Ultraverse® 014 and Ultraverse® 018 PTA Balloon Dilatation Catheters are recommended for use in percutaneous trasluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral, and peroneal arteries. These catheters are not for use in coronary arteries.

Device Description

The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter is a small vessel balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100 mm and greater, two radiopaque markers are positioned on the distal portion of the balloon and one radiopague marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis as well as a hydrophilic coating. The coaxial lumen, over the wire catheter is compatible with an 0.014" guidewire for the 014 platform, and compatible with an 0.014" or 0.018″ guidewire on the 018 platform, and is available in 75, 90, 100, 150 and 200 cm working lengths. 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 guidewire lumen. 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. This product is not manufactured with any latex.

The GeoAlign® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GeoAlign® markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GeoAlign® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GeoAlign® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GeoAlign® Marking System.

AI/ML Overview

The provided document is a 510(k) summary for the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study for novel performance claims.

Therefore, much of the requested information regarding acceptance criteria for device performance in clinical settings and studies proving said performance in a context of a novel claim (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) is not applicable or not explicitly detailed within this type of regulatory submission. This submission primarily relies on non-clinical (bench) testing to show that the new device's modifications do not alter its safety or efficacy compared to the predicate.

Here's an analysis of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists numerous in vitro tests performed (Page 6) and states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters are substantially equivalent to the predicate device." It also states, "The subject device...met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, the specific acceptance criteria values (e.g., minimum tensile strength, maximum burst pressure deviation) and the numerical results for each test are not provided in this 510(k) summary. The document only confirms that the device met these criteria.

List of in vitro tests performed (serving as performance aspects tested):

Catheter Shaft Length
Balloon Working Length
Marker Band Alignment
Balloon OD at OP
Balloon Rated Burst Pressure, Leak, & Burst Mode
Crossing Profile
Sheath Compatibility
Shaft Outer Diameter
Balloon Compliance / Distensibility
Fatigue
Hub to Shaft Tensile
Guidewire Compatibility
Inflation
Deflation
Balloon to Shaft Tensile
Catheter Elongation
Flushability
GeoAlign® Marking Positions
GeoAlign® Marking Durability
GeoAlign® Marking Legibility
Trackability
Reinsertion
Kink

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the in vitro tests. This document doesn't involve human clinical test sets in the way that AI/diagnostic devices often do.
Data Provenance: Not applicable in the context of clinical data for performance assessment. The tests are in vitro (bench tests).

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

Not applicable. The "ground truth" here is derived from engineering specifications, industry standards, and the performance of the predicate device, not expert interpretation of clinical data.

4. Adjudication method for the test set:

Not applicable. This is not a clinical study involving human readers or adjudicators.

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:

No. This is a medical device for angioplasty, not an AI or diagnostic imaging device.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For the in vitro tests, the "ground truth" or reference for comparison would be engineering specifications, design requirements, and performance data from the predicate device (K121856). The goal is to show the new device performs equivalently or acceptably within these established parameters.
For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1).

8. The sample size for the training set:

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable.

In summary:

This 510(k) submission is for a modified version of an existing PTA balloon dilatation catheter. The primary method of demonstrating "acceptance criteria" is through a comprehensive series of non-clinical (bench) tests to show that the new device remains substantially equivalent to its predicate. The document states that these tests were "performed on the subject device" and "met all predetermined acceptance criteria," but it does not provide the specific numerical acceptance criteria or the raw results of these tests. It leverages previously established predicate device data and existing standards for certain tests and biocompatibility.

