ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA

K990573 · Estech, Inc. · DXC · Mar 11, 1999 · Cardiovascular

Device Facts

• Record ID: K990573
• Device Name: ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA
• Applicant: Estech, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Mar 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

Device Story

Sterile, disposable, 21 French polyurethane cannula; features three integrated lumens and distal inflatable polyurethane balloon. Central lumen delivers arterial blood (up to 5 L/min) via multiple proximal outlet ports; secondary lumen delivers cardioplegia or vents aortic root; third lumen controls balloon inflation. Used in cardiovascular surgery by surgeons to establish extracorporeal cardiopulmonary bypass. Device provides antegrade flow pattern, mimicking physiological conditions. Radiopaque markers and depth marks assist positioning. Simplifies procedures by combining femoral artery cannulation and aortic occlusion functions into single device, replacing multi-component systems. Benefits include reduced procedural complexity and improved flow dynamics compared to retrograde-flow predicate systems.

Clinical Evidence

Evidence includes bench testing (balloon inflation/burst, repeat inflation, 6-hour hold, flow/pressure drop, hemolysis, biocompatibility), animal studies, and a clinical investigation. Bench testing demonstrated performance within specifications. Animal studies verified handling and functional modes. Clinical investigation conducted to verify safety, efficacy, and performance.

Technological Characteristics

Materials: Polyurethane. Dimensions: 21 French. Design: Triple-lumen, distal inflatable balloon, multiple proximal blood outlet ports. Energy: Mechanical (manual inflation). Connectivity: None. Sterilization: Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients undergoing cardiovascular surgery requiring extracorporeal cardiopulmonary bypass. Used for arterial perfusion of the aorta via femoral artery, aortic occlusion, cardioplegia delivery, and aortic root venting.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Heartport Arterial Perfusion Systems

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary

# ESTECH Arterial Remote Access Perfusion Cannula

Common/Classification Name: Cardiopulmonary Bypass vascular catheter, cannula or tubing as classified under 21 CFR 870.4210

ESTECH 4115 Blackhawk Plaza Circle, Suite 100 Danville, CA 94506 925-648-2033 (Tel), 925-648-2034 (Fax)

Prepared: February 19, 1999

#### Legally Marketed Predicate Device A.

The ESTECH Arterial Remote Access Perfusion Cannula is substantially equivalent to perfusion cannulae currently marketed in the U.S. The ESTECH cannula is specifically equivalent to the Heartport Arterial Perfusion Systems have the same intended use, which is to provide arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass. Both systems provide occlusion of the ascending aorta with an inflatable balloon and may be used for delivery of cardioplegia through an internal lumen of the device. Additional similarities between the ESTECH Arterial Perfusion Cannula and the Heartport Cannula are the ability to monitor Aortic Root Pressure and the capability to provide Left Ventricle Venting. The ESTECH cannula is 21 French in diameter and the Heartport system is offer in 21 and 23 French diameters.

The primary difference between the systems is that the Heartport Arterial Perfusion System requires the use of the Femoral Artery Cannula and an Aortic Occlusion cannula, which must be inserted through the Femoral Artery Cannula. These functions are combined in the single device ESTECH Arterial Remote Access Perfusion Cannula. The ESTECH device delivers blood into the Aorta "Antegrade Flow" and the Heartport device delivers blood into the femoral artery "Retrograde Flow".

#### B. Device Description

The ESTECH Arterial Remote Access Perfusion Cannula is a sterile, disposable, flexible polyurethane tube with three integrated lumens and an inflatable polyurethane balloon at the distal end of the cannula. The outside diameter of the cannula is 21 French. The cannula has a central lumen for delivery of arterial blood through multiple distal outlets at a flow rate up to 5 liters per minute, a small lumen for delivery of cardioplegia or venting at the aortic root, and an additional smaller lumen for control of the distal balloon. The blood outlet ports are multiple elongated openings along the cannula proximal to the occlusion balloon. Radiopaque balloon markers and insertion depth marks aid in positioning the device. The cannulas are provided sterile in individual packages for single use.

್ತು.

