(212 days)
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No
The device description and performance studies focus on the mechanical function of a surgical shunt and do not mention any AI or ML components.
Yes.
The device is used to temporarily occlude the artery and provide blood flow distal to the arteriotomy during coronary artery bypass procedures, directly impacting a physiological function.
No
The device is a temporary shunt used during coronary artery bypass procedures to manage blood flow and reduce blood in the operative field. It does not perform any diagnostic function.
No
The device description clearly describes a physical, hollow tube with tips and seals, and a Shunt Remover, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a surgical procedure (MIDCAB) to manage blood flow in the coronary artery. This is an in vivo application, meaning it interacts directly with the living body.
- Device Description: The description details a physical device (hollow tube, tips, seals, tether, remover) designed for temporary insertion into an artery. This is consistent with a surgical tool or device, not a diagnostic test performed on samples outside the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions.
- Anatomical Site: The device is used in the coronary artery, which is an internal anatomical site. IVDs typically work with samples taken from the body.
In summary, the CTS MIDCAB Coronary Shunt is a surgical device used to facilitate a specific procedure, not a diagnostic tool used to analyze samples for medical information.
N/A
Intended Use / Indications for Use
The CTS MIDCAB Coronary Shunt is intended to be used during minimally invasive direct coronary artery bypass ("MIDCAB") procedures in conjunction with or without the CTS MIDCAB™ Access Platform and Stabilizer. The CTS Coronary Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This CTS Coronary Shunt is not an implant and is removed prior to completion of the surgery.
Product codes
870.445(),870.4475,876.5540
Device Description
The CTS MIDCAB Coronary Shunt is a hollow tube with atraumatic tips on each end and two seals which are utilized for proximal and distal occlusion of the artery. The atraumatic tips are tapered for easy insertion and removal from the artery. Each tip contains holes to provide for blood flow into and out of the CTS Shunt. The thread or tether is attached to a tab and is used to aid insertion and removal of the CTS Shunt. The blood is occluded and flows through the Shunt which reduces the blood in the operative field. Also included with the CTS MIDCAB Coronary Shunt is a Shunt Remover, which is a cylinder which can be used to withdraw the CTS Shunt following completion of the procedure.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional testing was conducted on the CTS MIDCAB Coronary Shunt to ensure that the Shunt would function according to its intended use instructions. All testing conducted confirmed the acceptability of the CTS Shunt to perform as intended to help reduce blood in the operative field by temporary occlusion of the artery while providing blood flow distal to the arteriotomy.
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.
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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.
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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
APR -3 1997
510(k) Summary CardioThoracic Systems, Inc. CTS MIDCAB™ Coronary Shunt 510(k) Notification K 963503
GENERAL INFORMATION
| Manufacturer: | CardioThoracic Systems, Inc.
10600 N. Tantau Avenue
Cupertino, California
(408) 342-1700
(408) 342-1717 FAX
Est. Reg. No. (awaiting issuance) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Billig
Vice President, Regulatory, Quality, and Clinical Research |
| Date Prepared: | August 31, 1996 |
DEVICE DESCRIPTION
| Classification: | Class II |
|---|---|
| Trade Name: | CTS MIDCAB Coronary Shunt |
| Generic/Common Name: | Vascular clamp 870.445() |
| Surgical vessel dilator 870.4475 | |
| Blood access device and accessories 876.5540 |
PREDICATE DEVICES
- Bio-Vascular, Inc. Flo-Rester (1)
- Research Medical, Inc. Yacoubian Clamp External Coronary Artery Occluder (2)
- Research Medical, Inc. Carotid Artery Shunts (3)
- Research Medical, Inc. Vacu-Sponge Surgical Sponge (4)
INTENDED USE
The CTS MIDCAB Coronary Shunt is intended to be used during minimally invasive direct coronary artery bypass ("MIDCAB") procedures in conjunction with or without the CTS MIDCAB™ Access Platform and Stabilizer. The CTS Coronary Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This CTS Coronary Shunt is not an implant and is removed prior to completion of the surgery.
1
PRODUCT DESCRIPTION
The CTS MIDCAB Coronary Shunt is a hollow tube with atraumatic tips on each end and two seals which are utilized for proximal and distal occlusion of the artery. The atraumatic tips are tapered for easy insertion and removal from the artery. Each tip contains holes to provide for blood flow into and out of the CTS Shunt. The thread or tether is attached to a tab and is used to aid insertion and removal of the CTS Shunt. The blood is occluded and flows through the Shunt which reduces the blood in the operative field. Also included with the CTS MIDCAB Coronary Shunt is a Shunt Remover, which is a cylinder which can be used to withdraw the CTS Shunt following completion of the procedure.
SUBSTANTIAL EQUIVALENCE
The CTS MIDCAB Coronary Shunt is substantially equivalent to predicate devices currently being marketed. The marketed predicate devices are identified above. The CTS MIDCAB Coronary Shunt is substantially equivalent to the predicate devices with regard to intended use, function, physical characteristics, materials and sterilization method.
All necessary testing was performed on the CTS MIDCAB Coronary Shunt to ensure the product is substantially equivalent to the predicate devices and to ensure that the CTS Coronary Shunt does not have any differences which have a significant effect on safety and effectiveness.
FUNCTIONAL PERFORMANCE TESTING
Functional testing was conducted on the CTS MIDCAB Coronary Shunt to ensure that the Shunt would function according to its intended use instructions. All testing conducted confirmed the acceptability of the CTS Shunt to perform as intended to help reduce blood in the operative field by temporary occlusion of the artery while providing blood flow distal to the arteriotomy.
BIOCOMPATIBILITY EVALUATION
The biocompatibility testing was conducted on the CTS MIDCAB Coronary Shunt and Shunt materials to ensure the acceptability of the CTS MIDCAB Coronary Shunt when used as directed. The CTS Shunt and Shunt materials passed the necessary biocompatibility tests.
SUMMARY
As contained in this 510(k) summary, all necessary testing was conducted on the CTS MIDCAB Coronary Shunt to ensure that the device is safe and effective when used in accordance to its intended use.