CHASE CORONARY OSTIAL PERFUSION CANNULA

K971041 · Chase Medical, Inc. · DWF · May 13, 1997 · Cardiovascular

Device Facts

• Record ID: K971041
• Device Name: CHASE CORONARY OSTIAL 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 Coronary Ostial Perfusion Cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solutions directly to the coronary arteries.

Device Story

Device consists of basket-style tip attached to malleable stainless steel tube; terminates in locking female luer fitting. Used during cardiopulmonary bypass surgery by surgeons to deliver cardioplegia solutions directly to coronary arteries. Device provides localized perfusion; ensures secure connection via luer fitting. Benefits include reliable delivery of cardioplegic agents to maintain myocardial protection during bypass.

Clinical Evidence

Bench testing only. Testing included leak testing at 10 psi, luer connection compliance with ANSI/HIMA MD70.1-1983, package integrity testing per ASTM F1140-88, shipping/distribution vibration and drop tests, and accelerated aging for two-year shelf life validation.

Technological Characteristics

Malleable stainless steel tube with basket-style tip. Locking female luer fitting compliant with ANSI/HIMA MD70.1-1983. Sterilization via 100% Ethylene Oxide (Overkill Method, SAL 10⁻⁶). Packaging: Tyvek/Polymylar.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring direct delivery of cardioplegia solutions to the coronary arteries.

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

• Medtronic/DLP Coronary Ostial Perfusion Cannula

Submission Summary (Full Text)

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K971041
MAY 13 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CHASE CORONARY OSTIAL PERFUSION CANNULA

### I. General Information

A. Generic Name: Coronary Ostial Perfusion Cannula
B. Trade Name of Device: Chase Coronary Ostial 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 Coronary Ostial Perfusion Cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solutions directly to the coronary arteries.

### III. Device Description

These cannulae consist of a basket style tip attached to a malleable stainless steel tube. The cannula terminates with a locking female luer fitting.

### IV. Device Classification:

Class II device

### V. Safety and Effectiveness:

Substantial Equivalence: This device has been shown to be substantially equivalent to the Medtronic/DLP Coronary Ostial Perfusion Cannula.

### 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 Coronary Ostial Perfusion Cannula are non-differentiable as compared with the predicate.

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# SUMMARY OF SAFETY AND EFFECTIVENESS

| Leak Test Requirements: | No leaks at 10 psi air on Chase device. |
| --- | --- |
| 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 |