(90 days)
The catheter is designed to provide occlusion of the coronary sinus, to deliver cardioplegic solution to the coronary sinus and to monitor the coronary sinus pressure during cardiopulmonary bypass.
Not Found
The provided text is a 510(k) summary for a medical device (Heartport Endocoronary Sinus Catheter) from 1996. It describes the device's intended use and comparison to a predicate device.
However, the text does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving the device meets those criteria. The summary is very high-level and only states:
- "Performance testing has demonstrated with 95% confidence that the Endocoronary Sinus Catheter will meet or exceed Heartport's performance standards."
- "Performance testing has demonstrated that the Endocoronary Sinus Catheter will function safely and effectively, while meeting the anticipated clinical requirements for the intended use."
It does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts, ground truth establishment, or adjudication methods.
- Details on multi-reader multi-case studies or standalone algorithm performance.
- Sample sizes or ground truth establishment for a training set.
Therefore, I cannot extract the requested information from the provided document. The summary focuses on regulatory approval based on equivalence and general performance claims, rather than a detailed breakdown of a specific study and its findings against defined acceptance criteria for an AI/algorithm-based device.
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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: October 22, 1996
| Name: | Heartport, Inc. |
|---|---|
| Address: | 200 Chesapeake DriveRedwood City, CA 94063 |
| Contact Person: | Kevin F. MacDonald |
|---|---|
| Phone Number: | (415) 306-7900 |
| Fax Number: | (415) 306-7905 |
Device Information:
| Trade Name: | Heartport Endocoronary Sinus Catheter |
|---|---|
| Common Name: | Sinus Catheter |
| Classification Name: | Cardiopulmonary bypass vascular catheter |
Equivalent Device:
| Name: | Endosinus Catheter |
|---|---|
| Manufacturer: | Heartport, Inc. |
| Status: | Post-enactment |
| 510(k) # | K961270 |
| Cleared: June 18, 1996 |
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510(k) Summary of Safety and Effectiveness (continued)
Intended Use:
The catheter is designed to provide occlusion of the coronary sinus, to deliver cardioplegic solution to the coronary sinus and to monitor the coronary sinus pressure during cardiopulmonary bypass.
Comparison To Predicate Devices:
This device has the same intended use and technological characteristics as the predicate device.
Non-clinical Test Results:
Performance testing has demonstrated with 95% confidence that the Endocoronary Sinus Catheter will meet or exceed Heartport's performance standards.
Test Conclusions:
Performance testing has demonstrated that the Endocoronary Sinus Catheter will function safely and effectively, while meeting the anticipated clinical requirements for the intended use.
§ 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).