MC2X MULTI-STAGE VENOUS CANNULA

K031776 · Medtronic Perfusion Systems · DWF · Jul 25, 2003 · Cardiovascular

Device Facts

• Record ID: K031776
• Device Name: MC2X MULTI-STAGE VENOUS CANNULA
• Applicant: Medtronic Perfusion Systems
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

Device Story

MC2X Multi-Stage Venous Cannula is a single-piece, wire-wound catheter designed for venous drainage during cardiopulmonary bypass surgery. It features side ports in the distal tip and a ported atrial basket for drainage. The device is 15.25 inches long and includes insertion depth markings for positioning. It is supplied sterile, non-pyrogenic, and for single use; some models include a Carmeda bioactive coating. Used in the operating room by surgical staff, the cannula facilitates blood drainage from the right atrium and inferior vena cava simultaneously. By providing efficient venous return, it supports the extracorporeal circuit, enabling the bypass procedure and potentially improving patient outcomes during cardiac surgery.

Clinical Evidence

Bench testing only. Performance data included collapse, flow, kink, and tensile testing to verify mechanical integrity. For devices with Carmeda coating, additional testing was performed to evaluate coverage, bio-activity, leaching, and functional performance.

Technological Characteristics

Wire-wound, one-piece venous cannula; 15.25-inch length; includes side ports and ported atrial basket; optional Carmeda bioactive coating. Materials are biocompatible and non-pyrogenic. Mechanical design focuses on drainage flow, kink resistance, and tensile strength. No software or electronic components.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring venous drainage via the right atrium and inferior vena cava simultaneously for durations of six hours or less.

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

• Two Stage Venous Cannula (K915268)
• Extracorporeal Circuit with Bio-Active Surface (K891687)

Submission Summary (Full Text)

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JUL 25 2003

# 510(k) Summary

| Date Prepared: | July 14, 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: [phone]<br>Fax: [phone] |

## Device Name and Classification:

| Trade Name: | MC2X TM Multi-Stage Venous Cannula |
|--------------------|------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or<br>tubing |
| Classification: | Class II |
| Predicate Devices: | Two Stage Venous Cannula<br>K915268<br><br>Extracorporeal Circuit with Bio-Active Surface<br>K891687 |

:

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K031776
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#### Device Description:

The MC2 family of cannula, including the new MC2X™ Multi-Stage Venous Cannula, are one piece, wire wound bodies with side ports in the distal tip, with ported atrial basket drainage and with an overall length of 15 ¼". Insertion depth marks aid in positioning the cannula. All are supplied sterile, are non-pyrogenic and are single use. The devices may include a Carmeda® coating.

#### Indication for Use

This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

#### Comparison to Predicate Device

The predicate devices are cannulae are Two Stage Venous Cannulae with the same general design characteristics. The predicate 510(k) devices currently marketed have the same indications for use. The predicate devices also provide drainage of the vena cava at the tip and provide atrial drainage. The currently marketed predicate devices include the same French size devices.

#### Summary of Performance Data

Collapse, flow, kink and tensile testing were conducted to ensure proper performance. In addition coverage, bio-activity, leaching and functional testing was performed on Carmeda® coated devices.

### Conclusion

Medtronic Perfusion Systems has demonstrated that the modified MC2X Multi-Stage Venous Cannulae are substantially equivalent to the predicate devices based upon design. test results, and indications for use.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the snakes intertwined around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2003

Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Principal Regulatory Affairs Specialist 7611 Northland Boulevard Brooklyn Park, MN 55428

Re: K031776

Trade Name: MC2XTM Multi-Stage Venous Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter cannula Regulatory Class: Class II (two) Product Code: DWF Dated: July 14, 2003 Received: July 15, 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.

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

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#### Page 2 - Mr. Ronald W. Bennett

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,

h. Qer Q. TUL

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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K031776

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510(k) Number (if known): K031776

Device Name:

## MC2XTM Multi-Stage Venous Cannula

Indications for Use:

This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) N

Prescription Use Only

(Optional Format 3-10-98)