Ultraverse® RX PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the renal, femoral, popliteal, infrapopliteal, tibial, and peroneal arteries. This catheter is not for use in coronary arteries.

Device Description

The Ultraverse® RX PTA Dilatation Catheter is a small vessel balloon catheter consisting of a rapid exchange catheter and a balloon fixed at the distal tip. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The device will come in 80, 150. and 200 cm catheter shaft lengths. On the 150 and 200 cm catheter shaft lengths, two non-radiopaque markers are located 90 cm and 100 cm from the balloon catheter tip to help confirm when the balloon catheter tip exits the introducer sheaths or guide catheters. The catheter includes a radiopaque atraumatic tip and the Ultra-Cross™ Dual Layer Hydrophilic Coating (as used on Ultraverse 014/018) on the distal segment of the catheter shaft and balloon to facilitate advancement of the catheter to and through the stenosis. Ultraverse® RX Catheters are compatible with .014" guidewires. The proximal portion of the catheter includes a female luer lock hub connected to the catheter. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. A flushing needle is provided for catheter prep. These products are not made with any natural rubber latex.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ultraverse® RX PTA Dilatation Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary lists numerous performance tests but does not explicitly present a table of "acceptance criteria" alongside specific quantitative performance results for each criterion. Instead, it generally states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® RX PTA Dilatation Catheter is comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market with the same intended use."

However, we can infer some of the performance criteria from the list of in vitro tests performed:

Acceptance Criterion (Inferred from Test Name)	Reported Device Performance
Dimensional Verification (Outer Diameter, Lengths)	Comparable to predicate devices
Flushability	Comparable to predicate devices
Tip Taper	Comparable to predicate devices
Hub Torque	Comparable to predicate devices
Hub Stress	Comparable to predicate devices
Sheath Compatibility	Comparable to predicate devices
Reinsertion/Stylet/Refold	Comparable to predicate devices
Rated Burst Pressure	Comparable to predicate devices
Balloon Burst Mode	Comparable to predicate devices
Catheter Shaft Leaks	Comparable to predicate devices
Fatigue	Comparable to predicate devices
Balloon Distensibility	Comparable to predicate devices
Inflation Time	Comparable to predicate devices
Deflation Time	Comparable to predicate devices
Balloon to Shaft Tensile	Comparable to predicate devices
RX Junction Tensile	Comparable to predicate devices
Hub to Hypotube Tensile	Comparable to predicate devices
Trackability (Flexibility and Kink)	Comparable to predicate devices
Tip Radiopacity	Comparable to predicate devices
Marker Band Alignment	Comparable to predicate devices
Flushing Needle Stress	Comparable to predicate devices
Flushing Needle Torque	Comparable to predicate devices
Packaging Visual Inspection	Comparable to predicate devices
Dye Penetration	Comparable to predicate devices
Biocompatibility (ISO 10993-1:2010 based)
- Cytotoxicity	Biocompatible for intended use
- Irritation/Intracutaneous Reactivity	Biocompatible for intended use
- Sensitization	Biocompatible for intended use
- Acute Systemic Toxicity	Biocompatible for intended use
- Material Mediated Pyrogenicity	Biocompatible for intended use
- Hemocompatibility (Hemolysis & Thrombogenicity)	Biocompatible for intended use

The study proving these criteria are met consists of the execution of the listed "Performance Data" (in vitro tests) and "Biocompatibility" tests. The 510(k) summary explicitly states: "The subject device, the Ultraverse® RX 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."

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

Sample Size: The document does not specify the exact sample sizes used for each individual in vitro test or biocompatibility test. It only lists the types of tests performed.
Data Provenance: The studies are described as "in vitro tests" and "biocompatibility testing." This indicates the data is derived from laboratory testing of the device itself, rather than human clinical data. Therefore, there is no country of origin for human data or retrospective/prospective classification.

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

This information is not applicable. The device is a physical medical device (catheter) and the tests described are primarily engineering performance and material biocompatibility tests. There is no 'ground truth' in the context of expert visual interpretation or diagnosis required for these types of tests. The "ground truth" for these tests would be the established scientific and engineering principles, and the protocols defined in standards like ISO 10993-1.

4. Adjudication Method for the Test Set

This information is not applicable, as the tests are objective physical and chemical assessments rather than subjective assessments requiring adjudication.

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 510(k) submission is for a physical medical device (dilatation catheter), not an AI/imaging device, so no MRMC study or AI-assisted interpretation is relevant.

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

This information is not applicable, as this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the performance and biocompatibility studies conducted is based on:

Established scientific and engineering principles: Used to define the expected performance metrics (e.g., burst pressure, tensile strength).
FDA Guidance Documents on non-clinical testing of medical devices: These documents provide a framework for the types of tests and expected methodologies.
Internal Risk Assessment procedures: Used to identify critical performance parameters.
International Standards: Specifically, ISO 10993-1:2010 for biocompatibility, and likely other relevant ISO or ASTM standards for the mechanical and physical tests, although not explicitly named.
Test protocols and/or customer inputs: Defining the specific methods and acceptance limits for each test.

