A patient with isolated pulmonary valve stenosis .
A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention.

Device Description

The Vida PTV Dilatation Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. 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

Here's a breakdown of the acceptance criteria and the study information for the Vida PTV Dilatation Catheter, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document provides a table of acceptance criteria for several in-vitro tests but does not provide the reported device performance for each criterion. It only states that the device "met all predetermined acceptance criteria."

Test Performed	Acceptance Criteria	Vida PTV Dilatation Catheter Reported Performance
Visual Inspection	The catheters shall be free from contamination, discoloration, and any form of damage that could impact the proper functioning of the device.	Met criteria
Media Interaction (i.e. Balloon Preparation Test)	Each catheter shall be prepped per the procedure without any functional difficulties or anomalies. Guidewire lumen must be flushable (saline appears at distal end when injected from proximal end) with 5 ml of saline utilizing a 10-ml syringe or equivalent.	Met criteria
Catheter Shaft Length	100 ± 3 cm	Met criteria
Trackability	Using the IDTE, the trackability into an appropriately-sized 23-cm Cordis Avanti introducer or B.Braun Intradyn 23-cm (sheath sizes ≥ 12 Fr.) and through a worst-case pulmonary valve model should have forces ≤ 700 gF.	Met criteria
Inflation/Deflation Time (i.e. Balloon Inflation/Deflation Test, and Balloon Inflatability Test)	Inflation Time: Inflation achieved ≤ 20 seconds using 25:75 contrast: saline ratio. Simulated Use Deflation Time: Deflation achieved ≤ 20 seconds using 25:75 contrast:saline ratio. Removal Deflation Time: Deflation time ≤ 90 seconds with 25:75 contrast:saline ratio.	Met criteria

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

The document does not explicitly state the sample sizes used for each of the in-vitro tests listed. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The tests are described as "in vitro tests."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The study describes in-vitro performance testing of a medical device, not a diagnostic or AI-driven system that would require expert-established ground truth. The acceptance criteria are based on physical and functional requirements.

4. Adjudication Method for the Test Set:

Not applicable. As this is an in-vitro performance study, there is no mention of adjudication methods typically associated with clinical or expert review studies.

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

No, an MRMC comparative effectiveness study was not done. This document describes the performance testing of a physical medical device (catheter), not a diagnostic tool or an AI system that would assist human readers.

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

Not applicable. This is not an AI algorithm. The performance tests are for the physical properties and function of the catheter itself.

7. The Type of Ground Truth Used:

The "ground truth" for the in-vitro tests are the predefined acceptance criteria based on physical measurements, functional performance (e.g., inflation/deflation times), and visual inspection standards. These criteria are established based on "FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures."

8. The Sample Size for the Training Set:

Not applicable. This is not a study involving a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established:

Not applicable. No training set, as this is not an AI or machine learning study.

Summary

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K 131002

Page 111

JUL 0 2 2013

Vida PTV Dilatation 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 April 9, 2013

Subject Device Name:

Device Trade Name:	Vida PTV Dilatation Catheter
Common or Usual Name:	Pulmonary (Pulmonic) ValvuloplastyCatheters/Percutaneous ValvuloplastyCatheter (21 CFR 870.1250, Product CodeOMZ)
Classification:	Class II
Classification Panel:	Cardiovascular

Predicate Devices:

Bard PTV Dilatation Catheter (K122367; cleared November 2, 2012) .
Atlas Gold PTA Dilatation Catheter (K122984, cleared October 22, 2012) .

Bard Peripheral Vascular, Inc.

Image /page/0/Picture/18 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and have a geometric design, with sharp angles and straight lines. The overall appearance is modern and somewhat abstract due to the font choice.

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Device Description:

Attribute	Vida PTV Dilatation CatheterProduct Offering
Balloon Diameter(mm)	12, 14, 16, 18, 20, 22, 24, 26
Balloon Length(cm)	2, 4, 6
Catheter ShaftLength (cm)	100
Introducer SheathCompatibility(compatibleballoon sizes,diameter (mm) xlength (cm))	7F: (12x 2,4,6; 14x 2,4)8F: (14x 6; 16x 2,4,6; 18x 2,4)9F: (18x 6; 20x 2,4)10F: (22x 2,4; 24x 2,4)12F: (26x 2,4)

Indications for Use of Device:

The Vida PTV Dilatation Catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:

A patient with isolated pulmonary valve stenosis .
A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention.

Image /page/1/Picture/10 description: The image shows the word "BARD" in a bold, outlined font. The letters are large and spaced closely together. The overall impression is of a simple, yet impactful design.

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Comparison of Indications for Use to Predicate Devices:

The indications for use statement for the Vida PTV Dilatation 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 Vida PTV Dilatation Catheter, is substantially equivalent to the predicate devices.

