DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE

K141951 · Medtronic, Inc. · DWF · Aug 15, 2014 · Cardiovascular

Device Facts

• Record ID: K141951
• Device Name: DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
• Applicant: Medtronic, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Aug 15, 2014
• 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 conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

Device Story

DLP Silicone Coronary Artery Ostial Cannulae are sterile, single-use devices designed for use during cardiopulmonary bypass surgery. The device features a soft, beveled silicone bulb tip and a locking female luer fitting. Operated by a surgeon in an operating room, the cannula is inserted into the coronary artery ostia to deliver cardioplegia solutions. The device facilitates myocardial protection by providing a direct pathway for cardioplegic fluid. It is a passive delivery tool; it does not involve electronic processing, sensors, or automated algorithms.

Clinical Evidence

Bench testing only. Performance data included tensile pull-off force testing for the barbed female luer, dimensional analysis, rub-off testing for ink printing, and biocompatibility testing. All tests passed, demonstrating equivalence to the predicate.

Technological Characteristics

Materials: Silicone and Polypropylene. Design: Soft bulb beveled tip with locking female luer fitting. Energy source: None (passive). Connectivity: None. Sterilization: Sterile, single-use. The device is a mechanical cannula for fluid delivery.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring delivery of cardioplegia solutions directly to the coronary arteries for a duration 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

• DLP® Silicone Coronary Artery Ostial Cannulae (K131269)

Submission Summary (Full Text)

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

August 15, 2014

Kevin T. Lam Senior Regulatory Affairs Specialist Medtronic. Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428

Re: K141951

Trade/Device Name: DLP® Silicone Coronary Artery Ostial Cannulae: Model Numbers 30315, 30317, and 30320 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: II Product Code: DWF Dated: July 17, 2014 Received: July 18, 2014

Dear Mr. Lam:

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.

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

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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 (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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K141951

Device Name

DLP Silicone Coronary Artery Ostial Cannulae

#### Indications for Use (Describe)

These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) Summary

| Date Prepared: | July 17, 2014 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic, Inc.<br>Medtronic Perfusion Systems<br>7611 Northland Drive<br>Minneapolis, MN 55428<br>Establishment Registration Number: 2184009 |
| Contact Person: | Kevin T. Lam<br>Senior Regulatory Affairs Specialist<br>Medtronic Perfusion Systems<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Susan Fidler<br>Senior Regulatory Affairs Manager<br>Medtronic Perfusion Systems<br>Phone: [phone]<br>Fax: [phone] |

Email: [e-mail]

# Device Name and Classification

| Trade Name: | DLP® Silicone Coronary Artery Ostial Cannulae<br>Models: 30315, 30317, and 30320 |
|-------------------------|----------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Product Classification: | Class II |

# Predicate Devices

K131269

DLP® Silicone Coronary Artery Ostial Cannulae

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# Device Description

The DLP® Silicone Coronary Artery Ostial Cannulae feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.

# Indications for Use

These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

# Comparison to Predicate Devices

A comparison of the modified product to the currently marketed predicate products (K131269) indicates the following similarities:

- Same intended use ■
- ' Same technological characteristics
- Same operating principle 트
- 트 Same design features
- 트 Same base materials (Silicone and Polypropylene)
- 트 Same shelf life
- ' Same manufacturing process

## Summary of Performance Data

Testing has demonstrated that the DLP® Silicone Coronary Artery Ostial Cannulae are substantially equivalent to the predicate.

| Component | Base Material Changes | Verification/Validation | Results |
|------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------|----------------------|
| Barbed Female Luer | Current: Polypropylene<br>Proposed: Polypropylene | Hub tested for Tensile Pull-Off Force<br>Dimensional analysis<br>Biocompatibility | Pass<br>Pass<br>Pass |
| Silicone adhesive for ink printing | From: Silicone<br>To: Silicone | Rub off test<br>Biocompatibility | Pass<br>Pass |

The following performance tests were conducted:

## Conclusion

Medtronic has demonstrated that the material changes made to the DLP® Silicone Coronary Artery Ostial Cannulae presented in this submission resulted in a substantially equivalent device

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because the base material types, fundamental scientific principle, operating principle, design features, and intended use are unchanged from the predicate devices.