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

Device Description

The Bard 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 0.035" guidewire and is available in 75 and 100 cm working lengths. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bard PTV Dilatation Catheter, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Predicate Mullins-X Test / Attribute	Predicate Mullins-X Acceptance Criteria	Subject Bard PTV Dilatation Catheter Acceptance Criteria	Test Result
Visual Inspection	Free from contamination, discoloration, damage that could impact function.	Inspection for damage prior to testing; no abnormalities observed, confirmed by functional testing. Included in biocompatibility section.	PASS
Balloon Preparation Test	Prepped per procedure without functional difficulties or anomalies.	Guidewire lumen flushable with saline (10mL syringe or equivalent).	PASS
Diameter and Profile Test	Balloon diameter at rated burst pressure within +/- 10% of labeled diameter; fit through selected introducer.	Balloon Outer Diameter: +.04/-.03mm across all diameters (more robust than +/- 10% for 12mm balloon).	PASS
Balloon Inflatability Test (Deflation)	No interference with balloon deflation.	Deflation: Ability to deflate evaluated; no abnormalities, all samples fully deflated.	PASS
Tip Pull and Torque Test	Withstand at least 10 turns without breaking.	Tip Tensile: Minimum tensile force of 2 pounds-force (follows ISO10555-1).	PASS
Bond-Strength Test	All bonds must withstand at least 3 lbs of pull strength.	Joint Tensile: Minimum tensile force of 5 pounds-force (more robust).	PASS
Catheter Body Maximum Pressure Test	All samples must withstand 30 ATM (400psi).	Catheter Shaft Leak and Catheter Shaft Burst: Highest rated burst pressure for Atlas Gold is 18atm, proposed specification set to +5atm (23atm minimum).	PASS
Balloon Burst Pressure	Results must show statistically (at least 95% confidence) at least [criteria not fully visible in provided text, but implies burst pressure must be met].	Labeled rated burst pressure are higher; passed specified criteria (more robust).	PASS
Repeated Balloon Inflation (Fatigue Test)	[Criteria not fully visible in provided text, but implies withstand cycles to burst pressure.]	Catheter must be capable of withstanding 20 cycles to ≥ labeled rated burst pressure.	PASS
Balloon Distensibility	[Criteria not fully visible in provided text, but implies diameter change within a range].	≤ 5% across diameters (more robust).	PASS
Inflation/Deflation Time	Inflation achieved in less than 12 seconds; deflation achieved in less than 20 seconds.	[Not explicitly mentioned as a subject device acceptance criteria in the summary table, but 'Inflation Time' and 'Simulated Use Deflation Time' are listed as in-vitro tests performed.]	PASS (implied by "Inflation Time" and "Simulated Use Deflation Time" being performed and leading to overall PASS)
Trackability	[Not explicitly mentioned as a predicate criteria in the summary table, but listed as an in-vitro test performed on the subject device].	[Not explicitly mentioned in the summary table].	PASS (implied by "Trackability" being performed and leading to overall PASS)

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

Sample Size: The document does not explicitly state the specific numerical sample size for each individual test. It refers to "All results showed the subject device passed the specified criteria" and "all samples were able to be fully deflated," suggesting multiple units were tested for each criterion.
Data Provenance: The data is from in vitro testing conducted by Bard Peripheral Vascular, Inc. The document does not specify the country of origin of the data beyond the company's location (Tempe, Arizona, USA). It is prospective in the sense that these tests were performed on the device to demonstrate equivalence for regulatory submission.

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

This information is not applicable to this submission. The "ground truth" here is the performance specifications of the device, which are determined through engineering principles, regulatory standards (e.g., ISO10555-1 mentioned for Tip Tensile), and comparison to predicate devices. There is no expert review or consensus process for establishing the "ground truth" of mechanical performance metrics like burst pressure or tensile strength in the way there would be for image analysis or clinical diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are objective, quantitative mechanical and functional assessments (e.g., measuring diameter, forces, times), there is no need for expert adjudication of results. The results are Pass/Fail based on comparison to pre-defined numerical criteria.

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 information is not applicable. This submission is for a medical device (dilatation catheter), not an AI diagnostic or assistance system that would involve human readers or cases.

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

This information is not applicable. This refers to an algorithm's performance, which is not relevant for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria and performance evaluation is based on:

Engineering specifications and design requirements: Derived from the intended use and safety considerations.
Regulatory standards: Such as ISO10555-1 mentioned for the Tip Tensile test.
Performance of predicate devices: The "Predicate Mullins-X Acceptance Criteria" serve as a benchmark, and in some cases, the subject device's criteria are "more robust."

Essentially, the ground truth is established by a combination of relevant standards and established performance benchmarks for similar devices.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device. It does not involve a training set as would be used in machine learning or AI.

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

This information is not applicable for the same reason as point 8.

