K Number

Device Name

TRUE FLOW VALVULOPLASTY PERFUSION CATHETER

Manufacturer

C.R. BARD, INC.

Date Cleared

2015-04-17

(260 days)

Product Code

OZT

Regulation Number

870.1255

Intended Use

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

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 hemodynamic flow through its central orifice. The catheter is 110 cm long and has two lumens: one 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 quidewire 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. Three radiopaque markers are embedded in the balloon wall. These bands are positioned at the proximal and distal balloon shoulders, and in the middle. These bands 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K133569

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.

Therapeutic

Yes
The device is indicated for balloon aortic valvuloplasty, which is a therapeutic medical procedure to treat a diseased aortic valve.

Diagnostic

Justification: The True™ Flow Valvuloplasty Perfusion Catheter is used for balloon aortic valvuloplasty, a therapeutic procedure, not for diagnosis. Its description focuses on its mechanical features for delivering therapy (balloon inflation, guidewire passage) and not on detecting or identifying a medical condition.

SaMD (Software as a Medical Device)

The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "for balloon aortic valvuloplasty." This is a therapeutic procedure performed directly on a patient's heart valve.
Device Description: The description details a catheter with a balloon designed for mechanical intervention within the body.
Mechanism of Action: The device works by physically expanding a balloon to open a narrowed aortic valve.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition. The fluoroscopic positioning is for guiding the therapeutic device, not for diagnostic imaging itself.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

OZT

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

aortic valve

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

To demonstrate substantial equivalence of the subject device to the predicate device, 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:

. Dimensional Testing
Marker Band Alignment .
Dye Penetration ●
Visual Inspection of Product .
Visual Inspection of Sterile Barrier Packaging Heat Seals
Tip Morphology .
. Trackability
Sheath Compatibility ●
Media Interaction
Luer Interface ●
Hub Stress .
Inflation/Deflation Time ●
. Fatigue to Failure
. Tip to Balloon Tensile
Balloon Burst ●
Catheter Leak ●
Failure Mode
Shaft Burst ●
Catheter Elongation ●
Hub to Shaft Tensile .
. Balloon to Shaft Tensile
. Radiopacity
Balloon Distensibility ●
Perfusion Test
. Radial Force Test
MEM Elution Test ●
Kligman Maximization Test ●
Intracutaneous Injection Test ●
. Systemic Injection Test
Rabbit Pyrogen Test ●
Hemolysis Rabbit Blood Contact .
. Complement Activation Test
Prothrombin Time Assay ●
In Vitro Thrombogenicity .
In Vivo Thrombogenicity .

The following in vitro test was leveraged from the predicate True Dilatation™ device:

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133569

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1255 Balloon aortic valvuloplasty catheter.

(a)
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.(b)
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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

April 17, 2015

C.R. Bard, Inc. Aaron Conovaloff Regulatory Affairs Associate 1625 West 3rd St. Tempe, Arizona 85281-1740

Re: K142083

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: March 3, 2015 Received: March 4, 2015

Dear Aaron 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

M.A. Hilleman

for

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known)

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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True™ Flow Valvuloplasty Perfusion 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
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
| Phone: | 480-350-6012 |
| Fax: | 480-449-2546 |
| Contact: | Aaron Conovaloff, Regulatory Affairs Associate |
| Date: | August 14, 2014 |

Subject Device Name:

| Device Trade Name: | True™ Flow Valvuloplasty Perfusion
Catheter |
|-----------------------|----------------------------------------------------------------------------------------------|
| Common or Usual Name: | Balloon Aortic Valvuloplasty/Percutaneous
Catheter (21 CFR 870.1255, Product Code
OZT) |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |

Predicate Device:

. True Dilatation™ Balloon Valvuloplasty Catheter (K133569; cleared December 20, 2013)
Image /page/3/Picture/12 description: The image shows the word "BARD" in a stylized, sans-serif font. The letters are bold and outlined in black, giving them a distinct and modern appearance. The overall design is clean and simple, with a focus on readability and visual impact. The wordmark is likely a logo or branding element for a company or product named Bard.

