The Highlander™ 014 PTA Balloon Dilatation Catheted for use in percutaneous transluminal angioplasty (PTA) of the peripheral vasculature, including femoral, popliteal and renal arteries. This device is also indicated for post-dilatation of balloon expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

Device Description

The Highlander™ 014 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. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100mm and greater, two radiopague 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 balloon. The catheters include an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. A silicone-based, hydrophobic coating is present on the distal segment of the shaft and balloon. Highlander™ 014 is compatible with 0.014" guidewires. The proximal portion of the catheters include 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. These products are not made with natural rubber 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 text is a 510(k) summary for the Highlander™ 014 PTA Balloon Dilatation Catheter. This document details the device's characteristics, indications for use, and a comparison to a predicate device to demonstrate substantial equivalence. It is important to note that this document does not contain information about studies related to AI/ML device performance, ground truth establishment, or expert reviews as it is for a physical medical device (balloon catheter).

Therefore, this response will focus on the acceptance criteria and performance data for the physical device as described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various in vitro tests performed to demonstrate substantial equivalence. It does not provide specific numerical acceptance criteria or detailed quantitative performance results for each test. Instead, it states a general conclusion for each category: "The results from these tests demonstrate that the technological characteristics and performance criteria of the Highlander™ 014 PTA Balloon Dilatation Catheter 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." and "met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, based on the categories of tests listed, a general representation of acceptance criteria and reported performance is as follows:

Test Category	Acceptance Criteria (Implicit from "met all predetermined acceptance criteria")	Reported Device Performance
Physical Dimensions	Conformity to specified dimensions (Catheter Length, Tip Length, Balloon Working Length, Balloon OD at OP, Shaft Outer Diameter, Coating Length)	Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device.
Mechanical Performance	Acceptable limits for Marker Band Alignment, Balloon Rated Burst Pressure, Leak, & Burst Mode, Burst in Stent, Crossing Profile, Distensibility, Luer Lock Compatibility, Fatigue, Fatigue in Stent, Hub to Shaft Tensile, Shaft Inner Diameter/Guidewire Compatibility, Inflation, Deflation, Balloon to Shaft Tensile, Tip Tensile, Catheter Elongation, Trackability, Reinsertion, Kink Resistance, Torque Response, Flushability	Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device.
Material Characteristics	Acceptable limits for Particulate matter, Coating Integrity, Visual Inspection (e.g., absence of defects)	Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device.
Labeling/Marking	Accuracy and durability of GeoAlign™ Marking Position, GeoAlign™ Marking Durability, GeoAlign™ Marking Legibility	Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device.
Packaging Integrity	Acceptable performance for Packaging Integrity Visual Inspection, Bubble Emission Leak, Pouch Seal Strength, Heat Seal Visual Inspection	Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device.
Biocompatibility	Conformance to biocompatibility standards (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility)	Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device. The device is not made with natural rubber latex.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample sizes used for each in vitro test. The tests are "in vitro" (performed in a lab setting, not on human or animal subjects). Therefore, there is no data provenance in terms of country of origin or retrospective/prospective nature as would be relevant for clinical studies.

3. Number of Experts and Qualifications

This information is not applicable. The evaluations described are in vitro engineering and materials tests, not clinical studies requiring expert interpretation of diagnostic images or patient outcomes.

4. Adjudication Method

This information is not applicable as there is no mention of a ground truth needing adjudication by human experts in the context of this device's testing.

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

No. This type of study is typically performed for AI-driven diagnostic imaging devices to assess the impact of AI assistance on human reader performance. The Highlander™ 014 PTA Balloon Dilatation Catheter is a physical medical device, not an AI/ML diagnostic tool.

6. Standalone Performance Study

Yes, the in vitro tests conducted on the Highlander™ 014 PTA Balloon Dilatation Catheter can be considered a standalone performance study. These tests evaluated the device's physical and mechanical properties and biocompatibility independent of human use in a clinical setting. The conclusion states that "The subject device, the Highlander™ 014 PTA Balloon Dilatation Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This indicates a standalone assessment of its performance against established benchmarks.

7. Type of Ground Truth Used

The "ground truth" for the in vitro tests would be defined by the technical specifications, industry standards, relevant FDA guidance documents, and internal risk assessment procedures. For example, for physical dimensions, the ground truth is the specified design dimension; for burst pressure, it's the minimum acceptable pressure according to device-specific or industry standards. For biocompatibility tests, the ground truth is the pass/fail criteria established by recognized international standards (e.g., ISO 10993 series).

