equivalence" to a predicate device, rather than requiring extensive clinical trials with predefined acceptance criteria and performance metrics in the same way a new drug or a high-risk novel device might.
Therefore, I cannot extract the requested information from the provided text because it is not present. The document focuses on administrative details of the 510(k) submission, not on a detailed performance study with acceptance criteria.
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.