BARD PTV DILATATION CATHETER

{0}------------------------------------------------ K122367 #### Bard PTV Dilatation Catheter 2 2012 NOV 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: 480-379-2841 Fax: 480-449-2546 Contact: Erin Fox, Regulatory Affairs Specialist II August 1, 2012 Date # Subject Device Name: | Device Trade Name: | Bard PTV Dilatation Catheter | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------| | Common or Usual Name: | Pulmonary (Pulmonic) Valvuloplasty<br>Catheters/Percutaneous Valvuloplasty<br>Catheter (21 CFR 870.1250, Product Code<br>OMZ) | | Classification: | Class II | Classification Panel: Cardiovascular #### Predicate Devices: - Mullins-X PTV Catheter (K102473; cleared December 9, 2010) . - Atlas® PTA Balloon Dilatation Catheter (K120971, cleared April 19, 2012) . Image /page/0/Picture/18 description: The image shows the word "BARD" in a stylized, blocky font. The letters are outlined in black, giving them a bold and distinct appearance. The font style is geometric and somewhat angular, making the word visually striking. {1}------------------------------------------------ ### Device Description: (T.tre Bard PTV 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 noncompliant, 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 valve. The over the wire catheter is compatible with 0.035" guidewire and is available in 75 and 100 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. | Attribute | Bard PTV Dilatation Catheter<br>Product Offering | |--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Balloon Diameter<br>(mm) | 12, 14, 16, 18, 20, 22, 24, 26 | | Balloon Length<br>(cm) | 2, 4, 6 | | Catheter Shaft<br>Lengths (cm) | 75, 100 | | Introducer Sheath<br>Compatibility<br>(compatible<br>balloon sizes,<br>diameter (mm) x<br>length (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: The Bard PTV Dilatation Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - . A patient with isolated pulmonary stenosis - A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention. Image /page/1/Picture/10 description: The image shows the word "BARD" in a stylized, blocky font. The letters are outlined in black, giving them a bold and distinct appearance. The overall design is simple yet eye-catching, with a focus on readability and a modern aesthetic. {2}------------------------------------------------ #### Comparison of Indications for Use to Predicate Devices: The indication for use statement for the Bard PTV 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 devices. Therefore, the subject device, the Bard PTV Dilatation Catheter, is substantially equivalent to the predicate device. #### Technological Comparison to Predicate Devices: The Bard PTV Dilatation Catheter has the following similarities to the predicate devices: - Same intended use (Mullins-X PTV Catheter) . - Same indications for use (Mullins-X PTV Catheter) . - Same target population (Mullins-X PTV Catheter) . - 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 (Atlas® PTA Balloon Dilatation Catheter) #### Performance Data: To demonstrate substantial equivalence of the subject device, the Bard PTV Dilatation Catheter, to the predicate devices, 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: - . Catheter Shaft Length - Inflation Time . - Simulated Use Deflation Time . - Removal Deflation Time . - Trackability . The following in vitro tests were leveraged from the predicate device, the Atlas® PTA Balloon Dilatation Catheter: Bard Peripheral Vascular, Inc. Image /page/2/Picture/22 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined. The font style gives the word a modern and somewhat geometric appearance. {3}------------------------------------------------ - Tip Length . Balloon Outer Diameter . - Balloon Working Length . - Catheter Shaft Outer Diameter . - Catheter Shaft Inner Diameter . - Tip Visibility . - . Catheter Shaft Visibility - . Marker Band Visibility - Tip Morphology . - Tip Tensile . - Joint Tensile . - Catheter Elongation . - Nominal (Operating) Pressure . - Rated Burst Pressure . - Balloon Burst Mode . - Fatigue . - Catheter Shaft Leaks . - Catheter Shaft Burst . - Balloon Distensibility . - Marker Band Alignment . - Sheath Compatibility t - Equipment Interface . - Media Interaction . - Pouch Tensile Strength . The results from these tests demonstrate that the technological characteristics and performance criteria of the Bard PTV Dilatation Catheter are substantially equivalent