ATLAS PTA BALLOON DILATATION CATHETER

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows a handwritten number, which appears to be "K120971". The number is written in black ink on a white background. The handwriting is somewhat stylized, with the "K" having a distinct shape and the "0" being a perfect circle. Page 1 # Atlas® PTA Balloon 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<br>1625 West 3rd Street<br>Tempe, Arizona 85281 | |------------|-------------------------------------------------------------------------------| |------------|-------------------------------------------------------------------------------| Phone: 480-379-2848 480-449-2546 Fax: Megan Brown, Regulatory Affairs Associate Contact: Date March 12, 2012 #### Subject Device Name: | Device Trade Name: | Atlas® PTA Balloon Dilatation Catheter | |-----------------------|----------------------------------------------------------------------| | Common or Usual Name: | Percutaneous Catheter (21 CFR 870.1250,<br>Product Code DQY and LIT) | | Classification: | Class II | | Classification Panel: | Cardiovascular | ## Predicate Devices: - Atlas® PTA Balloon Dilatation Catheter (K052236; cleared August 23, ● 2005) - Vaccess® PTA Dilatation Catheter (K111850; cleared July 13, 2011) . Image /page/0/Picture/18 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and modern appearance. The overall design is simple yet impactful, making the word easily readable. Bard Peripheral Vascular, Inc. {1}------------------------------------------------ #### Device Description: The Atlas® PTA Balloon Dilatation Catheter is a high performance 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" guidewires and is available in 75 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 PTA Balloon Dilatation<br>Catheter Product Offering | |------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Balloon Diameter (mm) | 12, 14, 16, 18, 20, 22, 24, 26 | | Balloon Length (cm) | 2, 4, 6 | | Catheter Shaft Lengths (cm) | 75, 120 | | Introducer Sheath<br>Compatibility<br>(compatible balloon sizes,<br>mm x cm) | 7F: (12x 2,4,6; 14x 2,4)<br>8F: (14x 6; 16x 2,4,6; 18x 2,4)<br>9F: (18x 6; 20x 2,4)<br>10F: (22x 2,4; 24x 2,4)<br>12F: (26x 2,4) | #### Indications for Use of Device: Atlas® PTA Balloon Dilatation Catheters are indicated for use in Percutaneous Transluminal Angioplasty (PTA) 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. Bard Peripheral Vascular, Inc. {2}------------------------------------------------ ### Comparison of Indications for Use to Predicate Devices: The modified indications for use statement for the Atlas® PTA Balloon Dilatation Catheter does not raise any new issues of safety and effectiveness when compared to the predicate devices, the Atlas® PTA Balloon Dilatation Catheter and the Vacces® PTA Dilatation Catheter, as demonstrated through the risk analysis process. As such, the subject device, the Atlas® PTA Balloon Dilatation Catheter, is substantially equivalent to the predicate devices, the Atlas® PTA Balloon Dilatation Catheter and the Vacces® PTA Dilatation Catheter. #### Technological Comparison to Predicate Devices: The Atlas® PTA Balloon Dilatation Catheter has the following similarities to the predicate devices: - . Same intended use (both predicates) - . Similar indications for use (combination of both predicates) - Same target population (both predicates) - . Same fundamental scientific technology (both predicates) - . Same operating principle (both predicates) - . Same packaging materials and configuration (Atlas® PTA Balloon Dilatation Catheter) - . Same sterility assurance level and method of sterilization (both predicates) #### Performance Data: To demonstrate the substantial equivalence of the subject device, the Atlas® PTA Balloon Dilatation Catheter, to the predicate devices, the technological characteristics and performance criterion were evaluated. Using FDA Guidance Documents on nonclinical testing of medical devices and internal Risk Assessment procedures, the following additional in vitro tests were performed: - . Puncture Resistance - Robustness . - . Balloon Removal {3}------------------------------------------------ The results from these tests demonstrate that the technological characteristics and performance criteria of the subject Atlas® PTA Balloon Dilatation Catheter are comparable to the predicate devices 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 Atlas® PTA Balloon Dilatation Catheter, met all the predetermined acceptance criteria of design verification and validation activities for the modified indications for use statement, as specified by applicable standards, quidance, test protocols and/or customer inputs. The Atlas® PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Atlas® PTA Balloon Dilatation Catheter and the Vaccess® PTA Dilatation Catheter. {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 APRE 1 9r 2012 Bard Peripheral Vascular, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313 Re: K120971 Trade/Device Name: Atlas PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: LIT, DOY Dated: March 30, 2012 Received: April 2, 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. Ilsting 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. {5}------------------------------------------------ #### Page 2 - Mr. Mark Job 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 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/CDRH0ffices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. M.A. Killelea Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): K12097 | Device Name: Atlas® PTA Balloon Dilatation Catheter Indications for Use: Atlas® PTA Balloon Dilatation Catheters are indicated for use in Percutaneous Transluminal Angioplasty (PTA) 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 (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) zgkille (Division Sign-Division of Cardiovascular Devices 510(k) Number Image /page/6/Picture/14 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font style gives the word a blocky, almost three-dimensional appearance. Bard Peripheral Vascular, Inc.