REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH

K032632 · Estech, Inc. · DWF · Oct 22, 2003 · Cardiovascular

Device Facts

• Record ID: K032632
• Device Name: REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH
• Applicant: Estech, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is intended for use in arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). This device is indicated for short term cardiopulmonary bypass (< 6 hours). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

Device Story

Disposable 21 Fr, 31 cm flexible polyurethane cannula; features three lumens and distal inflatable polyurethane balloon for aortic occlusion (22-34 mm aorta diameters). Central lumen delivers arterial blood via multiple distal ports (1.0-5.0 L/min); secondary lumen delivers cardioplegia and vents aortic root; third lumen controls balloon. Includes radio-opaque arch segment and insertion depth marks. Used in cardiovascular surgery by surgeons; inserted via axillary artery over guidewire. Provides antegrade blood flow; balloon stabilizes position and occludes aorta. Benefits include minimally invasive access and integrated multi-functionality (perfusion, cardioplegia, venting) in single device.

Clinical Evidence

Bench testing only. Included occlusion balloon burst, volume/pressure/diameter, repeat inflation, and sustained inflation (6 hours) testing. Hemolysis testing performed in-vitro comparing device to predicates. Flow testing confirmed pressure drops and cardioplegia delivery rates within specifications. Biocompatibility testing relied on identical materials to predicate. Animal testing confirmed suitability for axillary insertion and placement.

Technological Characteristics

Polyurethane construction; 21 Fr (7 mm) OD; 31 cm length. Three-lumen design with distal inflatable polyurethane balloon. Radio-opaque markers. Single-use, sterile. Mechanical principle: multi-port "soaker hose" blood delivery and balloon-based aortic occlusion. No software or electronic components.

Indications for Use

Indicated for patients undergoing cardiovascular surgery requiring extracorporeal cardiopulmonary bypass (CPB) for < 6 hours. Used for arterial perfusion via the axillary artery, aortic occlusion, 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

• ESTECH Remote Access Perfusion Cannula (K990573)
• Edwards Lifesciences Axillary Access Arterial Cannula (K002578)

Submission Summary (Full Text)

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K032632

OCT 2 2 2003

## ਤ ਤੋਂ ਜਾਣ ਦੀ ਜ

# 510(k) Summary

### A. Submitter / 510(k) Sponsor: ESTECH, Inc. 4135 Blackhawk Plaza Circle Suite 150 Danville, CA 94506 Tel: [phone] Fax: [phone] Contact: Arthur Bertolero Date Prepared: 2002-09-05

#### B. Device Name:

### Remote Access Perfusion Cannula Left Axillary 21 French

#### Common/Generic Device Name: Cannula

Classification Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass under 21 CFR 870.4210

### C. Predicate Device(s)

| Predicate Device Name: | ESTECH Remote Access<br>Perfusion Cannula | Axillary Access Arterial<br>Cannula |
|-------------------------------------------|-------------------------------------------|-------------------------------------|
| Manufacturer: | ESTECH | Edwards Lifesciences |
| 510(k) Number: | K990573 | K002578 |
| Substantial Equivalence<br>Decision Date: | 1999-03-11 | 2002-04-11 |

### D. Device Description

The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is a disposable 31 cm long flexible polyurethane tube with three (3) lumens with an inflatable polyurethane balloon at the distal end of the cannula. The inflatable balloon has elastomeric properties designed to provide aortic occlusion in a range of aorta sizes with internal diameters from 22 mm to 34 mm. The outside diameter of the cannula is 21 Fr. (7 mm). The cannula has a central lumen for the delivery of arterial blood through multiple distal outlets at flow rates of 1.0 to 5.0L/min, a lumen that communicates with the aorta in the area of the aortic root for delivery of cardioplegia solution and left ventricle venting, and a small lumen for control of the distal balloon. Radio-opaque arch segment of cannula and insertion depth marks aid in positioning the device. The Cannula are provided sterile in individual packages for single use.

