EDWARDS TRANSFEMORAL BALLOON CATHETER

K140241 · Edwards Lifesciences, LLC · OZT · Jul 3, 2014 · Cardiovascular

Device Facts

• Record ID: K140241
• Device Name: EDWARDS TRANSFEMORAL BALLOON CATHETER
• Applicant: Edwards Lifesciences, LLC
• Product Code: OZT · Cardiovascular
• Decision Date: Jul 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1255
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Edwards Balloon Catheter is indicated for balloon aortic valvuloplasty.

Device Story

The Edwards Balloon Catheter is a percutaneous catheter used for balloon aortic valvuloplasty. The device consists of a nylon balloon, a thermoplastic elastomer (Polyether block amide) multidurometer braided shaft (130cm length), platinum/iridium radio-detectable markers, and a polycarbonate y-connector with an inflation port and guidewire lumen. It is supplied sterile for single use. The device is operated by a physician in a clinical setting. The balloon is inflated to perform valvuloplasty, which helps improve valve function. The device is intended for prescription use.

Clinical Evidence

Clinical assessment included a literature review, complaint analyses for the Edwards Transfemoral and RetroFlex Balloon Catheters, and review of post-market experience. This data, combined with results from the pivotal IDE G030069 (RetroFlex Balloon Catheter) reviewed under PMA P100041, supports the safety and effectiveness of the device.

Technological Characteristics

Materials: Nylon balloon, thermoplastic elastomer (Polyether block amide) braided shaft, platinum/iridium markers, polycarbonate y-connector. Dimensions: 130cm working length; 16mm, 20mm, 23mm, 25mm diameters. Sterilization: Ethylene oxide. Single-use. No software or electronic components.

Indications for Use

Indicated for balloon aortic valvuloplasty in patients requiring this procedure.

Regulatory Classification

Identification

A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible. (2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components. (3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal. (4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis. (5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.

In combination with the general controls of the FD&C Act, the NuMED NuCLEUS and NuCLEUS-X BAV Catheters are subject to the following special controls:

Predicate Devices

• Loma Vista Medical (BARD) TRUE Dilation Balloon Valvuloplasty Catheter (K121083)
• Z-MED and Z-MED II™ Balloon Aortic Valvuloplasty & Percutaneous Transluminal Valvuloplasty Catheter (K122012)

Submission Summary (Full Text)

{0}------------------------------------------------

| | 510(k) Summary |
|--|----------------|
|--|----------------|

JUL 0 3 2014

| Submitter: | Edwards Lifesciences, LLC<br>One Edwards Way<br>Irvine, CA 92614 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Eric Carrier, Phone: [phone], Fax: [phone] |
| Prepared: | January 28, 2014 |
| Trade Name: | Balloon Catheter |
| Common Name: | Percutaneous Catheter |
| Classification: | Catheter Introducer<br>21 CFR 870.1250, Product Code OZT |
| Predicate<br>Device(s): | Loma Vista Medical (BARD) TRUE Dilation Balloon Valvuloplasty<br>Catheter (K121083), and the Z-MED and Z-MED II™ Balloon Aortic<br>Valvuloplasty & Percutaneous Transluminal Valvuloplasty Catheter<br>(K122012). |

#### Device Description:

The Edwards Balloon Catheter, is used for balloon aortic valvuloplasty. The device consists of a nylon balloon, a thermoplastic elastomer (Polyether block amide) multidurometer braided shaft with 130cm working length, platinum/iridium radio-detectable markers, and a polycarbonate y-connector that consists of a balloon inflation port and guidewire lumen. The effective length of the balloon is 4cm and is offered in 16mm, 20mm, 23mm and 25mm diameters. The balloon catheter is supplied sterilized by ethylene oxide for single use.

#### Indication:

The Edwards Balloon Catheter is indicated for balloon aortic valvuloplasty.

#### Comparison to Predicate:

The Edwards Balloon Catheter is substantially equivalent to Loma Vista Medical (BARD) TRUE Dilation Catheter, 510(k) No .: K121083 and the Z-MED and Z-MED II™ Balloon Apric Valvuloplasty & Percutaneous Transluminal Valvuloplasty Catheter, 510(k) No.: K122012.

### Summary of Non-Clinical Testing:

Non-clinical testing was completed to demonstrate that the Edwards Balloon Catheter met the established performance characteristics , and to verify that design requirements are satisfied. Testing included biocompatibility evaluation per ISO 10993-1, ethylene oxide sterilization validation, and package qualification. Device functional testing included, Surface/Visual Inspection, Dimensional Inspection: Catheter and Balloon Working Length, Balloon

{1}------------------------------------------------

### K140241 page 2 of 2

Inflation/Deflation Time, Balloon Maximum Inflation Pressure for Nominal Volume, Balloon Diameter at Nominal Volume, Balloon Catheter Retrieval Force, Balloon Fatigue and Burst, Marker Band Bond Verification, Bond Strength: Catheter Shaft/Hub, and Bond Strength: Catheter Shaft/Hub (Torque).

# Summary of Clinical Data:

Clinical assessment for the Edwards Transfemoral Balloon Catheters consisted of a literature review, complaint analyses for the Edwards Transfemoral Balloon Catheter and RetroFlex Balloon Catheter, and review of post-market experience with the Edwards Transfemoral Balloon Catheter. This data, in combination with the results of the pivotal IDE G030069 (with the RetroFlex Balloon Catheter) reviewed as part of PMA P100041, provides reasonable assurance that the Edwards Transfemoral Balloon Catheter is safe and effective for its indicated use.

### Conclusion:

The Edwards Catheter is substantially equivalent to the predicate devices (Loma Vista Medical (BARD) TRUE Dilation Catheter the Z-MED and Z-MED II™ Balloon Aortic Valvuloplasty & Percutaneous Transluminal Valvuloplasty Catheter.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

March 20, 2015

Edwards Lifesciences, LLC. Eric Carrier Sr. Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614

Re: K140241

Trade/Device Name: Edwards Balloon Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OZT Dated: June 4, 2014 Received: June 5, 2014

Dear Mr. Carrier:

This letter corrects our substantially equivalent letter of July 3, 2014.

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 - Mr. Eric Carrier

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/ResourcesforYou/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,

Nicole G. Ibrahim -S

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

Enclosure

{4}------------------------------------------------

## K140241

## Indications For Use Statement

| 510(k) Number (if known) | |
|--------------------------|-----------------------------------------------------------------------------|
| Device Name | Edwards Balloon Catheter |
| Indications for Use | The Edwards Balloon Catheter is indicated for balloon aortic valvuloplasty. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Zillaham

Prescription Use メ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________