(211 days)
Occlusion of the aorta, delivery of cardioplegia, and monitoring of aortic root pressure during cardiopulmonary bypass.
Endoaortic Clamp Catheter
The provided text is a 510(k) summary for the Heartport Endoaortic Clamp Catheter, dating back to 1996. This document is a regulatory submission for a medical device and does not contain the level of detail typically found in a scientific study report, especially concerning acceptance criteria and detailed study methodology as would be expected for modern AI/ML medical devices.
Based on the provided text, here's what can be extracted:
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A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or performance metrics in a table format. It broadly states the device "successfully maintained cardiopulmonary pass."Acceptance Criteria Reported Device Performance Maintain cardiopulmonary bypass (implicit acceptance) Successfully maintained cardiopulmonary pass in ten subjects Function safely and efficaciously Demonstrated to function safely and efficaciously Meet anticipated clinical requirements Demonstrated to meet anticipated clinical requirements -
Sample size used for the test set and the data provenance
- Sample Size: Ten subjects.
- Data Provenance: The study was a "clinical investigation," implying a prospective collection for this specific device evaluation. There is no information on the country of origin.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable (N/A). This device is a mechanical clamp, not an AI/ML diagnostic system. The "ground truth" would be established by direct physiological measurements and clinical outcomes, not expert interpretation of outputs. -
Adjudication method for the test set
N/A. As this is not an interpretive diagnostic device, an adjudication method for establishing ground truth is not relevant in the context of expert consensus. Clinical outcomes and physiological parameters would be directly observed. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is a mechanical medical device, not an AI-assisted diagnostic tool requiring human reader studies. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a mechanical medical device. -
The type of ground truth used
The ground truth would be based on direct clinical observation of the device's function during cardiopulmonary bypass in human subjects, including physiological parameters (e.g., maintaining blood flow, pressure monitoring) and patient outcomes. The text states the device "successfully maintained cardiopulmonary pass," implying successful physiological functioning. -
The sample size for the training set
N/A. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense. The device was likely developed and refined through engineering testing and potentially pre-clinical (animal) studies, but these are not referred to as "training" in this context. -
How the ground truth for the training set was established
N/A. See explanation for point 8.
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Supplement I
Image /page/0/Picture/3 description: The image shows the text "510(k) 955132" which is circled. The text is horizontally oriented in the center of the circle. The circle is drawn with a thick black line.
Appendix E. 510(k) Summary of Safety and Effectiveness
JUN - 7 1996
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: K955132
Applicant Information:
November 2, 1995 Date Prepared:
Name: Heartport, Inc. Address: 200 Chesapeake Drive Redwood City, CA 94063
| Contact Person: | David A. Tucker |
|---|---|
| Phone Number: | (415) 306-7900 |
| Fax Number: | (415) 306-7905 |
Device Information:
| Trade Name: | Endoaortic Clamp |
|---|---|
| Common Name: | Endoaortic Clamp Catheter |
| Classification Name: | Cardiopulmonary bypass vascular catheter |
Equivalent Devices:
Medi-tech Occlusion Balloon Catheter RMI Coronary Sinus Perfusion & Pressure Monitoring Cannulae Cooley Aortic Clamp DLP Cardioplegia Pressure Cannula with Vent Line Datascope PERCLUDER™ - DL Occluding Balloon Fogarty Occluding Catheter
Predicate Device Descriptions:
Medi-tech Balloon Occlusion Catheter
This predicate is a pre-enactment device commercially distributed in multiple sizes. This device is a multi-lumen latex balloon catheter which occludes vasculature through one lumen, and delivers contrast material or therapeutic agents through the second lumen.
The RMI Coronary Sinus Perfusion & Pressure Monitoring Cannula
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The cannula is a post-enactment device distributed in multiple sizes. This device is a multi-lumen latex balloon cannula which occludes the coronary sinus, perfuses cardioplegia, and monitors pressure.
Cooley Aortic Clamp
This pre-enactment device is a stainless steel mechanical anastomosis clamp manufactured by Baxter Healthcare Corporation. The device is available in a variety of sizes, with varied jaw angles. It is intended to physically clamp the exterior of the aorta causing total occlusion.
DLP Cardioplegia Pressure Cannula with Vent Line
This post-enactment device is an aortic root cannula with a vent line manufactured by Medtronic, Inc.. The device is intended to deliver cardioplegia, monitor aortic root pressure, and provide venting.
Datascope PERCLUDER™ - DL Occluding Balloon
This post-enactment device is an occluding balloon manufactured by. Datascope. The device is indicated for use in internally occluding the aortic arch during cardio-pulmonary bypass grafting.
Fogarty Occluding Catheter
This pre-enactment device is an occluding balloon catheter manufactured by Baxter Healthcare. This device is indicated for use in internally occluding the aorta and delivering chemotherapeutic agents.
Intended Use:
Occlusion of the aorta, delivery of cardioplegia, and monitoring of aortic root pressure during cardiopulmonary bypass.
Comparison To Predicate Devices:
This device combines the same functions as the individual predicate devices, into a single catheter.
Clinical Test Results:
The Heartport Endoaortic Clamp Catheter successfully maintained cardiopulmonary pass in ten subjects of a clinical investigation.
Test Conclusions:
Performance testing has demonstrated that the Endoaortic Clamp will function safely and efficaciously, 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).