HEARTPORT CABLE BULLDOG CLAMP

K962366 · Heartport, Inc. · DXC · Nov 7, 1996 · Cardiovascular

Device Facts

• Record ID: K962366
• Device Name: HEARTPORT CABLE BULLDOG CLAMP
• Applicant: Heartport, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Nov 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Heartport Cable Bulldog Clamp is intended for the temporary occlusion of a vessel, including the Internal Mammary Artery or vein grafts, and other clamping procedures. The Cable Bulldog Clamp may be introduced to surgical sites through a thoracic port or incision for use during endoscopic cardiac surgical procedures.

Device Story

Device is a vascular clamp for temporary vessel occlusion; used during endoscopic cardiac surgery. Introduced to surgical site via thoracic port or incision. Provides clamping force to occlude vessels like Internal Mammary Artery or vein grafts. Operated by surgeons to facilitate cardiac procedures. Benefits include enabling minimally invasive access to vessels.

Clinical Evidence

Bench testing only. In vitro evaluation of clamping force demonstrated performance equivalent to predicate devices and meeting clinical requirements. Biocompatibility of materials established.

Technological Characteristics

Vascular clamp; mechanical actuation; materials similar to predicate devices with proven biocompatibility. Designed for endoscopic delivery via thoracic port.

Indications for Use

Indicated for temporary occlusion of vessels, including Internal Mammary Artery or vein grafts, during endoscopic cardiac surgical procedures.

Regulatory Classification

Identification

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

Predicate Devices

• Baxter Healthcare - Fogarty® Spring Clips (Softjaw®, Safejaw®, and Double Safejaw® Spring Clips) and Spring Clip Applicators
• Baxter Healthcare - EDWARDS Parallel Jaw Spring Clip and Applicator Forceps
• Baxter Healthcare - EDWARDS Single Softjaw and Double Softjaw Handleless Clamps

Submission Summary (Full Text)

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Heartport™ Cable Bulldog Clamp
Appendices

# APPENDIX A. 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.

NOV - 7 1996

The assigned 510(k) number is: K962366

## Applicant Information:

Date Prepared: June 17, 1996

Name: Heartport, Inc.

Address: 200 Chesapeake Drive
Redwood City, CA 94063

Contact Person: Ms. Isabella R. Abati
Director, Regulatory Affairs

Phone Number: [phone]

Fax Number: [phone]

## Device Information:

Classification: Class II

Trade Name: Heartport™ Cable Bulldog Clamp

Common Name: Cardiovascular Devices - Vascular Clamp, 21 CFR 870.4450

Product Code: 74DXC

## Equivalent Devices:

The Heartport Cable Bulldog Clamp are substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:

1. Baxter Healthcare - Fogarty® Spring Clips (Softjaw®, Safejaw®, and Double Safejaw® Spring Clips) and Spring Clip Applicators
2. Baxter Healthcare - EDWARDS Parallel Jaw Spring Clip and Applicator Forceps
3. Baxter Healthcare - EDWARDS Single Softjaw and Double Softjaw Handleless Clamps

Heartport, Inc.
CONFIDENTIAL
Page 24

{1}

Heartport™ Cable Bulldog Clamp
Appendices

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

## Intended Use:

The Heartport Cable Bulldog Clamp is intended for the temporary occlusion of a vessel, including the Internal Mammary Artery or vein grafts, and other clamping procedures. The Cable Bulldog Clamp may be introduced to surgical sites through a thoracic port or incision for use during endoscopic cardiac surgical procedures.

## Comparison To Predicate Devices:

The Heartport Cable Bulldog Clamps are equivalent in intended use and operational characteristics to the following devices: (1) Baxter Healthcare - Fogarty® Spring Clips (Softjaw®, Safejaw®, and Double Safejaw® Spring Clips) and Spring Clip Applicators; (2) Baxter Healthcare - EDWARDS Parallel Jaw Spring Clip and Applicator Forceps; and (3) Baxter Healthcare - EDWARDS Single Softjaw and Double Softjaw Handleless Clamps

The Heartport Cable Bulldog Clamp combines the same functions as the individual predicate devices into a single device.

## Non-Clinical Test Results:

### Performance

The Heartport Cable Bulldog Clamp was evaluated *in vitro* for clamping force. The performance testing demonstrated that the Heartport Cable Bulldog Clamp equivalent to the predicate device tested and meets the anticipated clinical requirements for its intended use.

### Biocompatibility

The materials used to fabricate the Heartport Cable Bulldog are similar to the predicate devices. All materials used in the Heartport Cable Bulldog Clamp have proven biocompatibility.

## Summary:

Based on the intended use, product information, performance and biocompatibility data provided in this Premarket Notification, Heartport Cable Bulldog Clamps have been shown to be substantially equivalent to currently marketed predicate devices.

Heartport, Inc.
CONFIDENTIAL
Page 25