(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.
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Image /page/0/Picture/2 description: The image shows the text "K961270" in a handwritten style. Below this text, the word "Appendices" is printed in a smaller, serif font. The text is black against a white background.
Appendix A. 510(k) Summary of Safety and Effectiveness
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Applicant Information:
Date Prepared: March 29, 1996
Name: Heartport, Inc. Address: 200 Chesapeake Drive Redwood City, CA 94063
| Contact Person: | Robert J. Chin |
|---|---|
| Phone Number: | (415) 306-7900 |
| Fax Number: | (415) 306-7905 |
Device Information:
| Trade Name: | Heartport Endosinus Catheter |
|---|---|
| Common Name: | Sinus Catheter |
| Classification Name: | Cardiopulmonary bypass vascular catheter |
Equivalent Devices:
| Name: | Coronary Sinus Perfusion & Pressure Monitoring Cannula |
|---|---|
| Manufacturer: | Research Medical, Inc. |
| Status: | Post-enactment |
| 510(k) # | K897137 |
| Name: | Baim Coronary Sinus Flow Catheter |
| Manufacturer: | Electro-Catheter Corporation |
| Status: | Post-enactment |
| 510(k) # | K810360 |
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510(k) Summary of Safety and Effectiveness (continued)
Intended Use:
Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during cardiopulmonary bypass.
Comparison To Predicate Devices:
This device has the same intended use and technological characteristics as the predicate devices.
Non-clinical Test Results:
Performance testing has demonstrated with 95% confidence that the Endosinus Catheter will meet or exceed Heartport's performance standards.
Test Conclusions:
Performance testing has demonstrated that the Endosinus Catheter will function safely and efficaciously, while meeting the anticipated clinical requirements for the intended use.
Heartport, Inc.
§ 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).