The UltraScore Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, and stent grafts in the peripheral vasculature.

Device Description

The ULTRASCORE™ Focused Force PTA Balloon consists of a flexible, over-the-wire (OTW) catheter shaft with a semi-compliant balloon fixed at the distal end. 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 radiopaque marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. Two scoring wires, oriented 180° apart, provide focused force upon dilatation. The ULTRASCORE™ Focused Force PTA Balloon is compatible with 0.014" or 0.035" guidewires, as denoted by the product labeling. The distal portion of the 0.014" guidewire compatible catheters is hydrophilically coated. 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 must be removed prior to use. A stylet is placed into the tip of the catheter. These products are not made with natural rubber latex.

AI/ML Overview

This document describes a 510(k) submission for the ULTRASCORE™ Focused Force PTA Balloon (K172571). The device is being submitted as substantially equivalent to a previously cleared device, also named ULTRASCORE™ Focused Force PTA Balloon (K163420).

Key Finding: This submission is for a device that is almost identical to its predicate, with the only change being a new formulation of PTFE on the scoring wires due to supplier discontinuance of the existing PTFE. Therefore, the "study" described is a series of non-clinical, in vitro tests to confirm the new formulation does not negatively impact performance or safety. There is no clinical study involving human participants described in this summary.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Non-Clinical Performance
Reinsertion	Met All Predetermined Acceptance Criteria. (Specific criteria not detailed in this summary, but implies mechanical integrity and functionality after reinsertion.)
Sheath Compatibility	Met All Predetermined Acceptance Criteria. (Specific criteria not detailed, but implies the device can be safely and effectively used with specified introducer sheaths without damage or hindrance.)
Biocompatibility (ISO 10993-1:2009)
Cytotoxicity	Met All Predetermined Acceptance Criteria. (Implies the device materials are not toxic to cells.)
Sensitization	Met All Predetermined Acceptance Criteria. (Implies the device materials do not cause allergic reactions.)
Intracutaneous Reactivity	Met All Predetermined Acceptance Criteria. (Implies the device materials do not cause irritation when in contact with tissue.)
Acute Systemic Toxicity	Met All Predetermined Acceptance Criteria. (Implies the device materials do not cause harmful effects via systemic exposure.)
Hemocompatibility	Met All Predetermined Acceptance Criteria. (Implies the device materials are compatible with blood and do not cause adverse blood reactions.)
Material Mediated Pyrogenicity	Met All Predetermined Acceptance Criteria. (Implies the device materials do not cause fever.)
Thrombogenicity	Met All Predetermined Acceptance Criteria. (Implies the device materials do not promote the formation of blood clots.)

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

Sample Size: The document does not specify the exact number of devices or samples used for each test. It refers to "the subject device" and its performance in various in vitro tests.
Data Provenance: The tests are described as in vitro. No human or clinical data is mentioned, so there is no country of origin or retrospective/prospective designation in this context. The testing was conducted internally as part of design verification and validation by the manufacturer, C.R. Bard, Inc. (Tempe, Arizona, USA).

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

This question is not applicable to this submission. The "ground truth" for these in vitro engineering and biocompatibility tests is based on established scientific principles, standardized test methods (e.g., ISO 10993-1:2009 for biocompatibility), and internal engineering specifications/risk assessments, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., image reading). The described tests are objective, measurable in vitro tests.

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 question is not applicable. No MRMC study was performed as this is a medical device (PTA Balloon), not an AI-powered diagnostic imaging device.

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

This question is not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the non-clinical and biocompatibility testing is based on:
- Applicable standards (e.g., ISO 10993-1:2009).
- FDA Guidance Documents on non-clinical testing.
- Internal Risk Assessment procedures.
- Predetermined acceptance criteria derived from these standards and assessments.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This question is not applicable. No training set exists.

Summary

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Public Health Service

Image /page/0/Picture/2 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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping human profiles.

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

September 22, 2017

C.R. Bard, Inc. Mr. Jonathan Holmes Regulatory Affairs Associate 1625 W 3rd St Tempe, Arizona 85281

Re: K172571

Trade/Device Name: UltraScore Focused Force PTA Balloon Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: August 25, 2017 Received: August 28, 2017

Dear Mr. Holmes:

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

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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 contact the Division of Industry and Consumer Education (DICE) 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" (21 CFR 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 (DICE) 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,

Kenneth J. Cavanaugh -S

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) K172571

Device Name UltraScore Focused Force PTA Balloon

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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ULTRASCORE™ Focused Force PTA Balloon

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:

Bard Peripheral Vascular, Inc 1625 West 3rd Street Tempe, Arizona 85281

Phone: 480-350-6161 Fax: 480-449-2546

Contact Person: Jonathan Holmes, Regulatory Affairs Associate Date of Submission: August 24, 2017

Subject Device Name:

Name of Device:	ULTRASCORE™ Focused Force PTA Balloon
Product Code:	PNO
Classification Name:	Catheter, Percutaneous, Cutting/Scoring
Regulatory Class:	Class II
Regulation Number:	21 CFR 870.1250
Predicate Device:
Name of Device:	ULTRASCORE™ Focused Force PTA Balloon(K163420, Cleared June 14, 2017)
Product Code:	PNO
Classification Name:	Catheter, Percutaneous, Cutting/Scoring
Regulatory Class:	Class II

Regulation Number: 21 CFR 870.1250

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Device Description:

Attribute	ULTRASCORE™ Focused Force PTA Balloon
Balloon Diameter (mm)	2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0
Balloon Length (cm)	20, 40, 60, 80, 100, 120, 150, 200, 250, 300
Catheter Shaft Length (cm)	40, 75, 100, 130, 150
.014" Platform Introducer SheathCompatibility	4F, 5F
.035" Platform Introducer SheathCompatibility	5F, 6F

Indications for Use of Device:

The ULTRASCORE™ Focused Force PTA Balloon is intended to dilate stenoses in the illac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, self-expanding stents, and stent qrafts in the peripheral vasculature.

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Comparison of Indications for Use to Predicate Device:

The indications for use statement for the ULTRASCORE™ Focused Force PTA Balloon is identical to that of the predicate device, and therefore does not raise any new issues of safety and effectiveness. Therefore, the subject device, the ULTRASCORE™ Focused Force PTA Balloon, is substantially equivalent to the predicate device.

Technological Comparison to Predicate Devices:

The ULTRASCORE™ Focused Force PTA Balloon is identical to the predicate device, the ULTRASCORE™ Focused Force PTA Balloon (clearance to market via K163420 on June 14, 2017) in the following ways:

Same intended use ●
o Same indications for use
o Same target population
o Same operating principle
Same fundamental scientific technology o
. Same sterility assurance level and method of sterilization

The following change has been made between the subject device and the predicate device:

A new formulation of PTFE on the scoring wires has been qualified due to supplier . discontinuance of existing PTFE.
Image /page/5/Picture/15 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The font is simple and modern, and the overall design is clean and professional. The image is likely a logo or branding element for a company or product named Bard.

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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:

. Reinsertion
Sheath Compatibility .

The following in vitro biocompatibility testing was conducted in accordance with ISO 10993-1: 2009

Cytotoxicity
o Sensitization
o Intracutaneous Reactivity
o Acute Systemic Toxicity
o Hemocompatibility
o Material Mediated Pyrogenicity
o Thrombogenicity

Conclusions:

The subject device, the ULTRASCORE™ Focused Force PTA Balloon, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The ULTRASCORE™ Focused Force PTA Balloon is substantially equivalent to the legally marketed predicate device, ULTRASCORE™ Focused Force PTA Balloon.

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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).