(149 days)
No
The device description and performance studies focus on the physical characteristics and functional performance of a mechanical cannula, with no mention of AI or ML.
Yes.
The device is intended for use in perfusing cardioplegia solutions, which is a therapeutic intervention to protect the heart during cardiac surgery.
No
This device is designed to perfuse cardioplegia solutions and monitor pressure within the coronary sinus, which are therapeutic and monitoring functions, not diagnostic.
No
The device description clearly outlines physical components such as a triple lumen cannula, balloon, stylet, and syringe, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The CHASE coronary sinus perfusion cannula is a surgical device used to deliver solutions directly into the coronary sinus within the body (in vivo). It is used for a therapeutic purpose (perfusing cardioplegia) during a medical procedure.
The description clearly outlines a device used for direct intervention within the body, not for testing samples taken from the body.
N/A
Intended Use / 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Leak Test Requirements: No leaks at 10 psi air on Chase device at 4ºC and 40°C
Tubing Bond Strength: Exceeds 10 lb. tensile strength @ 4℃ and 40℃
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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