VOYAGER QUAD CANNULA

K983270 · Cardiothoracic Systems, Inc. · DWF · Jul 28, 1999 · Cardiovascular

Device Facts

• Record ID: K983270
• Device Name: VOYAGER QUAD CANNULA
• Applicant: Cardiothoracic Systems, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

CTS Voyager Quad Cannula is a three-lumen device used during cardiopulmonary bypass. It features an elastomeric balloon at the distal tip for occluding the ascending aorta to partition the aortic root from arterial circulation. The central lumen delivers arterial perfusion; the side lumen delivers cardioplegic solution and vents fluid from the aortic root; the third lumen manages balloon inflation/deflation. An integrated marker indicates insertion depth, and a clamp ring secures the device position. Operated by surgeons in an OR setting, the device facilitates heart arrest and circulatory support. It benefits patients by enabling controlled access to the aortic root and maintaining perfusion during cardiac procedures.

Clinical Evidence

Functional bench testing and animal testing were conducted. Results verified that the device performs as designed and is suitable for its intended use.

Technological Characteristics

Three-lumen cannula with an elastomeric balloon. Features include a central perfusion lumen, a side lumen for cardioplegia/venting, and an inflation lumen. Includes an insertion depth marker and a clamp ring for fixation. Materials are not specified by ASTM standard in the text. Non-electronic, mechanical device.

Indications for Use

Indicated for patients undergoing cardiac surgery requiring cardiopulmonary bypass, specifically for aortic occlusion, arterial perfusion, cardioplegia delivery, and aortic root venting.

Regulatory Classification

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.

Predicate Devices

• Cardiopulmonary bypass cannulae manufactured by Medtronic
• Cardiopulmonary bypass cannulae manufactured by Sarns

Reference Devices

• Research Medical, Inc. (RMI) cannulae
• DLP (Medtronic) cannulae
• Sarns cannulae

Submission Summary (Full Text)

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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.

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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.<br>10600 North Tantau Avenue<br>Cupertino, California<br>[phone]<br>[phone] FAX<br>Est. Reg. No. 9027735 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Billig<br>Vice President, Regulatory, Quality, and Clinical<br>Research |
| Date Prepared: | September 16, 1998 |
| DEVICE DESCRIPTION | |
| Classification: | Cardiopulmonary Bypass Vascular Cannula, 21<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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