(177 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional equivalence to a predicate device, with no mention of AI or ML.
No.
The device is described as a cannula used for perfusion during surgical procedures, which is a tool for delivering substances rather than directly treating a disease or condition itself.
No
Explanation: The device description and intended use indicate that it is a cannula used for perfusion during surgical procedures, not for diagnosing a condition.
No
The device description clearly outlines physical components made of stainless steel and plastic tubing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass." This describes a device used in vivo (within the body) for a surgical procedure, not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description details a physical device (cannula) designed to be inserted into the aorta. This is consistent with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Aortic Arch Cannula is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Aortic Arch Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass in cases where aortic perfusion is deemed appropriate.
Product codes
Not Found
Device Description
The CHASE Aortic Arch Cannula consists of a curved thin-wall beveled stainless steel tip and a retention collar molded of rigid plastic with an indexing point which indicates the tip orientation when the cannula is in the aorta. The collar has two suture notches for holding the cannula in place. A short length of clear, flexible plastic tubing is attached to the collar. A molded plastic connector of rigid plastic attached to the flexible tube allows connection of the to the cannula.
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
Functional Testing
All functional characteristics of the Chase Medical Aortic Arch Cannula are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
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
APR 16 1997
18
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE AORTIC ARCH CANNULA
I. General Information
| A. Generic Name: | Aortic Arch Cannula |
|---|---|
| B. Trade Name of Device: | CHASE AORTIC ARCH 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 Arch Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass in cases where aortic perfusion is deemed appropriate.
-
III. Device Description
The CHASE Aortic Arch Cannula consists of a curved thin-wall beveled stainless steel tip and a retention collar molded of rigid plastic with an indexing point which indicates the tip orientation when the cannula is in the aorta. The collar has two suture notches for holding the cannula in place. A short length of clear, flexible plastic tubing is attached to the collar. A molded plastic connector of rigid plastic attached to the flexible tube allows connection of the to the cannula. -
IV. Device Classification: Class II device
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V. Safety and Effectiveness:
Substantial Equivalence: This device is substantially equivalent to the Sarns Aortic Arch Cannula K770429.
- 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-
Functional Testing
All functional characteristics of the Chase Medical Aortic Arch Cannula are non-differentiable 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:
Tubing Bond Strength:
Package Integrity:
Shipping & Distribution Testing:
Accelerated Aging:
No leaks at 10 psi air on Chase device at 4℃ and 40°C
Exceeds 10 lb. tensile strength @ 4°C and 40°C
Tyvek/Polymylar passed burst test per ASTM F1140-88
Per National Safe Transit Ass. vibration and drop tests
Two year shelf life
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