Summary

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K122367

Bard PTV Dilatation Catheter 2 2012 NOV 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: 480-379-2841

Fax: 480-449-2546

Contact: Erin Fox, Regulatory Affairs Specialist II

August 1, 2012 Date

Subject Device Name:

Device Trade Name:	Bard 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:

Mullins-X PTV Catheter (K102473; cleared December 9, 2010) .
Atlas® PTA Balloon Dilatation Catheter (K120971, cleared April 19, 2012) .

Image /page/0/Picture/18 description: The image shows the word "BARD" in a stylized, blocky font. The letters are outlined in black, giving them a bold and distinct appearance. The font style is geometric and somewhat angular, making the word visually striking.

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Device Description:

(T.tre Bard 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 0.035" guidewire and is available in 75 and 100 cm working lengths. 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.

Attribute	Bard PTV Dilatation CatheterProduct Offering
Balloon Diameter(mm)	12, 14, 16, 18, 20, 22, 24, 26
Balloon Length(cm)	2, 4, 6
Catheter ShaftLengths (cm)	75, 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 Bard PTV Dilatation Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

. A patient with isolated pulmonary 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 stylized, blocky font. The letters are outlined in black, giving them a bold and distinct appearance. The overall design is simple yet eye-catching, with a focus on readability and a modern aesthetic.

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Comparison of Indications for Use to Predicate Devices:

The indication for use statement for the Bard 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 Bard PTV Dilatation Catheter, is substantially equivalent to the predicate device.

Technological Comparison to Predicate Devices:

The Bard PTV Dilatation Catheter has the following similarities to the predicate devices:

Same intended use (Mullins-X PTV Catheter) .
Same indications for use (Mullins-X PTV Catheter) .
Same target population (Mullins-X PTV Catheter) .
Same fundamental scientific technology (both predicates) .
Same operating principle (both predicates) .
. Same packaging materials and configuration (Atlas® PTA Balloon Dilatation Catheter)
. Same sterility assurance level and method of sterilization (Atlas® PTA Balloon Dilatation Catheter)

Performance Data:

To demonstrate substantial equivalence of the subject device, the Bard PTV Dilatation Catheter, to the predicate devices, the technological characteristics and performance criterion 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:

. Catheter Shaft Length
Inflation Time .
Simulated Use Deflation Time .
Removal Deflation Time .
Trackability .

The following in vitro tests were leveraged from the predicate device, the Atlas® PTA Balloon Dilatation Catheter:

Bard Peripheral Vascular, Inc.

Image /page/2/Picture/22 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined. The font style gives the word a modern and somewhat geometric appearance.

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Tip Length .
Balloon Outer Diameter .
Balloon Working Length .
Catheter Shaft Outer Diameter .
Catheter Shaft Inner Diameter .
Tip Visibility .
. Catheter Shaft Visibility
. Marker Band Visibility
Tip Morphology .
Tip Tensile .
Joint Tensile .
Catheter Elongation .
Nominal (Operating) Pressure .
Rated Burst Pressure .
Balloon Burst Mode .
Fatigue .
Catheter Shaft Leaks .
Catheter Shaft Burst .
Balloon Distensibility .
Marker Band Alignment .
Sheath Compatibility t
Equipment Interface .
Media Interaction .
Pouch Tensile Strength .

The results from these tests demonstrate that the technological characteristics and performance criteria of the Bard 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 similar intended use. The following table provides a detailed summary of performance testing completed on the subject device, as compared to the corresponding performance testing completed on the predicate Mullins-X PTV Catheter.

Image /page/3/Picture/28 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and connected, giving the word a solid, block-like appearance. The overall design is simple and eye-catching.

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Page 97

Traditional 510(k)
Bard PTV Dilatation Catheter

Summary of Performance Testing

PredicateMullins-X Test	Predicate Mullins-XAcceptance Criteria	TestPerformedon SubjectDevice?	Subject Bard PTV Dilatation CatheterAcceptance Criteria	TestResult
VisualInspection	The catheters shall be free fromcontamination, discoloration, and anyform of damage that could impact theproper functioning of the device.	YES	Inspection of the device for damage is completed prior toany testing for informational purposes. Contamination of thedevice is covered in biocompatibility section 15.During testing no abnormalities were observed, which wasconfirmed through functional testing of the device (describedbelow).	PASS
BalloonPreparation Test	Each catheter shall be prepped perthe procedure without functionaldifficulties or anomalies.	YES	Media Interaction (as stated in Table 7)The specification for the subject device states that thecatheter's guidewire lumen must be flushable with salineutilizing a 10mL syringe or equivalent. Though wordeddifferently, the specification of the subject device is similar tothe Mullins-X predicate device, as they both ensure noanomalies are noted during simulated use.All results showed the subject device passed the specifiedcriteria.	PASS
Diameter andProfile Test	The balloon diameter at rated burstpressure shall be within +/- 10% of thelabeled balloon diameter and thesamples should fit through theselected introducer with no problems.	YES	Balloon Outer Diameter (as stated in Table 7)The specification for the subject device is +.04/-.03mmacross all diameters. When calculated for the smallestballoon size (12mm) a +/- 10% change in labeled diameterequates to +/-1.2mm.All results showed the subject device passed the specifiedcriteria, which is more robust than the Mullins-X predicatedevice criteria.	PASS

Bard Peripheral Vascular, Inc

: .

