HEARTPORT ENDOVENOUS DRAINAGE CANNULA

K962835 · Heartport, Inc. · DWF · Feb 10, 1997 · Cardiovascular

Device Facts

• Record ID: K962835
• Device Name: HEARTPORT ENDOVENOUS DRAINAGE CANNULA
• Applicant: Heartport, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use of the Heartport Endovenous Drainage Cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The Heartport Endovenous Drainage Cannula serves to drain non-oxygenated blood for cardiopulmonary bypass during cardiac surgery.

Device Story

Endovenous drainage cannula; used during cardiac surgery for cardiopulmonary bypass; drains non-oxygenated blood from patient; inserted into venous system; features surface coating for enhanced lubricity; operated by surgical team; provides flow rates comparable to predicate devices; facilitates extracorporeal circulation.

Clinical Evidence

Bench testing only. Performance testing demonstrated comparable flow rates to predicate devices and confirmed the device meets clinical requirements for intended use.

Technological Characteristics

Venous cannula for cardiopulmonary bypass; includes surface coating for enhanced lubricity; mechanical design provides flow rates comparable to predicate devices.

Indications for Use

Indicated for patients undergoing endovascular cardiopulmonary bypass requiring drainage of non-oxygenated blood during cardiac surgery.

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

• Medtronic DLP, Inc. - Femoral Venous Cannula
• Research Medical, Inc. - Fem-flex Femoral Access Cannulae

Submission Summary (Full Text)

{0}

Endovenous Drainage Cannula
K962835
FEB 10 1997
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:

Date Prepared: July 18, 1996

Name: Heartport, Inc.

Address: 200 Chesapeake Drive
Redwood City, CA 94063

Contact Person: Robert J. Chin

Phone Number: [phone]

Fax Number: [phone]

## Device Information:

Trade Name: Heartport Endovenous Drainage Cannula

Common Name: Venous Cannula

Classification Name: Cardiopulmonary bypass vascular cannula

## Equivalent Devices:

Medtronic DLP, Inc. - Femoral Venous Cannula

Research Medical, Inc. - Fem-flex Femoral Access Cannulae

## Intended Use:

Use of the Heartport Endovenous Drainage Cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The Heartport Endovenous Drainage Cannula serves to drain non-oxygenated blood for cardiopulmonary bypass during cardiac surgery.

## Comparison To Predicate Devices:

The Heartport Endovenous Drainage Cannula is not significantly different from the identified predicates. The only difference is the addition of a surface coating to enhance lubricity during insertion of the cannula.

Heartport, Inc.
CONFIDENTIAL
Page I

{1}

Endovenous Drainage Cannula
Appendices

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

### Non-clinical Test Results:

Performance testing has demonstrated that the Heartport Endovenous Drainage Cannula provides comparable flow rates to the identified predicate devices.

### Test Conclusions:

Performance testing has demonstrated that the Heartport Endovenous Drainage Cannula will function safely and efficaciously, while meeting the anticipated clinical requirements for the intended use.

Heartport, Inc.
CONFIDENTIAL
Page II