CAHSE AORTIC ROOT CANNULA

K964198 · Chase Medical, Inc. · DWF · Mar 19, 1997 · Cardiovascular

Device Facts

• Record ID: K964198
• Device Name: CAHSE AORTIC ROOT 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

Intended Use

Chase Medical aortic root cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

Device Story

Aortic root cannula used during open-heart surgery; facilitates delivery of cardioplegia solution to stop/preserve heart; enables aspiration of air from aorta post-bypass. Device consists of flexible PVC tubing, polycarbonate inlet, soft PVC tip, and stainless steel introducer. Vented version includes vent line adaptor. Operated by surgeons in clinical/OR settings. Provides bloodless, still surgical field. Benefits patient by enabling safe cardiac arrest and air removal during bypass procedures.

Clinical Evidence

Bench testing only. Testing included leak tests (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), and shipping/distribution vibration/drop tests. Accelerated aging supports two-year shelf life.

Technological Characteristics

Materials: PVC tubing, polycarbonate inlet/vent adaptor, stainless steel introducer. Dimensions: 12G and 14G tips. Connectivity: Female luer fitting. Sterilization: Ethylene Oxide (Overkill Method, SAL 10⁻⁶). Standards: ANSI/HIMA MD70.1-1983 (luer), ASTM F1140-88 (package burst).

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring cardioplegia solution delivery or aortic 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

• DLP, Inc. Aortic Root Cannula (K790565)

Submission Summary (Full Text)

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K964198
MAR 19 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CHASE MEDICAL AORTIC ROOT CANNULA

### I. General Information

A. Generic Name: Aortic Root Cannula
B. Trade Name of Device: Chase Aortic Root 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

Chase Medical aortic root cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

### III. Device Description

During open-heart surgery, the patient’s heart is temporarily stopped to allow the surgeon a bloodless, still surface in order to complete the surgical repair. The process of stopping the heart is often achieved by infusing into the heart a solution containing various drugs which act to stop and preserve the heart. This cardioplegia solution is delivered into the heart by way of the aorta and/or into vein grafts. The Chase Aortic Root Cannula is placed into the ascending aorta to deliver cardioplegia solution to the heart. The cannula may be used to aspirate air from the aorta at the conclusion of the bypass procedure.

The Aortic Root Cannula consists of flexible polyvinyl chloride tubing permanently attached to both the polycarbonate inlet and soft, flexible, polyvinyl chloride tip. Tip sizes include 12 gauge and 14 gauge. The inlet fitting is a female luer fitting. The suture ring is soft polyvinyl chloride. The introducer is stainless steel and packaged within the cannula body. The vented Aortic Root Cannula has polyvinyl chloride tubing with a polycarbonate vent line adaptor and vented tip sizes include 12 gauge and 14 gauge.

### IV. Device Classification: Class II

### V. Safety and Effectiveness

Substantial Equivalence: The device is substantially equivalent to the DLP, Inc. Aortic Root Cannula K790565.

### 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

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# SUMMARY OF SAFETY AND EFFECTIVENESS

## Functional Testing

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

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