HEARTPORT ENDOPULMONARY VENT

K961245 · Heartport, Inc. · DWF · Jun 18, 1996 · Cardiovascular

Device Facts

• Record ID: K961245
• Device Name: HEARTPORT ENDOPULMONARY VENT
• Applicant: Heartport, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jun 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for the removal of blood from the pulmonary artery and decompression of the heart during endovascular cardiopulmonary bypass.

Device Story

Endopulmonary Vent is a pulmonary artery vent catheter; used during endovascular cardiopulmonary bypass. Device facilitates removal of blood from pulmonary artery; enables decompression of heart. Operated by clinicians in surgical settings. Output is mechanical drainage/venting of blood; assists in maintaining hemodynamic stability during bypass procedures. Benefits patient by preventing cardiac distension and improving surgical field visualization.

Clinical Evidence

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

Technological Characteristics

Pulmonary artery vent catheter; design incorporates features from existing pulmonary artery catheters. Materials and construction validated via performance testing to meet safety standards.

Indications for Use

Indicated for patients undergoing endovascular cardiopulmonary bypass requiring pulmonary artery blood removal and cardiac decompression.

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

• Pulmonary Artery Vent Catheter (K845046)

Reference Devices

• Edslab Pulmonary Artery Catheter (pre-enactment)
• Swan-Ganz® Heparin Coated, Pulmonary Artery Catheter (K811411)

Submission Summary (Full Text)

{0}

JUN 18 1996
Endopulmonary Vent
K961245
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: March 29, 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: Endopulmonary Vent
Common Name: Pulmonary Vent Catheter
Classification Name: Cardiopulmonary bypass catheter

## Equivalent Devices:

Name: Pulmonary Artery Vent Catheter
Manufacturer: DLP
Status: Post-enactment
510(k) # K845046

Name: Edslab Pulmonary Artery Catheter
Manufacturer: Baxter Healthcare Corporation
Status: Pre-enactment
510(k) # not applicable

Name: Swan-Ganz® Heparin Coated, Pulmonary Artery Catheter
Manufacturer: Baxter Healthcare Corporation
Status: Post-enactment
510(k) # K811411

Heartport, Inc.
13
CONFIDENTIAL

{1}

Endopulmonary Vent
Appendices

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

## Intended Use:

Intended for the removal of blood from the pulmonary artery and decompression of the heart during endovascular cardiopulmonary bypass.

## Comparison To Predicate Devices:

This device has the same intended use as the DLP Pulmonary Artery Vent Catheter and uses a combination of the technological characteristics of the identified predicate devices.

## Non-clinical Test Results:

Performance testing has demonstrated with 95% confidence that the Endopulmonary Vent will meet or exceed Heartport’s performance standards.

## Test Conclusions:

Performance testing has demonstrated that the Endopulmonary Vent will function safely and effectively, while meeting the anticipated clinical requirements for the intended use.

Heartport, Inc.
14
CONFIDENTIAL