Summary

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October 3, 2019

Bard Peripheral Vascular, Inc. % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K192318

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 Product Code: LIT Dated: August 23, 2019 Received: August 26, 2019

Dear Mr. Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters

Indications for Use (Describe)

	Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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Ultraverse® 014 and 018 PTA Balloon 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:	480-449-2587
Fax:	480-449-2546
Contact:	Andrew Quach, Regulatory Affairs Associate
Date:	September 20, 2019

Subject Device Name:

Device Trade Name:	Ultraverse® 014 and 018 PTA Balloon DilatationCatheters
Common or Usual Name:	Catheter, Angioplasty, Peripheral, Transluminal
Product Code:	LIT
Classification:	Class II
Review Panel:	Cardiovascular
Regulation Number:	21 CFR 870.1250

Predicate Device:

Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters (K121856; cleared July 11, 2012)

Reference Device:

. Ultraverse® 035 PTA Balloon Dilatation Catheters (K142261; cleared September 24, 2014)

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Device Description:

Attribute	Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter
Balloon Diameter (mm)	1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9
Balloon Length (mm)	20, 40, 60, 80, 100, 120, 150, 200, 220, 250, 300
Catheter Shaft Length (cm)	75, 90, 100, 130, 150, 200
.014" Platform Introducer	4F, 5F
Sheath Compatibility
.018" Platform Introducer	4F, 5F, 6F
Sheath Compatibility

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Indications for Use of Device:

The Ultraverse® 014 and Ultraverse ® 018 PTA Balloon Dilatation Catheters are recommended for use in percutaneous transluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral and peroneal arteries. These catheters are not for use in coronary arteries.

Comparison of Indications for Use to Predicate Device:

The indications for use statement for the subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter, are the same as compared to the predicate device. Therefore, the subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter, is substantially equivalent to the predicate device.

Technological Comparison to Predicate Devices:

The subject Ultraverse® 014 and 018 PTA Dilatation Balloon Catheters have the following similarities to the Ultraverse® 014 and 018 PTA Balloon Catheters predicate device (K121856 - cleared on July 11, 2012):

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

The subject device, Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters has the following differences when compared to the predicate device:

Increased radiopaque marker bands lengths and additional marker band . added to the distal end of the balloon for balloon lengths 100mm or longer
. GeoAlign® Marking System added along the shaft of the catheter
Opaque colorant used instead of clear shaft color .

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Strain relief on Ultraverse® 014 platform changed to blue color to . differentiate product
. 0.014" guidewire compatibility for Ultraverse®018 platform
Extension of product size offering .
. Extended 4Fr compatibility range

Performance Data:

To demonstrate substantial equivalence of the subject device to the predicate device, its technological characteristics and performance criteria 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:

Catheter Shaft Length .
Balloon Working Length .
Marker Band Alignment
Balloon OD at OP .
Balloon Rated Burst Pressure, Leak, . & Burst Mode
Crossing Profile ●
. Sheath Compatibility
. Shaft Outer Diameter
Balloon Compliance / Distensibility ●
. Fatigue
. Hub to Shaft Tensile
Guidewire Compatibility .
Inflation .
. Deflation
Balloon to Shaft Tensile .
Catheter Elongation .
. Flushability
GeoAlign® Marking Positions
GeoAlign® Marking Durability .
GeoAlign® Marking Legibility .
Trackability ●
. Reinsertion
Kink .

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

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The following tests performed for the predicate device are leveraged as applicable tests for the subject device for components which remained unchanged from the predicate device:

Radiopacity .
. Tip Taper / Tip Length
. Stylet / Refold
. Hub Torsion / Hub Stress
Device Compatibility .
. Packaging Integrity
- Packaging Visual Inspection o
- Dye Penetration o
- Pouch Seal Strength o

Biocompatibility:

To demonstrate substantial equivalence of the subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter to the predicate device, the following biocompatibility testing was performed in accordance ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.

. Cytotoxicity
Sensitization .
Intracutaneous Reactivity .
. Acute Systemic Toxicity
Material Mediated Pyrogenicity .
. Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity)
Chemical Characterization .

The results from these tests demonstrate that the subject device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters, is comparable to the predicate device and that it is considered safe and biocompatible for its intended use.

Conclusions:

The subject device, the Ultraverse® 014 & 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 & 018 PTA Balloon Dilatation Catheters is substantially equivalent to the legally marketed predicate device.

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).