RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA

K123187 · Edwards Lifesciences, LLC · DWF · Feb 22, 2013 · Cardiovascular

Device Facts

• Record ID: K123187
• Device Name: RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA
• Applicant: Edwards Lifesciences, LLC
• Product Code: DWF · Cardiovascular
• Decision Date: Feb 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Retrograde coronary sinus cardioplegia catheters with and without Duraflo coating are intended for delivery of blood or cardioplegia solution intraoperatively to avoid cardiac damage and aid in myocardial protection. Retrograde coronary sinus cardioplegia catheters may be used in pediatric or adult populations based on the requirements of individual patient anatomy. This device is for short-term use only (≤ 6 hours). Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

Device Story

Sterile, single-use, multi-lumen catheters for retrograde cardioplegia delivery during cardiopulmonary bypass; provides myocardial protection by delivering blood or cardioplegia solution to coronary sinus. Features include 2-3 lumens for cardioplegia delivery, pressure monitoring, and balloon inflation/stiffening wire; includes smooth or textured occlusion balloons (manually or self-inflating) and insertion stylet. Available with Duraflo (heparin) coating for heparin-bonded blood path. Used intraoperatively by surgeons; provides pressure monitoring feedback to guide delivery. Benefits include reduced cardiac damage during bypass. Device sizes range 9-14 French, 8-12.5 inches length; balloons 9mm-3cm.

Clinical Evidence

Clinical assessment based on published literature provided to support pediatric indication. Bench testing performed for sterility (ISO 11135-1), biocompatibility (ISO 10993-1), ethylene oxide residuals (ISO 10993-7), conical fittings, wire encapsulation, assembly leak, kink resistance, balloon burst/leak, pressure monitoring, corrosion, and tensile strength.

Technological Characteristics

Flexible/non-flexible polymeric materials; multi-lumen catheter design; occlusion balloon (smooth/textured); insertion stylet. Standards: ISO 10993-1 (biocompatibility), ISO 10993-7 (EO residuals), ISO 11135-1 (sterilization), ISO 14971 (risk management). Duraflo (heparin) coating option. Sizes: 9-14 French, 8-12.5 inches length. Balloon sizes: 9mm-3cm.

Indications for Use

Indicated for pediatric and adult patients undergoing cardiopulmonary bypass surgery requiring myocardial protection via delivery of blood or cardioplegia solution to the coronary sinus. Short-term use only (≤ 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

• Retrograde Coronary Sinus Cardioplegia Cannulae (K880103)
• Retrograde Cardioplegia Cannulae with Duraflo Treatment (K991170)
• Steerable Retrograde Cardioplegia Cannula with and without Duraflo Treatment (K001565)

Submission Summary (Full Text)

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K128187

#### 510(k) Summary

| Submitter: | Edwards Lifesciences LLC |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Jones, Senior Manager, Regulatory Affairs<br>12050 Lone Peak Pkwy<br>Draper, UT 84020<br>[phone] |
| Date Prepared: | October 10, 2012 |
| Trade Name: | Edwards Lifesciences® Retrograde Cardioplegia Catheters<br>with and without Duraflo Coating |
| Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary<br>Bypass, 21 CFR Part 870.4210, Product Code DWF, Class II |
| Predicate Device: | K880103 - Retrograde Coronary Sinus Cardioplegia Cannulae<br>K991170 - Retrograde Cardioplegia Cannulae with Duraflo<br>Treatment<br>K001565 - Steerable Retrograde Cardioplegia Cannula with and<br>without Duraflo Treatment |

#### Device Description:

Edwards Retrograde Coronary Sinus Cardioplegia Catheters (or Retrograde Cardioplegia Cannulae) are sterile, non-pyrogenic, single-use catheters made of flexible and non-flexible polymeric materials. They are intended to provide retrograde cardioplegia to the coronary sinus during cardiopulmonary bypass procedures.

Retrograde Cardioplegia Catheters have two or three lumens. One lumen delivers cardioplegia. A second lumen monitors pressure within the coronary sinus. If a third lumen is present, it either facilitates a manually inflated balloon or a stiffening wire.

