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Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.

Endoaortic Clamp Catheter

The provided text describes a 510(k) Notification for the Heartport Endoaortic Clamp™, a medical device used for aortic occlusion, cardioplegic solution delivery, and aortic root pressure monitoring during cardiopulmonary bypass.

However, the provided text does not contain any information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truthing, MRMC studies, standalone performance studies, or details about training sets.

The only information provided about testing is:

• Non-clinical Test Results: "Performance testing has demonstrated with 95% confidence that the Heartport Endoaortic Clamp™ will meet or exceed Heartport, Inc. performance standards."
• Test Conclusions: "Performance testing has demonstrated that the Endoaortic Clamp will function safely and effectively, while meeting the anticipated clinical requirements for the intended use."

This is a very high-level statement indicating that the device met internal performance standards, but it does not specify what those standards are, how they were measured, or the details of the study proving it.

Therefore, I cannot populate the requested table or answer the specific questions about the study design, as that information is not present in the provided text. The text focuses on the device's identity, intended use, and equivalence to predicate devices, rather than detailed performance study results.

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