18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II

K073559 · Edwards Lifesciences Research Medical · DQR · Jan 31, 2008 · Cardiovascular

Device Facts

• Record ID: K073559
• Device Name: 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
• Applicant: Edwards Lifesciences Research Medical
• Product Code: DQR · Cardiovascular
• Decision Date: Jan 31, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for <6 hours. Cannulation site is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.

Device Story

Polymeric arterial perfusion cannula; provides return of oxygenated blood to patient during cardiopulmonary bypass. Available in various sizes and tip configurations; some models feature stainless steel wire reinforcement to prevent kinking; includes options for movable suture ring, fixed suture ring, or fixed suture bump/flange for fixation. Used in clinical settings (e.g., OR) by surgeons. Device is sterile, non-pyrogenic, and single-use. Facilitates extracorporeal circulation; supports patient during cardiac procedures.

Clinical Evidence

Bench testing only. Functional data demonstrate performance equivalent to the predicate device.

Technological Characteristics

Polymeric tube construction; stainless steel wire reinforcement (optional); various tip configurations; includes suture fixation features (ring, bump, or flange). Sterile, non-pyrogenic, single-use.

Indications for Use

Indicated for patients requiring arterial perfusion in an extracorporeal circuit for less than 6 hours during cardiopulmonary bypass procedures. Cannulation sites include femoral artery or aortic arch.

Regulatory Classification

Identification

A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.

Predicate Devices

• Edwards Lifesciences Arterial Perfusion Cannula

Submission Summary (Full Text)

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### 510(k) Summary

| Submitter: | Edwards Lifesciences Research Medical, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John W. Nicholson, Senior Regulatory Affairs Associate<br>6864 South 300 West<br>Midvale, UT 84047<br>801-565-6282 |
| Date Prepared: | December 18, 2007 |
| Trade Name: | Edwards Lifesciences Arterial Perfusion Cannula II |
| Classification Name: | Cardiovascular Diagnostic Devices, CFR 870.1300, Catheter<br>Cannula, Product Code DQR, Class II |
| Predicate Device: | Edwards Lifesciences Arterial Perfusion Cannula |

Device Description: Edwards Arterial Perfusion Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood to a patient during cardiopulmonary bypass procedures.

The cannulae are available in a range of sizes and in a variety of tip configurations. Some cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking; other cannulae are non-reinforced. Some cannulae are provided with a movable suture ring, a fixed suture ring or a fixed suture bump or flange to facilitate the fixation of the cannula.

The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.

Intended Use: The Edwards Lifesciences Arterial Perfusion Cannula is indicated for arterial perfusion in the extracorporeal circuit for <6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.

Comparative Analysis: It has been demonstrated that the APC II arterial perfusion cannulae are comparable to the predicate devices in intended use, fundamental scientific technology, material type, principles of operation and functional performance evaluations.

Functional/Safety Testing: The functional data indicate that the subject devices perform in a substantially equivalent manner when compared with the predicate device.

Conclusion: The APC II arterial cannulae are substantially equivalent to the cited predicate devices.

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Public Health Service

JAN 31 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edwards Lifesciences Research Medical, Inc. c/o Mr. John Nicholson Senior Regulatory Affairs Associate 6864 South 300 West Midvale, Utah 84047

Re: K073559

Arterial Perfusion Cannula II Regulation Number: 21 CFR 870.1300 Regulation Name: Catheter cannula Regulatory Class: Class II (two) Product Code: DOR Dated: January 24, 2008 Received: January 22, 2008

Dear Mr. Nicholson:

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 -- Mr. John Nicholson

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 (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. 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/industry/support/index.html.

Sincerely yours.

Dma R. Vachner

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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## Section 5.

# Indications for Use Statement

510(k) Number (if known):

Device Name: Edwards Lifesciences Arterial Perfusion Cannula II

### Indications for Use:

The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for <6 hours. Cannulation site is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.

Prescription Use 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)

Dummer R. Vuhmes
Division Sign-Off)
sion of Cardiovascular Devices

。10(k) Number_K073559