8. The Sample Size for the Training Set

This information is not applicable. There is no 'training set' as this is a physical medical device, not a machine learning model.

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

This information is not applicable, as there is no 'training set'.

Summary

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Ultraverse® RX PTA Dilatation Catheter

510(k) Summary 21 CFR 807.92

MAY 3 0 2013

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: 480-350-6014

Fax: 480-449-2546

Mario Thomas, Regulatory Affairs Contact:

Date February 27, 2013

Subject Device Name:

ಗ

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

Predicate Device:

. Ultraverse 014/018 PTA Balloon Dilatation Catheter (K121856, cleared July 11, 2012)
Clearstream LitePAC RX PTA Catheter (K100490, cleared March 16, . 2010)

Bard Peripheral Vascular, Inc.

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Device Description:

Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. A flushing needle is provided for catheter prep. These products are not made with any natural rubber latex.

Indications for Use of Device:

The Ultraverse® RX PTA Dilatation Catheter is indicated for use in Percutaneous Transfuminal Angioplasty of the renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries. This catheter is not for use in coronary arteries.

Comparison of Indications for Use to Predicate Devices:

The indication for use statement for the Ultraverse® RX 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 subject device, the Ultraverse® RX PTA Dilatation Catheter, is substantially equivalent to the predicate devices.

Image /page/1/Picture/10 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, with a focus on readability.

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Technological Comparison to Predicate Devices:

The Ultraverse® RX PTA Dilatation Catheter has the following similarities to the predicate device:

. Same intended use (Same as Ultraverse 014/018 predicate device)
. Similar indications for use (combines LitePAC and Ultraverse 014/018 predicate devices)
Same target population (Same as Ultraverse 014/018 predicate device) .
Same operating principle (Same as LitePAC predicate) .
Similar materials (Combination of LitePAC and Ultraverse 014/018 . materials)
Same fundamental scientific technology (Same as all predicates) .
Similar packaging materials and configurations ( Similar to all predicates) .
Same sterility assurance level and method of sterilization (Same as all . predicates)

Performance Data:

To demonstrate substantial equivalence of the subject device, the Ultraverse® RX PTA Dilatation Catheter to the predicate device, 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:

Dimensional Verification .
- Balloon Outer Diameter o
- Balloon Working Length o
- Hypotube Outer Diameter o
- Catheter Shaft Length O
- RX Junction Length o
Flushability ◆
Tip Taper .
Hub Torque .
. Hub Stress
Sheath Compatibility .
Reinsertion/Stylet/Refold .
Rated Burst Pressure ●

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K131199 p. 4 of 5

Balloon Burst Mode ●
. Catheter Shaft Leaks
. Fatigue
Balloon Distensibility .
Inflation Time .
Deflation Time .
Balloon to Shaft Tensile .
RX Junction Tensile .
Hub to Hypotube Tensile .
Trackability (Flexibility and Kink) .
. Tip Radiopacity
Marker Band Alignment .
. Flushing Needle Stress
. Flushing Needle Torque
. Packaging Visual Inspection
Dye Penetration .

The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® RX PTA Dilatation Catheter is comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market with the same intended use.

Biocompatibility:

To demonstrate substantial equivalence of the subject device, the Ultraverse® RX PTA Dilatation Catheter to the predicate device, 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
. Irritation/Intracutaneous Reactivity
Sensitization .
Acute Systemic Toxicity .

Bard Peripheral Vascular, Inc.

Image /page/3/Picture/25 description: The image shows the word "BARD" in a stylized, bold font. The letters are interconnected, creating a sense of unity and visual interest. The font appears to be sans-serif, with sharp angles and clean lines, giving it a modern and geometric look.

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Material Mediated Pyrogenicity ●
Hemocompatibility (Hemolysis and Thrombogenicity) .

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

Conclusions:

The subject device, the Ultraverse® RX 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 Ultraverse® RX PTA Dilatation Catheter is substantially equivalent to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. The text is in all capital letters and is in a simple, sans-serif font.

Public Health Service

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

May 30, 2013

Bard Peripheral Vascular, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K131199

Trade/Device Name: Ultraverse® RX PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: LIT Dated: April 25, 2013 Received: April 26, 2013

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. Y

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

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Page 2 - Mr. Mark Job

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerman-S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 28

Indications for Use

510(k) Number (if known):

Device Name: Ultraverse® RX PTA Balloon Dilatation Catheter

Indications for Use: Ultraverse® RX PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the renal, femoral, popliteal, infrapopliteal, tibial, and peroneal arteries. This catheter is not for use in coronary arteries.

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)

Bram D. Zuckerman -S
2013.05.30 09:51:08
-04'00'

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).