(170 days)
Not Found
No
The device description and performance studies focus on mechanical function and material composition, with no mention of AI or ML.
No.
The device is used to perfuse solutions during surgery and does not directly treat or cure a disease or condition.
No
This device is a cannula intended for perfusing solutions during surgery, not for diagnosing conditions. The pressure monitoring lumen is for operational monitoring during infusion, not for diagnostic purposes.
No
The device description clearly describes a physical cannula with lumens, a balloon, and a stylet, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Chase Retrograde Cardioplegia Cannula is a surgical device used during cardiopulmonary bypass surgery to deliver solutions directly into the coronary sinus. It is an invasive device used in vivo (within the living body) for therapeutic and procedural purposes, not for testing samples in vitro (outside the living body).
- Intended Use: The intended use clearly states "perfusion of blood or cardioplegia solutions via the coronary sinus during cardiopulmonary bypass surgery." This is a surgical procedure, not a diagnostic test.
The device description and intended use clearly indicate it's a surgical tool for delivering fluids during a medical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Chase Retrograde Cardioplegia Cannula is intended for use in perfusing blood or cardioplegia solutions via the coronary sinus during cardiopulmonary bypass surgery.
Product codes
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Device Description
The Chase Retrograde Cardioplegia Cannula is a dual lumen 14 FR cannula. The cannula body contains a primary lumen for infusing blood or cardioplegia solutions and a secondary pressure monitoring lumen that begins at the cannula's tip and terminates in a stopcock with a female luer lock. During infusions, differential pressures occurring within the cannula automatically inflate a soft, low pressure balloon located near the cannula's distal tip. When flow ceases, the balloon spontaneously deflates. A stylet is also provided to aid transatrial cannula placement within the coronary sinus.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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 Retrograde Cardioplegia Cannula are nondifferentiable 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
K0664393 APR 23 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE RETROGRADE CARDIOPLEGIA CANNULA
General Information l.
| A. Generic Name: | Retrograde Cardioplegia Cannula |
|---|---|
| B. Trade Name of Device: | CHASE Retrograde Cardioplegia Cannula |
| C. Applicant's Name and Address: | CHASE Medical Inc. |
| 1876 Firman Drive. | |
| Richardson, Texas 75081 | |
| D. Pre-market Notification Number: | Not yet assigned |
0. Indications for Use
The Chase Retrograde Cardioplegia Cannula is intended for use in perfusing blood or cardioplegia solutions via the coronary sinus during cardiopulmonary bypass surgery.
III. Device Description
The Chase Retrograde Cardioplegia Cannula is a dual lumen 14 FR cannula. The cannula body contains a primary lumen for infusing blood or cardioplegia solutions and a secondary pressure monitoring lumen that begins at the cannula's tip and terminates in a stopcock with a female luer lock. During infusions, differential pressures occurring within the cannula automatically inflate a soft, low pressure balloon located near the cannula's distal tip. When flow ceases, the balloon spontaneously deflates. A stylet is also provided to aid transatrial cannula placement within the coronary sinus.
IV. Device Classification: Class II
V. Safety and Effectiveness
Substantial Equivalence: The device is substantially equivalent to the Research Medical Retrograde Cardioplegia Cannula (K880103).
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 Retrograde Cardioplegia 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°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 |