ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)

K140569 · Maquet Cardiopulmonary, AG · DWF · Nov 19, 2014 · Cardiovascular

Device Facts

• Record ID: K140569
• Device Name: ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DWF · Cardiovascular
• Decision Date: Nov 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Antegrade Cardioplegia Cannula acts as an infusion cannula for cardioplegic solutions. The cardioplegic solution is perfused via the aortic root into the coronaries. Furthermore, the Antegrade Cardioplegia Cannula can be used for left ventricular relaxation and aortic arch de-airing during cardiopulmonary bypass. The maximum duration of use is 6 hours.

Device Story

Antegrade Cardioplegia Cannula (N-Type) is a sterile, single-use infusion cannula used during cardiopulmonary bypass. It is inserted into the aortic root via purse-string suture to deliver cardioplegic solution into the coronary arteries (antegrade delivery) to induce asystole. It also facilitates left ventricular relaxation and aortic arch de-airing. The device is operated by surgeons in an operating room setting. This version is a redesign of the predicate (K020515) to eliminate DEHP plasticizer from PVC components and introduces new configurations, including options with/without a trocar, pressure monitoring systems, and varying infusion line lengths/clamps. The device provides a physical conduit for fluid delivery; it does not involve electronic processing or software.

Clinical Evidence

Bench testing only. Performance evaluation included flow rate, pressure resistance, leak testing, bond joint tensile strength, kink resistance, stress cracking, and functional testing of plugs, clamps, and trocars. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemocompatibility, and genotoxicity. All tests met acceptance criteria.

Technological Characteristics

Single-use, sterile (ethylene oxide) infusion cannula. Materials include PVC (DEHP-free). Features include infusion line, optional trocar, pressure monitoring system, and vent/air plugs. Mechanical design for aortic root insertion.

Indications for Use

Indicated for patients undergoing operative procedures requiring cardiopulmonary bypass where cardioplegic solution delivery to the heart is necessary to induce asystole.

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

• Jostra Antegrade Cardioplegia Cannula (K020515)

Submission Summary (Full Text)

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Public Health Service

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

November 19, 2014

MAQUET Cardiopulmonary AG Sarah Betz Manager Regulatory Affairs Kehler Strasse 31 76437 Rastatt, Germany

Re: K140569

Trade/Device Name: Antegrade cardioplegia cannula (n-type) Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula Or Tubing Regulatory Class: Class II Product Code: DWF Dated: October 17, 2014 Received: October 22, 2014

Dear Sarah Betz,

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 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

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

Sincerely yours,

M.A. Hillebrand

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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#### Indications for Use

| 510(k) Number: | To be assigned K140569 |
|----------------|-----------------------------------------|
| Device Name: | Antegrade Cardioplegia Cannula (N-Type) |

#### Intended Use:

The Antegrade Cardioplegia Cannula acts as an infusion cannula for cardioplegic solutions. The cardioplegic solution is perfused via the aortic root into the coronaries. Furthermore, the Antegrade Cardioplegia Cannula can be used for left ventricular relaxation and aortic arch de-airing during cardiopulmonary bypass. The maximum duration of use is 6 hours.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) Summary

| Device Proprietary Name: | Antegrade Cardioplegia Cannula (N-Type) |
|----------------------------|----------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula on<br>tubing |
| Classification Regulation: | 870.4210 |
| Device Class: | II |
| Submitter's Name: | MAQUET Cardiopulmonary AG |
| Address: | Kehler Straße 31<br>76437 Rastatt, Germany |
| Contact Person: | Sarah Betz |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |

Date Summary Prepared: February 22, 2014

## Device Description

The Antegrade Cardioplegia Cannula (N-Type) by MAQUET is used to administer cardioplegia solution into the heart in operative procedures where cardiopulmonary bypass is utilized. The cardioplegia solution causes asystole so that the operative procedure can be performed on a still heart.

The Antegrade Cardioplegia Cannula (N-Type) is inserted into the aortic root through a purse-string suture towards the aortic cross clamp. This method allows the cardioplegia solution to flow into the coronary arteries, which is known as antegrade delivery.

## Purpose of Submission

The Antegrade Cardioplegia Cannula (N-Type) is a redesign of the currently marketed Antegrade Cardioplegia Cannula, cleared under K020515. The main reason for designing the new cannula is to replace the plasticizer DEHP in blood contacting components containing PVC as the raw material. In addition, two new configurations of

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the Antegrade Cardioplegia Cannula (N-Type) are being added, the Cannula with Trocar and Pressure Monitoring System and the Cannula without a Trocar. Special configurations are being added, such as an additional clamp on the infusion line and different length of infusion line.

## Intended Use:

The Antegrade Cardioplegia Cannula acts as an infusion cannula for cardioplegic solutions. The cardioplegic solution is perfused via the aortic root into the coronaries. Furthermore, the Antegrade Cardioplegia Cannula can be used for left ventricular relaxation and aortic arch de-airing during cardiopulmonary bypass. The maximum duration of use is 6 hours.

# Predicate Device:

The predicate device is the Jostra Antegrade Cardioplegia Cannula, manufactured by MAQUET Cardiopulmonary AG, which was cleared on April 24, 2002 under K020515.

## Technological Characteristics/Substantial Equivalence:

The Antegrade Cardioplegia Cannula (N-Type) has the same intended use, is manufactured from the same or similar materials and incorporates the same technological characteristics as the predicate device.

The Antegrade Cardioplegia Cannula (N-Type) is provided sterile by ethylene oxide and is for single use only.

## Performance Data:

The Antegrade Cardioplegia Cannula (N-Type) has been evaluated through non-clinical performance testing for flow rate, pressure resistance, leak testing, bond joint tensile strength, kink resistance, stress cracking of the handle, functional testing of the air plug and vent plug as well as the clamp and corrosion of the trocar. The Antegrade Cardioplegia Cannula (N-Type) met all of the acceptance criteria.

Biocompatibility testing was also performed and included Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility and Genotoxicity. The Antegrade Cardioplegia Cannula (N-Type) passed all biocompatibility testing.

The Antegrade Cardioplegia Cannula (N-Type) was found to be substantially equivalent to the predicate device based on non-clinical testing.