DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF

K123762 · Medtronic, Inc. · DWF · Mar 27, 2013 · Cardiovascular

Device Facts

• Record ID: K123762
• Device Name: DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF
• Applicant: Medtronic, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Mar 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.

Device Story

DLP Retrograde Coronary Sinus Perfusion Cannula; used during cardiopulmonary bypass surgery; delivers cardioplegia solution retrogradely through coronary sinus. Device body constructed of PVC or silicone wirewound material; features auto-inflate cuff; includes locking female luer; utilizes guidewire or solid stylet for trans-atrial introduction. Operated by surgical team in OR. Single-use, sterile, nonpyrogenic. Provides stable perfusion access; cuff inflation secures position within coronary sinus.

Clinical Evidence

Bench testing only. Verification testing included kink test, simulated use, bond joint tensile test, leak testing, and introducer functional tests (twist and tensile). Performance testing included cuff retention force testing. All samples passed testing.

Technological Characteristics

Materials: PVC or silicone wirewound body. Features: Auto-inflate cuff, locking female luer, guidewire/stylet compatibility. Form factor: Cannula for coronary sinus cannulation. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring retrograde cardioplegia delivery via the coronary sinus for up to six hours.

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

• Retrograde Coronary Sinus Perfusion Cannula (K901074)
• Retrograde Coronary Sinus Perfusion Cannula without Pressure Monitoring Lumen (K030696)

Submission Summary (Full Text)

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# 510(k) Summary

December 6, 2012 Date Prepared: Submitter:

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

Contact Person:

Chelsea L. Pioske Associate Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: [phone] Fax: [phone] Email: [e-mail]

#### Alternate Contact:

Susan Fidler Senior Regulatory Affairs Manager Medtronic Perfusion Systems Phone: [phone] Fax: [phone] Email: susan.c.fidler(@medtronic.com

#### Device Name and Classification

DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Trade Name: Cuff Common Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing 21 CFR 870.4210 Regulation Number: Product Code: DWF Product Class II Classification:

# Predicate Devices

Retrograde Coronary Sinus Perfusion Cannula K901074 K030696 Retrograde Coronary Sinus Perfusion Cannula without Pressure Monitoring Lumen

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# Device Description

The cannulae consist of either a Polyvinyl Chloride (PVC) body or a silicone wirewound kink-resistant body with auto-inflate cuff. The cannula is used for direct cannulation within the coronary sinus to deliver cardioplegia solution during cardiopulmonary bypass surgery. The back of the cannula body terminates in a locking female luer. These cannulae utilize a guidewire or solid stylet to facilitate trans-atrial introduction. The cannulae are nonpyrogenic. single use, and sterile.

#### Indications for Use

This device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.

### Comparison to Predicate Devices

A comparison of the modified product to the currently marketed products (K901074 and K030696) indicates the following similarities:

- Same intended use
- 트 Same technological characteristics
- Same operating principle
- Same design features
- Same base materials
- Same shelf life ■

# Summary of Design Verification Testing

The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional French size option, which was tested through the design verification process. The samples were subjected to a kink test, a simulated use test, functional tests of the cannula (bond joint tensile test and leak testing of all bonded connections), and functional tests of the introducer (twist test and tensile test). All samples passed the verification testing.

### Summary of Performance Testing

The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional cuff style, which was performance tested. The samples were subjected to retention force testing to ensure acceptable retention within the coronary sinus. All samples passed the verification testing.

### Conclusion

Medtronic has demonstrated that the modifications made to the DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family described in this submission result in a substantially equivalent device the fundamental scientific principle, operating principle, design features and intended from the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 27, 2013

Medtronic, Inc. C/O Chelsea Pioske 8200 Coral Sea Street NE Mounds View, MN 55433

Re: K123762 Trade/Device Name: DLP Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula or tubing Regulatory Class: Class II Product Code: DWF Dated: March 7, 2013 Received: March 8, 2013

Dear Ms. Pioske:

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. Iisting 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.

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

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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.

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/CDRH/CDRHOffices/ucm115809.html 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.htmfor 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,

# Matthew G. Hillebrenner

for

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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# Statement of Indications for Use

510(k) Number (if known): K123762

Device Name: DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff

Indications for Use:

This device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.

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)

# Matthew G. Hillebrenner

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