DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT

K120988 · Medtronic, Inc. · DWF · Jul 25, 2012 · Cardiovascular

Device Facts

• Record ID: K120988
• Device Name: DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT
• Applicant: Medtronic, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 25, 2012
• 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

DLP Single Stage Venous Cannulae are medical devices used during cardiopulmonary bypass surgery. The device collects and directs venous blood from the right side of the heart (superior and inferior vena cava) into the bypass circuit. The cannula consists of a wirewound, kink-resistant PVC plastisol body, available in sizes 12Fr to 40Fr and lengths of 12 to 15 inches. Some versions feature a Carmeda BioActive Surface, a heparin-based coating designed to improve biocompatibility and reduce platelet activation. The device is sterile, single-use, and disposable. It is operated by surgical staff in an operating room environment. By facilitating blood diversion during bypass, the device enables the heart to be bypassed during surgical procedures, providing a temporary pathway for blood circulation.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Wirewound, kink-resistant PVC plastisol body; 12Fr-40Fr diameter; 12-15 inch length. Available with Carmeda BioActive Surface (heparin-based end-point attached biosurface). Sterile, single-use, disposable. No software or electronic components.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring venous blood collection from the right side of the heart via the superior and inferior vena cava. Contraindicated for long-term use, such as ventricular assist 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

• Venous Cannula with Bent, Tip Wire (K842374)
• Malleable Single Stage Venous Cannula (K022272)
• Malleable Single Stage Venous Cannula with Carmeda T BioActive Surface (K111972)

Submission Summary (Full Text)

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# K120988 JUL 25 2012

2 5 2012

# 510(k) Summary

Date Prepared:

March 30, 2012

Submitter:

Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establishment Registration Number: 2184009

Contact Person:

:

Jacqueline A Hauge Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: [phone].367.8360 Fax: Email: jacqueline.a.hauge(@medtronic.com

### Alternate Contact:

Susan Fidler Senior Regulatory Affairs Manager Medtronic Perfusion Systems Phone: [phone] Fax: [phone] Email: [e-mail]

### Device Name and Classification

| Trade Name: | DLP® Single Stage Venous Cannula<br>DLP® Right Angle Single Stage Venous Cannula<br>DLP® Single Stage Venous Cannula with Right Angle Metal Tip<br>DLP® Malleable Single Stage Venous Cannula |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Product Classification: | Class II |

K842374 K022272 K111972

Venous Cannula with Bent, Tip Wire Malleable Single Stage Venous Cannula Malleable Single Stage Venous Cannula with Carmeda T BioActive Surface

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#### Device Description

DLP® Single Stage Venous Cannulae devices are used during cardiopulmonary bypass surgical procedures for collecting and directing blood from the right side of the heart via the superior and inferior vena cava into the bypass circuit. These cannulae are comprised of wirewound, kink-resistant Polyvinyl Chloride (PVC) plastisol bodies with a nominal outer diameter of 12Fr to 40Fr (in 2Fr increments) and overall lengths from 12 inches to 15 inches. These cannulae are available in Carmeda® Bioactive Surface coated and uncoated versions. All DLP® Single Stage Venous Cannulae are provided as sterile, nonpyrogenic, disposable, single use devices.

Carmeda® BioActive Surface is a durable, non-leaching end point attached heparin Biosurface that mimics the heparin sulfate naturally found on the vascular endothelium lining the circulatory system. Carmeda® provides thromboresistance, enhanced biocompatibility, and enhanced blood compatibility while reducing platelet activation and adhesion formation.

#### 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.

#### Contraindications

These cannulae are contraindicated for long-term use. Do not use for extended terms such as Ventricular Assist procedures.

#### Comparison to Predicate Devices

A comparison of the modified product to the currently marketed product (K845045 and K022272) indicate the following similarities:

- I Same intended use
- 파 Same technological characteristics
- l Same operating principle
- 트 Same design features
- 트 Same base materials prior to coating
- Same shelf life

A comparison of the modified product and the currently marketed DLP® Single Stage Venous Cannula with Carmeda® BioActive Surface (K111972) indicated the following similarities:

- I Same Carmeda® BioActive Surface coating

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### Conclusion

Medtronic has demonstrated that the modifications made to the DLP® Single Stage Venous Cannula product family described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted in a simple, black and white design, and the text is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 2 5 2012

Medtronic, Inc. c/o Ms. Jacqueline A. Hauge Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K120988

> DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right Angle Metal Tip and DLP Malleable Single Stage Venous Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: June 28, 2012 Received: June 29, 2012

Dear Ms. Hauge:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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# Page 2 - Ms. Jacqueline A. Hauge

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

signature

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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## Indications for Use

#### 510(k) Number (if known): K120988

Device Name: DLP® Single Stage Venous Cannula

DLP® Right Angle Single Stage Venous Cannula

DLP® Single Stage Venous Cannula with Right Angle Metal Tip DLP®:Malleable Single Stage Venous Cannula

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 of less.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Divis of Sign-Off) f of Cardiovascular Devices Number

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