(70 days)
The Heartport Endovascular Cardiopulmonary Bypass Systems are indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass and an arrested heart. The system consists of a set of catheters, cannulae and accessories that permits a patient to be maintained on cardiopulmonary bypass and the patient's heart to be arrested without the need for a median sternotomy.
The Heartport Endovascular Cardiopulmonary Bypass Systems are composed of the following commercially available bypass catheters, cannulae and accessories: Heartport Endoaortic Clamp, Heartport Endopulmonary Vent, Heartport Endoarterial Return Cannula, Medtronic DLP Venous Drainage Cannula or a substantially equivalent Heartport manufactured device. The Heartport Endovascular Antegrade/Retrograde Cardiopulmonary Bypass System consists of the above Antegrade Kit in addition to: Heartport Endosinus Catheter.
This document (K962858) does not contain information regarding acceptance criteria, device performance, study design, or ground truth establishment. This 510(k) summary is for the 'Heartport Endovascular Cardiopulmonary Bypass Systems' and primarily focuses on its intended use and comparison to predicate devices, stating "There are no changes from the predicate devices other than the shelf packaging and its label." This indicates that the device is substantially equivalent to previously cleared devices, and detailed performance studies are not presented in this summary.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.
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Appendices
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:
July 19, 1996 Date Prepared:
| 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: | Endovascular Cardiopulmonary Bypass Systems |
|---|---|
| Common Name: | Cardiopulmonary bypass catheter kits |
| Classification Name: | Cardiopulmonary bypass vascular catheter |
Equivalent Devices:
The Heartport Endovascular Antegrade Cardiopulmonary Bypass System is composed of the following commercially available bypass catheters, cannulae and accessories:
Heartport Endoaortic Clamp (K955132) Heartport Endopulmonary Vent (K961245) Heartport Endoarterial Return Cannula (K955121) Medtronic DLP Venous Drainage Cannula (K875353) or a substantially equivalent Heartport manufactured device
The Heartport Endovascular Antegrade/Retrograde Cardiopulmonary Bypass System consists of the above Antegrade Kit in addition to:
Heartport Endosinus Catheter (K961270)
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Intended Use:
The Heartport Endovascular Cardiopulmonary Bypass Systems are indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass and an arrested heart. The system consists of a set of catheters, cannulae and accessories that permits a patient to be maintained on cardiopulmonary bypass and the patient's heart to be arrested without the need for a median sternotomy.
Comparison To Predicate Devices:
There are no changes from the predicate devices other than the shelf packaging and its label.
§ 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).