MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES

K033264 · Medtronic Perfusion Systems · DWF · Oct 31, 2003 · Cardiovascular

Device Facts

• Record ID: K033264
• Device Name: MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
• Applicant: Medtronic Perfusion Systems
• Product Code: DWF · Cardiovascular
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

Device Story

Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface; venous drainage cannula for cardiopulmonary bypass surgery. Device features malleable body for custom positioning; surface treated with heparin-based Carmeda® BioActive coating to improve hemocompatibility. Used in surgical settings by perfusionists or surgeons; collects venous blood from right heart via superior/inferior vena cava. Provides drainage for extracorporeal circulation; supports bypass procedures up to six hours. Benefits include reduced thrombogenicity via bioactive surface and improved surgical access via malleability.

Clinical Evidence

Bench testing only. No clinical data provided. Performance established via in vitro visual, coverage, bioactivity, leaching, functional, and biocompatibility testing on Carmeda® coated devices.

Technological Characteristics

Venous drainage cannula; malleable construction; heparin-based Carmeda® BioActive surface coating. Available in sizes 12-40 Fr. Class II device; non-electronic; mechanical design.

Indications for Use

Indicated for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery for patients requiring such procedures for up to 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

• Malleable Single Stage Venous Cannula (K022272)
• Extracorporeal Circuit with Bio-Active Surface (K8918687)

Submission Summary (Full Text)

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K033264

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# 510(k) Summary

| Date Prepared: | September 26, 2003 |
|-----------------|------------------------------------------------------------------------------------|
| Submitter: | Medtronic Perfusion Systems<br>7611 Northland Boulevard<br>Brooklyn Park, MN 55428 |
| Contact Person: | Preeti Jain<br>Director, Regulatory/Clinical Affairs |
| | Phone: [phone]<br>Fax: [phone] |

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# Device Name and Classification:

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| Trade Name: | Malleable Single Stage Venous Cannula with Carmeda®<br>BioActive Surface<br>12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40 Fr. |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or<br>tubing |
| Classification: | Class II |
| Predicate Devices: | Malleable Single Stage Venous Cannula<br>K022272 |
| | Extracorporeal Circuit with Bio-Active Surface<br>K8918687 |

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#### Device Description:

The Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface, is designed for use with cardiopulmonary bypass as a venous drainage cannula. The malleability feature allows the cannulae to be shaped and positioned to meet each customer's specific needs. The Carmeda® BioActive Surface adds a heparin based coating to the cannulae surface.

#### Indication for Use

These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

### Comparison to Predicate Devices

The predicate devices are cannulae with the same design characteristics. The predicate Malleable Single Stage Venous Cannula has the same indications for use.

#### Summary of Performance Data

In vitro visual, coverage, bioactivity, leaching, functional and biocompatibility testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications of this device from previously marketed devices.

#### Conclusion

Medtronic Perfusion Systems has demonstrated that the Malleable Venous Cannulae with Carmeda® BioActive Surface are substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 2003

Medtronic Perfusion Systems c/o Ms. Preeti Jain Director, Regulatory/Clinical Affairs 7611 Northland Drive N Brooklyn Park, MN 55428-1088

#### Re: K033264

Malleable Single Stage Venous Cannula with Carmeda® BioActive Suface Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: 74 DWF Dated: October 2, 2003 Received: October 9, 2003

#### Dear Ms. Jain:

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. Preeti Jain

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

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 _ 1 _

510(k) Number (if known):

Device Name:

### Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface

Indications for Use:

These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K033264