(88 days)
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No
The device description and intended use describe a purely mechanical device for occluding blood vessels. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is used to occlude blood vessels to create a bloodless field during anastomosis in coronary artery bypass procedures, which is a therapeutic intervention.
No
Explanation: The device is used to occlude blood vessels during anastomosis to create a bloodless field, which is a therapeutic function, not a diagnostic one. It does not provide information about a patient's health status.
No
The device description explicitly states it is composed of physical components (silicone rubber bulbs, flexible shaft, tab, tether) and is used internally to occlude blood vessels, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "internally occlude blood vessels during anastomosis." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical device (silicone rubber bulbs on a shaft) used to physically block blood flow within a vessel.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) outside of the body to provide diagnostic information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.
This device is clearly intended for in vivo use (within the living body) during a surgical procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Vessel Occluder is intended to be used to internally occlude blood vessels during anastomosis.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Vessel Occluder is composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a "T" configuration. Vessel Occluders are useful in coronary artery bypass procedures to create a bloodless field at the anastomosis. The occluder bulbs are inserted proximally and distally through the vessel opening. The occluder bulbs allow a dry field to be maintained during the anastomosis of bypass graft.
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
blood vessels
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial Equivalence: This device has been shown to be substantially equivalent to the Bio-Vascular "Flo-Rester" vessel occluder (K883696).
All functional characteristics of the Chase Vessel Occluder are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
Bond Strength: Exceeds ().4 Ib tensile strength (@ 4°C and 40°C
Package Integrity: Tyvek/Polymylar passed burst test por ASTM F1140-88
Shipping & Distribution Tcsting: Per National Safe Transit Assoc. Vibration and drop tests
Accelerated Aging: Five year shelf life
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE VESSEL OCCLUDER
General Information I.
| A. Generic Name: | Vessel Occluder |
|---|---|
| B. Trade Name of Device: | CHASE VESSEL OCCLUDER |
| C. Applicant's Name and Address: | CHASE MEDICAL INC., Richardson, TX |
| D. Pre-market Notification Number: | Not assigned |
II. Indication for Use:
The Vessel Occluder is intended to be used to internally occlude blood vessels during anastomosis.
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Device Description III.
The Vessel Occluder is composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a "T" configuration. Vessel Occluders are useful in coronary artery bypass procedures to create a bloodless field at the anastomosis. The occluder bulbs are inserted proximally and distally through the vessel opening. The occluder bulbs allow a dry field to be maintained during the anastomosis of bypass graft. -
IV. Device Classification: Class II device
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V. Safety and Effectiveness:
Substantial Equivalence: This device has been shown to be substantially equivalent to the Bio-Vascular "Flo-Rester" vessel occluder (K883696).
- 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 Vessel Occluder are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
1
FROM Chase Medical 2142353446
SUMMARY OF SAFETY AND EFFECTIVENESS
Bond Strength:
Package Integrity:
Exceeds ().4 Ib tensile strength (@ 4°C and 40°C
Tyvek/Polymylar passed burst test por ASTM F1140-88
Shipping & Distribution Tcsting:
Per National Safe Transit Assoc. Vibration and drop tests
Accelerated Aging:
Five year shelf life