The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.

Device Description

The subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are small vessel balloon catheters consisting of an over the wire catheter with a balloon fixed at the distal tip. The semi-compliant, low profile balloon has two radiopaque marker bands to delineate the working length of the balloon and aid in balloon placement. The coaxial, over the wire catheter is compatible with 0.014" and 0.018" guidewires.

AI/ML Overview

The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters underwent a series of non-clinical in vitro tests to demonstrate substantial equivalence to a predicate device and ensure they met predetermined acceptance criteria.

1. Acceptance Criteria and Reported Device Performance:

The document describes a comprehensive set of in vitro tests performed to evaluate the physical and performance characteristics of the Ultraverse® catheters. The acceptance criteria for these tests are generally implied to be conformity with established standards, guidance documents, and internal risk assessments. The reported performance is that the devices "met all predetermined acceptance criteria" and "demonstrate that the technological characteristics and performance criteria of the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the same intended use."

Here's a table summarizing the tested parameters and the reported outcome:

Acceptance Criteria (Implied)	Reported Device Performance
Material/Design Specifications:
Catheter Length	Met acceptance criteria
Guidewire Inner Lumen Diameter	Met acceptance criteria
Shaft Outer Diameter	Met acceptance criteria
Balloon Outer Diameter at Operating Pressure	Met acceptance criteria
Balloon Length	Met acceptance criteria
Marker Band Spacing/Alignment	Met acceptance criteria
Tip Length	Met acceptance criteria
Tip Taper	Met acceptance criteria
Guidewire Compatibility	Met acceptance criteria
Mechanical Performance:
Distensibility	Met acceptance criteria
Balloon Fatigue	Met acceptance criteria
Balloon Inflation and Deflation	Met acceptance criteria
Balloon Burst Strength	Met acceptance criteria
Balloon to Catheter Shaft Bond Strength	Met acceptance criteria
Joint Strength of Hub to Shaft	Met acceptance criteria
Hub Torsion Testing	Met acceptance criteria
Hub Stress Testing	Met acceptance criteria
Catheter Shaft Leaks	Met acceptance criteria
Catheter Elongation	Met acceptance criteria
Crossing Profile	Met acceptance criteria
Rewrapping with Stylet	Met acceptance criteria
Usability/Visibility:
Simulated Use: Introducer Sheath Compatibility	Met acceptance criteria
Simulated Use: Trackability	Met acceptance criteria
Marker Band Visibility	Met acceptance criteria
Compatibility with Standard Luer Locks	Met acceptance criteria
Packaging/Sterility:
Package Integrity	Met acceptance criteria
Dye Penetration of Packaging	Met acceptance criteria
Pouch Seal Strength	Met acceptance criteria

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

The document describes in vitro tests, which are laboratory-based tests. Therefore, the concept of a "test set" in the context of clinical data (like patient data with a specific provenance) does not directly apply here. The sample sizes for each specific in vitro test (e.g., number of balloons tested for burst strength) are not explicitly stated in this document but would have been defined in the individual test protocols. The data provenance is from in vitro laboratory testing, conducted according to FDA Guidance Documents and internal Risk Assessment procedures.

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

Not applicable. For in vitro engineering and performance tests of medical devices, "ground truth" is typically established by physical measurements, established engineering standards, and pre-defined acceptance limits, rather than expert consensus on interpretive data (like in image analysis).

4. Adjudication Method for the Test Set:

Not applicable. As described above, the acceptance was based on meeting pre-defined physical and engineering specifications and performance criteria, not on human adjudication of medical findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This document describes in vitro engineering and performance testing for a medical device (balloon catheters), not a diagnostic algorithm or imaging system requiring human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

6. Standalone (Algorithm Only) Performance Study:

No. This document does not describe the evaluation of an algorithm or AI system. It focuses on the physical and mechanical performance of a medical device.

