(179 days)
THE DEVICE IS INTENDED FOR USE AS AN ABDOMINAL ACCESS PORT DURING LAPARASCOPIC PROCEDURE AND THE VALVE FOR ATTACHING INSUFFLATION TUBING TO MAINTAIN PNEUMOPERITONEAL PRESSURE.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance testing, or any studies conducted on the device "Introducer Port SC" (K972112). The document is solely an FDA 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It does not contain details regarding performance studies, clinical trials, or any specific acceptance criteria that the device had to meet.
§ 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.