(27 days)
The UreSil Drainage Catheters are to be used for percutaneous drainage of abscesses, nephrostomies, and other fluids.
Not Found
This document is a 510(k) clearance letter from the FDA for a General Purpose Drainage Catheter. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
Based on the provided text, there is no information regarding acceptance criteria related to device performance in terms of algorithms, studies proving performance, sample sizes, expert involvement, or grand truth. The document is a regulatory approval letter, not a clinical trial report or a technical performance evaluation.
Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them with the provided input.
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.