to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the similar intended use. The following table provides a detailed summary of performance testing completed on the subject device, as compared to the corresponding performance testing completed on the predicate Mullins-X PTV Catheter. Image /page/3/Picture/28 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and connected, giving the word a solid, block-like appearance. The overall design is simple and eye-catching. {4}------------------------------------------------ Page 97 Traditional 510(k) Bard PTV Dilatation Catheter Summary of Performance Testing . | Predicate<br>Mullins-X Test | Predicate Mullins-X<br>Acceptance Criteria | Test<br>Performed<br>on Subject<br>Device? | Subject Bard PTV Dilatation Catheter<br>Acceptance Criteria | Test<br>Result | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Visual<br>Inspection | The catheters shall be free from<br>contamination, discoloration, and any<br>form of damage that could impact the<br>proper functioning of the device. | YES | Inspection of the device for damage is completed prior to<br>any testing for informational purposes. Contamination of the<br>device is covered in biocompatibility section 15.<br><br>During testing no abnormalities were observed, which was<br>confirmed through functional testing of the device (described<br>below). | PASS | | Balloon<br>Preparation Test | Each catheter shall be prepped per<br>the procedure without functional<br>difficulties or anomalies. | YES | Media Interaction (as stated in Table 7)<br><br>The specification for the subject device states that the<br>catheter's guidewire lumen must be flushable with saline<br>utilizing a 10mL syringe or equivalent. Though worded<br>differently, the specification of the subject device is similar to<br>the Mullins-X predicate device, as they both ensure no<br>anomalies are noted during simulated use.<br><br>All results showed the subject device passed the specified<br>criteria. | PASS | | Diameter and<br>Profile Test | The balloon diameter at rated burst<br>pressure shall be within +/- 10% of the<br>labeled balloon diameter and the<br>samples should fit through the<br>selected introducer with no problems. | YES | Balloon Outer Diameter (as stated in Table 7)<br><br>The specification for the subject device is +.04/-.03mm<br>across all diameters. When calculated for the smallest<br>balloon size (12mm) a +/- 10% change in labeled diameter<br>equates to +/-1.2mm.<br><br>All results showed the subject device passed the specified<br>criteria, which is more robust than the Mullins-X predicate<br>device criteria. | PASS | Bard Peripheral Vascular, Inc : . BARD {5}------------------------------------------------ aditional 510(k) ard PTV Dilatation Cathe Page 98 PASS PASS PASS PASS sults showed the subject device passed the specif a, and no breaks were seen. I Burst Pressure (as stated in Table 7) All results showed the subject device passed the spec criteria, which is more robust than the Mullins-X predic device criteria, because the labeled rated burst pressu are hi esults showed the subject device passed the spe The specification for the subject device is ≤ 5% acro iameters. .Il results showed the subject device passed the s riteria which is more robust than the Mullins-X pre evice criteria. specification for the subject device states that that the the states that the states that the states that the states of the states of the be sure is greater than the Mullinspecification for the subject device states th ter must be capable of withstanding 20 cyc on to ≥ labeled rated burst pressure. ation and Deflation (as stated in Tab oon Distensibility (as stated in Ta tigue (as stated in Table criteria ્ટર્ટ ES ES ES e results must show statistically in at least 95% confidence, at least and the more of the bearth and the more of the more of burnst pressure. results must demonstrate that on diameter is within + k & Mithin + K BP abeled diameter is within + K BP not be significantly increased by and bed easingly higher pressuress. tion achieved ss than 12 seconds and def eved in less than 20 second o breaks allowe Balloon inflation Deflation Test Balloon Minimur Burst Strength Repeated Balloon Inflation (Balloon Fatigu Test) Balloon Distensibilit BARI Peripheral Vascular {6}------------------------------------------------ Page 99 Traditional 510(k) Bard PTV Dilatation Catheter ... ← ← : : | Balloon<br>Inflatability Test, | There should be no interference with<br>balloon deflation | YES | Deflation (as stated in Table 7) | PASS | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | The balloon's ability to deflate is evaluated during deflation<br>testing as mentioned above. Any abnormalities during<br>testing are documented. | | | | | | During testing no abnormalities during deflation were<br>observed and all samples were able to be fully deflated. | | | | | Tip Pull.and.