The Ultraverse® 035 PTA Dilatation Catheter is intended to dilate stenoses in the peripheral arteries, to treat obstructive lesions of native or synthetic AV fistulae and/or re-expand endoluminal stent graft elements in the iliac arteries. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

Device Description

The Ultraverse® 035 PTA Dilatation Catheter is a semi-compliant balloon catheter consisting of an over the wire (OTW) catheter with an angioplasty balloon fixed at the distal tip. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter also includes a radiopaque, atraumatic tip. GeoAlign™ Marker Bands are designated on the catheter shaft by 1cm increment bands. Each 10cm increment is labeled with the distance from the distal balloon tip. Thicker bands denote the midway point (5cm) between the labeled distances. GeoAlign™ Marker Bands are designed to be used as a location reference tool. GeoAlign™ Marker Bands are also designed to be used as a guide to assist with geographic alignment when used with an adjunctive therapy that utilizes the same GeoAlign™ Marker Bands. The aforementioned design elements of the GeoAlign " Marker Bands facilitate increased procedure efficiency and minimize fluoroscopy exposure. The Ultraverse® 035 PTA Dilatation Catheter is compatible with .035" guidewires. The proximal portion of the catheter includes a female luer lock hub connected to the catheter with a guidewire lumen and an inflation lumen. Packaged with every product is a protective sheath that is positioned over the balloon and should be removed prior to use. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. A rewrapping tool is also provided on the catheter shaft. These products are not made with natural rubber latex.

AI/ML Overview

The provided text describes a medical device, the Ultraverse® 035 PTA Dilatation Catheter, and its substantial equivalence to a predicate device. This document is a 510(k) summary from the FDA, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

However, the document does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity. Instead, it details non-clinical (in vitro) and biocompatibility tests to show substantial equivalence.

Therefore, an exhaustive answer to your request cannot be fully provided based solely on the given text. I will extract the available information and explicitly state where the requested information is not present.

Here's a breakdown of the available information structured to best answer your prompt:

1. A table of acceptance criteria and the reported device performance

The document lists various in vitro and biocompatibility tests performed. For the biocompatibility tests, it explicitly states "PASS" for each, indicating they met the acceptance criteria for those specific tests. For the in vitro tests, it generally states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® 035 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." Specific numeric acceptance criteria or detailed device performance results (e.g., specific measurements for dimensional verification, exact burst pressures) are not provided in this summary.

Test Category	Specific Test	Reported Device Performance (Acceptance Criteria)
In Vitro Tests	Dimensional Verification (Tip length, Balloon Outer Diameter, Balloon Length, Shaft Outer Diameter, Catheter Shaft Length)	Comparable to predicate devices; performs equivalently for intended use (Specific numeric criteria not provided)
	Gradient Marking Position	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Gradient Marking Legibility	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Gradient Marking Durability	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Trackability	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Sheath Compatibility	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Flushability	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Reinsertion	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Stylet/Refold	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Device Compatibility	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Guidewire Compatibility	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Balloon Distensibility	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Inflation	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Deflation	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Balloon Rated Burst Pressure	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Leak	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Burst Mode	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Fatigue	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Balloon Fatigue in a Stent/Stent Graft	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Balloon Burst in a Stent/Stent Graft	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Balloon Removal from a Stent/Stent Graft	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Balloon to Shaft Tensile	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Catheter Elongation	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Hub to Shaft Tensile	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Tip Taper	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Tip Radiopacity	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Marker Band Radiopacity	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Marker Band Alignment	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Hub Torque/Hub Stress	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
	Packaging (Visual Inspection, Dye Penetration, Pouch Tensile)	Comparable to predicate devices; performs equivalently for intended use (Specific criteria not provided)
Biocompatibility	Cytotoxicity (MEM Elution Test)	PASS
	Sensitization (Murine Local Lymph Node Assay)	PASS
	Sensitization (Guinea Pig Maximization Test)	PASS
	Intracutaneous (Intracutaneous Injection Test)	PASS
	Acute Systemic Toxicity (Systemic Injection Test)	PASS
	Hemocompatibility (In Vivo Hemolysis)	PASS
	Hemocompatibility (Thrombogenicity)	PASS
	Hemocompatibility (Complement Activation)	PASS
	USP Pyrogen Study (Material Mediated Pyrogenicity)	PASS

