HEARTPORT ENDOARTERIAL RETURN CANNUAL

K955121 · Heartport, Inc. · DWF · May 10, 1996 · Cardiovascular

Device Facts

• Record ID: K955121
• Device Name: HEARTPORT ENDOARTERIAL RETURN CANNUAL
• Applicant: Heartport, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: May 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use of the endoarterial return cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The endoarterial return cannula serves to deliver oxygenated blood for cardiopulmonary bypass during cardiac surgery and to allow hemostatic introduction, removal and securing of the endoartic clamp catheter into the femoral artery.

Device Story

Extracorporeal cannula; used for vessel cannulation and perfusion during cardiac surgery. Functions as conduit for oxygenated blood delivery; provides access port for hemostatic introduction, removal, and securing of endoartic clamp catheter into femoral artery. Used in OR by surgeons. Combines bypass perfusion and catheter introduction functions in single device. Features lubricious inner/outer tip coating to facilitate catheter insertion. Benefits patient by enabling endovascular cardiopulmonary bypass procedures.

Clinical Evidence

Bench testing only. Performance testing demonstrated with 95% confidence that device meets or exceeds performance standards.

Technological Characteristics

Extracorporeal vascular cannula; includes lubricious inner and outer tip coating. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing endovascular cardiopulmonary bypass during cardiac surgery requiring blood oxygenation and endoartic clamp catheter access via the femoral artery.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Bio-Medicus Cannula-Tubing
• Tuohy-Borts Y Hemostasis Valve

Submission Summary (Full Text)

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Endoarterial Return Cannula
K955121
Appendices

# Appendix A. 510(k) Summary of Safety and Effectiveness

MAY 10 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: _________________________.

## Applicant Information:

Date Prepared: November 6, 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: Endoarterial Return Cannula
Common Name: Arterial Return Cannula
Classification Name: Cardiopulmonary bypass vascular cannula

## Equivalent Devices:

Bio-Medicus Cannula-Tubing
Tuohy-Borts Y Hemostasis Valve

## Device Descriptions:

### Cannula-Tubing

This post-enactment device is an extracorporeal cannula used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment.

### Tuohy-Borts Y Hemostasis Valve

This post-enactment device is a hemostatic valve mounted on a “Y” connector attached on the distal (hub) end of a guiding (large bore) catheter. The device is intended for use in: pressure monitoring, flushing, infusion, and guiding catheter insertion for balloon dilatation angioplasty.

Heartport, Inc.
CONFIDENTIAL
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Endoarterial Return Cannula
Appendices

# 510(k) Summary of Safety and Effectiveness (continued)

## Intended Use:

Use of the endoarterial return cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The endoarterial return cannula serves to deliver oxygenated blood for cardiopulmonary bypass during cardiac surgery and to allow hemostatic introduction, removal and securing of the endoartic clamp catheter into the femoral artery.

## Comparison To Predicate Devices:

The Endoarterial Return Cannula is not significantly changed from the predicates. The only difference is the addition of an inner and outer tip coating to enhance lubricity during insertion of catheters. The Endoarterial Return Cannula provides the surgeon with one device that can be utilized to both introduce catheters and maintain cardiopulmonary bypass.

## Non-clinical Test Results:

Performance testing has demonstrated with 95% confidence that the endoarterial return cannula will meet or exceed Heartport, Inc. performance standards.

## Test Conclusions:

Performance testing has demonstrated that the endoarterial return cannula will function safely and efficaciously, while meeting the anticipated clinical requirements for the intended use.

Heartport, Inc.
CONFIDENTIAL
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