EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE

K033463 · Edwards Lifesciences, LLC · DWF · Jul 28, 2004 · Cardiovascular

Device Facts

• Record ID: K033463
• Device Name: EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
• Applicant: Edwards Lifesciences, LLC
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Edwards Lifesciences Research Medical Pediatric Aortic Perfusion Cannulae are indicated for perfusion of the aorta so that perfusion of the arteries via a heart-lung machine may take place. The Edwards Lifesciences Research Medical Pediatric Arterial Perfusion Cannulae are indicated for perfusion of the femoral artery during procedures requiring cardiopulmonary bypass where femoral artery cannulation is deemed appropriate. The Edwards Lifesciences Research Medical Pediatric Femoral Arterial Cannulae are indicated for use in situations which require rapid femoral arterial access for short term cardiopulmonary bypass. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-coated blood path is desired.

Device Story

Pediatric arterial cannulae used for aortic or femoral artery access during cardiopulmonary bypass; facilitates blood flow via heart-lung machine. Device inserted by clinicians in surgical settings. Provides conduit for extracorporeal circulation; enables perfusion during cardiac procedures. Benefits include specialized sizing for pediatric anatomy; supports short-term bypass requirements.

Clinical Evidence

Bench testing only; functional and biocompatibility testing performed.

Technological Characteristics

Pediatric arterial cannulae; available in various models (e.g., PEDA, PAA, APC, FEMII series). Features Duraflo heparin-coated blood path option. Designed for aortic or femoral artery cannulation. Class II device.

Indications for Use

Indicated for pediatric patients requiring cardiopulmonary bypass, specifically for aortic perfusion, femoral artery perfusion, or rapid femoral arterial access for short-term bypass.

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

• Research Industries' Various Cardiovascular Devices
• Research Medical, Inc. Fem-Flex Femoral Access Cannulation Kit
• Terumo L-Series 1964 Type Pediatric Aortic Cannulae

Submission Summary (Full Text)

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## 510(k) Summary

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, California 92614 USA |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Smith, Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | October 29, 2003 |
| Trade Name: | Edwards Lifesciences Research Medical Inc. Pediatric<br>Arterial Cannulae (abbreviated to ERMI Pediatric Arterial<br>Cannulae) |
| Common Name: | Cardiopulmonary Bypass Vascular Catheter, Cannula, or<br>Tubing (21 CFR 870.4210) |
| Predicate<br>Devices: | Research Industries' Various Cardiovascular Devices<br>Research Medical, Inc. Fem-Flex Femoral Access<br>Cannulation Kit<br>Terumo L-Series 1964 Type Pediatric Aortic Cannulae |
| Device<br>Description: | The ERMI Pediatric Arterial Cannulae are used to access<br>the aorta or femoral artery during cardiopulmonary<br>bypass. |
| Indications for<br>Use: | The ERMI Pediatric Aortic Perfusion Cannulae are<br>indicated for perfusion of the aorta so that perfusion of the<br>arteries via a heart-lung machine may take place.<br><br>The ERMI Pediatric Arterial Perfusion Cannulae are<br>indicated for perfusion of the femoral artery during<br>procedures requiring cardiopulmonary bypass where<br>femoral artery cannulation is deemed appropriate.<br><br>The ERMI Pediatric Femoral Arterial Cannulae are<br>indicated for use in situations which require rapid femoral<br>arterial access for short term cardiopulmonary bypass. |
| Comparative<br>Analysis: | Extracorporeal circuit components with a Duraflo<br>Treatment are indicated for use in cardiopulmonary<br>surgery when a heparin-treated blood path is desired.<br>The only difference between the subject catheters and the<br>predicate Research Medical catheters is the subject<br>catheters are smaller in diameter and length. Aside from<br>the smaller sizes, there is no difference between the ERMI<br>Pediatric Arterial Cannulae and the predicate devices. |
| Functional/Safety<br>Testing: | The ERMI Pediatric Arterial Cannulae have successfully<br>undergone functional and biocompatibility testing. |
| Conclusion: | The ERMI Pediatric Arterial Cannulae are substantially<br>equivalent to the predicate devices. |

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Aron Shultz 11/26/03

Jason Smith Senior Regulatory Affairs Specialist Edwards Lifesciences LLC

Date

Edwards Lifesciences Research Medical Inc. - Confidential Edwards Lifesciences Research Medical Inc. - Connidential
Edwards Lifesciences Research Medical Inc. Pediatric Arterial Cannulae

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2004

Edwards Lifesciences LLC c/o Mr. Jason Smith Senior Regulatory Affairs Specialist One Edwards Way Irvine, CA 92614

Re: K033463

Edwards Lifesciences Research Medical Pediatric Arterial Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula and Tubing Regulatory Class: Class II (two) Product Code: DWF~ Dated: May 25, 2004 Received: May 26, 2004

Dear Mr. Smith:

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.

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 - Jason Smith.

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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.

Duma R. Vidanel

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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## Indications for Use

510(k) Number (if known): K033463

Device Name: Edwards Lifesciences Research Medical Pediatric Arterial Cannulae

Indications For Use:

(Models PEDA008SB, PEDA010SB, PEDA012SB, PEDA014SB, PEDA016SB, PAA010CB, PAA012CB, PAA014CB, PAA016CB, AA018S, AA018C): The Edwards Lifesciences Research Medical Pediatric Aortic Perfusion Cannulae are indicated for perfusion of the aorta so that perfusion of the arteries via a heart-lung machine may take place.

(Models APC018, APC018B) The Edwards Lifesciences Research Medical Pediatric Arterial Perfusion Cannulae are indicated for perfusion of the femoral artery during procedures requiring cardiopulmonary bypass where femoral artery cannulation is deemed appropriate.

(Models FEMII010A, FEMII014A, FEMII014A, FEMII008AT, FEMII010AT, FEMII012AT, FEMII014AT): The Edwards Lifesciences Research Medical Pediatric Femoral Arterial Cannulae are indicated for use in situations which require rapid femoral arterial access for short term cardiopulmonary bypass.

Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-coated blood path is desired.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deanna P. Richter

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K0 3346

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