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 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 luerlock 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 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 quidewire size are indicated on the package label.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the True™ Flow Valvuloplasty Perfusion Catheter. It details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not describe an AI/machine learning device or a study involving human readers or expert consensus on medical images. The "performance data" section (page 6) lists in vitro tests conducted on the physical catheter and its components (e.g., balloon diameter, catheter shaft length, burst pressure, biocompatibility tests). These are engineering performance criteria for a physical medical device, not AI model performance.

Therefore, many of the requested elements for an AI device's acceptance criteria and study proving its performance (e.g., sample size for test set, adjudication method, MRMC study, training set details) cannot be extracted from this document because it is not about an AI device.

Here's an attempt to address the parts that are applicable to this document, with a strong disclaimer that it is not an AI device:

Device: True™ Flow Valvuloplasty Perfusion Catheter

Type of Device: Physical medical device (catheter for balloon aortic valvuloplasty), NOT an AI/machine learning device.

Study Purpose (as described): To demonstrate substantial equivalence of the subject device to a predicate device by evaluating its technological characteristics and performance criteria through in vitro testing.

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

The document lists performance tests but does not provide a quantitative table of acceptance criteria and reported numerical performance values. It broadly states that the device "met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

Below is a list of the types of performance criteria and tests mentioned, but no specific numerical values or pass/fail thresholds are provided in this document.

Acceptance Criteria (Test Category / Parameter)	Reported Device Performance (Qualitative Summary)
Physical Dimensions
Catheter Shaft Length	Met criteria
Catheter Shaft Inner Diameter	Met criteria
Catheter Shaft Outer Diameter	Met criteria
Balloon Outer Diameter	Met criteria
Balloon Length	Met criteria
Marker Band Alignment	Met criteria
Functional Performance
Trackability	Met criteria
Sheath Compatibility	Met criteria
Luer Interface	Met criteria
Hub Stress (and 48 Hours)	Met criteria
Inflation	Met criteria
Deflation to Restore Valve Function	Met criteria
Complete Deflation	Met criteria
Rated Burst Pressure	Met criteria
Catheter Leak	Met criteria
Shaft Burst	Met criteria
Catheter Elongation	Met criteria
Perfusion Test	Met criteria
Radial Force Test	Met criteria
Radiopacity—Prior to Inflation	Met criteria
Radiopacity—Inflated	Met criteria
Balloon Distensibility	Met criteria
Biocompatibility / Safety
Dye Penetration	Met criteria
Media Interaction	Met criteria
MEM Elution Test	Met criteria
Kligman Maximization Test	Met criteria
Intracutaneous Injection Test	Met criteria
Systemic Injection Test	Met criteria
Rabbit Pyrogen Test	Met criteria
Hemolysis - Rabbit Blood Contact	Met criteria
Complement Activation Test	Met criteria
In Vitro Thrombogenicity	Met criteria
In Vivo Thrombogenicity	Met criteria
Integrity / Durability
Visual Inspection of Product	Met criteria
Visual Inspection of Sterile Barrier Packaging Heat Seals	Met criteria
Tip Morphology	Met criteria
Fatigue	Met criteria
Tip to Balloon Tensile	Met criteria
Failure Mode	Met criteria
Hub to Shaft Tensile	Met criteria
Balloon to Shaft Tensile	Met criteria
Pouch Tensile (leveraged from previous testing)	Met criteria

Regarding AI-specific criteria (not applicable to this document):

Sample sizes for test set and data provenance: Not applicable. The document describes in vitro engineering tests, not a dataset for an AI model.
Number of experts and qualifications for ground truth: Not applicable. Ground truth for an AI model (e.g., image annotations) is not relevant for a physical medical device.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable. This study focuses on the physical performance of a catheter, not on the impact of AI assistance on human readers.
Standalone (algorithm-only) performance: Not applicable. There is no algorithm.
Type of ground truth used: For this device, the "ground truth" for performance is established through physical measurements, engineering specifications, and established biocompatibility testing standards. It's not based on expert consensus, pathology, or outcomes data in the context of diagnostic AI.
Sample size for training set: Not applicable. There is no AI model that requires a training set.
How ground truth for training set was established: Not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Public Health Service

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

January 19, 2016

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

Re: K152613

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: December 18, 2015 Received: December 21, 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 (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,

M.A. Hillebrenner
for

for

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)

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)

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.

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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, Inc1625 West 3rd StreetTempe, Arizona 85281
Phone:	480-350-6012
Fax:	480-449-2546
Contact:	Aaron Conovaloff, Regulatory Affairs Specialist
Date	September 11, 2015

Subject Device Name:

Device Trade Name:	True™ Flow Valvuloplasty PerfusionCatheter
Common or Usual Name:	Balloon Aortic Valvuloplasty (21 CFR870.1255, Product Code OZT)
Classification:	Class II
Classification Panel:	Cardiovascular

Predicate Device:

. True™ Flow Valvuloplasty Perfusion Catheter (K142083; cleared April 17, 2015)

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Device Description:

Attribute	True™ Flow Valvuloplasty PerfusionCatheterProduct Offering
Balloon Diameter(mm)	18, 20, 22, 24, 26
Balloon Length(cm)	3.5
Catheter ShaftLength (cm)	110
Introducer SheathCompatibility byBalloon Diameter(mm)	11F: 18 mm, 20 mm12F: 22 mm14F: 24 mm16F: 26 mm

Indications for Use of Device:

The True™ Flow Valvuloplasty Perfusion 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 True™ Flow Valvuloplasty Perfusion Catheter does not raise any new issues of safety and effectiveness based on the proposed indications for use statement as compared to the predicate device. Therefore, the subject device, the True™ Flow Valvuloplasty Perfusion Catheter, is substantially equivalent to the predicate device.

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 K142083 on April 17, 2015):

. 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 subject True™ Flow Valvuloplasty Perfusion Catheter incorporates the following changes as compared to the predicate device:

. Offering of additional balloon diameters
. Change in balloon design and materials
Change in marker band materials and positions .
. Change in guidewire lumen material
Change in catheter tip material .
. Change in packaging components

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:

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Catheter Shaft Length
Catheter Shaft Inner Diameter .
Catheter Shaft Outer Diameter
Balloon Outer Diameter ●
Balloon Length ●
Marker Band Alignment ●
Dye Penetration ●
Visual Inspection of Product ●
Visual Inspection of Sterile . Barrier Packaging Heat Seals
Tip Morphology ●
. Trackabilitv
Sheath Compatibility ●
Media Interaction ●
Luer Interface ●
Hub Stress .
Hub Stress (48 Hours) ●
Inflation ●
Deflation to Restore Valve . Function
Complete Deflation .
. Fatigue
Tip to Balloon Tensile .
. Rated Burst Pressure
Catheter Leak .
. Failure Mode
Shaft Burst ●
Catheter Elongation ●
Hub to Shaft Tensile ●
. Balloon to Shaft Tensile
Radiopacity—Prior to Inflation .
Radiopacity—Inflated ●
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 ●
In Vitro Thrombogenicity .
In Vivo Thrombogenicity ●

The following in vitro test was leveraged from previous testing:

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.

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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™ Flow Valvuloplasty Perfusion Catheter.

Image /page/7/Picture/6 description: The image shows the word "BARD" in a stylized, bold, sans-serif font. The letters are interconnected, with the "A" having a unique design where the crossbar is angled upwards. The overall design is clean and modern, with a focus on geometric shapes.

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.