(79 days)
Sponge drains are used during surgery to protect delicate tissue from trauma, absorb fluids and to act as a filter to aspirate
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Ultracell Suction Sponge" and indicates that the device has been found substantially equivalent to predicate devices. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics.
Therefore, I cannot provide the requested information based on the given text. The provided document is a regulatory approval, not a performance study report.
§ 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.