(36 days)
The Retrograde Coronary Sinus Perfusion cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrograde through the coronary sinus up to six hours or less.
The RCSP cannula consists of kink resistant , silicone or extruded PVC body. The silicone cannula are wire wound. The tip of the cannula has a bevel with side holes or bullet nose with multi ports to allow the free flow in the coronary sinus. The back of the cannula terminates in a locking female luer. An inflatable balloon is located at the closer to the tip. The inflation assembly for the manual models is located at the back of the cannula body and contains a female slip luer and a one-way valve assembly. These devices are offered with either a guidewire stylet or a solid stylet to help position the cannula.
The provided text is a 510(k) summary for a medical device. It describes a Retrograde Coronary Sinus Perfusion Cannula and states that no performance testing was necessary because the modification (removal of a pressure monitoring line) had no effect on the design or functionality of the product.
Therefore, the document does not contain information related to acceptance criteria or a study proving the device meets said criteria in the context of typical performance metrics such as accuracy, sensitivity, or specificity. The submission relies on substantial equivalence to predicate devices for which performance would have been established previously.
Specifically, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: No performance criteria or metrics are listed as no new performance testing was conducted.
- Sample sized used for the test set and the data provenance: No test set was used for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set for performance.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance study: The document explicitly states "No product performance testing was necessary for the product."
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable as there's no mention of an algorithm or AI model requiring training.
- How the ground truth for the training set was established: Not applicable.
The conclusion drawn by Medtronic Perfusion Systems is that the modified device is "substantially equivalent to predicate devices based upon design and indications for use." This implies that the regulatory acceptance criteria for this specific submission were met by demonstrating that the modification did not alter the fundamental safety and effectiveness previously established for the predicate devices.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).