7. Type of Ground Truth Used:

For the in vitro tests, the "ground truth" was based on established engineering specifications, physical measurements, and performance benchmarks derived from FDA Guidance Documents and internal risk assessments. For example, a balloon's burst strength would be compared against a pre-defined minimum pressure it must withstand.

8. Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this study is not for a machine learning or AI algorithm. It involves direct physical and functional testing of device prototypes/samples.

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

Not applicable. As there is no training set for an AI algorithm mentioned, the process of establishing ground truth for a training set is irrelevant to this submission.

Summary

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Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters

510(k) Summary

MAR 1 7 2010

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 summary of the information upon which substantial equivalence determination is based as follows:

Submitter Information:

Applicant: Bard Peripheral Vascular, Inc.

1625 West Third Street

Tempe, Arizona 85281

Phone: 480-303-2662

Fax: 480-449-2546

Contact: Candace Wade, Regulatory Affairs Associate

Date: December 22, 2009

Subject Device:

Device Trade Name:	Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters
Common or Usual Name:	Catheter, Angioplasty, Peripheral, Transluminal/
	Catheter, Percutaneous
Classification:	Class II
Classification Panel:	Cardiovascular

3. Predicate Device:

Device Trade Name:	Ultraverse® Small Vessel PTA Balloon Dilatation Catheter
Cleared 510(K) Number:	K012913
Date of Cleared 510(K):	09/28/01

4. Summary of Change:

The modifications from the predicate device, the Ultraverse® Small Vessel PTA Balloon Dilatation Catheter, to the subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters, were to the balloon design, catheter design, and performance characteristics.

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5. Device Description:

14093969

6. Indications for Use of Device:

The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters, are recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.

7. Technological Comparison to Predicate Device:

The technological characteristics of the subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters, are substantially equivalent to those of the predicate device, the Ultraverse Small Vessel PTA Balloon Dilatation Catheter, in terms of intended use, indications for use, fundamental scientific technology, target population, operating principle, sterility assurance level and method of sterilization.

8. Performance Testing Summary:

To demonstrate substantial equivalence of the subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters 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:

Catheter Length .
Guidewire Inner Lumen Diameter .
Shaft Outer Diameter .
Balloon Outer Diameter at Operating Pressure ●
Balloon Length .
Marker Band Spacing/Alignment .
. Tip Length
. Tip Taper
Guidewire Compatibility .

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Distensibility .
Balloon Fatigue .
. Balloon Inflation and Deflation
Balloon Burst Strength .
Balloon to Catheter Shaft Bond Strength .
Joint Strength of Hub to Shaft .
Hub Torsion Testing .
Hub Stress Testing .
Simulated Use: Introducer Sheath Compatibility .
Catheter Shaft Leaks .
Catheter Elongation .
Crossing Profile .
Simulated Use: Trackability 4
Marker Band Visibility .
. Compatibility with Standard Luer Locks
Rewrapping with Stylet ●
. Package Integrity
. Dye Penetration of Packaging
. Pouch Seal Strength

The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

9. Conclusions:

The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are substantially equivalent to the legally marketed predicate device, the Ultraverse® Small Vessel PTA Balloon Dilatation Catheter.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, with its arms outstretched. The logo is simple and uses a monochromatic color scheme.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR ] 7 2010

Bard Peripheral Vascular, Inc. c/o Candace Wade Regulatory Affairs Associate 1625 West Third Street Tempe, AZ 85281

Re: K093965

Trade/Device Name: Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT, DOY Dated: February 5, 2010 Received: February 12, 2010

Dear Ms. Wade:

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.

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

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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/ResourcesforYou/Industry/default.htm.

https://www.fda.gov/MedicalDevices/ResourcesforYouIndustry/default.htm

Sincerely yours,

er R. V. Mmer

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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Page 73

Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

KO93965

Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters

The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popiteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.

Prescription Use × (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)

Rma R. V. Lines

(Division Sign-Off) (Division Sign Silvascular Devices

510(k) Number K 093965

TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

BARD

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).