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Image /page/1/Picture/0 description: The image contains the word "ESTECH" in a bold, sans-serif font inside a black oval. Below the oval, the words "LEAST INVASIVE CARDIAC SURGERY" are printed in a smaller, sans-serif font. The text is arranged in a way that suggests a logo or branding for a medical company specializing in minimally invasive heart surgery.

#### E. Indications for Use

The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is intended for use in arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). This device is indicated for short term cardiopulmonary bypass (< 6 hours). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

#### F. Summary of Technological Characteristics Comparison

For complete detail regarding comparison of the proposed device with predicate devices please see Section IIb of this 510(k) application. The following table lists the feature comparison of the three devices:

| ESTECH RAP Cannula<br>Left Axillary 21Fr | ESTECH RAP Cannula<br>(Femoral) | Edwards Axillary Access<br>Arterial Cannula |
|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended for use in arterial<br>perfusion via axillary<br>artery | Intended for use in arterial<br>perfusion via femoral<br>artery | Intended for use in arterial<br>perfusion via axillary<br>artery |
| Intended for short-term<br>CPB (<6hrs) | Intended for short-term<br>CPB (<6hrs) | Intended for short-term<br>CPB (<6hrs) |
| Multi-channel, multi-<br>function integrated<br>cannula | Multi-channel, multi-<br>function integrated<br>cannula | Single-channel, single-<br>function cannula |
| Single step insertion | Single step insertion | Single step insertion |
| Facilitates Antegrade<br>Blood Flow | Facilitates Antegrade<br>Blood Flow | Facilitates Antegrade<br>Blood Flow |
| Low pressure/velocity<br>blood flow system<br>("soaker hose") via<br>multiple blood outlet ports | Low pressure/velocity<br>blood flow system<br>("soaker hose") via<br>multiple blood outlet ports | Higher pressure/velocity<br>blood flow system<br>("nozzle") via single<br>blood outlet port |
| Rated for blood flow rates<br>1.0-5.0L/min | Rated for blood flow rates<br>1.0-5.0L/min | Rated for blood flow rates<br>1.0-5.0L/min |
| Flat-sided distal aortic<br>occlusion balloon - more<br>anatomical, easier<br>placement, better stability | Flat-sided distal aortic<br>occlusion balloon - more<br>anatomical, easier<br>placement, better stability | No aortic clamping.<br>Perfusion only. |
| Designed to provide aortic<br>occlusion in a range of<br>aorta sizes with internal<br>diameters from 22 mm to<br>34 mm | Designed to provide aortic<br>occlusion in a range of<br>aorta sizes with internal<br>diameters from 22 mm to<br>34 mm | No aortic clamping.<br>Perfusion only. |
| Usable Length = 31cm<br>(designed for axillary | Usable Length = 81cm<br>(designed for femoral | Usable Length = 33 cm<br>(designed for axillary |

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| Outside diameter of the<br>cannula is 21 Fr. (7 mm)<br>Advanced over guidewire<br>to insure accurate<br>placement<br>Internal obturator to<br>prevent kinking<br>Radio-opaque arch<br>segment of cannula and<br>insertion depth marks aid<br>in positioning the device<br>Delivers cardioplegia and<br>facilitates aortic root<br>venting<br>Provided sterile. Single<br>use device.<br>On-site customized<br>training | Outside diameter of the<br>cannula is 21 Fr. (7 mm)<br>Advanced over guidewire<br>to insure accurate<br>placement<br>Internal obturator to<br>prevent kinking<br>Radio-opaque arch<br>segment of cannula and<br>insertion depth marks aid<br>in positioning the device<br>Delivers cardioplegia and<br>facilitates aortic root<br>venting<br>Provided sterile. Single<br>use device.<br>On-site customized<br>training | Outside diameter of the<br>cannula is 22 Fr. (7.3 mm)<br>Does not advance over<br>guidewire<br>Wire-wrapped to prevent<br>kinking<br>No radio-opaque materials<br>or insertion depth marks<br>No cardioplegia delivery<br>or venting. Perfusion<br>only.<br>Provided sterile. Single<br>use device.<br>Unknown training<br>program |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

#### G. Summary of Non-Clinical Performance Data

The laboratory testing adhered to Good Laboratory Practices guidlelines. All test protocols and results can be found in Section III Device Specifications of this 510(k) applications. Below is a bried summary of tests conducted.