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists "in vitro tests" and "biocompatibility testing." These are laboratory-based tests of the device itself, not clinical studies involving patient data or images. Therefore, the concepts of "test set sample size" and "data provenance" in the typical AI/medical imaging context (e.g., country of origin, retrospective/prospective clinical data) do not apply to the testing described. The sample sizes for each specific in vitro and biocompatibility test are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question relates to clinical studies and expert review for ground truth, which is not applicable to the pre-market notification (510k) summary provided, as it describes in vitro and biocompatibility testing of a physical medical device, not an AI or imaging diagnostic device requiring expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

As per point 3, this question is not applicable to the type of testing described in the document.

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

The document describes a physical medical device (catheter), not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance was not done and is not applicable.

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

This question is also related to AI/algorithm performance. As the device is a physical catheter, this is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the biocompatibility tests, the "ground truth" or reference for "PASS" is an objective laboratory determination based on established test methods and standards (e.g., ISO 10993-1).
For the in vitro tests, the "ground truth" for evaluating performance would be engineering specifications and standards for the physical and functional properties of the device.
No expert consensus, pathology, or outcomes data are mentioned as ground truth in this 510(k) summary, as these typically relate to clinical evaluations, which are not the primary focus of this type of pre-market submission for this device.

8. The sample size for the training set

The document describes a physical medical device undergoing in vitro and biocompatibility testing, not an AI algorithm requiring a training set. Therefore, a "training set sample size" is not applicable.

9. How the ground truth for the training set was established

As per point 8, this question is not applicable.

Summary

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

September 24, 2014

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

Re: K142261

Trade/Device Name: Ultraverse 035 PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT Dated: August 13, 2014 Received: August 14, 2014

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.

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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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

M.G. Hillebrand

for 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)

K142261

Device Name

Ultraverse® 035 PTA Balloon Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Ultraverse® 035 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, Inc
	1625 West 3rd Street
	Tempe, Arizona 85281

480-350-6014 Phone:

Fax: 480-449-2546

Contact: Mario Thomas, Regulatory Affairs
Date July 23, 2014

Subject Device Name:

Device Trade Name:	Ultraverse® 035 PTA Dilatation Catheter
Common or Usual Name:	Percutaneous Catheter (21 CFR 870.1250,Product Code LIT)
Classification:	Class II
Classification Panel:	Cardiovascular

Predicate Device:

Rival PTA Balloon Dilatation Catheter (K120722, cleared April 19, 2012) .
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Device Description:

Attribute	Ultraverse® 035 PTA Dilatation CatheterProduct Offering
Balloon Diameter (mm)	3, 4, 5, 6, 7, 8, 9, 10, 12
Balloon Length (mm)	10, 20, 40, 60, 80, 100, 120, 150, 200, 250, 300
Catheter Shaft Lengths(cm)	40, 75, 100, 130, 150
Introducer SheathCompatibility	5F: 3.0	10, 20, 40, 60, 80, 100, 120, 150, 200, 250, 300
Compatible BalloonDiameters and Lengths(mm x mm)	4.0	10, 20, 40, 60, 80, 100, 120, 150, 200, 250, 300

Bard Peripheral Vascular, Inc.

