EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,

K031518 · Medtronic Vascular · DWF · May 22, 2003 · Cardiovascular

Device Facts

• Record ID: K031518
• Device Name: EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,
• Applicant: Medtronic Vascular
• Product Code: DWF · Cardiovascular
• Decision Date: May 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2

Intended Use

These cannulae are intended for use with cardiopulmonary bypass as an arterial return cannula.

Device Story

EOPA CAP™ is an elongated one-piece arterial cannula used during cardiopulmonary bypass. It functions as an arterial return conduit and includes an integrated pressure monitoring line for measuring central arterial pressure. Available in 18, 20, 22, and 24 Fr. diameters with optional vented/non-vented caps and Carmeda® coating. Used in clinical settings (e.g., OR) by perfusionists or surgeons. The device provides a direct pathway for blood return and real-time pressure data to the clinician, facilitating hemodynamic monitoring during bypass. Benefits include combined arterial return and pressure monitoring capabilities in a single device.

Clinical Evidence

Bench testing only. Evidence includes in vitro visual, dimensional, simulated use, and functional testing to verify performance characteristics of the modified design. Additional testing was conducted on Carmeda® coated devices to evaluate coverage, bio-activity, and functionality.

Technological Characteristics

Vascular cannula for cardiopulmonary bypass; 18-24 Fr. diameters; includes integrated pressure monitoring line; optional Carmeda® coating. Materials and dimensions are consistent with predicate devices. No electronic components 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 (K031037)
• SELECT CAP™ Arterial Cannula with Pressure Monitoring Line (K010737)

Submission Summary (Full Text)

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# 331518

## 510(k) Summary

Date Prepared: May 14, 2003

Submitter:

(1.1a) 1.7, 3.86

Medtronic Perfusion Systems 7611 Northland Boulevard Brooklyn Park, MN 55428

Contact Person: Dawn M. Stenstrom Senior Regulatory Affairs Specialist

MAY 22 2003

Phone: [phone] [phone] Fax:

## Device Name and Classification:

| Trade Name: | EOPA CAP™ Elongated One-Piece Arterial Cannula with<br>Pressure Monitoring Line<br>18, 20, 22, 24 Fr. |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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>18, 20, 22, 24 Fr.<br>K031037<br>SELECT CAP™ Arterial Cannula with Pressure<br>Monitoring Line<br>K010737 |

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#### Device Description:

The EOPA CAP™ Elongated One-Piece Arterial Cannula with Pressure Monitoring Line is designed for use with cardiopulmonary bypass as an arterial return cannula. The pressure monitoring line allows measurement of central arterial pressure. The device is available in 18, 20, 22, and 24 Fr. diameters, with vented or non-vented caps. The device may also include 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 with the same design characteristics. The predicate cannulae EOPA Elongated One-Piece Arterial Cannula has the same indications for use. The other predicate cannulae SELECT CAP Arterial Cannula features the same pressure monitoring line as the EOPA CAP.

## 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 and functional testing was performed on Carmeda® coated devices.

#### Conclusion

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

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 22 2003

Medtronic Perfusion Systems c/o Ms. Dawn Stenstrom Principal Regulatotry Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428

Re: K031518

EOPA Elongated One-Piece Arterial Cannula with Pressure Monitoring Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular Regulatory Class: Class II (two) Product Code: DWF Dated: May 14, 2003 Received: May 15, 2003

Dear Ms. Stenstrom:

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 - Ms. Dawn Stenstrom

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,

V. D. Sriram, 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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510(k) Number (if known): K031518

Device Name:

# EOPA CAP™ Elongated One-Piece Arterial Cannula with Pressure Monitoring Line

Indications for Use:

These cannulae are 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

V. Deaton

510(k) Numb

(Optional Format 3-10-98)