EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA

K102420 · Edwards Lifesciences, LLC · DWF · Oct 26, 2010 · Cardiovascular

Device Facts

• Record ID: K102420
• Device Name: EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
• Applicant: Edwards Lifesciences, LLC
• Product Code: DWF · Cardiovascular
• Decision Date: Oct 26, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMBOL-X Access Device/Aortic Cannula is indicated for the ascending aota during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

Device Story

Polymeric aortic cannula used during cardiopulmonary bypass (CPB) surgery; provides return of oxygenated blood from oxygenator to patient; includes port for optional insertion of EMBOL-X filter device. Operated by surgical team in OR. Features stainless steel wire reinforcement within cannula wall to prevent kinking. Available in three configurations (open tip or alternate tip hole designs). Single-use, sterile, non-pyrogenic. Facilitates hemostatic access for intravascular devices during CPB.

Clinical Evidence

Bench testing only. Performed cannula/tip bending inspection, static pressure testing (6 hours), dynamic pressure testing (6 hours), and tip/cannula bond strength tensile testing. All data met pre-established acceptance criteria.

Technological Characteristics

Polymeric tube with stainless steel wire reinforcement encapsulated in wall. Three configurations: open tip and alternate tip hole designs. Sterile, single-use. No electronic or software components.

Indications for Use

Indicated for patients undergoing short-term (≤ 6 hours) cardiopulmonary bypass (CPB) surgery requiring perfusion of the ascending aorta and hemostatic introduction/removal of compatible intravascular devices.

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

• EMBOL-X® Aortic Cannula

Submission Summary (Full Text)

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K10.2420

# 510(k) Summary

| Submitter: | Edwards Lifesciences® LLC | OCT 26 2010 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Dannette Crooms, Regulatory Affairs Associate<br>12050 Lone Peak Pkwy<br>Draper, UT 84020 | |
| Date Prepared: | October 25, 2010 | |
| Trade Name: | Edwards Lifesciences® EMBOL-X® Access Device / Aortic Cannula | |
| Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass<br>21 CFR Part 870.4210, Product Code DWF, Class II | |
| Predicate Device: | EMBOL-X® Aortic Cannula | |

## Device Description:

The Edwards Lifesciences EMBOL-X Access Device / Aortic Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood from the oxygenator to the patient during cardiopulmonary bypass procedures. A port is included for optional insertion of the EMBOL-X filter device.

The cannulae are available in three configurations. Variants include one code with an open tip and two codes with an alternate tip hole configuration. Cannulae bodies are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.

### Intended Use:

The EMBOL-X Access Device/Aortic Cannula is indicated for the ascending aota during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

### Comparative Analysis:

lt has been demonstrated that the EMBOL-X Access Device / Aortic Cannula is comparable to the predicate device in intended use and other labeling, fundamental scientific technology, material types, principles of operation and functional performance evaluations.

### Functional/Safety Testing:

The functional data indicate that the EMBOL-X Access Device / Aortic Cannula performs in a substantially equivalent manner when compared with the predicate device. The following functional tests were performed. All data met pre-established acceptance criteria.

- Cannula / Tip Bending Inspection for defects after manipulation of the cannula / tip. .
- . Static Pressure (6hrs) - Inspection for defects after exposure to static air pressure and manipulation of the cannula/tip.
- Dynamic Pressure (6 hrs) Inspection for defects after exposure to dynamic water flow and . manipulation of the cannula/tip.

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- Tip/Cannula Bond Strength Tensile test of the tip / cannula bond. .
## Conclusion:

The EMBOL-X Access Device / Aortic Cannula is substantially equivalent to the cited predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Edwards Lifesciences, LLC. c/o Ms. Dannette Crooms Regulatory Affairs Associate 12050 Lone Peak Parkway Draper, UT 84020

OCT 2 6 2010

Re: K102420 EMBOL-X® Access Device/Aortic Cannula EMBOL-X® Slim Access Device/Aortic Cannula EMBOL-X® Glide Access Device/Aortic Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWF Dated: September 24, 2010 Received: September 27, 2010

Dear Ms. Crooms:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Dannette Crooms

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

er R. Vachner

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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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K102420

# Statement of Indications for Use

## Indications for Use

510(k) Number (if known): K102420

OCT 2 6 2010

Device Name: Edwards Lifesciences EMBOL-X® Access Device / Aortic Cannula

The EMBOL-X Access Device / Aortic Cannula is indicated for the perfusion of the ascending aorta during short-term (≤ 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office Of Device Evaluation (ODE)

una D. V. kline

on Sign-Off) Division of Cardiovascular Devices

510(k) Number_K102420