The True™ Dilatation Balloon Valvuloplasty Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. 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 guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is noncompliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque marker bands are provided for fluoroscopic positioning of the device across the aortic valve. These bands are positioned at the proximal and distal balloon shoulders. Balloon catheter dimensions, balloon nominal pressure, maximum inflation pressure, recommended introducer size, and recommended guidewire size are indicated on the package label.

AI/ML Overview

This document describes a 510(k) premarket notification for the True™ Dilatation Balloon Valvuloplasty Catheter. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K133569).

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria with corresponding performance values in a side-by-side format. Instead, it lists the types of in vitro tests performed and states that the device "met all predetermined acceptance criteria." The acceptance criteria would likely be specified in the internal test protocols.

Given the information in the document, we can infer some of the tests that would have had acceptance criteria:

Test Type	Reported Device Performance
Dimensional Testing (catheter shaft length, balloon OD, balloon length)	Met predetermined acceptance criteria (implies dimensions are within specified tolerances)
Marker Band Alignment	Met predetermined acceptance criteria (implies marker bands are correctly positioned)
Visual Inspection of Product	Met predetermined acceptance criteria (implies no visible defects)
Visual Inspection of Sterile Barrier Packaging Heat Seals	Met predetermined acceptance criteria (implies seals are intact and meet specifications)
Trackability	Met predetermined acceptance criteria (implies catheter navigates effectively)
Sheath Compatibility	Met predetermined acceptance criteria (implies compatibility with specified introducer sheath sizes)
Inflation/Deflation	Met predetermined acceptance criteria (implies proper balloon inflation/deflation within specified pressures)
Fatigue	Met predetermined acceptance criteria (implies durability under repeated stress)
Tip to Balloon Tensile	Met predetermined acceptance criteria (implies secure attachment of tip to balloon)
Balloon Burst	Met predetermined acceptance criteria (implies burst pressure meets safety margins)
Catheter Leak	Met predetermined acceptance criteria (implies no leaks in lumens)
Failure Mode	Met predetermined acceptance criteria (implies analysis of potential failures and mitigations)
Shaft Burst	Met predetermined acceptance criteria (implies shaft integrity under pressure)
Radiopacity (inflated)	Met predetermined acceptance criteria (implies visibility under fluoroscopy when inflated)
Balloon Distensibility	Met predetermined acceptance criteria (implies consistent diameter at specified pressures)
Reinsertion	Met predetermined acceptance criteria (implies durability for reinsertion if applicable)

Notes on "predetermined acceptance criteria": These criteria would be derived from applicable standards, guidance documents, internal test protocols, and customer input. For a 510(k) submission, the primary goal is to show the new device performs as safely and effectively as the predicate, so acceptance criteria often reflect performance parameters established for the predicate or industry standards.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the "test set" (i.e., the units tested for performance). It only refers to "the subject device" and "the predicate device" in general terms. The tests listed are "in vitro tests," meaning they were conducted in a lab environment. The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. Since these are in vitro tests, the concepts of retrospective/prospective clinical data are not directly applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The document describes "in vitro tests" of a physical medical device (catheter). It does not involve human subjects, imaging data, or expert interpretations requiring a "ground truth" established by clinical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of diagnostic outputs. The described tests are laboratory-based performance evaluations of a medical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The submission is for a balloon valvuloplasty catheter, a mechanical device used in a medical procedure, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This section is not applicable. The device is a physical catheter, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This section is not applicable. As explained in point 3, the tests concern the physical and mechanical performance of a device, not diagnostic accuracy requiring a "ground truth" in the clinical sense. The "ground truth" for these tests would be the engineering specifications and tolerances to which the device must conform.

8. The sample size for the training set

This section is not applicable. The document describes a traditional 510(k) submission for a physical medical device, not an AI/Machine Learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

This section is not applicable. As explained in point 8, there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing 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

June 17, 2015

C.R. Bard, Inc. Dr. Aaron Conovaloff Regulatory Affairs Associate 1625 W. Third St. Tempe, Arizona 85281

Re: K150667

Trade/Device Name: True Dilatation Balloon Valvuloplasty Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Regulatory Class: Class II Product Code: OZT Dated: March 13, 2015 Received: March 19, 2015

Dear Dr. 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. Isting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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" (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,

Kenneth J. Cavanaugh -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

True™ Dilatation Balloon Valvuloplasty Catheter

Indications for Use (Describe)

The TrueTM Dilatation Balloon Valvuloplasty 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (701) 443-574) EF

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True™ Dilatation 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	March 13, 2015

Subject Device Name:

Device Trade Name:	True™ Dilatation Balloon Valvuloplasty 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)

Summary of Change:

The modifications from the predicate device, the True™ Dilatation Balloon Valvuloplasty Catheter, to the subject device, the True™ Dilatation Balloon Valvuloplasty Catheter,

Image /page/3/Picture/14 description: The image shows the word "BARD" in a stylized, geometric font. Each letter is formed by thick, black lines, giving it a bold and modern appearance. The letters are interconnected, creating a sense of unity and visual interest. The overall design is clean and minimalist, emphasizing the word's shape and form.

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include additional size offerings, different balloon bonding materials, different hub and strain relief design and materials, different packaging hoop design, and improved readability and updated branding in the IFU.

Device Description:

Attribute	True™ Dilatation Balloon ValvuloplastyCatheterProduct Offering
Balloon Diameter(mm)	18, 20, 21, 22, 23, 24, 25, 26, 28
Balloon Length(cm)	4.5
Catheter ShaftLength (cm)	110
Introducer SheathCompatibility (Fr)	11, 12, 13, 14

Indications for Use of Device:

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

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Comparison of Indications for Use to Predicate Device:

The indications for use statement for the subject True™ Dilatation 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™ Dilatation Balloon Valvuloplasty Catheter, is substantially equivalent to the predicate device.

Technological Comparison to Predicate Device:

The subject True™ Dilatation Balloon Valvuloplasty Catheter has the following similarities to the predicate device (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

Performance Data:

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 (catheter shaft length, balloon OD, balloon length)
Marker Band Alignment .
Visual Inspection of Product ●
Visual Inspection of Sterile Barrier Packaging Heat Seals ●
. Trackability
Sheath Compatibility ●
Inflation/Deflation .

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Fatigue
Tip to Balloon Tensile .
Balloon Burst
Catheter Leak ●
Failure Mode ●
Shaft Burst
Radiopacity (inflated) ●
Balloon Distensibility ●
Reinsertion .

The following in vitro tests were leveraged from the predicate True™ Dilatation device:

. Dimensional testing (shaft ID, shaft OD)
. Dye Penetration
Pouch Tensile ●
. Tip Morphology
Media Interaction .
Catheter Elongation ●
Balloon to Shaft Tensile ●
. Radiopacity (prior to inflation)

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

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.