(169 days)
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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Endoaortic Clamp
APR - 4 1997
64161
510(k) Notification
and the same of the same of the same of the same of
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:
October 16, 1996 Date Prepared:
| Name: | Heartport, Inc. |
|---|---|
| Address: | 200 Chesapeake DriveRedwood City, CA 94063 |
| Contact Person: | Kevin F. MacDonald |
| Phone Number: | (415) 306-7900 |
Device Information:
Fax Number:
| Trade Name: | Heartport Endoaortic ClampTM |
|---|---|
| Common Name: | Endoaortic Clamp Catheter |
| Classification Name: | Cardiopulmonary bypass vascular catheter |
(415) 306-7905
Equivalent Devices:
Heartport Endoaortic Clamp - K962510 Heartport Endoaortic Clamp - K955132
Intended Use:
Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.
Comparison To Predicate Devices:
and the same of the same of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the stat
This device has the same intended use and technological characteristics as the predicate device.
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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.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).