(252 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical function of the shunt and do not mention any AI/ML components or capabilities.
Yes.
The device temporarily occludes an artery to reduce blood in the operative field while maintaining distal blood flow, which is a therapeutic intervention.
No
The device is designed for temporary occlusion of an artery to reduce blood in the operative field and provide distal blood flow during surgery, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines a physical medical device made of polymer and polyester, designed for temporary occlusion of an artery. It does not mention any software components.
Based on the provided information, the CTS FloCoil Shunt is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) during surgery to temporarily manage blood flow in an artery. IVD devices are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor medical conditions.
- Device Description: The description details a physical device inserted into an artery, not a reagent, instrument, or system used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the CTS FloCoil Shunt is a surgical device used directly on a patient during a procedure, not an IVD.
N/A
Intended Use / Indications for Use
The CTS FloCoil 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 FloCoil Shunt is not an implant and is removed prior to completion of the anastomosis.
Product codes
DXC
Device Description
The CTS FloCoil Shunt consists of coil reinforced polymer shaft with a polymer seal on each end and tapered polymer tips. The polymer seals on each end contact the vessel wall and cause occlusion of the artery proximal and distal to the arteriotomy . The FloCoil Shunt is selected according to the outer diameter of the polymer seals and is available in various sizes for various vessel diameters. There is a hole in both tapered tip ends of the FloCoil Shunt to allow for the perfusion of blood through the shunt's inner lumen and beyond the arteriotomy. A polyester thread (tether) is attached to the FloCoil Shunt in the middle of the shaft. Attached to the tether is a radiopaque tab which is used to aid insertion and removal of the FloCoil Shunt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Functional testing was conducted on the CTS FloCoil Shunt to ensure that the Shunt would function according to its intended use instructions. All testing conducted confirmed the acceptability of the CTS FloCoil 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. The biocompatibility testing was conducted on the CTS FloCoil Shunt and Shunt materials to ensure the acceptability of the CTS FloCoil Shunt when used as directed. The CTS FloCoil Shunt and Shunt materials passed the necessary biocompatibility tests.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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K97a638
510(k) Summary CardioThoracic Systems, Inc. CTS FloCoil™ Shunt 510(k) Notification K970638
GENERAL INFORMATION
OCT 30 1997
| 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 |
DEVICE DESCRIPTION
| Classification: | Class II |
|---|---|
| Trade Name: | CTS FloCoil™ Shunt |
| Generic/Common Name: | Vascular clamp (21 CFR 870.4450) |
| Surgical Vessel Dilator (21 CFR 870.4475) | |
| Blood Access Device and Accessories (21 CFR 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 FloCoil Shunt is designed to help reduce blood in the operative field by temporary The CTS FIOOd Brain is actery and to provide blood flow distal to the arteriotomy. This FloCoil Shunt is not an implant and is removed prior to completion of the anastomosis.
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PRODUCT DESCRIPTION
The CTS FloCoil Shunt consists of coil reinforced polymer shaft with a polymer seal on each end and tapered polymer tips. The polymer seals on each end contact the vessel wall and cause occlusion of the artery proximal and distal to the arteriotomy . The FloCoil Shunt is selected according to the outer diameter of the polymer seals and is available in various sizes for various vessel diameters. There is a hole in both tapered tip ends of the FloCoil Shunt to allow for the perfusion of blood through the shunt's inner lumen and beyond the arteriotomy. A polyester thread (tether) is attached to the FloCoil Shunt in the middle of the shaft. Attached to the tether is a radiopaque tab which is used to aid insertion and removal of the FloCoil Shunt.
SUBSTANTIAL EQUIVALENCE
The CTS FloCoil Shunt is substantially equivalent to predicate devices currently being marketed. The marketed predicate devices are identified above. The CTS FloCoil 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 FloCoil Shunt to ensure the product is substantially equivalent to the predicate devices and to ensure that the CTS FloCoil 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 FloCoil Shunt to ensure that the Shunt would function according to its intended use instructions. All testing conducted confirmed the acceptability of the CTS FloCoil 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 FloCoil Shunt and Shunt materials to ensure the acceptability of the CTS FloCoil Shunt when used as directed. The CTS FloCoil 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 FloCoil™ Shunt to ensure that the device is safe and effective when used in accordance to its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Michael J. Billig Vice President Requlatory, Quality and Clinical Research CardioThoracic Systems 10600 N. Tantau Avenue Cupertino, California 95014-0739
OCT 30 1997
K970638 Re : CTS MIDCAB Fixed Diameter Coronary Shunt Regulatory Class: II (Two) Product Code: DXC Dated: August 18, 1997 Received: August 21, 1997
Dear Mr. Billig:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html."
Sincerely yours,
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CardioThoracic Systems, Inc. CTS FloCoil Shunt 510(k) Premarket Notification
Statement of Indications for Use
The CTS FloCoil 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 FloCoil Shunt is not an implant and is removed prior to completion of the anastomosis.
Bree L. Campese
(Division Sign-Off)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970638
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