(211 days)
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No
The summary describes a physical catheter used for mechanical occlusion and delivery, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for occlusion of the aorta and delivery of cardioplegia during cardiopulmonary bypass, which are therapeutic interventions.
No
The device is described as an "Endoaortic Clamp Catheter" used for occlusion, delivery of cardioplegia, and monitoring pressure during bypass. These are interventional and monitoring functions, not diagnostic ones. Performance studies mention maintaining cardiopulmonary bypass, which is a treatment, not a diagnosis.
No
The device description explicitly states "Endoaortic Clamp Catheter," which is a physical, hardware device. The intended use also describes physical actions like "occlusion of the aorta" and "delivery of cardioplegia," which are performed by a hardware catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for surgical procedures (occlusion of the aorta, delivery of cardioplegia, monitoring pressure). IVDs are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description "Endoaortic Clamp Catheter" clearly indicates a device designed for insertion into the body.
- Anatomical Site: The listed anatomical sites (aorta, aortic root, coronary sinus) are all internal body structures.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens, laboratory testing, or any of the typical characteristics of an IVD.
Therefore, this device is a surgical/interventional device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Occlusion of the aorta, delivery of cardioplegia, and monitoring of aortic root pressure during cardiopulmonary bypass.
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
aorta, aortic root
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The Heartport Endoaortic Clamp Catheter successfully maintained cardiopulmonary pass in ten subjects of a clinical investigation. Performance testing has demonstrated that the Endoaortic Clamp will function safely and efficaciously, while meeting the anticipated clinical requirements for the intended use.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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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
1
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.