Ultraverse 035 PTA Balloon Dilatation Catheter

K142261 · Bard Peripheral Vascular, Inc. · LIT · Sep 24, 2014 · Cardiovascular

Device Facts

• Record ID: K142261
• Device Name: Ultraverse 035 PTA Balloon Dilatation Catheter
• Applicant: Bard Peripheral Vascular, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Sep 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

Ultraverse 035 PTA Dilatation Catheter is an over-the-wire (OTW) semi-compliant balloon catheter; features radiopaque markers for balloon placement and atraumatic tip; includes GeoAlign marker bands at 1cm increments for geographic alignment and procedure efficiency. Device is used by physicians in clinical settings for peripheral vascular interventions. Input: manual inflation via inflation lumen; output: mechanical dilation of stenoses or stent expansion. Benefits: restores vessel patency; facilitates stent placement/optimization. Device includes protective sheath, stylet for rewrap, and rewrapping tool. Not made with natural rubber latex.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via dimensional verification, trackability, sheath compatibility, flushability, reinsertion, balloon distensibility, inflation/deflation, rated burst pressure, fatigue testing, tensile testing, and radiopacity. Biocompatibility testing performed per ISO 10993-1:2010 (cytotoxicity, sensitization, intracutaneous, systemic toxicity, hemocompatibility, pyrogenicity) with all tests passing.

Technological Characteristics

Semi-compliant balloon catheter; OTW design; compatible with .035" guidewires. Materials: similar to predicate. Features: radiopaque markers, GeoAlign marker bands. Sterilization: standard method (not specified). Software: none.

Indications for Use

Indicated for patients requiring dilation of peripheral artery stenoses, treatment of obstructive lesions in native or synthetic AV fistulae, re-expansion of iliac artery endoluminal stent graft elements, and post-dilatation of peripheral balloon-expandable or self-expanding stents. Contraindicated for use in coronary arteries.

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

• Rival PTA Balloon Dilatation Catheter (K120722)

Submission Summary (Full Text)

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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 [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" (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 [phone] or [phone] 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)

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.

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)

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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: [phone]

- 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,<br>Product Code LIT) |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |

#### Predicate Device:

- Rival PTA Balloon Dilatation Catheter (K120722, cleared April 19, 2012) .
Image /page/3/Picture/16 description: The image shows the word "BARD" in a stylized, all-caps font. The letters are bold and 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. The overall design is clean and minimalist, focusing on the word itself.

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#### 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.

| Attribute | Ultraverse® 035 PTA Dilatation Catheter<br>Product 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<br>(cm) | 40, 75, 100, 130, 150 | |
| Introducer Sheath<br>Compatibility | <b>5F:</b> 3.0 | 10, 20, 40, 60, 80, 100, 120, 150, 200, 250, 300 |
| Compatible Balloon<br>Diameters and Lengths<br>(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 Catheter<br>Product 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.

Image /page/7/Picture/30 description: The image shows the word "BARD" in a stylized, bold font. The letters are all capitalized and connected, giving the word a unified appearance. The font is sans-serif and has a modern, geometric look.

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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 Lymph<br>Node Assay | PASS |
| Sensitization | Guinea Pig<br>Maximization Test | PASS |
| Intracutaneous | Intracutaneous<br>Injection Test | PASS |
| Acute Systemic Toxicity | Systemic Injection<br>Test | PASS |
| Hemocompatibility | In Vivo Hemolysis | PASS |
| | Thrombogenicity | PASS |
| | Complement<br>Activation | PASS |
| USP Pyrogen Study | Material Mediated<br>Pyrogenicity | 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.