<br>Torque Test, | Must withstand at least 10 turns<br>without breaking | YES | Tip Tensile (as stated in Table 7) | PASS | | | The tip specification for the subject device is different than<br>the Mullins-X predicate device in that it follows ISO10555-1;<br>specifically, the tip is tested for tensile strength. The tip<br>tensile specification for the subject device states that the<br>catheter must withstand a minimum tensile force of 2<br>pounds-force. | | | | | | All results showed the subject device passed the specified<br>criteria from the ISO standard. | | | | | Bond-Strength<br>Test | All bonds must withstand at least 3 lbs<br>of pull strength. | YES | Joint Tensile (as stated in Table 7) | PASS | | | The bond strength specification for the subject device states<br>that the catheter must withstand a minimum tensile force of<br>5 pounds-force. | | | | | | All results showed the subject device passed the specified<br>criteria, which is more robust than the Mullins-X predicate<br>device criteria. | | | | | Catheter Body<br>Maximum<br>Pressure Test | All samples must withstand 30 ATM<br>(400psi). | YES | Catheter Shaft Leak and Catheter Shaft Burst (as stated<br>in Table 7) | PASS | | | | | The highest rated burst pressure for Atlas Gold is 18atm,<br>and as a safety factor the proposed specification was set to<br>+5atm above the highest rated burst pressure (23atm<br>minimum). Though the value is less than the Mullins-X<br>specification, it is adequate for the labeled burst pressure of<br>the subject device. | | | | | | All results showed the subject device passed the specified<br>criteria. | | . .. : . Bard Peripheral Vascular, Inc . ' BARID {7}------------------------------------------------ Traditional 510(k) Traditional 510(k) Bard Prv Dilatation Cathete 。 2017/07/14 .. : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : : 上一 Page 100 : . . . · . 19 . 1000 : . 30000 . : 11:4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . រៀង ក្រុងប្រជាជាងមួយម៉ែត្រីជួរប៉ុន្តែព្រឹមពីមួយ Vascular, Inc ﺮ ﺗﻢ ﺗﻌﻠﻴﻤﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ . - - — - . . . {8}------------------------------------------------ #### Conclusions: The subject device, the Bard PTV 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 Bard PTV Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Mullins-X PTV Catheter and the Atlas® PTA Balloon Dilatation Catheter. Image /page/8/Picture/5 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and prominent appearance. The overall design is simple and clean, focusing on the clarity and readability of the word. {9}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002 NOV 2 2012 Bard Peripheral Vascular, Inc. c/o Ms. Erin Fox Regulatory Affairs Specialist C. R. Bard 1625 West Third Street Tempe, AZ 85281 Re: K122367 Trade/Device Name: Bard PTV Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Pulmonary Valvuloplasty Catheter Regulatory Class: Class II Product Code: OMZ Dated: August 2, 2012 Received: August 5, 2012 Dear Ms. Fox: 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. {10}------------------------------------------------ # Page 2 - Ms. Erin Fox 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 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/ReportalProblem/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 yours, Aus Hille Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {11}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Bard PTV Dilatation Catheter Indications for Use: The Bard PTV Dilatation Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis . - A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention. 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) Mskiel (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K122367 Image /page/11/Picture/16 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, and the interior of the letters is white. The letters are evenly spaced and appear to be in a slightly condensed style. The overall impression is a clean and modern design. Bard Peripheral Vascular, Inc.