The Conquest® 40 PTA Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Device Description

The Conquest® 40 PTA Dilatation Catheter is a high pressure percutaneous transluminal angioplasty (PTA) balloon catheter consisting of a 0.035" compatible over the wire catheter with a low profile balloon fixed at the distal tip. 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 stenosis. 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 quidewire 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. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. This product is not manufactured with any latex.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Conquest® 40 PTA Dilatation Catheter:

Based on the provided 510(k) summary, the device is a PTA Dilatation Catheter (a physical medical device), not an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test set, provenance, number of experts, adjudication, MRMC study, training set details) are not applicable to this submission. The "acceptance criteria" here refer to the performance standards and safety criteria for the physical device, not an algorithm's performance.

The submission focuses on demonstrating substantial equivalence to predicate devices through in vitro testing and biocompatibility assessments, rather than clinical efficacy studies in the way an AI/ML device would.

Acceptance Criteria and Device Performance (for a physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

Test/Attribute	Acceptance Criteria (Implied by equivalence to predicates and industry standards)	Reported Device Performance Conclusion
In Vitro Tests (Newly Performed for Conquest® 40)	Meets design specifications, comparable to predicate devices, and adheres to relevant FDA Guidance Documents and internal Risk Assessment procedures.	"The results from these tests demonstrate that the technological characteristics and performance criteria of the Conquest® 40 PTA Dilatation Catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the similar intended use." Specific numeric criteria/results are not detailed in this summary.
Specific In Vitro Tests:
- Tip Length	Meets design specifications for safe and effective use; comparable to predicates.	Demonstrated comparability.
- Balloon Outer Diameter	Meets design specifications for stated diameters (4, 5, 6, 7, 8, 9, 10, 12 mm); comparable to predicates.	Demonstrated comparability.
- Shaft Outer Diameter	Meets design specifications for device profile; comparable to predicates.	Demonstrated comparability.
- Balloon Distensibility	Meets design specifications for controlled expansion; comparable to predicates.	Demonstrated comparability.
- Fatigue	Withstands expected operational stresses and cycles without failure.	Demonstrated comparability.
- Fatigue in a Stent/Stent Graft/Graft	Maintains integrity when used within stents/grafts.	Demonstrated comparability.
- Balloon Burst Strength in a Stent/Stent Graft and Balloon Removal	Withstands specified pressures without catastrophic failure, and allows for safe removal.	Demonstrated comparability.
- Balloon Inflation and Deflation Time	Achieves inflation/deflation within clinically acceptable times.	Demonstrated comparability.
- Balloon Burst Strength and Burst Mode	Withstands specified pressures without catastrophic failure, and fails in a safe manner.	Demonstrated comparability.
- Balloon to Shaft Tensile Force	Maintains secure connection under stress.	Demonstrated comparability.
- Catheter Shaft Elongation	Remains within acceptable elongation limits during use.	Demonstrated comparability.
- Guidewire Extension to Bifurcate Tensile Force	Maintains secure connection under stress.	Demonstrated comparability.
- Bifurcate to Shaft Tensile Force	Maintains secure connection under stress.	Demonstrated comparability.
- Guidewire Hub to Guidewire Extension Tensile Force	Maintains secure connection under stress.	Demonstrated comparability.
- Introducer Sheath Compatibility	Compatible with specified introducer sheath sizes (6F, 7F, 8F).	Demonstrated comparability.
- Catheter Shaft Leaks	No leaks under operational pressure.	Demonstrated comparability.
- Trackability and Guidewire Compatibility	Navigates vascular anatomy effectively and is compatible with standard guidewires.	Demonstrated comparability.
- Syringe Inflation Pressure Capability	Compatible with standard inflation devices and pressures.	Demonstrated comparability.
Biocompatibility Tests (Newly Performed for Conquest® 40)	Meets biological safety requirements as per ISO 10993-1:2010 and Blue Book Memorandum G95-1.	"The results from these tests demonstrate that the subject device, the Conquest® 40 PTA Dilatation Catheter, is comparable to the predicate devices and that it is considered safe and biocompatible for its intended use."
- Cytotoxicity	No unacceptably high cytotoxic effects.	Demonstrated comparability.
- Chemical Characterization	Identification and quantification of leachable substances within acceptable limits.	Demonstrated comparability.
Leveraged Biocompatibility Tests (from Predicate Devices)	Meets biological safety requirements as per ISO 10993-1:2010 and Blue Book Memorandum G95-1.	"The results from these tests demonstrate that the subject device... is comparable to the predicate devices and that it is considered safe and biocompatible for its intended use."
- Irritation/Intracutaneous Reactivity	No unacceptable irritation or intracutaneous reactivity.	Demonstrated comparability.
- Sensitization	No unacceptable sensitization potential.	Demonstrated comparability.
- Acute Systemic Toxicity	No unacceptable acute systemic toxicity.	Demonstrated comparability.
- Material Mediated Pyrogenicity	No unacceptable pyrogenic response.	Demonstrated comparability.
- Hemocompatibility (Hemolysis and Thrombogenicity)	Acceptable levels of hemolysis and thrombogenicity.	Demonstrated comparability.