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

Occlusion Balloon Restricted Burst Test: This test was performed to characterize the inflation characteristics of the balloon up to burst in a restricted environment. The pressure data as a function of inflation volume were collected.

Occlusion Balloon Volume/Pressure/Diameter: This test was performed to characterize 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.

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

Hemolysis Testing: This test was performed to evaluate the cellular damage produced by the system when used during the cardiac bypass procedures. Due to the

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Image /page/3/Picture/0 description: The image shows the logo for ESTECH Least Invasive Cardiac Surgery. The word "ESTECH" is written in large, bold, white letters inside a black oval. Below the oval, the words "LEAST INVASIVE CARDIAC SURGERY" are written in a smaller font.

fact that all cardiac bypass procedures produce some degree of hemolysis which may be at least partially compensated for in human and animal testing, an in-vitro test was used to evaluate the relative effect of the device in the circuit as compared to the predicate devices.

Flow Testing: The pressure drop across the cannula was measured for a range of arterial perfusion flow rates from 0-5 liters per minute and was within specification. Minimum cardioplegia delivery flow rates for a given pressure were also within specification.

Biocompatibility Testing: Biocompatibility testing has been completed for the currently marketed predicate device, ESTECH Remote Access Perfusion Cannula. All materials used in the manufacture of the current device are identical and thus testing will not be repeated.

Animal Testing: Animal testing was conducted to demonstrate that the device was suitable for its intended use in terms of insertion via axillary artery and placement. Performance of the device, including the occlusion balloon and perfusion/cardioplegia flow, are known to be safe and effective for its intended use as these features have either remained unchanged from the predicate device or have been demonstrated to be adequate based on the tests described above.

#### H. Substantial Equivalence Summary

The proposed device is an adaptation of the currently marketed remote access perfusion cannula, designed for femoral artery access. The only design changes to the current device included reducing the length of the cannula to facilitate insertion via axillary artery and changing the outlet blood port configuration to suit the new length of the device.

The proposed device has a modified indication for use statement. The new indication. for arterial perfusion by cannulation of the axillary artery, versus femoral artery, does not change the intended use of the device, which is arterial perfusion during cardiopulmonary bypass. The proposed device, therefore is substantially equivalent . to the predicate device in intended use.

ESTECH has demonstrated through its comparison of characteristics with predicate device and comparison of performance testing with predicate device that the Remote Access Perfusion Cannula LA 21 Fr is substantially equivalent to the predicate device in technology, material, manufacture and design.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

ESTECH, Inc. c/o Mr. Arthur Bertolero 4135 Blackhawk Plaza Circle, Suite 150 Danville, CA 94506

Re: K032632

Remote Access Perfusion Cannula Left Axillary 21 French Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: August 25, 2003 Received: August 29, 2003

Dear Mr. Bertolero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 – Mr. Arthur Bertolero

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable; the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Q. M. Ellis

Image /page/5/Picture/4 description: The image shows a close-up of a handwritten symbol or character. It appears to be a combination of curved and straight lines, possibly representing a letter or a stylized design. The lines are thick and dark, creating a bold and distinct shape against the white background. The symbol has a loop at the top and a stroke extending downwards.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K032632

Page 1 of 1

Device Name: Remote Access Perfusion Cannula Left Axillary 21 French

#### Indications For Use:

The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is intended for use in arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). This device is indicated for short term cardiopulmonary bypass (< 6 hours). 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 ANTOHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Division Sign-Off)

Division of Cardiovascular Devices

| 510(k) Number | K032632 |
|---------------|---------|
|---------------|---------|