TRUE BA V BALLOON VALVULOPLASTY CATHETER

K141985 · C.R. Bard, Inc. · OZT · Sep 18, 2014 · Cardiovascular

Device Facts

• Record ID: K141985
• Device Name: TRUE BA V BALLOON VALVULOPLASTY CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: OZT · Cardiovascular
• Decision Date: Sep 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1255
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The True™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Device Story

The True™ BAV Balloon Valvuloplasty Catheter is an over-the-wire, high-performance balloon catheter used for balloon aortic valvuloplasty. It features a proprietary, non-compliant, low-profile balloon fixed at the distal tip, designed for consistent diameters and lengths. Two radiopaque markers delineate the working length for placement. The coaxial catheter includes an atraumatic tip for valve advancement and is compatible with .035" guidewires. Proximal components include dual female luer-lock hubs for inflation and guidewire lumens. The device is supplied with a profile-reducing sheath and a re-wrapping tool. It is used by clinicians in a cardiovascular setting to dilate the aortic valve. The device is non-latex. Performance is verified through bench testing, including balloon distensibility, burst pressure, fatigue, and trackability, ensuring it functions equivalently to predicate devices.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing only. In vitro testing included visual inspection, balloon distensibility, tip length, balloon/shaft dimensions, marker band visibility, tip morphology, tensile testing (tip, balloon-to-shaft, hub-to-shaft), balloon nominal/burst pressure, fatigue (repeated inflation), shaft leaks/burst, media interaction, trackability, inflation/deflation time, marker band alignment, sheath compatibility, equipment interface, dye penetration, and pouch tensile strength.

Technological Characteristics

Over-the-wire balloon catheter; non-compliant, low-profile balloon; coaxial design; radiopaque markers; .035" guidewire compatibility; 100 cm shaft length; female luer-lock hubs; non-latex materials. Mechanical sensing/actuation via hydraulic inflation. 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

• True Dilatation™ Balloon Valvuloplasty Catheter (K133569)
• Vida™ PTV Dilatation Catheter (K131002)

Submission Summary (Full Text)

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# True™ BAV Balloon Valvuloplasty Catheter 510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

#### Submitter Information:

| Applicant: | Bard Peripheral Vascular, Inc<br>1625 West 3rd Street<br>Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
| Phone: | 480-350-6012 |
| Fax: | 480-449-2546 |
| Contact: | Aaron Conovaloff, Regulatory Affairs Associate |
| Date: | July 21, 2014 |

### Subject Device Name:

| Device Trade Name: | True™ BAV Balloon Valvuloplasty Catheter |
|-----------------------|---------------------------------------------------------------------|
| Common or Usual Name: | Balloon Aortic Valvuloplasty (21 CFR<br>870.1250, Product Code OZT) |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |

### Predicate Devices:

- True Dilatation™ Balloon Valvuloplasty Catheter (K133569; cleared . December 20, 2013)
- Vida™ PTV Dilatation Catheter (K131002, cleared July 2, 2013) ●

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#### Device Description:

The True™ BAV Balloon Valvuloplasty Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" quidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.

| Attribute | True™ BAV Balloon Valvuloplasty Catheter<br>Product Offering |
|-------------------------------------------------------------------|--------------------------------------------------------------|
| Balloon Diameter<br>(mm) | 18, 20, 22, 24, 26 |
| Balloon Length<br>(cm) | 4 |
| Catheter Shaft<br>Length (cm) | 100 |
| Introducer Sheath<br>Compatibility by<br>Balloon Diameter<br>(mm) | 8F: 18 mm<br>9F: 20 mm<br>10F: 22 mm, 24 mm<br>12F: 26 mm |

#### Indications for Use of Device:

The True™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

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## Comparison of Indications for Use to Predicate Devices:

The indications for use statement for the True™ BAV Balloon Valvuloplasty Catheter does not raise any new issues of safety and effectiveness as demonstrated through the risk analysis process based on the proposed indications for use statement as compared to the predicate devices. Therefore, the subject device, the True™ BAV Balloon Valvuloplasty Catheter, is substantially equivalent to the predicate devices.

