ATLAS GOLD PTA DILATATION CATHETER

K122984 · C.R. Bard, Inc. · LIT · Oct 22, 2012 · Cardiovascular

Device Facts

• Record ID: K122984
• Device Name: ATLAS GOLD PTA DILATATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Oct 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Atlas Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Device Story

Over-the-wire PTA dilatation catheter with fixed distal balloon; designed for consistent diameter/length at high pressures. Features radiopaque markers for placement, atraumatic tip for stenosis navigation, and dual luer-lock hubs for inflation and guidewire lumens. Compatible with 0.035" guidewires. Used by physicians in clinical settings for peripheral vascular interventions. Includes profile-reducing sheath and re-wrapping tool. Provides mechanical dilatation of stenotic lesions or stent expansion; benefits patient by restoring vessel patency.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only, including dimensional verification, mechanical integrity (burst, fatigue, tensile), and biocompatibility testing (cytotoxicity, sensitization, reactivity, toxicity, hemocompatibility, pyrogenicity).

Technological Characteristics

Non-compliant balloon catheter; 0.035" guidewire compatible; 80/120 cm lengths. Materials biocompatible per ISO 10993-1. Radiopaque markers for visualization. Mechanical inflation/deflation. Sterilized product. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty of iliac arteries, treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae, or post-dilatation of stents/stent grafts in peripheral vasculature. 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

• Atlas® PTA Balloon Dilatation Catheter (K120971)

Submission Summary (Full Text)

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K122984

Page 168

# Atlas Gold PTA Dilatation Catheter 510(k) Summary 21 CFR 807.92

OCT 2 2012

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<br>1625 West 3rd Street<br>Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
| Phone: | 480-303-2752 |
| Fax: | 480-449-2546 |
| Contact: | Jennifer Logvin, Senior Regulatory Affairs Specialist |
| Date: | July 20, 2012 |

### Subject Device Name:

| Device Trade Name: | Atlas Gold PTA Dilatation Catheter |
|-----------------------|-------------------------------------------------------------------|
| Common or Usual Name: | Percutaneous Catheter (21 CFR 870.1250.<br>Product Code DQY, LIT) |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |

# Predicate Device:

- Atlas® PTA Balloon Dilatation Catheter (K120971, cleared April 19, 2012) .
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### Device Description:

The Atlas Gold PTA Dilatation Catheter is 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. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The over the wire catheter is compatible with 0.035" guidewire and is available in 80 and 120 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 re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.

| Attribute | Atlas Gold PTA Dilatation Catheter<br>Product Offering |
|---------------------------------------------------------------------------------------|--------------------------------------------------------|
| Balloon Diameter (mm) | 12, 14, 16, 18, 20, 22, 24, 26 |
| Balloon Length (cm) | 2, 4, 6 |
| Catheter Shaft Lengths (cm) | 80, 120 |
| Introducer Sheath Compatibility<br>Compatible Balloon Diameters and Lengths (mm x cm) | 7F: 12 2,4,6 |
| | 14 2,4 |
| | 8F: 14 6 |
| | 16 2,4,6 |
| | 18 2,4 |
| | 9F: 18 6<br>20 2,4 |
| | 10F: 22 2,4<br>24 2,4<br>12F: 26 2,4 |

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# Indications for Use of Device:

The Atlas Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

### Comparison of Indications for Use to Predicate Device:

The indication for use statement for the Atlas Gold PTA Dilatation Catheter is identical to that of the predicate device, the Atlas PTA Balloon Dilatation Catheter.

#### Technological Comparison to Predicate Device:

The Atlas Gold PTA Dilatation Catheter has the following similarities to the predicate device:

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

#### Performance Data:

To demonstrate substantial equivalence of the subject device, the Atlas Gold 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 Working Length O

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- Catheter Shaft Outer Diameter o
- Catheter Shaft Inner Diameter o
- o Catheter Shaft Length
- Media Interaction .
- . Equipment Interface
- . Sheath Compatibility
- Rated Burst Pressure .
- Balloon Burst Mode ●
- Catheter Shaft Leaks .
- Catheter Shaft Burst .
- . Fatigue
- . Balloon Nominal Pressure
- Balloon Distensibility .
- . Inflation Time
- Deflation Time .
- Balloon to Shaft Tensile .
- Catheter Shaft Elongation .
- . Hub to Shaft Tensile
- . Tip Tensile
- Tip Morphology .
- Trackability (Flexibility and Kink) .
- Tip Visibility .
- Catheter Shaft Visibility .
- Marker Band Visibility .
- Marker Band Alignment .
- Balloon Burst Strength in a Stent/Stent Graft .
- Fatigue in a Stent/Stent Graft .
- Balloon Removal from a Stent/Stent Graft .
- t Visual Inspection of Packaging
- Dye Penetration .
- Pouch Tensile Strength .

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The results from these tests demonstrate that the technological characteristics and performance criteria of the Atlas Gold PTA Dilatation Catheter is comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the similar intended use.

#### Biocompatibility:

To demonstrate substantial equivalence of the subject device, the Atlas Gold PTA Dilatation Catheter to the predicate device, the following biocompatibility testing was performed in accordance ISO 10993-1:2009, "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."

- . Cytotoxicity
- Sensitization .
- Intracutaneous Reactivity .
- Acute Systemic Toxicity .
- Hemocompatibility .
- Hemolysis, In Vivo Thrombogenicity, Complement Activation .
- . Material Mediated Pyrogenicity

The results from these tests demonstrate that the subject device, the Atlas Gold 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 Atlas Gold 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 Atlas Gold PTA Dilatation Catheter is substantially equivalent to the legally marketed predicate device. the Atlas PTA Balloon Dilatation Catheter.

Image /page/4/Picture/16 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and clear appearance. The overall design is simple and straightforward, focusing on the legibility of the word.

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

OCT 22 2012

Bard Peripheral Vascular, Inc. C/O Mr. Mark Job Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K122984

Trade/Device Name: Atlas GOLD PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: September 25, 2012 Received: September 26, 2012

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

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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerety yours,

C

Bram 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):

Device Name: Atlas Gold PTA Dilatation Catheter

Indications for Use: The Atlas Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Prescription Use_X (Part21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division Sign-Off | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| K Number | K122984 |

Image /page/7/Picture/11 description: The image shows the text "Bard Peripheral Vascular, Inc.". The text is in bold and is black. The background is white.