HEARTPORT ENDOSINUS CATHETER

K961270 · Heartport, Inc. · DWF · Jun 18, 1996 · Cardiovascular

Device Facts

• Record ID: K961270
• Device Name: HEARTPORT ENDOSINUS CATHETER
• 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

Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during cardiopulmonary bypass.

Device Story

Endosinus Catheter; used during cardiopulmonary bypass; functions to occlude coronary sinus; enables delivery of cardioplegia; allows monitoring of coronary sinus pressure. Operated by clinicians in surgical settings. Provides mechanical access to coronary sinus for fluid delivery and pressure sensing. Benefits patient by facilitating myocardial protection during bypass procedures.

Clinical Evidence

Bench testing only; performance testing demonstrated with 95% confidence that the catheter meets or exceeds performance standards.

Technological Characteristics

Cardiopulmonary bypass vascular catheter; design facilitates coronary sinus occlusion, cardioplegia delivery, and pressure monitoring. Materials and dimensions consistent with predicate devices.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring coronary sinus occlusion, cardioplegia delivery, and pressure monitoring.

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

• Coronary Sinus Perfusion & Pressure Monitoring Cannula (K897137)
• Baim Coronary Sinus Flow Catheter (K810360)

Submission Summary (Full Text)

{0}

Endosinus Catheter
JUN 18 1996
K961270
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: Heartport Endosinus Catheter
Common Name: Sinus Catheter
Classification Name: Cardiopulmonary bypass vascular catheter

## Equivalent Devices:

Name: Coronary Sinus Perfusion & Pressure Monitoring Cannula
Manufacturer: Research Medical, Inc.
Status: Post-enactment
510(k) # K897137

Name: Baim Coronary Sinus Flow Catheter
Manufacturer: Electro-Catheter Corporation
Status: Post-enactment
510(k) # K810360

Heartport, Inc.
CONFIDENTIAL
15

{1}

Endosinus Catheter
Appendices

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

## Intended Use:

Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during cardiopulmonary bypass.

## Comparison To Predicate Devices:

This device has the same intended use and technological characteristics as the predicate devices.

## Non-clinical Test Results:

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

## Test Conclusions:

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

Heartport, Inc.
CONFIDENTIAL
16