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Attribute	Ultraverse® 035 PTA Dilatation CatheterProduct Offering
	5.0	10, 20, 40, 60, 80, 100, 120, 150, 200, 250, 300
	6.0	10, 20, 40, 60, 80, 100, 120, 150, 200, 250, 300
	7.0	10, 20, 40, 60, 80, 100, 120, 150, 200
	8.0	10, 20, 40, 60, 80
6F:	7.0	250, 300
	8.0	100, 120, 150, 200
	9.0	10, 20, 40, 60, 80, 100
	10.0	10, 20, 40, 60, 80, 100

7F:	8.0	250, 300
	12.0	10, 20, 40, 60, 80, 100

Indications for Use of Device:

The Ultraverse® 035 PTA Dilatation Catheter is intended to dilate stenoses in the peripheral arteries, to treat obstructive lesions of native or synthetic AV fistulae and/or re-expand endoluminal stent graft elements in the iliac arteries. This device is also recommended for post dilatation of balloon expandable and self expanding stents in the peripheral vasculature. 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® 035 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

Image /page/5/Picture/8 description: The image shows the word "BARD" in a stylized, bold, sans-serif font. The letters are outlined in black, giving them a distinct and modern appearance. The "A" in "BARD" is designed with a unique triangular shape, setting it apart from the other letters.

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devices. Therefore, the subject device, the Ultraverse® 035 PTA Dilatation Catheter, is substantially equivalent to the predicate device.

Technological Comparison to Predicate Devices:

The Ultraverse® 035 PTA Dilatation Catheter has the following similarities to the predicate device:

. Similar intended use
Similar indications for use .
Same target population
Same operating principle .
. Similar materials
Same fundamental scientific technology .
Similar packaging materials and configurations
. Same sterility assurance level and method of sterilization

Performance Data:

To demonstrate substantial equivalence of the subject device, the Ultraverse® 035 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 .
- o Tip Length
- Balloon Outer Diameter O
- Balloon Length O
- Shaft Outer Diameter o
- Catheter Shaft Length о
Gradient Marking Position ●
Gradient Marking Leqibility .
Gradient Marking Durability
Trackability ●
Sheath Compatibility .
Flushability

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. Reinsertion
Stylet/Refold .
Device Compatibility
Guidewire Compatibility .
Balloon Distensibility .
Inflation
. Deflation
Balloon Rated Burst Pressure .
. Leak
Burst Mode ●
. Fatique
Balloon Fatique in a Stent/Stent Graft .
. Balloon Burst in a Stent/Stent Graft
. Balloon Removal from a Stent/Stent Graft
. Balloon to Shaft Tensile
. Catheter Elongation
Hub to Shaft Tensile ●
. Tip Taper
. Tip Radiopacity
Marker Band Radiopacity ●
Marker Band Alignment .
Hub Torque/Hub Stress .
. Packaging
- o Visual Inspection
- Dye Penetration o
- Pouch Tensile o

The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® 035 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.

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Biocompatibility:

To demonstrate substantial equivalence of the subject device, the Ultraverse® 035 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."

Biocompatibility Test	Test Method	Results
Cytotoxicity	MEM Elution Test	PASS
Sensitization	Murine Local LymphNode Assay	PASS
Sensitization	Guinea PigMaximization Test	PASS
Intracutaneous	IntracutaneousInjection Test	PASS
Acute Systemic Toxicity	Systemic InjectionTest	PASS
Hemocompatibility	In Vivo Hemolysis	PASS
	Thrombogenicity	PASS
	ComplementActivation	PASS
USP Pyrogen Study	Material MediatedPyrogenicity	PASS

The results from these tests demonstrate that the subject device, the Ultraverse® 035 PTA Dilatation Catheter, is comparable to the predicate device and that it is considered safe and biocompatible for its intended use.

Conclusions:

The subject device, the Ultraverse® 035 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® 035 PTA Dilatation Catheter is substantially equivalent to the legally marketed predicate devices.

Image /page/8/Picture/9 description: The image shows the word "BARD" in a stylized, bold font. The letters are all capitalized and connected, giving the word a solid, block-like appearance. The font is sans-serif, and the overall design is clean and modern.

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).