8. Sample Size for the Training Set

This information is not applicable. The described tests are for a physical medical device and do not involve AI/ML algorithms that require training data.

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

This information is not applicable for the reasons stated in point 8.

Summary

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January 20, 2023

C.R. Bard, Inc. Andrew Quach Senior Regulatory Affairs Specialist 1625 West 3rd St Tempe, Arizona 85281

Re: K223177

Trade/Device Name: Highlander™ 014 PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT Dated: December 21, 2022 Received: December 22, 2022

Dear Andrew Quach:

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.

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

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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 (QS) 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 W.
O'connell -S

Digitally signed by Gregory W.
O'connell -S
Date: 2023.01.20 16:16:10 -05'00'

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) K223177

Device Name Highlander™ 014 PTA Balloon Dilatation Catheter

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)

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Highlander™ 014 PTA Balloon Dilatation Catheter

510(k) Summary - K223177 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:	602-830-5680
Fax:	480-449-2546
Contact:	Andrew Quach, Senior Regulatory Affairs Specialist
Date:	January 20, 2023

Subject Device Name:

Name of Device	: Highlander™ 014 PTA Balloon Dilatation Catheter
Common or Usual Name	: Catheter, Angioplasty, Peripheral, Transluminal
Classification Pro Code	: LIT
Regulatory Class	: Class II
Regulation Number	: 21 CFR 870.1250

Predicate Device:

510(k) Number : K192318 : Ultraverse™ 014 and 018 PTA Balloon Dilatation Catheters Name of Device Common or Usual Name: Catheter, Angioplasty, Peripheral, Transluminal Classification Pro Code : LIT Regulatory Class : Class II Regulation Number : 21 CFR 870.1250

Reference Device:

510(k) Number	: K072283
Name of Device	: Dorado™ PTA Balloon Dilatation Catheter
Common or Usual Name	: Catheter, percutaneous
Classification Pro Code	: DQY, LIT
Regulatory Class	: Class II
Regulation Number	: 21 CFR 870.1250

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Device Description:

Indications for Use:

The Highlander™ 014 Balloon Dilatation Catheter is indicated for use in percutaneous transluminal angioplasty (PTA) of the peripheral vasculature, including femoral, popliteal, infra-popliteal and renal arteries. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

Technological Comparison to Predicate Devices:

The subject Highlander™ 014 PTA Balloon Dilatation Catheter has the following similarities to the Ultraverse™ 014 and 018 PTA Balloon Dilatation Catheters predicate device (K192318 - cleared on October 3, 2019):

. Same intended use
o Similar indications for use
. Same target population

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Same operating principle
Same fundamental scientific technology
. Same sterility assurance level
. Same method of sterilization

The subject device, Highlander™ 014 PTA Balloon Dilatation Catheter has the following differences when compared to the predicate device:

Incorporation of non-compliant fiber balloon
. Change from hydrophilic coating to hydrophobic/silicone coating
Change in colorant used on outer tubing .
Alternative hub & strain relief designs .

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:

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. Visual Inspection
Catheter Length ●
Tip Length
Balloon Working Length ●
Marker Band Alignment o
Balloon OD at OP o
Balloon Rated Burst Pressure, Leak, & Burst Mode
Burst in Stent
. Crossing Profile
Sheath Compatibility
o Shaft Outer Diameter
Distensibility
Luer Lock Compatibility ●
. Fatique
Fatigue in Stent
Hub to Shaft Tensile o
Shaft Inner Diameter/ Guidewire Compatibility
Inflation
Deflation .
. Particulate
Coating Integrity ●
Coating Length ●
Balloon to Shaft Tensile ●
Tip Tensile
Catheter Elongation .
. Flushability
GeoAlign™ Marking Position
GeoAlign™ Marking Durability ●
GeoAlign™ Marking Legibility
. Trackabilitv
Reinsertion ●
Kink Resistance ●
Torque Response ●
Packaging Integrity Visual Inspection ●
Bubble Emission Leak .
Pouch Seal Strength ●
Heat Seal Visual Inspection ●
Cytotoxicity ●
Sensitization .
Intracutaneous Reactivity o
Acute Systemic Toxicity ●
Material Mediated Pyrogenicity
Hemocompatibility ●

The results from these tests demonstrate that the technological characteristics and performance criteria of the Highlander™ 014 PTA Balloon Dilatation Catheter 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.

Conclusions:

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

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).