CHASE AORTIC PERFUSION CANNULA

K970914 · Chase Medical, Inc. · DWF · May 13, 1997 · Cardiovascular

Device Facts

• Record ID: K970914
• Device Name: CHASE AORTIC PERFUSION CANNULA
• Applicant: Chase Medical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: May 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aortic Perfusion Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass. Additionally, the Aortic Perfusion Cannula can be used to occlude the ascending aorta as well as deliver cardioplegia solution to and aspirate air from the aorta.

Device Story

Three-lumen cannula; primary lumen returns oxygenated blood from extracorporeal circuit to ascending aorta; second lumen inflates distal balloon for aortic occlusion; third lumen delivers cardioplegia solution via proximal orifices; used by surgeons during cardiopulmonary bypass; facilitates perfusion, occlusion, and cardioplegia delivery in single device.

Clinical Evidence

Bench testing only; functional characteristics compared to predicates.

Technological Characteristics

Three-lumen cannula; distal balloon; cardioplegia delivery orifices; materials identical to predicate devices; sterilization via 100% Ethylene Oxide (Overkill Method) to SAL 10⁻⁶.

Indications for Use

Indicated for patients undergoing surgical procedures requiring cardiopulmonary bypass; used for ascending aorta perfusion, aortic occlusion, cardioplegia delivery, and air aspiration.

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

• Sarns Aortic Arch Cannula (K770429)
• DLP Aortic Root Cannula (K790565)

Submission Summary (Full Text)

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K970914
MAY 13 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CHASE AORTIC PERFUSION CANNULA

### I. General Information

A. Generic Name: Aortic Perfusion Cannula

B. Trade Name of Device: CHASE AORTIC PERFUSION CANNULA

C. Applicant’s Name and Address: CHASE MEDICAL INC., Richardson, TX

D. Pre-market Notification Number: Not assigned

### II. Indication for Use:

The Aortic Perfusion Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass. Additionally, the Aortic Perfusion Cannula can be used to occlude the ascending aorta as well as deliver cardioplegia solution to and aspirate air from the aorta.

### III. Device Description

The CHASE Aortic Perfusion Cannula is a three lumen cannula. The primary lumen is the conduit that returns oxygenated blood from the extracorporeal circuit to the ascending aorta. A second lumen allows a balloon to be inflated at the distal tip of the cannula. A third lumen delivers cardioplegia solution through orifices proximal to the balloon.

### IV. Device Classification: Class II device

### V. Safety and Effectiveness:

Substantial Equivalence: This device is substantially equivalent to the combination of Sarns Aortic Arch Cannula (K770429), DLP Aortic Root Cannula (K790565), and an aortic cross clamp.

### VI. Other Safety and Effectiveness Data:

Materials: All materials are identical to materials used in similar devices that have similar intended uses.

Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶

## Functional Testing

All functional characteristics of the Chase Medical Aortic Perfusion Cannula are non-differentiable as compared with the predicates.