EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE

K031037 · Medtronic Perfusion Systems · DWF · May 13, 2003 · Cardiovascular

Device Facts

• Record ID: K031037
• Device Name: EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
• Applicant: Medtronic Perfusion Systems
• Product Code: DWF · Cardiovascular
• Decision Date: May 13, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is intended for use with cardiopulmonary bypass as an arterial return cannula.

Device Story

Flexible, wirewound arterial cannula; tapered distal tip; includes depth markings and adjustable radiopaque suture ring; proximal end features 3/8" connector. Facilitates arterial return during cardiopulmonary bypass. Includes plastic tapered tip introducer with porous plug and guidewire port for 0.038" guidewire. Available in 18, 20, 22, and 24 Fr. diameters; optional Carmeda® bio-active coating. Used by perfusionists or surgeons in clinical settings during bypass surgery to return oxygenated blood to the patient.

Clinical Evidence

Bench testing only. Performance established through in vitro visual, dimensional, simulated use, and functional testing. Coated devices underwent additional testing for coverage, bio-activity, and leaching.

Technological Characteristics

Flexible, thin-wall wirewound body; tapered distal tip; radiopaque suture ring. Sizes: 18, 20, 22, 24 Fr. Optional Carmeda® bio-active coating. Mechanical device; no energy source or software.

Indications for Use

Indicated for use as an arterial return cannula during cardiopulmonary bypass procedures.

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

• EOPA Elongated One-Piece Arterial Cannula and EOPA Elongated One-Piece Arterial Cannula with Guidewire 20, 22 Fr. (K991066 and K000274)
• Extracorporeal Circuit with Bio-Active Surface (K891687)

Submission Summary (Full Text)

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K031037

# MAY 1 3 2003

(Optional Format 3-10-98)

## 510(k) Summary

| Date Prepared: | March 27, 2003 |
|-----------------|------------------------------------------------------------------------------------|
| Submitter: | Medtronic Perfusion Systems<br>7611 Northland Boulevard<br>Brooklyn Park, MN 55428 |
| Contact Person: | Ronald W. Bennett<br>Principal Regulatory Affairs Specialist |
| Phone: | (763)-391-9086 |
| Fax: | [phone] |

## Device Name and Classification:

| Trade Name: | EOPA Elongated One-Piece Arterial Cannula and<br>EOPA Elongated One-Piece Arterial Cannula with<br>Guidewire<br>18, 20, 22, 24 Fr. with Carmeda® Coating |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or<br>tubing |
| Classification: | Class II |
| Predicate Devices: | EOPA Elongated One-Piece Arterial Cannula and<br>EOPA Elongated One-Piece Arterial Cannula with<br>Guidewire<br>20, 22 Fr.<br>K991066 and K000274<br>Extracorporeal Circuit with Bio-Active Surface<br>K891687 |

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#### Device Description:

The EOPA Elongated One-Piece Arterial Cannulae have a flexible, thin wall wirewound body with a tapered distal tip. The tip features depth markings and an adjustable radiopaque suture ring to indicate insertion depth. The proximal end of the cannula terminates in a vented or non-vented 3/8" (0.95 cm) connector. A plastic tapered tip introducer with porous plug is provided to facilitate cannula insertion and priming. The introducer features a guidewire port for use with a 0.038" (0.1 cm) guidewire. Some models include a guidewire while some do not. The devices are marketed in 18, 20, 22, and 24 Fr. diameters. The devices may include a Carmeda® coating.

#### Indication for Use

This product is intended for use with cardiopulmonary bypass as an arterial return cannula.

### Comparison to Predicate Device

The predicate devices are cannulae are also Elongated One-Piece Arterial Cannulae with the same design characteristics. Predicate 510(k)s described the 20 and 22 Fr. device. The predicate devices were uncoated. The predicate cannulae have the same indications for use.

#### Summary of Performance Data

In vitro visual, dimensional, simulated use and functional testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices. In addition coverage, bio-activity, leaching and functional testing was performed on Carmeda® coated devices.

#### Conclusion

Medtronic Perfusion Systems has demonstrated that the modified Elongated One-Piece Arterial Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2003

Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Principal Regulatotry Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428

Re: K031037

EOPA Elongated One-Piece Arterial Cannula w/o Guidewire Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular Regulatory Class: Class II (two) Product Code: DWF Dated: April 1, 2003 Received: May 6, 2003

Dear Mr. Bennett:

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.Ronald Bennett

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/dsma/dsmamain.html

Sincerely yours,

Prem D. Zuckerman, M.D.

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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Page _ 1_ of _________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): __KO31037

Device Name:

EOPA Elongated One-Piece Arterial Cannula and EOPA Elongated One-Piece Arterial Cannula with Guidewire

Indications for Use:

This product is intended for use with cardiopulmonary bypass as an arterial return cannula.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only

Valester
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Division of Cardiovascular Devices
510(k) Number K031037