(53 days)
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No
The device description and performance studies focus on the physical characteristics and functional performance of a mechanical cannula, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for delivery of cardioplegia solutions directly to the coronary arteries during cardiopulmonary bypass surgery, which is a therapeutic intervention.
No
Explanation: The device is used for delivery of cardioplegia solutions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical cannula made of a basket style tip and a malleable stainless steel tube, terminating in a luer fitting. This is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering solutions directly to the coronary arteries during surgery. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical instrument used for delivering fluids, not a reagent, kit, or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for direct delivery of a substance to a patient's anatomy.
N/A
Intended Use / Indications for Use
The Coronary Ostial Perfusion Cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solutions directly to the coronary arteries.
Product codes
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Device Description
These cannulae consist of a basket style tip attached to a malleable stainless steel tube. The cannula terminates with a locking female luer fitting.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
coronary arteries
Indicated Patient Age Range
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Intended User / Care Setting
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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
Functional Testing: All functional characteristics of the Chase Coronary Ostial Perfusion Cannula are non-differentiable as compared with the predicate.
Leak Test Requirements: No leaks at 10 psi air on Chase device.
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
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Predicate Device(s)
Medtronic/DLP Coronary Ostial Perfusion Cannula.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '9', '7', '1', '0', '4', and '1'. The handwriting style is simple and clear, with each character distinctly formed. The numbers and letter are all in black ink, contrasting with the white background.
MAY 13 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE CORONARY OSTIAL PERFUSION CANNULA
| I. | General Information | |
|---|---|---|
| A. Generic Name: | Coronary Ostial Perfusion Cannula | |
| B. Trade Name of Device: | Chase Coronary Ostial Perfusion Cannula | |
| C. Applicant's Name and Address: | CHASE MEDICAL, INC., Richardson, TX | |
| D. Pre-market Notification Number: | Not assigned | |
| II. | Indication for Use: | |
| The Coronary Ostial Perfusion Cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solutions directly to the coronary arteries. | ||
| III. | Device Description | |
| These cannulae consist of a basket style tip attached to a malleable stainless steel tube. The cannula terminates with a locking female luer fitting. | ||
| IV. | Device Classification: | Class II device |
| V. | Safety and Effectiveness: | |
| Substantial Equivalence: | This device has been shown to be substantially equivalent to the Medtronic/DLP Coronary Ostial Perfusion Cannula. | |
| 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 -6 |
Functional Testing
All functional characteristics of the Chase Coronary Ostial Perfusion Cannula are non-differentiable as compared with the predicate.
1
SUMMARY OF SAFETY AND EFFECTIVENESS
Leak Test Requirements:
Luer Connections:
Package Integrity:
Shipping & Distribution Testing:
Accelerated Aging:
No leaks at 10 psi air on Chase device.
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