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

Sample Size: Not specified for individual in vitro tests. For physical device testing, sample sizes are typically determined by statistical rationale to ensure confidence in the results for each specific test (e.g., n=3, n=5, n=10 per batch, etc.). The summary states "in vitro tests were performed" but does not detail the sample sizes.
Data Provenance: The data is from in vitro testing conducted by the manufacturer, Bard Peripheral Vascular, Inc. This is not clinical data, so concepts like country of origin or retrospective/prospective do not apply in the same way they would for a clinical study with patients.

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

Not Applicable. This is a physical device submission focused on engineering performance and biocompatibility rather than diagnostic accuracy or human interpretation tasks. Ground truth for in vitro tests is based on established engineering principles, metrology, and standardized test methods.

4. Adjudication Method for the Test Set

Not Applicable. As above, this is not a diagnostic or interpretive task requiring expert adjudication. Test results are objectively measured against pre-defined engineering specifications and standards.

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

No. An MRMC study is for evaluating the impact of a new diagnostic tool (often AI) on human reader performance. This submission is for a physical medical device (catheter) and does not involve human readers evaluating cases with or without AI assistance.

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

Not Applicable. This device is a physical medical device. There is no "algorithm" in the context of AI/ML to test in a standalone manner.

7. The Type of Ground Truth Used

For in vitro performance tests: Ground truth is established by engineering specifications, material science standards, and validated test methods (e.g., ISO standards). Measurements are taken directly from the manufactured devices.
For biocompatibility tests: Ground truth is established by biological endpoints (e.g., cellular viability for cytotoxicity, specific immune responses for sensitization) as defined by international standards (ISO 10993).

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not Applicable. As above, there is no training set for a physical medical device. Manufacturing processes and design controls are validated through engineering studies and quality assurance practices.

Summary of Device Performance (Overall):

The submission concludes that the Conquest® 40 PTA Dilatation Catheter met all predetermined acceptance criteria for design verification and validation. This was based on:

Direct in vitro testing of various physical and mechanical attributes.
Direct in vitro biocompatibility testing (cytotoxicity, chemical characterization).
Leveraging in vitro test data from its predicate devices where components and materials were identical (e.g., balloon operating pressure, marker band visibility, irritation, sensitization).

The study demonstrates that the new device is substantially equivalent to legally marketed predicate devices by showing comparable technological characteristics and performance criteria, and by being deemed safe and biocompatible for its intended use.

Summary

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Conquest® 40 PTA 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, Inc1625 West 3rd StreetTempe, Arizona 85281
Phone:	480-303-2664
Fax:	480-449-2546
Contact:	Ashley Fickett, Regulatory Affairs Associate
Date	January 13, 2012

Subject Device Name:

Device Trade Name:	Conquest® 40 PTA Dilatation Catheter
Common or Usual Name:	Percutaneous Catheter (21 CFR 870.1250,Product Code DQY, LIT)
Classification:	Class II
Classification Panel:	Cardiovascular

Predicate Devices:

Conquest® PTA Balloon Dilatation Catheter (K083657, cleared December . 24, 2008)
Dorado® PTA Balloon Dilatation Catheter (K072283; cleared September . 19, 2007)

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Device Description:

Attribute	Conquest® 40 PTA Dilatation CatheterProduct Offering
Balloon Diameter(mm)	4, 5, 6, 7, 8, 9, 10, 12
Balloon Length(cm)	2, 3, 4, 6, 8, 10
Catheter ShaftLengths (cm)	50, 75
Introducer SheathCompatibility(compatibleballoondiameters, mm)	6F: (4, 5, 6, 7, 8)7F: (9,10)8F: (12)

Indications for Use of Device:

Conquest® 40 PTA Dilatation Catheter is recommended for use in Perculaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents and stent grafts in the peripheral This for use in coronary vasculature. catheter ાંડ not arteries.

Image /page/1/Picture/10 description: The image shows the word "BARD" in a stylized, bold font. The letters are outlined in black, giving them a distinct and modern appearance. The font choice is sans-serif, contributing to the clean and contemporary aesthetic of the logo.

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Comparison of Indications for Use to Predicate Devices:

The indications for use statement for the subject device, the Conquest® 40 PTA Dilatation Catheter, is a combination of the two predicate devices, the Conquest® PTA Balloon Dilatation Catheter and the Dorado® PTA Balloon Dilatation Catheter. There are no new indications outside of the previously cleared predicate devices. Therefore, the Conquest® 40 PTA 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, the Conquest® PTA Balloon Dilatation Catheter and the Dorado® PTA Balloon Dilatation Catheter. Therefore, the subject device, the Conquest® 40 PTA Balloon Dilatation Catheter, is substantially equivalent to the predicate devices.

