(314 days)
Not Found
Not Found
No
The description focuses on the mechanical function and design of a cannula for cardiopulmonary bypass, with no mention of AI or ML technologies.
Yes
The device is used to deliver arterial perfusion and cardioplegia during cardiac surgery, and to occlude the aorta. These functions directly contribute to the treatment of a patient during a medical procedure.
No
The device is described as a cannula used for perfusion, occlusion, and delivery of substances during cardiopulmonary bypass, and it does not mention any function related to diagnosing medical conditions.
No
The device description clearly describes a physical, multi-lumen cannula with an elastomeric balloon, clamp ring, and marker, 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 for "perfusion and occlusion of the ascending aorta during cardiopulmonary bypass." This is a surgical procedure performed directly on a patient's body.
- Device Description: The description details a physical cannula with lumens and a balloon for use within the circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical tool used in vivo during a medical procedure.
N/A
Intended Use / Indications for Use
The CTS Voyager Quad Cannula is intended for use in perfusion and occlusion of the ascending aorta during cardiopulmonary bypass. The cannula functions to occlude the ascending aorta when the balloon is inflated. The main lumen of the cannula provides delivery of arterial perfusion. The side lumen allows delivery of cardioplegia to arrest the heart and venting of fluid from the aortic root during cardiac surgery.
Product codes
DWF
Device Description
The CTS Voyager Quad Cannula is a three lumen cannula with an elastomeric balloon near the distal tip for occluding the ascending aorta in order to partition the aortic root from arterial circulation. The compliant balloon expands to occlude a range of aorta sizes. The large central lumen of the cannula serves to provide arterial perfusion. The side lumen serves two functions: delivery of cardioplegic solution to the aortic root and venting of fluid from the aortic root during cardiac surgery. The remaining lumen serves as a conduit for balloon inflation and deflation. The marker on the cannula outer shaft indicates the insertion depth. The clamp ring provided on the cannula allows the cannula to be fixed into position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aorta
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 bench testing and animal testing has been conducted and the results of the testing verified that the Voyager Quad Cannula performs as designed and is suitable for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 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
JUL 28 1999
2983270
510(k) Premarket Notification CTS Voyager Quad Cannula
SECTION 2
510(k) SUMMARY of SAFETY and EFFECTIVENESS
This summary of the 510(k) premarket notification for the CTS Voyager Quad Cannula is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1
510(k) Premarket Notification CTS Voyager Quad Cannula
510(k) Summary CardioThoracic Systems, Inc. Voyager Quad Cannula 510(k) Notification K_
GENERAL INFORMATION
| Manufacturer: | CardioThoracicSystems, Inc.
10600 North Tantau Avenue
Cupertino, California
(408) 342-1700
(408) 342-1717 FAX
Est. Reg. No. 9027735 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Billig
Vice President, Regulatory, Quality, and Clinical
Research |
| Date Prepared: | September 16, 1998 |
| DEVICE DESCRIPTION | |
| Classification: | Cardiopulmonary Bypass Vascular Cannula, 21
CFR 870.4210 |
| Trade Name: | CTS Voyager Quad Cannula |
| Generic/Common Name: | Cardiopulmonary Bypass Vascular Cannula |
PREDICATE DEVICES
Cardiopulmonary bypass cannulae manufactured by Medtronic and Sarns.
INTENDED USE
The CTS Voyager Quad Cannula is intended for use in perfusion and occlusion of the ascending aorta during cardiopulmonary bypass. The cannula functions to occlude the ascending aorta when the balloon is inflated. The main lumen of the cannula provides delivery of arterial perfusion. The side lumen allows delivery of cardioplegia to arrest the heart and venting of fluid from the aortic root during cardiac surgery.
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PRODUCT DESCRIPTION
The CTS Voyager Quad Cannula is a three lumen cannula with an elastomeric balloon near the distal tip for occluding the ascending aorta in order to partition the aortic root from arterial circulation. The compliant balloon expands to occlude a range of aorta sizes. The large central lumen of the cannula serves to provide arterial perfusion. The side lumen serves two functions: delivery of cardioplegic solution to the aortic root and venting of fluid from the aortic root during cardiac surgery. The remaining lumen serves as a conduit for balloon inflation and deflation. The marker on the cannula outer shaft indicates the insertion depth. The clamp ring provided on the cannula allows the cannula to be fixed into position.
SUBSTANTIAL EQUIVALENCE
The CTS Voyager Quad Cannula is intended for use in perfusion and occlusion of the ascending aorta during cardiopulmonary bypass. The CTS Voyager Quad Cannula is substantially equivalent to other cannulae and catheters currently on the market for use in cardiopulmonary bypass procedures, manufactured by companies such as Research Medical, Inc, (RMI), DLP (Medtronic) and Sarns. The Voyager Quad Cannula is substantially equivalent to these predicate devices in regards to device design, intended use, patient population and anatomical site. Any differences between the Voyager Quad Cannula and its predicate devices do not raise any new issues of safety or effectiveness.
Functional bench testing and animal testing has been conducted and the results of the testing verified that the Voyager Quad Cannula performs as designed and is suitable for its intended use.
SUMMARY
As contained in this 510(k) summary, the CTS Voyager Quad Cannula is substantially equivalent to the predicate device identified in that the Voyager Quad Cannula is substantially equivalent in regards to device design, intended use, patient population and anatomical site.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 28 1999 Mr. Michael Billig Vice President, Regulatory, Ouality and Clinical Research CardioThoracic Systems, Inc. 10600 N. Tantau Avenue Cupertino, CA 95014-0739
Re: K983270 CTS Voyager™ Quad Cannula Requlatory Class: II (Two) Product Code: DWF Dated: June 18, 1999 Received: June 21, 1999
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 legally marketed predicate 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 to A substantially equivalent determination assumes compliance with 895. 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 regulatory 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 requlations.
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Page 2 - Mr. Michael Billig
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 regulation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callaha 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 Voyager™ Quad Cannula 510(k) Premarket Notification
STATEMENT OF INDICATIONS FOR USE
The CTS Voyager Quad Cannula is intended for use in perfusion and occlusion of the ascending aorta during cardiopulmonary bypass. The cannula functions to occlude the ascending aorta when the balloon is inflated. The main lumen of the cannula provides delivery of arterial perfusion. The side lumen allows delivery of cardioplegia to arrest the heart and venting of fluid from the aortic root during cardiac surgery.
Mr. Rugh
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Dev 510(k) Number