Technological Comparison to Predicate Devices:

The Vida PTV Dilatation Catheter has the following similarities to the predicate device. the Bard PTV Dilatation Catheter (clearance to market via K122367 on November 2. 2012):

. 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 Vida PTV Dilatation Catheter has the following similarities to the predicate device, the Atlas Gold PTA Dilatation Catheter (clearance to market via K122984, on October 22, 2012):

. 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
Image /page/2/Picture/21 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a hollow appearance. The font style is consistent throughout the word, with each letter having a uniform thickness and design.

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Traditional 510(k) Vida PTV Dilatation Catheter

Media Interaction (i.e. Balloon Preparation Test) ●
Catheter Shaft Length .
Trackability .
Inflation/Deflation Time (i.e. Balloon Inflation/Deflation Test, and Balloon . Inflatability Test)

The following in vitro tests were leveraged from the predicate Atlas Gold PTA Dilatation Catheter:

Tip Length .
Balloon Outer Diameter (i.e. Diameter and Profile Test) .
Balloon Working Length .
Catheter Shaft Outer Diameter .
· Catheter Shaft Inner Diameter .
. Tip Visibility
Catheter Shaft Visibility .
. Marker Band Visibility
Tip Morphology .
Tip Tensile (i.e. Tip Pull and Torque Test, and Bond Strength Test) .
Balloon to Shaft Tensile .
Hub to Shaft Tensile .
Catheter Shaft Elongation .
Balloon Nominal (Operating) Pressure �
Rated Burst Pressure (i.e. Balloon Minimum Burst Strength) .
. Balloon Burst Mode
� · Fatigue (i.e. Repeated Balloon Inflation)
Catheter Shaft Leaks (i.e. Catheter Body Maximum Pressure Test) .
. Catheter Shaft Burst (i.e. Catheter Body Maximum Pressure Test)
Balloon Distensibility ●
Marker Band Alignment .
Sheath Compatibility .
Equipment Interface ●
Visual Inspection of Packaging .
Dye Penetration

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Pouch Tensile Strength .

The results from these tests demonstrate that the technological characteristics and performance criteria of the Vida PTV Dilatation 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. The following table provides a detailed summary of performance testing completed on the subject device.

Image /page/4/Picture/5 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and sans-serif, with a slight three-dimensional effect created by the outline. The overall impression is a clean and modern design.

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Test Performed	Acceptance Criteria	Vida
Visual Inspection	The catheters shall be free from contamination, discoloration, and any form ofdamage that could impact the proper functioning of the device.
Media Interaction (i.e.Balloon Preparation Test)	Each catheter shall be prepped per the procedure without any functionaldifficulties or anomalies.Guidewire lumen must be flushable (saline appears at distal end when injectedfrom proximal end) with 5 ml of saline utilizing a 10-ml syringe or equivalent.
Catheter Shaft Length	$100 \pm 3$ cm
Trackability	Using the IDTE, the trackability into an appropriately-sized 23-cm CordisAvanti introducer or B.Braun Intradyn 23-cm (sheath sizes ≥ 12 Fr.) andthrough a worst-case pulmonary valve model should have forces ≤ 700 gF.
Inflation/Deflation Time(i.e. BalloonInflation/Deflation Test,and Balloon InflatabilityTest)	Inflation TimeInflation achieved ≤ 20 seconds using25:75 contrast: saline ratio.
	Simulated Use Deflation TimeDeflation achieved ≤ 20 seconds using25:75 contrast:saline ratio.
	Removal Deflation TimeDeflation time ≤ 90 seconds with 25:75contrast:saline ratio.

Summary of Performance Testing

Bard Peripheral Vascular, Inc.

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Conclusions:

The subject device, the Vida PTV Dilatation Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Vida PTV Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Bard PTV Dilatation Catheter and the Atlas Gold PTA Dilatation Catheter.

Image /page/6/Picture/5 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The letters are slightly stylized, with the "A" having a pointed top and the "R" having a curved leg. The word is centered and takes up most of the frame.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

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

July 2, 2013

Aaron Conovaloff, Ph.D. Regulatory Affairs Associate Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe, AZ 85281

Re: K131002

Trade/Device Name: Vida ™ PTV Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Pulmonary Valvuloplasty Catheters Regulatory Class: Class II Product Code: OMZ Dated: April 26, 2013 Received: April 29, 2013

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

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Page 2 - Aaron Conovaloff, Ph.D.

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

MZtillehem

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): K131002

Device Name: Vida PTV Dilatation Catheter

Indications for Use: The Vida PTV Dilatation Catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:

A patient with isolated pulmonary valve stenosis .
A patient with valvular pulmonary stenosis with other minor congenital heart ● disease that does not require surgical intervention.

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)

M.A. Hillemann

Bard Peripheral Vascular, Inc.

Image /page/9/Picture/15 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined with a thick black border, giving it a distinct and prominent appearance. The font style is unique, with sharp angles and geometric shapes forming the letters.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).