{1}------------------------------------------------

### C. Indications for Use

The ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

### D. Substantial Equivalence Summary

The ESTECH Arterial Remote Access Perfusion Cannula has the same intended use as the 510(k) cleared Heartport Perfusion System. Both systems provide arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass.

The primary difference is that the Heartport Arterial Perfusion System requires the use of a Femoral Artery Cannula and an Aortic Occlusion cannula, which must be inserted through the Femoral Artery Cannula. These functions are combined in the single device ESTECH Perfusion Cannula to simplify the procedure.

Another difference is the perfusion flow pattern of each system. The multiple holes along the length of the ESTECH cannula produce a normal antegrade flow pattern similar to physiological conditions of flow. Heartport produces retrograde flow from a single outlet port of the Heartport femoral cannula. Testing was performed to demonstrate that the ESTECH cannula does not induce a higher degree of hemolysis or pressure drop than expected during bypass procedures.

All materials used in the ESTECH cannula have a safe history of use in medical devices and are used by the manufacturer to produce similar 510(k) cleared devices.

The ESTECH Arterial Remote Access Perfusion Cannula is therefore substantially equivalent to currently marketed devices.

## E. Technological Characteristics

See Device Description, above.

#### F. Testing

The laboratory testing adhered to Good Laboratory Practices guidelines.

The occlusion balloon has been tested to demonstrate that it meets performance and safety specifications as follows:

Occlusion Balloon Volume/Pressure/Diameter: This test was performed to document the inflation characteristics of the balloon up to burst. The pressure and diameter data as a function of inflation volume were collected.

Occlusion Balloon Repeat Inflation Test: This test was performed to demonstrate that the balloon can be inflated repeatedly if necessary.

{2}------------------------------------------------

Occlusion Balloon Inflation Hold Test: This test was performed to demonstrate that the balloon can withstand at least 6 hours of inflation.

Hemolysis Testing: This test was performed to evaluate the cellular damage produced by the system when used during cardiac bypass procedures. Since all cardiac bypass procedures produce some degree of hemolysis which may be at least partially compensated for in human or animal testing, an in vitro test was used to evaluate the relative effect of the ESTECH cannula in the circuit.

Flow Testing: The pressure drop was measured for a range of arterial perfusion flow rates of 0-5 liters per minute. In additional testing, the pressure/flow characteristics of the Heartport cannula were measured. While the pressure drop was determined to be within ESTECH specifications, the outlet blood velocity of the Heartport device was determined to be unacceptable.

Biocompatability Testing: Biocompatability Testing was performed on all critical components of the Cannula to verify biocompatability.

Animal Testing: Animal studies of the ESTECH Arterial Remote Access Cannula to evaluate the handling characteristics and to verify performance of all intended functions. The ESTECH perfusion cannula was used in all functional modes. The conclusion of this study was that complete function of the ESTECH Arterial Remote Access Perfusion Cannula and ease of use were demonstrated.

Clinical Investigation: A Clinical Investigation was conducted to verify the safety. efficacy, and performance of the device.

## G. Conclusions

ESTECH has demonstrated through its comparison of characteristics with predicate device and comparison of performance testing with the predicate device that the ESTECH Arterial Remote Access Perfusion Cannula is substantially equivalent to the predicate device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned within a circle that contains the text "HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR I I 1999

Mr. Arthur A. Bertolero Estech, Inc. 4115 Blackhawk Plaza Circle, Suite 100 Danville, CA 94506

Re : K990573 Estech Arterial Remote Access Perfusion Cannula Requlatory Class: II (Two) Product Code: 74 DXC, 74 DWF Dated: February 22, 1999 Received: February 23, 1999

Dear Mr. Bertolero:

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 The general controls provisions of the provisions of the Act. Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 In addition, FDA may publish further regulatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation 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.

{4}------------------------------------------------

## Page 2 - Mr. Arthur A. Bertolero

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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Also, please note the regulation Compliance at [phone]. entitled, "Misbranding by reference to premarket notification" Other general information on your (21CFR 807.97). 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. Allelson

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 1

510(k) Number (if known): _ K 9005 73 ________________________________________________________________________________________________________________________________________

Device Name: ESTECH Arterial Remote Access Perfusion Cannula

Indications for Use:

The ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use __________________

(Optional Format 1-2-96)

M. Page.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_