Summary of Change:

The modifications from the predicate device, the True Dilatation™ Balloon Valvuloplasty Catheter, to the subject device, the True™ Flow Valvuloplasty Perfusion Catheter, include balloon design, balloon materials, catheter colorant, contraindications, and performance characteristics.

Device Description:

| Attribute | True™ Flow Valvuloplasty Perfusion
Catheter
Product Offering |
|------------------------------------|--------------------------------------------------------------------|
| Balloon Diameter
(mm) | 24 |
| Balloon Length
(cm) | 3.5 |
| Catheter Shaft
Length (cm) | 110 |
| Introducer Sheath
Compatibility | 18F |

Image /page/4/Picture/8 description: The image shows the word "BARD" in a stylized, all-caps font. The letters are bold and outlined in black, giving them a distinct and modern look. The font choice appears to be custom, with unique angles and shapes forming each letter. The overall design is clean and minimalist, focusing on the word itself.

Indications for Use of Device:

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

Comparison of Indications for Use to Predicate Device:

The indications for use statement for the True™ Flow Valvuloplasty Perfusion 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™ Flow Valvuloplasty Perfusion Catheter, is substantially equivalent to the predicate device.

Technological Comparison to Predicate Device:

The True™ Flow Valvuloplasty Perfusion Catheter has the following similarities to the predicate device, the True Dilatation™ Balloon Valvuloplasty Catheter (clearance to market via K133569 on December 20, 2014):

. 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™ Flow Valvuloplasty Perfusion Catheter incorporates the following new technological features as compared to the predicate device:

. Change in balloon design and materials to allow hemodynamic flow through the balloon while inflated
. Change in marker band materials and positions
. Change in catheter shaft color
Change in balloon proximal bond ●
Change in hub bonding materials .

Image /page/5/Picture/21 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and geometric, with the "A" represented by a triangle without a horizontal crossbar. The overall design is clean and modern, with a focus on the shape and form of the letters.

. Change in strain relief design
Addition of packaging component ●

Performance Data:

. Dimensional Testing
Marker Band Alignment .
Dye Penetration ●
Visual Inspection of Product .
Visual Inspection of Sterile Barrier Packaging Heat Seals
Tip Morphology .
. Trackability
Sheath Compatibility ●
Media Interaction
Luer Interface ●
Hub Stress .
Inflation/Deflation Time ●
. Fatigue to Failure
. Tip to Balloon Tensile
Balloon Burst ●
Catheter Leak ●
Failure Mode
Shaft Burst ●
Catheter Elongation ●
Hub to Shaft Tensile .
. Balloon to Shaft Tensile

Image /page/6/Picture/28 description: The image shows the word "BARD" in a stylized, all-caps font. The letters are bold and outlined in black, giving them a distinct and modern appearance. The font choice is geometric and sans-serif, contributing to the overall clean and professional look of the word. The image is simple and monochromatic, focusing solely on the word itself.

. Radiopacity
Balloon Distensibility ●
Perfusion Test
. Radial Force Test
MEM Elution Test ●
Kligman Maximization Test ●
Intracutaneous Injection Test ●
. Systemic Injection Test
Rabbit Pyrogen Test ●
Hemolysis Rabbit Blood Contact .
. Complement Activation Test
Prothrombin Time Assay ●
In Vitro Thrombogenicity .
In Vivo Thrombogenicity .

The following in vitro test was leveraged from the predicate True Dilatation™ device:

. Pouch Tensile
The results from these tests demonstrate that the technological characteristics and performance criteria of the True™ Flow Valvuloplasty Perfusion Catheter are substantially equivalent to the predicate device, 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™ Flow Valvuloplasty Perfusion 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™ Flow Valvuloplasty Perfusion Catheter is substantially equivalent to the legally marketed predicate device, the True Dilatation™ Balloon Valvuloplasty Catheter.

Image /page/7/Picture/22 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is bold and connected to the adjacent letters, creating a continuous, block-like appearance. The font is sans-serif and has a modern, geometric feel.