(177 days)
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No
The device description and performance studies focus on the physical and functional characteristics of a medical device used in cardiopulmonary bypass surgery, with no mention of AI or ML.
Yes
This device is used in conjunction with cardiopulmonary bypass surgery for simultaneous perfusion of the aortic root and 3 or 4 vein grafts, which is a therapeutic intervention.
No
The device is used for delivering cardioplegia solution during open-heart surgery, which is a treatment or surgical support function, not a diagnostic one.
No
The device description and performance studies clearly indicate a physical medical device (perfusion set) used in cardiopulmonary bypass surgery, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "simultaneous perfusion of the aortic root and 3 or 4 vein grafts" during cardiopulmonary bypass surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a set used to deliver a "cardioplegia solution" into the heart during surgery. This is a therapeutic intervention, not a diagnostic test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) on samples to provide diagnostic information. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
Chase Medical multiple perfusion sets are intended for use in conjunction with cardiopulmonary bypass surgery for simultaneous perfusion of the aortic root and 3 or 4 vein grafts.
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 multiple perfusion set allows the simultaneous perfusion of cardioplegia into the aortic root and vein grafts.
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
Heart, aorta, vein grafts
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 Medical multiple perfusion set 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 4ºC and 40°C
Tubing Bond Strength: Exceeds 10 lb. tensile strength @ 4℃ and 40℃
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)
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).
0
K96400
510K Summary
Chase Medical Multiple Perfusion Set
General Information 1.
| A. Generic Name: | Multiple Perfusion Set |
|---|---|
| B. Trade Name of Device: | Chase Multiple Perfusion Set |
| C. Applicant's Name and Address: | Chase Medical Inc. |
| 1876 Firman Drive. | |
| Richardson, Texas 75081 | |
| D. Pre-market Notification Number: | Not yet assigned |
ll. Indications for Use
Chase Medical multiple perfusion sets are intended for use in conjunction with cardiopulmonary bypass surgery for simultaneous perfusion of the aortic root and 3 or 4 vein grafts.
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 multiple perfusion set allows the simultaneous perfusion of cardioplegia into the aortic root and vein grafts.
IV. Device Classification: Class II
Safety and Effectiveness V.
The device is substantially equivalent to the Substantial Equivalence: DLP, Inc. Multiple Perfusion Set # K791498.
VI. Other Safety and Effectiveness Data
All material are identical to the predicate device. Materials: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10° Sterilization:
Functional Testing
All functional characteristics of the Chase Medical multiple perfusion set are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
월
1
SUMMARY OF SAFETY AND EFFECTIVENESS
Leak Test Requirements:
Tubing Bond Strength:
Luer Connections:
Package Integrity:
Shipping & Distribution Testing:
Accelerated Aging:
No leaks at 10 psi air on Chase device at 4ºC and 40°C
Exceeds 10 lb. tensile strength @ 4℃ and 40℃
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