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Catheters include manually inflating or self-inflating smooth or textured occlusion balloons. A curved semi-rigid or malleable insertion stylet is provided with each catheter.

Edwards Retrograde Cardioplegia Catheters are also available with Duraflo™ (heparin) coating.

#### Indications for Use:

Retrograde coronary sinus cardioplegia catheters with and without Duraflo coating are intended for delivery of blood or cardioplegia solution intraoperatively to avoid cardiac damage and aid in myocardial protection.

Retrograde coronary sinus cardioplegia catheters may be used in pediatric or adult populations based on individual patient anatomy.

This device is for short-term use only (≤ 6 hours)

Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

#### Comparative Analysis:

The Retrograde Cardioplegia Catheters have the same fundamental scientific technology and principles of operation as the predicate devices. Minor differences in features relate to customer reference rather than the clinical performance of the device. The product range of sizes now includes 9 to 14 French, 8 to 12.5 inches in length, and balloons from 9mm to 3cm. Size variations relate directly to patient anatomy. Balloons have a smooth or textured surface, and can either be self inflating or manually inflating. Additionally, the polymeric material formulations in the devices have evolved, but material types remain the same as those originally cleared in predicate submissions.

#### Non Clinical Testing:

Bench and laboratory testing was performed and assures that the product meets its specifications per the table below. The performance testing met the acceptance criteria.

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| Testing | Criteria |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Sterility | Per ISO11135-1, Sterilization of health care products - Ethylene oxide - Part 1: |
| Ethylene oxide<br>sterilization residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: |
| Biocompatibility | Per ISO 10993-1 for External communicating device, direct<br>circulating blood path, duration ≤ 24 hours. |
| Conical Fittings | Fittings must be compatible with standard connections. |
| Wire Encapsulation | Cannula body wire reinforcement shall be fully encapsulated. |
| Assembly Leak | Pressure drop must meet minimum requirement. |
| Kink | The cannulae shall not kink at a pre determined diameter. |
| Balloon Burst | Minimum pressures, diameter, and volume at burst must be<br>maintained. |
| Balloon Leak | Balloon must not leak when inflated with pre determined volumes. |
| Pressure Monitoring | Flow testing will confirm patency of the pressure monitoring lumen. |
| Corrosion | The metallic components shall show no signs of corrosion. |
| Tensile | Confirmation of the bond strength of the catheter assembly must<br>meet pre determined loads. |

The Retrograde Cardioplegia Catheters conform to the following standards:

- · ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing.
- · 1SO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- · ISO11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- · ISO14971, Medical devices Application of risk management to medical devices

#### Clinical Assessment:

A clinical assessment based on published studies was provided to support the pediatric indication.

#### Conclusion:

The Retrograde Cardioplegia Catheters are substantially equivalent to the cited predicate devices. The nonclinical tests and clinical assessment demonstrate that the devices are as safe and as effective as the legally marketed devices.

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

February 22, 2013

Edwards Lifesciences LLC Karen Jones, Senior Principal Project Manager 12050 Lone Peak Pkwy. Draper, UT 84020

Re: K123187

Trade/Device Name: Retrograde Cardioplegia Catheter Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula or tubing Regulatory Class: Class II Product Code: DWF Dated: January 25, 2013 · Received: January 28, 2013

Dear Ms. Jones:

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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Page 2 - Ms. Karen Jones

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" (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,

## 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): K123187

Device Name: Edwards Lifesciences® Retrograde Cardioplegia Catheter

Indications for Use:

Retrograde coronary sinus cardioplegia catheters with and without Duraflo coating are intended for delivery of blood or cardioplegia solution intraoperatively to avoid cardiac damage and aid in myocardial protection.

Retrograde coronary sinus cardioplegia catheters may be used in pediatric or adult populations based on the requirements of individual patient anatomy.

This device is for short-term use only (≤ 6 hours).

Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

Prescription Use × (Per 21 CFR 801.109)

OR Over-The-Counter Use

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

# Matthew GM lebrenner