(149 days)
The CHASE coronary sinus perfusion cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
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 silcone 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.
This document is a "Summary of Safety and Effectiveness" for a medical device, specifically a "Coronary Sinus Perfusion Cannula." It details the device's purpose, description, classification, and claims of substantial equivalence to a predicate device.
The document describes functional testing and other safety/effectiveness data. However, it does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML device performance. The information provided pertains to the physical and functional aspects of a traditional medical device (cannula), including material composition, sterilization, leak tests, bond strength, and packaging integrity.
Therefore, I cannot fulfill your request for the detailed table and analysis related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies. This document does not describe an AI/ML device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a handwritten string of numbers and letters. The string appears to be "K964199". The handwriting is in black ink and is somewhat stylized. The numbers and letters are connected, giving the impression of a single, continuous stroke.
MAR 1 9 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE MEDICAL CORONARY SINUS PERFUSION CANNULA
General Information l.
| 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 |
ll. 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.
011. 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 silcone 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
Safety and Effectiveness V.
Substantial Equivalence: The device is substantially equivalent to the Quest Coronary Sinus Perfusion Cannula K941166.
VI. Other Safety and Effectiveness Data
All material are identical to the predicate device. Materials: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10° Sterilization:
Functional Testing
All functional characteristics of the Chase Medical coronary sinus perfusion cannula are nondifferentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
{1}------------------------------------------------
SUMMARY OF SAFETY AND EFFECTIVENESS
Leak Test Requirements:
No leaks at 10 psi air on Chase device at 4ºC and 40°C
Tubing Bond Strength:
Luer Connections:
Package Integrity:
Shipping & Distribution Testing:
Accelerated Aging:
Exceeds 10 lb. tensile strength @ 4℃ and 40℃
Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings
Tyvek/Polymylar passed burst test per ASTM F1140-88
Per National Safe Transit Ass. vibration and drop tests
Two year shelf life
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
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.(b)
Classification. Class II (performance standards).