Search Results

The devices are used for capping off the two dialysate port access ends of a hollow fiber dialyzer. The devices are used by technicians in a dialysis unit during the cleaning, reprocessing, and disinfecting of the dialyzer. During the disinfecting procedure, the technician fills the dialyzer with a sterilant solution that sterilizes the inner filter membrane of the dialyzer. The dialysate port caps prevent the large-scale leakage of the fluid stored inside the dialyzer. The vented dialysate port caps, in the process of venting pressure, may leak a very small amount of fluid. The device replaces the original equipment manufacturer's closure ports after the initial use of the dialyzer.

The devices are clean, but not sterile. The inside opening of the caps are tapered to match the standard dialysate ports found on hollow fiber dialyzers. The devices mate directly to the dialysate port. The caps are affixed by placing the open end of the cap over the "male" end of the dialysate ports. They are released by pulling them straight off. The surface of the dialysate port and the surface of the dialysate port cap device meet, and create a friction seal that prevents stored fluids from leaking out of the dialyzer. The vented dialysate port cap has a po-up piece at the top of the device. These vented caps are specifically for use with a sterilant solution known as Renalin, and manufactured by Minntech Corp. This sterilant is known to create pressure inside the dialyzer. The vented cap is a device to relieve this pressure buildup.

The provided document is a 510(k) clearance letter for a medical device: "Vented dialysate port cap (Our Catalog No. DPC101VS)". This letter primarily states that the device has been deemed substantially equivalent to a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study proving that the device meets such criteria.

510(k) clearances, especially for devices in Class II like this one, primarily focus on demonstrating substantial equivalence to a predicate device already on the market. While manufacturers typically perform testing to ensure their device functions as intended and safely, the 510(k) clearance letter itself and the "Indications for Use" section provided do not detail a specific study with acceptance criteria and reported performance.

Therefore, I cannot fulfill your request for the tables and study details because the information is not present in the provided text.

To answer your questions, the following kind of information would be needed:

• A "Performance Data" section or similar within a 510(k) submission, which would detail the specific tests conducted, the acceptance criteria for those tests, and the results achieved.
• A "Clinical Study" or "Non-Clinical Testing" report if such studies were performed to support the 510(k) submission (though often not required in detail for devices like this, especially those demonstrating equivalence via non-clinical bench testing).

Without that additional information, I cannot provide the requested details.

Ask a specific question about this device