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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.

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The rinse lines are used to connect one blood port of a dialyzer to the opposite blood port to create a loop. When both blood ports are so connected, the line itself is connected to a pump on a rinse machine which primes the dialyzer with rinse solution and fills it with a sterilant solution, so the dialyzer can be disinfected, while it is stored on the shelf awaiting its next use. The rinse line is also used for taking a sample of the sterilant solution. This is done by inserting a needle through an access site on the rinse line, and taking a sample for testing. The devices are clean, but not sterile.

The t-connectors are used during the rinse procedure of the dialyzer. They connect each end of the two blood ports on a dialyzer to the reprocessing system and allow cleaning solutions to be passed through the membrane of the dialyzer. The devices are clean, but not sterile.

Pump Segment Rinse Lines & T-Connectors
Pump segment rinse line w/ slip-on connector (Our Catalog No. PS100R)
Pump segment rinse line w/ luer-lock connector (Our Catalog No. PS100B)

T-connector, short, w/ slip-on connector (Our Catalog No. ST100R)
T-connector, short, w/ luer-lock connector (Our Catalog No. ST100B)
T-connector, long, w/ slip-on connector (Our Catalog No. LT100R)
T-connector, long, w/ luer-lock connector (Our Catalog No. LT100B)

The connecting ends of the rinse lines and the t-connectors are of two possible types: a slip-on connector or a luer-lock, screw-on connector.

The slip-on connector is tapered to securely adhere to the "male" end of the blood port. It is released by pulling it straight off. The surface of the blood port and the surface of the slip-on connector meet, and create a frction seal that prevents any fluids from leaking out of the dialyzer.

The luer-lock, screw-on connector securely screws on to the "male" end of the blood port. It is released by unscrewing it. The surface of the blood port and the surface of the luer-lock, screw-on connector meet, and create a frotion seal that prevents any fluids from leaking out of the dia

The provided text is a 510(k) premarket notification letter from the FDA to DaySpring Medical, Inc. regarding their Pump Segment Rinse Lines and T-Connectors. This document does not contain any information about acceptance criteria or a study proving device performance as it relates to software or AI.

The letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's indications for use and general controls, not on specific performance studies or acceptance criteria for a device that would typically involve AI or software components.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document pertains to a medical device that appears to be physical components (rinse lines and T-connectors) used in dialyzer reprocessing, without any mention of AI or software performance.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device