(62 days)
NOT APPLICABLE
No
The summary describes a mechanical device (cannula) with lumens and a balloon, and there is no mention of AI, ML, image processing, or data analysis related to the device's function.
Yes
This device is used for perfusion of the ascending aorta, to occlude the aorta, and to deliver cardioplegia solution, all of which are direct interventions aimed at treating a medical condition during surgery.
No
Explanation: The device is described as an "Aortic Perfusion Cannula" used for perfusing and occluding the aorta, and delivering/aspirating solutions during surgical procedures. Its function is to facilitate
cardiopulmonary bypass and cardioplegia delivery, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly describes a physical, three-lumen cannula, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a cannula used for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass. It is a physical device used in vivo (within the body) to manage blood flow and deliver solutions directly to the aorta.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition. Its function is purely therapeutic and procedural.
Therefore, the Aortic Perfusion Cannula is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aorta
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
All functional characteristics of the Chase Medical Aortic Perfusion Cannula are non-differentiable as compared with the predicates.
Key Metrics
Not Found
Predicate Device(s)
Sams Aortic Arch Cannula (K770429), DLP Aortic Root Cannula (K790565)
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
MAY 13 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE AORTIC PERFUSION CANNULA
| General Information |
|---|
| --------------------- |
I
| 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 |
Indication for Use: ll.
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 Description III.
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. -
Class II device IV. Device Classification:
-
V. Safety and Effectiveness:
Substantial Equivalence: This device is substantially equivalent to the combination of Sams 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.