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.

AI/ML Overview

The provided text describes a medical device, the True™ BAV Balloon Valvuloplasty Catheter, and its substantial equivalence to predicate devices, rather than a study evaluating an AI/ML device. Therefore, much of the requested information regarding acceptance criteria and studies for AI/ML performance (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance) is not applicable here.

However, I can extract the information related to device performance and acceptance criteria as presented in the document for this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that 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."

However, specific numerical acceptance criteria and their corresponding reported device performance values are not provided in the text. The document lists the types of in-vitro tests performed, implying that for each of these, acceptance criteria existed and were met.

Here's a table based on the provided text, outlining the tests performed, which inherently means they had acceptance criteria that were met, but the specific numerical criteria and results are not detailed.

Acceptance Criteria Category (Test Performed)	Reported Device Performance (Implied)
Visual Inspection	Met predetermined acceptance criteria
Balloon Distensibility	Met predetermined acceptance criteria
Tip Length	Met predetermined acceptance criteria
Balloon Outer Diameter (Diameter and Profile Test)	Met predetermined acceptance criteria
Balloon Working Length	Met predetermined acceptance criteria
Catheter Shaft Outer Diameter	Met predetermined acceptance criteria
Catheter Shaft Inner Diameter	Met predetermined acceptance criteria
Tip Visibility	Met predetermined acceptance criteria
Catheter Shaft Visibility	Met predetermined acceptance criteria
Marker Band Visibility	Met predetermined acceptance criteria
Tip Morphology	Met predetermined acceptance criteria
Tip Tensile (Tip Pull, Torque, and Bond Strength Tests)	Met predetermined acceptance criteria
Balloon to Shaft Tensile	Met predetermined acceptance criteria
Hub to Shaft Tensile	Met predetermined acceptance criteria
Catheter Shaft Elongation	Met predetermined acceptance criteria
Balloon Nominal (Operating) Pressure	Met predetermined acceptance criteria
Rated Burst Pressure (Balloon Minimum Burst Strength)	Met predetermined acceptance criteria
Balloon Burst Mode	Met predetermined acceptance criteria
Fatigue (Repeated Balloon Inflation)	Met predetermined acceptance criteria
Catheter Shaft Leaks (Catheter Body Maximum Pressure Test)	Met predetermined acceptance criteria
Catheter Shaft Burst (Catheter Body Maximum Pressure Test)	Met predetermined acceptance criteria
Media Interaction (Balloon Preparation Test)	Met predetermined acceptance criteria
Catheter Shaft Length	Met predetermined acceptance criteria
Trackability	Met predetermined acceptance criteria
Inflation/Deflation Time (Balloon Inflatability Test)	Met predetermined acceptance criteria
Marker Band Alignment	Met predetermined acceptance criteria
Sheath Compatibility	Met predetermined acceptance criteria
Equipment Interface	Met predetermined acceptance criteria
Visual Inspection of Packaging	Met predetermined acceptance criteria
Dye Penetration	Met predetermined acceptance criteria
Pouch Tensile Strength	Met predetermined acceptance criteria

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text describes in-vitro (bench) testing, not clinical studies with patients or data sets in the typical sense for AI/ML validation. There's no mention of sample sizes for individual tests or the provenance of any "data."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device submission. There is no mention of experts or ground truth establishment as it typically refers to for AI/ML diagnostic devices. The acceptance criteria for this device are based on engineering specifications and performance standards through in-vitro testing.

4. Adjudication Method

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are relevant for reconciling differing expert opinions, which isn't part of this device's testing and validation process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device like a balloon catheter.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done. This device is a physical catheter, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is based on engineering specifications, established performance standards, and internal risk assessment procedures as demonstrated through the in-vitro tests listed. It's not based on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device's ground truth would be.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" applies to machine learning algorithms, which is not what this device is.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this device.

Summary

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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, Inc1625 West 3rd StreetTempe, 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 CFR870.1250, 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:

Attribute	True™ BAV Balloon Valvuloplasty CatheterProduct Offering
Balloon Diameter(mm)	18, 20, 22, 24, 26
Balloon Length(cm)	4
Catheter ShaftLength (cm)	100
Introducer SheathCompatibility byBalloon Diameter(mm)	8F: 18 mm9F: 20 mm10F: 22 mm, 24 mm12F: 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 (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" (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 (800) 638-2041 or (301) 796-7100 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)

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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.