Technological Comparison to Predicate Devices:

The Conquest® 40 PTA Dilatation Catheter has the following similarities to the predicate devices:

. Similar intended use (both predicates)
Similar indications for use (combination of both predicates) .
Same target population (both predicates) t
Same fundamental scientific technology (both predicates) .
Same operating principle (both predicates) .
Same packaging materials and configuration (Dorado) .
Same sterility assurance level and method of sterilization (both predicates) .

Performance Data:

To demonstrate substantial equivalence of the subject device, the Conquest® 40 PTA 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:

. Tip Length
Balloon Outer Diameter .
Shaft Outer Diameter t
Balloon Distensibility .

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Traditional 510(k) Conquest 40 PTA Dilatation Catheter

. Fatique
Fatigue in a Stent/Stent Graft/Graft .
Balloon Burst Strength in a Stent/Stent Graft and Balloon Removal .
. Balloon Inflation and Deflation Time
. Balloon Burst Strength and Burst Mode
t Balloon to Shaft Tensile Force
Catheter Shaft Elongation .
Guidewire Extension to Bifurcate Tensile Force t
Bifurcate to Shaft Tensile Force .
Guidewire Hub to Guidewire Extension Tensile Force .
Introducer Sheath Compatibility .
Catheter Shaft Leaks .
Trackability and Guidewire Compatibility .
. Syringe Inflation Pressure Capability

The following in vitro tests were leveraged from the predicate devices, the Conquest® PTA Balloon Dilatation Catheter and the Dorado® PTA Balloon Dilatation Catheter:

Balloon Operating Pressure t
. Balloon Length
. Marker Band Visibility
. Marker Band Alignment
Tip Taper .
Tip Visibility .
. Tip Tensile
Shaft Visibility .
Shaft Length .
Balloon Hub to Balloon Extension Tensile Force .
Balloon Extension to Bifurcate Tensile Force .
. Media Interaction
Guidewire Lumen ID .
Equipment Interface .
Packaging Tensile Strength .

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The results from these tests demonstrate that the technological characteristics and performance criteria of the Conquest® 40 PTA Dilatation Catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the similar intended use.

Biocompatibility:

To demonstrate substantial equivalence of the subject device, the Conquest® 40 PTA Dilatation Catheter, to the predicate devices, the following biocompatibility testing was performed in accordance ISO 10993-1:2010, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process," and "Blue Book Memorandum - G95-1 Use of International Standard ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."

. Cytotoxicity
Chemical Characterization .

Since all materials in the subject device, the Conquest® 40 PTA Dilatation Catheter, are utilized in the predicate devices, the Conquest® PTA Balloon Dilatation Catheter and the Dorado® PTA Balloon Dilatation Catheter, the following biocompatibility tests were leveraged from the predicate devices:

. Irritation/Intracutaneous Reactivity
. Sensitization
Acute Systemic Toxicity .
Material Mediated Pyrogenicity .
. Hemocompatibility (Hemolysis and Thrombogenicity)

The results from these tests demonstrate that the subject device, the Conquest® 40 PTA Dilatation Catheter, is comparable to the predicate devices and that it is considered safe and biocompatible for its intended use.

Conclusions:

The subject device, the Conquest® 40 PTA Dilatation Catheter, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Conquest®

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40 PTA Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Conquest® PTA Balloon Dilatation Catheter and the Dorado® PTA Balloon Dilatation Catheter.

Image /page/5/Picture/5 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined in black, giving it a distinct and prominent appearance. The font style is unique, with sharp angles and a slightly futuristic feel.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Public Health Service

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

MAR 1 5- 2012

Bard Peripheral Vascular, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25" Street NW Buffalo, MN 55313

Re: K120660

Trade/Device Name: Conquest 40 PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: LIT, DQY Dated: March 2, 2012 Received: March 5, 2012

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) pressure is substantially equivalent (for the indications felerenced above and nave acterimes ally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food, Drug, devices malliave been reclassified in accessful of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica You may, therefore, market the device, subject to the general controls provisions of the Act. The Y ou may, ulerelove, market me device, babyer to the more of manual registration, listing of general controls provisions of the flee labeling, and prohibitions against mistranding and devices, good manufacturing practice, taceming was not elated to contract liability.
adulteration. Please note: CDRH does not evaluate information related wat micleand adulteration. Flease not. CDICT doos not of artists and the truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
e If your device is classified (sec above) . Existing major regulations affecting your device can be
may be subject to additional controls. Existing major regulations affective may be subject to additional Controls: "Existing may or 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parti 800 Register found in the Code of I edetal Regarations, cour device in the Federal Register.

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Page 2 - Mr. Mark Job

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/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 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.

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: Conquest® 40 PTA Dilatation Catheter

Indications for Use: The Conquest® 40 PTA Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

{PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-Off)

Division of Gastroenterology Devices
510(k) Number 420660

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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).