HEARTPORT MULTIFIRE CLIP APPLIER

K961333 · Heartport, Inc. · DSS · Nov 15, 1996 · Cardiovascular

Device Facts

• Record ID: K961333
• Device Name: HEARTPORT MULTIFIRE CLIP APPLIER
• Applicant: Heartport, Inc.
• Product Code: DSS · Cardiovascular
• Decision Date: Nov 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multifire Clip Applier is designed to automatically deliver small hemostatic clips for ligation of blood vessels. The device is intended for use on vessels, which in the opinion of the surgeon, require a small ligating clip. The Multifire Clip Applier may be used during endoscopic procedures such as the endoscopic harvesting of the Internal Mammary Artery.

Device Story

Sterile, single-use, disposable surgical instrument; contains 15 pre-loaded titanium hemostatic clips. Operates by automatically delivering and closing clips onto blood vessels; eliminates manual clip loading. Used by surgeons in endoscopic or open surgical settings. Provides hemostasis for vessels; facilitates vessel ligation during procedures like Internal Mammary Artery harvesting. Benefits patient by enabling efficient, secure vessel closure during minimally invasive surgery.

Clinical Evidence

In vitro performance testing evaluated clip feeding and closure functions. In vivo studies conducted to confirm safety and effectiveness for intended clinical use.

Technological Characteristics

Materials: Titanium (biocompatible, identical to Pilling Weck Hemoclip S15). Form factor: Disposable, multi-fire clip applier. Mechanism: Automatic clip feeding and closure. Sterilization: Sterile.

Indications for Use

Indicated for ligation of blood vessels requiring small hemostatic clips during surgical procedures, including endoscopic procedures such as Internal Mammary Artery harvesting.

Regulatory Classification

Identification

A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels.

Predicate Devices

• Pilling Weck - Hemoclip S15 Automatic Applier
• U.S. Surgical - PREMIUM SURGICLIP Disposable Automatic Clip Applier
• U.S. Surgical - ENDO CLIP Disposable Appliers
• Ethicon - LIGACLIP Endoscopic Clip Applier

Submission Summary (Full Text)

{0}

Multifire Clip Applier
K961333
Appendices

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

NOV 15 1996

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: April 5, 1996

Name: Heartport, Inc.
Address: 200 Chesapeake Drive
Redwood City, CA 94063

Contact Person: Isabella Abati
Phone Number: [phone]
Fax Number: [phone]

## Device Information:

Classification: Class II
Trade Name: Heartport Multifire Clip Applier
Common Name: Implantable Clip/Vascular Clip/Hemostatic Clip Applier
Classification Name: Surgical Devices: Implantable Clip, 21 CFR 878.4300
Cardiovascular Prosthetic Devices: Vascular Clip, 21 CFR 870.3250

## Equivalent Devices:

The Heartport Multifire Clip Applier is substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:

1. Pilling Weck - Hemoclip S15 Automatic Applier
2. U.S. Surgical - PREMIUM SURGICLIP Disposable Automatic Clip Applier
3. U.S. Surgical - ENDO CLIP Disposable Appliers
4. Ethicon - LIGACLIP Endoscopic Clip Applier

Heartport, Inc.
CONFIDENTIAL
Page 18

{1}

Multifire Clip Applier
K961333
Appendices

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

## Intended Use

The Multifire Clip Applier is designed to automatically deliver small hemostatic clips for ligation of blood vessels. The device is intended for use on vessels, which in the opinion of the surgeon, require a small ligating clip. The Multifire Clip Applier may be used during endoscopic procedures such as the endoscopic harvesting of the Internal Mammary Artery.

## Comparison To Predicate Devices

The Heartport Multifire Clip Applier is a sterile, single, use disposable device containing 15 small Titanium ligating clips. The device is designed to automatically deliver small hemostatic clips for ligation of blood vessels. The Multifire Clip Applier is equivalent in intended use and operational characteristics to the following devices: (1) Pilling Weck - Hemoclip S15 Automatic Applier, (2) U.S. Surgical - PREMIUM SURGICLIP Disposable Automatic Clip Applier, (3) U.S. Surgical - ENDO CLIP Disposable Appliers and (4) Ethicon - LIGACLIP Endoscopic Clip Applier. All predicates deliver and close a sequence of ligating clips automatically without the need for manual loading of individual clips. The Heartport Multifire Clip Applier combines the same functions as the individual predicate devices into a single clip applier.

## Non-Clinical Test Results

### Performance:

The Multifire Clip Applier was evaluated *in vitro* for clip feeding and clip closure functions. In addition, the Clip Applier was evaluated during *in vivo* studies. Performance testing demonstrated that the Heartport Multifire Clip Applier was safe and effective, while meeting the anticipated clinical requirements for its intended use.

### Biocompatibility:

The patient contacting materials used in the Multifire Clip Applier are identical to those used in the Pilling Weck - Hemoclip S15 Automatic Applier.

## Summary

Based on the product information, intended use, performance and biocompatibility data provided in this Notification, the Heartport Multifire Clip Applier has been shown to be substantially equivalent to currently marketed predicate devices.

Heartport, Inc.
CONFIDENTIAL
Page 19