BARD

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aditional 510(k)
ard PTV Dilatation Cathe

Page 98

PASS PASS PASS PASS sults showed the subject device passed the specif
a, and no breaks were seen.
I Burst Pressure (as stated in Table 7) All results showed the subject device passed the spec
criteria, which is more robust than the Mullins-X predic
device criteria, because the labeled rated burst pressu
are hi esults showed the subject device passed the spe The specification for the subject device is ≤ 5% acro
iameters. .Il results showed the subject device passed the s
riteria which is more robust than the Mullins-X pre
evice criteria. specification for the subject device states that that the the states that the states that the states that the states of the states of the be
sure is greater than the Mullinspecification for the subject device states th
ter must be capable of withstanding 20 cyc
on to ≥ labeled rated burst pressure. ation and Deflation (as stated in Tab oon Distensibility (as stated in Ta tigue (as stated in Table criteria ્ટર્ટ ES ES ES e results must show statistically
in at least 95% confidence, at least and the more of the bearth and the more of the more of burnst pressure. results must demonstrate that
on diameter is within + k & Mithin + K BP
abeled diameter is within + K BP
not be significantly increased by and bed
easingly higher pressuress. tion achieved
ss than 12 seconds and def
eved in less than 20 second o breaks allowe Balloon inflation
Deflation
Test Balloon Minimur
Burst Strength Repeated
Balloon Inflation
(Balloon Fatigu
Test) Balloon
Distensibilit

BARI

Peripheral Vascular

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Page 99

Traditional 510(k)
Bard PTV Dilatation Catheter

...

← ←

BalloonInflatability Test,	There should be no interference withballoon deflation	YES	Deflation (as stated in Table 7)	PASS
	The balloon's ability to deflate is evaluated during deflationtesting as mentioned above. Any abnormalities duringtesting are documented.
	During testing no abnormalities during deflation wereobserved and all samples were able to be fully deflated.
Tip Pull.and.Torque Test,	Must withstand at least 10 turnswithout breaking	YES	Tip Tensile (as stated in Table 7)	PASS
	The tip specification for the subject device is different thanthe Mullins-X predicate device in that it follows ISO10555-1;specifically, the tip is tested for tensile strength. The tiptensile specification for the subject device states that thecatheter must withstand a minimum tensile force of 2pounds-force.
	All results showed the subject device passed the specifiedcriteria from the ISO standard.
Bond-StrengthTest	All bonds must withstand at least 3 lbsof pull strength.	YES	Joint Tensile (as stated in Table 7)	PASS
	The bond strength specification for the subject device statesthat the catheter must withstand a minimum tensile force of5 pounds-force.
	All results showed the subject device passed the specifiedcriteria, which is more robust than the Mullins-X predicatedevice criteria.
Catheter BodyMaximumPressure Test	All samples must withstand 30 ATM(400psi).	YES	Catheter Shaft Leak and Catheter Shaft Burst (as statedin Table 7)	PASS
			The highest rated burst pressure for Atlas Gold is 18atm,and as a safety factor the proposed specification was set to+5atm above the highest rated burst pressure (23atmminimum). Though the value is less than the Mullins-Xspecification, it is adequate for the labeled burst pressure ofthe subject device.
			All results showed the subject device passed the specifiedcriteria.

.. :

Bard Peripheral Vascular, Inc

. '

BARID

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Traditional 510(k) Traditional 510(k)
Bard Prv Dilatation Cathete

。 2017/07/14

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រៀង ក្រុងប្រជាជាងមួយម៉ែត្រីជួរប៉ុន្តែព្រឹមពីមួយ Vascular, Inc

ﺮ ﺗﻢ ﺗﻌﻠﻴﻤﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

—

. .

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Conclusions:

The subject device, the Bard 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 Bard PTV Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Mullins-X PTV Catheter and the Atlas® PTA Balloon Dilatation Catheter.

Image /page/8/Picture/5 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and prominent appearance. The overall design is simple and clean, focusing on the clarity and readability of the word.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

NOV 2 2012

Bard Peripheral Vascular, Inc. c/o Ms. Erin Fox Regulatory Affairs Specialist C. R. Bard 1625 West Third Street Tempe, AZ 85281

Re: K122367

Trade/Device Name: Bard PTV Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Pulmonary Valvuloplasty Catheter Regulatory Class: Class II Product Code: OMZ Dated: August 2, 2012 Received: August 5, 2012

Dear Ms. Fox:

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.

{10}------------------------------------------------

Page 2 - Ms. Erin Fox

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Aus Hille

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: Bard PTV Dilatation Catheter

Indications for Use: The Bard PTV Dilatation Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

A patient with isolated pulmonary 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)

Mskiel

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K122367

Image /page/11/Picture/16 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, and the interior of the letters is white. The letters are evenly spaced and appear to be in a slightly condensed style. The overall impression is a clean and modern design.

Bard Peripheral Vascular, Inc.

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).