The Rival® PTA Dilatation Catheters are intended to dilate stenoses in the peripheral arteries, treat obstructive lesions of native or synthetic A-V fistulae, and/or re-expand endoluminal stent graft elements in the aorta and iliac arteries. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Device Description

The Rival® PTA Dilatation Catheter is a 0.035" guidewire compatible balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The hub of the catheter includes inflation and guidewire ports with female luer locks. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Rival® PTA Dilatation Catheter, focusing on acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (510(k) Summary) states that the Rival® PTA Dilatation Catheter met all predetermined acceptance criteria. However, it does not explicitly list numerical acceptance criteria or specific performance values for the device in a comparative table a typical "acceptance criteria" table might present. Instead, it refers to comparable performance to predicate devices based on in vitro tests.

Here's an interpretation based on the available information:

Acceptance Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance
General Performance	Comparable to predicate devices (Edwards Peripheral Dilation Catheter, Dorado® PTA Dilatation Catheter) in technological characteristics and performance criteria.	"The results from these tests demonstrate that the technological characteristics and performance criteria of the Rival® 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."
Puncture Resistance	To be comparable to predicate devices.	Performed an in vitro test. Results indicated comparability.
Robustness	To be comparable to predicate devices.	Performed an in vitro test. Results indicated comparability.
Safety & Effectiveness	No new issues of safety and effectiveness compared to predicate devices, based on risk analysis and proposed indications for use.	Demonstrated through risk analysis process.
Design Verification & Validation	Met all predetermined acceptance criteria as specified by applicable standards, guidance, test protocols and/or customer inputs.	Device "met all the predetermined acceptance criteria of design verification and validation."

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

Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data. The performance evaluation was based on in vitro tests. Therefore, the "sample size" would refer to the number of devices or iterations tested during the Puncture Resistance and Robustness in vitro studies. This specific number is not provided in the summary.
Data Provenance: The data is from in vitro studies conducted by the manufacturer, Bard Peripheral Vascular, Inc. The document does not mention any clinical data, country of origin for clinical data, or whether it was retrospective or prospective, as no human studies were described for substantial equivalence.

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

This question is not applicable as the described performance evaluation relies solely on in vitro testing, not on human-based adjudication or ground truth establishment for a test set of data.

4. Adjudication Method for the Test Set

This question is not applicable as the described performance evaluation relies solely on in vitro testing, not on human-based adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states the evaluation was based on in vitro tests to demonstrate substantial equivalence to predicate devices, not on human-in-the-loop performance or comparison of human readers with and without AI assistance.

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

This is not applicable as the device is a physical medical instrument (dilatation catheter), not an algorithm or AI system. The "standalone performance" here refers to the device's physical and mechanical properties. These were evaluated in vitro as described.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/image analysis is not directly applicable here. For this physical device, the "ground truth" for its performance is established by the engineering specifications and performance metrics defined for Puncture Resistance and Robustness in the in vitro tests. The "truth" is that the device either meets these defined physical performance standards or it doesn't, relative to its predicate devices.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical instrument and does not involve AI or machine learning algorithms that require a "training set."

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

This question is not applicable for the same reason as above – no training set was involved for this physical device.

Summary

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APR 1 9 2012

Rival® 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 (1)(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 30 Street
	Tempe, Arizona 85281

Phone: 480-303-2662
Fax: 480-449-2546
Contact: Candace Wade, Regulatory Affairs Specialist
September 1, 2011 Date

Subject Device Name: Device Trade Name:

Rival® PTA Dilatation Catheter

Common or Usual Name:	Percutaneous Catheter (21 CFR 870.1250,Product Code DQY and LIT)
Classification:	Class II

Classification Panel: Cardiovascular

Predicate Devices:

. Edwards Peripheral Dilation Catheter (K052149; cleared September 2, 2005)
Dorado® PTA Dilatation Catheter (K072283; cleared September 19, 2007) .

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Device Description:

Attribute	Rival PTA Dilatation CatheterProduct Offering
Balloon Diameter(mm)	3, 4, 5, 6, 7, 8, 9, 10
Balloon Length(cm)	2, 4, 6, 8, 10, 15
Catheter ShaftLengths (cm)	80, 120, 135
Introducer SheathCompatibility(compatibleballoondiameters, mm)	5F: (3, 4, 5, 6)6F: (6, 7, 8, 9)7F: (10)

Indications for Use of Device:

Image /page/1/Picture/8 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 evenly spaced and aligned horizontally. The overall impression is clean and modern.

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Comparison of Indications for Use to Predicate Devices:

The indication for use statement for the Rival® 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 Edwards Peripheral Dilation Catheter and the Dorado® PTA Dilatation Catheter. Therefore, the subject device, the Rival® PTA Dilatation Catheter, is substantially equivalent to the predicate devices.

Technological Comparison to Predicate Devices:

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

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

Performance Data:

To demonstrate substantial equivalence of the subject device, the Rival 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:

Puncture Resistance .
Robustness .

The results from these tests demonstrate that the technological characteristics and performance criteria of the Rival® 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.

Image /page/2/Picture/19 description: The image shows the word "BARID" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and clear appearance. The font style is simple and easy to read.

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Conclusions:

The subject device, the Rival® 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 Rival® PTA Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Edwards Peripheral Dilation Catheter and the Dorado® PTA Dilatation Catheter,

Image /page/3/Picture/5 description: The image shows the word "BARD" in a bold, outlined font. The letters are large and evenly spaced, filling the frame. The outline gives the word a three-dimensional effect, making it stand out against the background.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

APR 1 9 2012

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

Re: K120722

Trade/Device Name: Rival PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: LIT, DQY Dated: March 8, 2012 Received: March 9, 2012

Dear Mr. Job:

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.

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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 vours,

M. G. Milliken

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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aditional 510(k) ival® PTA Dilatation Catheter

Indications for Use

510(k) Number (if known): K120722

Device Name: Rival® PTA Dilatation Catheter

Indications for Use: The Rival® PTA Dilatation Catheters are intended to dilate stenoses in the peripheral arteries, treat obstructive lesions of native or synthetic A-V fistulae, and/or re-expand endoluminal stent graft elements in the aorta and iliac arteries. This device is also recommended for post-dilatation of balloon expandable and selfexpanding stents in the peripheral vasculature.

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. Hillen

(Division Sian-Off) Division of Cardiovascular Devices

510(k) Number K120722

Image /page/6/Picture/16 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a blocky appearance. The overall design is simple and eye-catching.

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).