CHASE AORTIC ARCH CANNULA

K964193 · Chase Medical, Inc. · DWF · Apr 16, 1997 · Cardiovascular

Device Facts

• Record ID: K964193
• Device Name: CHASE AORTIC ARCH CANNULA
• Applicant: Chase Medical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aortic Arch Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass in cases where aortic perfusion is deemed appropriate.

Device Story

Aortic arch cannula; used for perfusion of ascending aorta during cardiopulmonary bypass. Device features curved thin-wall beveled stainless steel tip; rigid plastic retention collar with indexing point for tip orientation; suture notches for securement; flexible plastic tubing; molded plastic connector for perfusion line attachment. Operated by surgeons in OR. Provides conduit for blood flow during bypass; facilitates surgical access to heart/aorta. Benefits patient by enabling extracorporeal circulation during cardiac surgery.

Clinical Evidence

Bench testing only. Leak testing (10 psi at 4°C and 40°C); tubing bond strength (>10 lb tensile at 4°C and 40°C); package integrity (ASTM F1140-88); shipping/distribution testing (NSTA vibration/drop); accelerated aging (2-year shelf life).

Technological Characteristics

Stainless steel tip; rigid plastic retention collar; flexible plastic tubing. Sterilization: Ethylene Oxide (Overkill Method, SAL 10⁻⁶). Packaging: Tyvek/Polymylar per ASTM F1140-88.

Indications for Use

Indicated for patients undergoing surgical procedures requiring cardiopulmonary bypass where ascending aortic perfusion is appropriate.

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)

Submission Summary (Full Text)

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K964193
APR 16 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CHASE AORTIC ARCH CANNULA

### I. General Information

A. Generic Name: Aortic Arch Cannula
B. Trade Name of Device: CHASE AORTIC ARCH 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 Arch Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass in cases where aortic perfusion is deemed appropriate.

### III. Device Description

The CHASE Aortic Arch Cannula consists of a curved thin-wall beveled stainless steel tip and a retention collar molded of rigid plastic with an indexing point which indicates the tip orientation when the cannula is in the aorta. The collar has two suture notches for holding the cannula in place. A short length of clear, flexible plastic tubing is attached to the collar. A molded plastic connector of rigid plastic attached to the flexible tube allows connection of the perfusion line to the cannula.

### IV. Device Classification: Class II device

### V. Safety and Effectiveness:

Substantial Equivalence: This device is substantially equivalent to the Sarns Aortic Arch Cannula K770429.

### 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 Aortic Arch 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

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