(36 days)
Intended Use: To provide an access port into the peritoneal cavity.
Not Found
This appears to be a 510(k) clearance letter from the FDA for a Peritoneal Catheter. This document does not include information about acceptance criteria or a study proving device performance against such criteria.
The letter explicitly states:
- "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
- "This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."
This indicates that the device received marketing clearance based on a demonstration of substantial equivalence to a predicate device, not necessarily on a performance study against specific acceptance criteria. While the manufacturer would have performed testing to support the 510(k) submission, the details of that testing, acceptance criteria, and study results are not contained within this FDA clearance letter.
Therefore, I cannot provide the requested information based on the input document. The document is an FDA clearance letter, not a study report or a summary of acceptance criteria and performance data.
§ 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.