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
Indications 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.
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.
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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.
