ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX

K031827 · Medtronic Perfusion Systems · DWF · Jul 2, 2003 · Cardiovascular

Device Facts

• Record ID: K031827
• Device Name: ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX
• Applicant: Medtronic Perfusion Systems
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 2, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These cannulae are intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.

Device Story

ULTRAFLEX™ Venous Cannula is a medical device used during cardiopulmonary bypass surgery to facilitate venous drainage from the right atrium and inferior vena cava. The device features an occluder with a malleable stylet to assist clinicians in positioning and placement within the patient. Available in 23 and 29 Fr. diameters, the cannula may optionally include a Carmeda® bioactive coating. It is intended for use by trained medical professionals in a surgical setting. By providing a pathway for venous blood drainage, the device supports the extracorporeal circulation process, enabling the heart-lung machine to oxygenate blood and maintain systemic perfusion during cardiac procedures.

Clinical Evidence

Bench testing only. Performance established through in vitro visual, dimensional, simulated use, and functional testing. Additional testing performed on Carmeda® coated devices to verify coverage and bio-activity.

Technological Characteristics

Venous drainage cannula available in 23 and 29 Fr. diameters. Features an occluder with a malleable stylet for positioning. Optional Carmeda® bioactive coating. Device is a passive mechanical catheter for cardiopulmonary bypass.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring venous drainage via the right atrium and inferior vena cava simultaneously.

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

• VC2® Venous Cannula (K845045)
• Bio-Medicus® Femoral Cannula and Introducer (K924642)
• Extracorporeal Circuit with Bio-Active Surface (K8918687)

Submission Summary (Full Text)

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# j( 03) 827

#### JUL 2 2003

510(k) Summary

June 12, 2003 Date Prepared:

Submitter:

Medtronic Perfusion Systems 7611 Northland Boulevard

Brooklyn Park, MN 55428

Preeti Jain Contact Person: Senior Manager, Regulatory Affairs

> Phone: [phone] [phone] Fax:

# Device Name and Classification:

| Trade Name: | ULTRAFLEX™ Venous Cannula<br>23, 29 Fr. |
|--------------------|----------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or<br>tubing |
| Classification: | Class II |
| Predicate Devices: | VC2® Venous Cannula<br>K845045 |
| | Bio-Medicus® Femoral Cannula and Introducer<br>K924642 |
| | Extracorporeal Circuit with Bio-Active Surface<br>K8918687 |

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### Device Description:

The ULTRAFLEX™ Venous Cannula is designed for use with cardiopulmonary bypass as a venous drainage cannula. The occluder with a malleable stylet aids in positioning and placement of the cannula. The device is available in 23 and 29 Fr. diameters. The device may also include Carmeda® coating.

#### Indication for Use

This product is intended for use with cardiopulmonary bypass as a venous drainage cannula.

#### Comparison to Predicate Devices

The predicate devices are cannulae with the same or similar design characteristics. The predicate cannulae VC2® Two Stage Venous Cannula has the same indications for use. The other predicate cannulae Bio-Medicus® Femoral Cannula and Introducer features the same material and similar introducer configuration and tip design to the ULTRAFLEX™.

#### 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 ULTRAFLEX™ Venous 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/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, with three parallel lines that curve and flow into a serpentine shape at the bottom.

JUL 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Perfusion Systems c/o Mr. Preeti Jain 7611 Northland Drive N Minneapolis, MN 55428-1088

Re: K031827

ULTRAFLEXTM Venous Cannula Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, ad Tubing Regulatory Class: Class II (two) Product Code: 74 DWF Dated: June 12, 2003 Received: June 13, 2003

Dear Mr 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 – Mr. 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), 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,

Quesada Vaz Sr

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:

# ULTRAFLEXTM Venous Cannula

Indications for Use:

These cannulae are intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only

(Optional Format 3-10-98)

Alina D. Ag fr BPZ 7/1/03

510(k) Numbe