# Technological Comparison to Predicate Devices:

The True™ BAV Balloon Valvuloplasty Catheter has the following similarities to the predicate device, the True Dilatation™ Balloon Valvuloplasty Catheter (clearance to market via K133569 on December 20, 2013):

- . Same intended use
- . Same indications for use
- Same target population .
- Same operating principle .
- Same fundamental scientific technology ●
- Same sterility assurance level and method of sterilization .

The True™ BAV Balloon Valvuloplasty Catheter has the following similarities to the predicate device, the Vida™ PTV Dilatation Catheter (clearance to market via K131002, on July 2, 2013):

- Same operating principle .
- . Same fundamental scientific technology
- Same packaging materials and configurations .
- . Same sterility assurance level and method of sterilization

### Performance Data:

To demonstrate substantial equivalence of the subject device to the predicate devices, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:

- . Visual Inspection
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- o Balloon Distensibility
The following in vitro tests were leveraged from the predicate Vida™ PTV Dilatation Catheter:

- 0 Tip Length
- Balloon Outer Diameter (i.e. Diameter and Profile Test) o
- Balloon Working Length .
- Catheter Shaft Outer Diameter o
- 0 Catheter Shaft Inner Diameter
- 0 Tip Visibility
- 0 Catheter Shaft Visibility
- Marker Band Visibility 0
- Tip Morphology o
- Tip Tensile (i.e. Tip Pull and Torque Test, and Bond Strength Test) 0
- Balloon to Shaft Tensile 0
- 0 Hub to Shaft Tensile
- Catheter Shaft Elongation 0
- o Balloon Nominal (Operating) Pressure
- Rated Burst Pressure (i.e. Balloon Minimum Burst Strength) 0
- o Balloon Burst Mode
- Fatigue (i.e. Repeated Balloon Inflation) 0
- Catheter Shaft Leaks (i.e. Catheter Body Maximum Pressure Test) 0
- Catheter Shaft Burst (i.e. Catheter Body Maximum Pressure Test) 0
- 0 Media Interaction (i.e. Balloon Preparation Test)
- Catheter Shaft Length .
- Trackability
- Inflation/Deflation Time (i.e. Balloon Inflation/Deflation Test, and Balloon . Inflatability Test)
- Marker Band Alignment .
- Sheath Compatibility 0
- Equipment Interface o
- 0 Visual Inspection of Packaging

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- 0 Dye Penetration
- Pouch Tensile Strength .

The results from these tests demonstrate that the technological characteristics and performance criteria of the True™ BAV Balloon Valvuloplasty Catheter are substantially equivalent to the predicate devices, and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

#### Conclusions:

The subject device, the True™ BAV Balloon Valvuloplasty Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The True™ BAV Balloon Valvuloplasty Catheter is substantially equivalent to the legally marketed predicate devices, the True Dilatation™ Balloon Valvuloplasty Catheter and the Vida™ PTV Dilatation Catheter.

Image /page/4/Picture/9 description: The image shows the word "BARD" in a stylized, blocky font. Each letter is outlined in black, giving it a bold and distinct appearance. The "A" in "BARD" is designed with a unique triangular shape, setting it apart from the other letters.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

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

March 20, 2015

Bard Peripheral Vascular, Inc. Dr. Aaron Conovaloff Regulatory Affairs Associate 1625 West 3rd Street Tempe, Arizona 85281

Re: K141985

Trade/Device Name: True BAV Balloon Valvuloplasty Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OZT Dated: July 21, 2014 Received: July 22, 2014

Dear Dr. Conovaloff:

This letter corrects our substantially equivalent letter of September 18, 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

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Page 2 - Dr. Aaron Conovaloff

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

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# Indications for Use

510(k) Number (if known): K141985

Device Name: True™ BAV Balloon Valvuloplasty Catheter

Indications for Use: The True™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Prescription Use X (Part21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/7/Picture/12 description: The image shows the word "BARD" in a stylized, blocky font. The letters are bold and outlined in black. The "A" is designed with a triangular shape in the middle, and the "D" has a rounded shape.