CHASE CORONARY SINUS PERFUSION CANNULA

K964199 · Chase Medical, Inc. · DWF · Mar 19, 1997 · Cardiovascular

Device Facts

• Record ID: K964199
• Device Name: CHASE CORONARY SINUS PERFUSION CANNULA
• Applicant: Chase Medical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Mar 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CHASE coronary sinus perfusion cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.

Device Story

Triple-lumen cannula for retrograde cardioplegia delivery; transatrial placement. Main lumen delivers cardioplegia/blood; second lumen monitors pressure; third lumen inflates/deflates distal balloon. Includes stylet for placement and syringe for balloon control. Used in OR by cardiac surgeons. Wire-reinforced silicone body. Output: cardioplegia delivery and pressure monitoring. Benefits: enables myocardial protection during cardiac procedures.

Clinical Evidence

Bench testing only. Testing included leak testing (10 psi at 4°C/40°C), tubing bond strength (>10 lb tensile), Luer connection compliance (ANSI/HIMA MD70.1-1983), package integrity (ASTM F1140-88), shipping/distribution vibration/drop tests, and accelerated aging (2-year shelf life).

Technological Characteristics

Triple-lumen cannula; wire-reinforced silicone body. Luer connections per ANSI/HIMA MD70.1-1983. Packaging: Tyvek/Polymylar per ASTM F1140-88. Sterilization: Ethylene Oxide (Overkill Method, SAL 10⁻⁶).

Indications for Use

Indicated for patients undergoing cardiac surgery requiring retrograde cardioplegia delivery via the coronary sinus.

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

• Quest Coronary Sinus Perfusion Cannula (K941166)

Submission Summary (Full Text)

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K964199
MAR 19 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CHASE MEDICAL CORONARY SINUS PERFUSION CANNULA

### I. General Information

A. Generic Name: Coronary Sinus Perfusion Cannula
B. Trade Name of Device: Chase Coronary Sinus Perfusion Cannula
C. Applicant's Name and Address: Chase Medical Inc.
1876 Firman Drive.
Richardson, Texas 75081
D. Pre-market Notification Number: Not yet assigned

### II. Indications for Use

The CHASE coronary sinus perfusion cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.

### III. Device Description

The CHASE coronary sinus perfusion cannula is a triple lumen cannula. The main lumen is the delivery conduit for blood or cardioplegia solution. A second lumen is a pressure monitoring line and begins at the tip of the cannula and terminates with a connector for coupling to a pressure monitoring device. A third lumen is used as a means to inject or withdraw air or fluid for the inflation and deflation of a balloon located near the tip of the cannula. The cannula's silicone body is reinforced with wire wound axially along the length of the cannula. A stylet is included to facilitate transatrial placement of the cannula into the coronary sinus. A syringe is included for balloon inflation and deflation.

### IV. Device Classification: Class II

### V. Safety and Effectiveness

Substantial Equivalence: The device is substantially equivalent to the Quest Coronary Sinus Perfusion Cannula K941166.

### VI. Other Safety and Effectiveness Data

Materials: All material are identical to the predicate device.
Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶

### Functional Testing

All functional characteristics of the Chase Medical coronary sinus perfusion cannula are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.

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# SUMMARY OF SAFETY AND EFFECTIVENESS

Leak Test Requirements: No leaks at 10 psi air on Chase device at 4°C and 40°C

Tubing Bond Strength: Exceeds 10 lb. tensile strength @ 4°C and 40°C

Luer Connections: Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings

Package Integrity: Tyvek/Polymylar passed burst test per ASTM F1140-88

Shipping & Distribution Testing: Per National Safe Transit Ass. vibration and drop tests

Accelerated Aging: Two year shelf life