MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L

K100274 · Medtronic, Inc. · DWF · May 10, 2010 · Cardiovascular

Device Facts

• Record ID: K100274
• Device Name: MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L
• Applicant: Medtronic, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: May 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MiAR™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia for up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.

Device Story

Single-use, sterile, nonpyrogenic aortic root cannula; designed for cardioplegia delivery and air aspiration during cardiopulmonary bypass surgery. Features Flow-Guard™ mechanism to maintain hemostasis during introducer needle removal. Extended length facilitates use in minimally invasive procedures (mini-sternotomy, right thoracotomy). Operated by surgeons under direct visualization. Device provides access to the aorta; helps maintain surgical field integrity during bypass.

Clinical Evidence

Bench testing only. Performance evaluated via flow rate versus pressure drop, distal tip visibility under fluoroscopic visualization, and structural integrity of bonded joints. No clinical data required.

Technological Characteristics

Single-use, sterile, nonpyrogenic vascular cannula. Features Flow-Guard™ hemostasis mechanism. Extended length for minimally invasive access. Materials and connectors identical to predicate devices. No electronic components or software.

Indications for Use

Indicated for patients undergoing cardiac surgery requiring cardiopulmonary bypass, including median sternotomy or minimally invasive approaches (mini-sternotomy or right thoracotomy). Used for cardioplegia delivery and aortic air aspiration for up to 6 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

• Medtronic DLP Aortic Root Cannula (K790565)
• Medtronic Pediatric Aortic Root Cannula (K040173)

Submission Summary (Full Text)

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510(k) Summary

MiAR™ Aortic Root Cannula with Flow-Guard™ Traditional 510/k

| Date Prepared: | January 28, 2010 | MAY 10 2010 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter: | Medtronic 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009 | |
| Contact Person: | Caralee Walton Senior Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: [e-mail] | |

## Device Name and Classification

| Trade Name: | MiART™ (Minimally Invasive) Aortic Root Cannula with Flow-<br>Guard™ |
|--------------------|----------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Classification: | Class II |

### Predicate Devices

Medtronic DLP Aortic Root Cannula (K790565) Medtronic Pediatric Aortic Root Cannula (K040173)

### Device Description

MiARTM Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the aorta in an antegrade manner, for periods up to six hours during cardiopulmonary bypass surgery. These devices are available in models that feature two tip sizes and the Flow-Guard™ feature to maintain hemostasis during removal of the introducer needle from the cannula. The increased overall length of these cannulae relative to standard models, make them easier to use when minimally invasive surgical approaches are utilized (i.e., mini-sternotomy and right thoracotomy).

### Indications for Use

The MiAR™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia for up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.

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### Comparison to Predicate Devices

A comparison of the modified product and the currently marketed Aortic Root Cannula indicates the following similarities to the device which received 510(k) clearance:

- . Same technological characteristics
- Same operating principle .
- Same design features, only longer length .
- . Same Flow-Guard™ introducer
- Same connectors .
- Same materials ●

.

- Same shelf life .
### Summary of Performance Data

Bench testing was used to establish the performance characteristics of the modifications of this device from previously marketed Medtronic cannula devices. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:

- . Flow Rate Versus Pressure Drop
- . Distal tip visibility Under Fluoroscopic Visualization
- Structural Integrity (bonded joints) .

#### Conclusion

Medtronic has demonstrated that the MiAR™ Cannulae are substantially equivalent to the predicate device based upon design and test results. Any noted differences do not raise new issues of safety and effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAY 1 0 2010

Medtronic, Inc. c/o Ms. Caralee A. Walton Senior Regulatory Affairs Specialist 710 Medtronic Parkway NE Minneapolis, MN 55432

Re: K100274

MiAR™ (Minimally Invasive) Aortic Root Cannula with Flow-Guard™ Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: II Product Code: DWF Dated: May 3, 2010 Received: May 4, 2010

Dear Ms. Walton:

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 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

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Page 2 - Ms. Caralee A. Walton

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 (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.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" (21 CFR 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.him 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

R. Richmen

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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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MiAR™ Aortic Root Cannula with Flow-Guard™ Traditional 510(k)

# Indications for Use

510(k) Number (if known): _ K100274

Device Name: MiAR™ Aortic Root Cannula with Flow-Guard™

Indications for Use:

The MiAR™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dina R. Viinik

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K\00274