(149 days)
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No
The device description and performance studies focus on the physical properties and functional performance of a medical cannula, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as a delivery mechanism for a therapeutic solution (cardioplegia solution) and for air aspiration, but it is not itself a therapeutic agent or device that directly treats a condition.
No
The device is a cannula used during open-heart surgery to deliver cardioplegia solution and aspirate air, which are therapeutic and procedural functions, not diagnostic.
No
The device description clearly outlines physical components made of materials like polyvinyl chloride, polycarbonate, and stainless steel, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Chase Medical aortic root cannula is a surgical device used during a surgical procedure (cardiopulmonary bypass surgery) to deliver a solution directly into the patient's aorta and to aspirate air. It is used on the patient, not to test specimens from the patient.
- Intended Use: The intended use clearly states its purpose is for delivering cardioplegia solution and aspirating air during surgery. This is a therapeutic and procedural use, not a diagnostic one.
The description and intended use of this device align with a surgical instrument used directly on a patient, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
Chase Medical aortic root cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.
Product codes
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Device Description
During open-heart surgery, the patient's heart is temporarily stopped to allow the surgeon a bloodless, still surface in order to complete the surgical repair. The process of stopping the heart is often achieved by infusing into the heart a solution containing various drugs which act to stop and preserve the heart. This cardioplegia solution is delivered into the heart by way of the aorta and/or into vein grafts. The Chase Aortic Root Cannula is placed into the ascending aorta to deliver cardioplegia solution to the heart. The cannula may be used to aspirate air from the aorta at the conclusion of the bypass procedure.
The Aortic Root Cannula consists of flexible polyvinyl chloride tubing permanently attached to both the polycarbonate inlet and soft, flexible, polyvinyl chloride tip. Tip sizes include 12 gauge. The inlet fitting is a female luer fitting. The suture ring is soft polyvinyl chloride. The introducer is stainless steel and packaged within the cannula body. The vented Aortic Root Cannula has polyvinyl chloride tubing with a polycarbonate vent line adaptor and vented tip sizes include 12 gauge and 14 gauge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
ascending aorta
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
All functional characteristics of the Chase Medical Aortic Root Cannula are non-differentiable 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 4°C and 40°C
Tubing Bond Strength: Exceeds 10 lb. tensile strength @ 4°C and 40°C
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
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE MEDICAL AORTIC ROOT CANNULA
l. General Information
| A. Generic Name: | Aortic Root Cannula |
|---|---|
| B. Trade Name of Device: | Chase Aortic Root Cannula |
| C. Applicant's Name and Address: | Chase Medical Inc. |
| 1876 Firman Drive. | |
| Richardson, Texas 75081 | |
| D. Pre-market Notification Number: | Not yet assigned |
11. Indications for Use
Chase Medical aortic root cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.
III. Device Description
During open-heart surgery, the patient's heart is temporarily stopped to allow the surgeon a bloodless, still surface in order to complete the surgical repair. The process of stopping the heart is often achieved by infusing into the heart a solution containing various drugs which act to stop and preserve the heart. This cardioplegia solution is delivered into the heart by way of the aorta and/or into vein grafts. The Chase Aortic Root Cannula is placed into the ascending aorta to deliver cardioplegia solution to the heart. The cannula may be used to aspirate air from the aorta at the conclusion of the bypass procedure.
The Aortic Root Cannula consists of flexible polyvinyl chloride tubing permanently attached to both the polycarbonate inlet and soft, flexible, polyvinyl chloride tip. Tip sizes include 12 gauge. The inlet fitting is a female luer fitting. The suture ring is soft polyvinyl chloride. The introducer is stainless steel and packaged within the cannula body. The vented Aortic Root Cannula has polyvinyl chloride tubing with a polycarbonate vent line adaptor and vented tip sizes include 12 gauge and 14 gauge.
IV. Device Classification: Class II
V. Safety and Effectiveness
The device is substantially equivalent to the Substantial Equivalence: DLP, Inc. Aortic Root Cannula K790565.
VI. Other Safety and Effectiveness Data
Materials: All material are identical to the predicate device. Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10° Sterilization:
1
SUMMARY OF SAFETY AND EFFECTIVENESS
Functional Testing
All functional characteristics of the Chase Medical Aortic Root Cannula are non-differentiable 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 4°C
and 40°C |
|----------------------------------|-------------------------------------------------------------------------|
| Tubing Bond Strength: | Exceeds 10 lb. tensile strength @ 4°C and 40°C |
| 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 |