(77 days)
Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during cardiopulmonary bypass.
Heartport Endosinus Catheter, Common Name: Sinus Catheter, Classification Name: Cardiopulmonary bypass vascular catheter
This document is a 510(k) summary for a medical device (Heartport Endosinus Catheter) and does not contain information about acceptance criteria for an AI/ML powered device, nor does it describe a study proving the device meets such criteria.
The 510(k) summary primarily focuses on:
- Device Identification: Trade name, common name, classification, and applicant information.
- Intended Use: Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during cardiopulmonary bypass.
- Predicate Devices: Comparison to existing devices for substantial equivalence.
- Non-clinical Test Results: A very high-level statement that "Performance testing has demonstrated with 95% confidence that the Endosinus Catheter will meet or exceed Heartport's performance standards."
- Test Conclusions: A general statement about safety and efficacy based on performance testing.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this document pertains to a traditional medical device submission and does not involve AI/ML technology or corresponding evaluation methodologies.
§ 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).