ULTRASCORE Focused Force PTA Balloon

K172571 · C. R. Bard · PNO · Sep 22, 2017 · Cardiovascular

Device Facts

• Record ID: K172571
• Device Name: ULTRASCORE Focused Force PTA Balloon
• Applicant: C. R. Bard
• Product Code: PNO · Cardiovascular
• Decision Date: Sep 22, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

The UltraScore Focused Force PTA Balloon is an over-the-wire (OTW) catheter featuring a semi-compliant balloon and two scoring wires oriented 180° apart. These wires concentrate dilatation force to treat stenoses in peripheral arteries and arteriovenous dialysis fistulae. The device is used by clinicians in a clinical setting to dilate vessels or post-dilate stents/stent grafts. The clinician advances the catheter to the target lesion using a 0.014" or 0.035" guidewire; the scoring wires provide focused force during inflation to facilitate vessel opening. The device includes radiopaque markers for placement, an atraumatic tip, and a protective sheath. It is not made with natural rubber latex. The device benefits patients by restoring blood flow in obstructed peripheral vessels.

Clinical Evidence

Bench testing only. Performance evaluated via in vitro testing (reinsertion, sheath compatibility) and biocompatibility testing per ISO 10993-1:2009, including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, material-mediated pyrogenicity, and thrombogenicity.

Technological Characteristics

Over-the-wire (OTW) catheter with semi-compliant balloon and two 180°-opposed scoring wires. Materials include PTFE-coated scoring wires. Compatible with 0.014" or 0.035" guidewires. Radiopaque markers for positioning. Hydrophilic coating on distal portion of 0.014" models. Female luer lock hub. Sterilized. No natural rubber latex.

Indications for Use

Indicated for patients requiring dilation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Also indicated for post-dilatation of balloon-expandable stents, self-expanding stents, and stent grafts in peripheral vasculature.

Regulatory Classification

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.

Predicate Devices

• ULTRASCORE™ Focused Force PTA Balloon (K163420)

Submission Summary (Full Text)

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Public Health Service

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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: [phone] Fax: [phone]

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 |
| <b>Predicate Device:</b> | |
| Name of Device: | ULTRASCORE™ Focused Force PTA Balloon<br>(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:

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.

| 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 Sheath<br>Compatibility | 4F, 5F |
| .035" Platform Introducer Sheath<br>Compatibility | 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.

Image /page/4/Picture/8 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be a solid, dark color, possibly black or a dark gray. The font style is geometric and modern, with clean lines and a uniform thickness throughout each letter.

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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.
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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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