True Flow Valvuloplasty Perfusion Catheter

K172932 · C.R. Bard, Inc. · OZT · Dec 13, 2017 · Cardiovascular

Device Facts

• Record ID: K172932
• Device Name: True Flow Valvuloplasty Perfusion Catheter
• Applicant: C.R. Bard, Inc.
• Product Code: OZT · Cardiovascular
• Decision Date: Dec 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1255
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The True® Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

Device Story

The True Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter featuring a fixed, non-compliant balloon at the tip. Designed for use in clinical settings by physicians, the device allows continuous hemodynamic flow through a central orifice during balloon inflation. The catheter is positioned across the aortic valve using fluoroscopic guidance via two radiopaque markers. Radiopaque contrast media is delivered through an inflation lumen to dilate the stenotic aortic valve. The device enables complete valve dilation without requiring rapid pacing. The catheter is compatible with specific introducer sheaths and guidewires. Clinical benefit includes effective valve dilation prior to TAVI procedures.

Clinical Evidence

Prospective, observational study (TRUE-FLOW) of 24 subjects (adults with aortic stenosis undergoing TAVI). Primary performance endpoint: successful aortic valve dilatation. Primary safety endpoint: freedom from device/procedure-related death, stroke, annulus rupture, coronary occlusion, or ventricular perforation. Results: 87.5% (21/24) achieved successful dilatation without clinically significant movement; no device-related serious adverse events reported. Study demonstrated the device allows adequate blood flow for complete dilation without rapid pacing.

Technological Characteristics

Over-the-wire co-axial catheter; 110 cm length; non-compliant balloon; two-lumen design (inflation and guidewire); radiopaque markers for fluoroscopic positioning. Compatible with 11F-16F introducer sheaths depending on balloon diameter (18-26 mm). Sterilization method same as predicate.

Indications for Use

Indicated for balloon aortic valvuloplasty in adult patients scheduled for Transcatheter Aortic Valve Implantation (TAVI) for treatment of aortic stenosis.

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® Flow Valvuloplasty Perfusion Catheter (K152613)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" above the words "U.S. FOOD & DRUG" and the word "ADMINISTRATION" below.

December 13, 2017

C. R. Bard, Inc. Aaron Conovaloff Regulatory Affairs Specialist 1625 West 3rd Street Tempe, Arizona 85281

Re: K172932

Trade/Device Name: True Flow Valvuloplasty Perfusion Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Catheter Regulatory Class: Class II Product Code: OZT Dated: September 25, 2017 Received: September 26, 2017

Dear Mr. Conovaloff:

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

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801); medical device 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# 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) K172932

#### Device Name

True® Flow Valvuloplasty Perfusion Catheter

Indications for Use (Describe)

The True® Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### True® Flow Valvuloplasty Perfusion Catheter

#### Submitter Information:

Bard Peripheral Vascular, Inc. 1625 West Third St. Tempe, AZ 85281

Phone: [phone] Fax: [phone]

Contact Person: Aaron Conovaloff, Regulatory Affairs Specialist Date of Submission: September 25, 2017

### Subject Device Name:

| Name of Device: | True® Flow Valvuloplasty Perfusion Catheter |
|-----------------------|---------------------------------------------|
| Common or Usual Name: | Balloon Aortic Valvuloplasty |
| Classification Name: | Balloon Aortic Valvuloplasty |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 870.1255 |

### Predicate Device:

| Name of Device: | True® Flow Valvuloplasty Perfusion Catheter (K152613 |
|-----------------------|------------------------------------------------------|
| Common or Usual Name: | Balloon Aortic Valvuloplasty |
| Classification Name: | Balloon Aortic Valvuloplasty |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 870.1255 |

### Device Description:

The True® Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables continuous hemodynamic flow through its central orifice. The catheter is 110 cm long and has two lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque markers are located

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on the guidewire lumen. These bands are positioned at the proximal and distal balloon shoulders. These markers are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum guidewire size are indicated on the package label.

| Attribute | True® Flow Valvuloplasty Perfusion Catheter<br>Product Offering |
|-------------------------------------------------------------------|-----------------------------------------------------------------|
| Balloon Diameter<br>(mm) | 18, 20, 22, 24, 26 |
| Balloon Length<br>(cm) | 3.5 |
| Catheter Shaft<br>Length (cm) | 110 |
| Introducer Sheath<br>Compatibility by<br>Balloon Diameter<br>(mm) | 11F: 18 mm, 20 mm<br>12F: 22 mm<br>14F: 24 mm<br>16F: 26 mm |

## Indications for Use of Device:

The True® Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

### Technological Comparison to Predicate Devices:

The True® Flow Valvuloplasty Perfusion Catheter has the following similarities to the predicate device, the True® Flow Valvuloplasty Perfusion Catheter (clearance to market via K152613 on January 19, 2016):

- . 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 .

It should be noted that the subject True® Flow Valvuloplasty Perfusion Catheter is identical to the predicate device with respect to manufacturing and design. The only difference between the subject and predicate devices is an update to the Instructions for Use to provide results from clinical experience with the device.

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#### Performance Data:

Subsequent to clearance of K152613, a post-market clinical study (the TRUE-FLOW study) was conducted on the predicate True® Flow Valvuloplasty Perfusion Catheter. Twenty- five subjects were enrolled, of which all were successfully treated with the study device. One subject withdrew consent following all study procedures and hospital discharge, and is thus not included in the Analysis Population (n =24). Subjects eligible to be enrolled in this study were adult male and non-pregnant females scheduled to undergo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of aortic stenosis who had an annulus diameter that could be treated with the available sizes of the study device, in accordance with the IFU. The primary performance endpoint was successful dilatation of the aortic valve using the True® Flow Valvuloplasty Perfusion Catheter. The primary safety endpoint was freedom from device-related or procedure-related death, stroke, annulus rupture, coronary occlusion, ventricular perforation, during the pre-dilatation procedure. In 21 (87.5%) cases the True® Flow catheter successfully dilated the aortic annulus without clinically significant movement. For one subject these data were not recorded. No device related serious adverse events were reported during the study. The results of the TRUE-FLOW prospective, observational study indicated that the design of the True® Flow Valvuloplasty Perfusion Catheter allowed adequate blood flow through the device's central orifice to perform complete dilation of a stenotic aortic valve prior to TAVI without the need for rapid pacing.

#### Conclusions:

As the only difference between the subject and predicate devices is the addition of the above clinical experience to the IFU, there is no change to the intended use or indications for use, or any design specifications or manufacturing. Therefore the subject True® Flow Valvuloplasty Perfusion Catheter is substantially equivalent to the legally marketed predicate device, the True® Flow Valvuloplasty Perfusion Catheter.