PaxWire Occlusion Balloon System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping profiles facing to the right. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 14, 2015 AccessClosure, Inc. Kelly Jabbal Manager, Regulatory Affairs 5452 Betsy Ross Drive Santa Clara, California 95054 Re: K143613 > Trade/Device Name: PaxWire Occlusion Balloon System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: July 13, 2015 Received: July 14, 2015 Dear Kelly Jabbal, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K143613 Device Name PaxWire Occlusion Balloon System Indications for Use (Describe) The PaxWire Occlusion Balloon System is indicated for temporary flow occlusion in the iliofemoral artery. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a red graphic element above the company name. The graphic element is made up of several curved lines that converge at a point. The text "CardinalHealth" is written in a bold, sans-serif font. # 510(k) Summary PaxWire™ Occlusion Balloon System ### Submitter's Name and Address: AccessClosure, Inc. A Cardinal Health Company 5452 Betsy Ross Drive Santa Clara, CA 95054 Tel: 408-610-6517 Fax: 408-610-6702 ### Contact Name and Information: Kelly Jabbal Manager, Regulatory Affairs Tel: 408-610-6517 Fax: 408-610-6702 ### Date Prepared: August 13, 2015 ### Proprietary Name: PaxWire™ Occlusion Balloon System ("PaxWire System") Model No. ACX101 #### Common Name: Vascular Clamp ### Product Code: MJN - Catheter, Intravascular Occluding, Temporary #### Regulation Number: 21 CFR 870.4450 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a red abstract symbol above the company name. The symbol is made up of several curved lines that resemble a stylized bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font. # Predicate Device: Primary: Berenstein Occlusion Balloon Catheter ("Berenstein Catheter") Boston Scientific Corp. K132990 Secondary: Amplatz Super Stiff Guidewire ("Amplatz Guidewire") Meadox Medicals, a Division of Boston Scientific Corp. K930622 ## Device Description: The PaxWire™ Occlusion Balloon System (PaxWire System) is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures. The PaxWire System consists of the following: - An occlusion catheter (see Figure 1 below) with a distal atraumatic stainless-steel J-tip (23 cm in length), a compliant Chronoprene balloon, an 80 cm working length stainless steel shaft with a maximum 0.035" diameter proximal to the balloon, and an internal valve on the proximal end of the catheter. The effective length of the Pax Wire System is 99 cm with the inflation handle attached. The balloon can be inflated up to 12 mm for temporary flow occlusion in the iliofemoral artery (shown in un-inflated view in Figure 1 below). The balloon includes radiopaque markers located at each end of the balloon to aid positioning during fluoroscopy. The internal valve can be manually opened to control balloon inflation. Image /page/4/Figure/8 description: The image shows a medical device with several labeled components. Starting from the left, there is a "Flexible J-tip", followed by a "Compliant Balloon". Next to the balloon is the "Shaft", and finally, on the right side, there is an "Internal Valve". The device appears to be designed for insertion into a body cavity or vessel. Figure 1. PaxWire Occlusion Balloon System (Catheter) - . An inflation handle that is manually operated and is used to inflate and deflate the balloon. The inflation handle can be removed while the balloon is inflated so that a dilator can be advanced over the proximal end of the device. - A 10 cc Prep Syringe ● - A 3 cc Inflation Syringe {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a red graphic element above the company name. The graphic element is composed of several curved lines that resemble a stylized bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font. # Intended Use / Indications for Use: The PaxWire System is indicated for temporary flow occlusion in the iliofemoral artery. ## Comparison of Technological Characteristics: The PaxWire System can be regarded as a "hybrid" of two predicate devices: the Berenstein Catheter and the Amplatz Guidewire. Both the PaxWire System and the Berenstein Catheter employ the same scientific concept of utilizing an internal lumen to inflate a distal compliant balloon to provide temporary occlusion. The Berenstein Catheter is placed over the guidewire, whereas the Paxwire System allows for placement independent of a guidewire. The Pax Wire System also utilizes the same scientific concept of a wire feature of the Amplatz Guidewire to allow a sheath dilator to be advanced over the proximal end of the PaxWire System shaft. It is in this configuration that the PaxWire System is appropriately compared to the predicate devices. ## Performance Data: Performance data to support a determination of substantial equivalence included biocompatibility and bench testing as follows: ## Biocompatibility Testing: - Cytotoxicity - Sensitization ● - Intracutaneous Reactivity ● - Hemolysis, direct contact using pooled blood from 3 donors - Hemolysis, extract using pooled blood from 3 donors - Systemic Toxicity - . Materials Mediated Pyrogenicity - Partial Thromboplastin Time (PTT) - Complement Activation - Thromboresistance Test in Canine ● - Bacterial Endotoxin {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a red abstract symbol resembling a bird in flight, positioned above the company name. The text "CardinalHealth" is written in a bold, sans-serif font, with "Cardinal" in black and "Health" in a slightly lighter shade of black. # Bench Testing: - Package Integrity ● - . Balloon Integrity - Deflation Time ● - Leak Test - Weld Strength - Inflated Balloon Pull and Torque - Unconstrained Inflated Balloon Diameter and Burst - Valve Remains Closed - Force to Open/Close Valve and Maximum Force to Actuate the Valve - Valve Tensile Strength and Cycling - Extension Line to Stopcock and Inflation Handle Tensile Strength - Lateral (Shaft) Stiffness - . Tip Flexibility - Buckling - Kinking - Dimensional Verification of Crossing Profile, J-Tip Radius, Diameter and Effective Length - . Balloon Fatigue Cycling - Corrosion - Simulated Use # Conclusion: The conclusions drawn from the testing outlined above demonstrate that the PaxWire System is substantially equivalent to the predicates.