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Intended Use: To provide an access port into the peritoneal cavity.

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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.

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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.

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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.

Ask a specific question about this device

Ask a specific question about this device