HEARTPORT ENDOAORTIC CLAMP

K955132 · Heartport, Inc. · DXC · Jun 7, 1996 · Cardiovascular

Device Facts

• Record ID: K955132
• Device Name: HEARTPORT ENDOAORTIC CLAMP
• Applicant: Heartport, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Jun 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Occlusion of the aorta, delivery of cardioplegia, and monitoring of aortic root pressure during cardiopulmonary bypass.

Device Story

Endoaortic Clamp Catheter; multi-lumen balloon catheter; used during cardiopulmonary bypass. Functions: internal aortic occlusion, cardioplegia delivery, aortic root pressure monitoring. Operated by surgeons in OR. Combines functions of multiple predicate catheters into single device. Benefits: enables minimally invasive or specialized bypass procedures by replacing external mechanical clamps with internal balloon occlusion.

Clinical Evidence

Clinical investigation conducted on ten subjects. Primary endpoint: successful maintenance of cardiopulmonary bypass. Results demonstrated device functioned safely and met clinical requirements.

Technological Characteristics

Multi-lumen balloon catheter. Materials include latex. Functions: vascular occlusion, fluid delivery, pressure monitoring. Form factor: catheter-based.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring aortic occlusion, cardioplegia delivery, and aortic root pressure monitoring.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate 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

Submission Summary (Full Text)

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Appendix E. 510(k) Summary Supplement I
510(k) 955132

# 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:

Date Prepared: November 2, 1995

Name: Heartport, Inc.
Address: 200 Chesapeake Drive
Redwood City, CA 94063

Contact Person: David A. Tucker
Phone Number: [phone]
Fax Number: [phone]

### 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

Heartport, Inc.
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CONFIDENTIAL

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Appendix E. 510(k) Summary Supplement I 510(k) 955132

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.

Heartport, Inc. Page 16 CONFIDENTIAL