(108 days)
The Manan™ Potts-Cournand Needle is intended for use for carotid angiography, direct arterial pressure monitoring, blood sampling, and percutaneous catheterization.
This needle is made in various gauges from 15 to 21 ga, and in various lengths from 2 to 2-1/2 in. It is a three piece assembly made up of an outer cannula with a short, tapered bevel which is matched to the inner cannula. The inner cannula has chisel bevel which extends past the outer cannula. An obturator with a rounded, blunt tip fits inside of the inner cannula, and extends past the tip of the inner cannula.
The provided text is a 510(k) summary for the Manan™ Potts-Cournand Needle. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any analytical or clinical study results.
The document primarily focuses on:
- Identifying the applicant, contact, and device trade/common/classification names.
- Establishing substantial equivalence to a predicate device (Manan Medical Products' Potts-Cournand needle, K851832).
- Providing a brief description of the device's physical characteristics.
- Stating the intended use/indications for use (carotid angiography, direct arterial pressure monitoring, blood sampling, and percutaneous catheterization).
- The FDA's letter of clearance.
Therefore, I cannot fulfill your request for details regarding acceptance criteria and device performance studies based solely on the provided input. This type of 510(k) summary often references "general controls" and substantial equivalence, implying that the device's safety and effectiveness are established by its similarity to a legally marketed predicate device, rather than through extensive new performance studies detailed in the summary itself.
§ 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.