WavelinQ Plus EndoAVF System

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October 17, 2019 Bard Peripheral Vascular Kulveen Dhatt Senior Regulatory Affairs Specialist 1625 West 3rd Street Tempe, AZ 85281 Re: K192239 Trade/Device Name: WavelinQ EndoAVF System Regulation Number: 21 CFR 870.1252 Regulation Name: Percutaneous Catheter for Creation Of An Arteriovenous Fistula Regulatory Class: Class II Product Code: PQK Dated: August 16, 2019 Received: August 19, 2019 Dear Ms. Dhatt: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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Sincerely, Carmen Gacchina Johnson Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192239 Device Name WavelinQ EndoAVF System #### Indications for Use (Describe) The WavelinQ™ EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------| | <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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}------------------------------------------------ ## WavelinQ™ EndoAVF System ### 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 | | Phone: | 480-379-2875 | | Fax: | 480-449-2546 | | Contact: | Kulveen Dhatt, Senior Regulatory Affairs Specialist | | Date: | August 16, 2019 | ### Subject Device Name: | Device Trade Name: | WavelinQ™ EndoAVF System | |-----------------------|--------------------------------------------------------------------| | Common or Usual Name: | Percutaneous catheter for creation of an arteriovenous fistula for | | | hemodialysis access | | Classification Name: | Percutaneous catheter for creation of an arteriovenous fistula for | | | hemodialysis access | | Product Code: | PQK | | Regulatory Class: | Class II | | Review Panel: | Cardiovascular | | Regulation Number: | 21 CFR 870.1252 | | Predicate Device: | | | Device Trade Name: | WavelinQ™ 4F EndoAVF System | |-----------------------|----------------------------------------------------------------------------------------| | 510(k) Number: | K182796 | | Common or Usual Name: | Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access | {4}------------------------------------------------ K192239 | Classification Name: | Percutaneous catheter for creation of an arteriovenous fistula for<br>hemodialysis access | |----------------------|-------------------------------------------------------------------------------------------| | Product Code: | PQK | | Regulatory Class: | Class II | | Review Panel: | Cardiovascular | | Regulation Number: | 21 CFR 870.1252 | ### Device Description: The WavelinQ™ EndoAVF System consists of two single-use disposable magnetic catheters: a venous catheter and an arterial catheter. The venous catheter contains an array of magnets positioned on either side of a radiofrequency (RF) cutting electrode contained within an isolative housing. The arterial catheter contains a matching array of magnets positioned on either side of an electrode "backstop". The backstop serves as a mechanical stop for the cutting electrode to contact following the creation of the AVF. The magnets in the two catheters serve to align and appose the arterial backstop of the arterial catheter with the RF electrode of the venous catheter when positioned in the target AVF location. Radiofrequency energy can then be delivered through the electrode for cutting tissue and AVF creation. The arterial and venous catheters are both comprised of braid reinforced Pebax catheter shafts. These shafts provide flexibility for device delivery and torquability to aid in rotational alignment and positioning. Both catheters include a soft, radiopaque, rapid exchange style Pebax tip for atraumatic device navigation with radiographic visibility. These tips allow the catheters to track over a standard guide wire 0.014" or smaller. The catheters include a handle/hub to facilitate device delivery, positioning and alignment. ### Indications for Use of Device: The WavelinQ™ EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis. {5}------------------------------------------------ K192239 ### Technological comparison to Predicate Device: The subject WavelinQ™ EndoAVF System has the following similarities to the WavelinQ™ 4F EndoAVF System predicate device (K182796 – cleared on February 6, 2018): same intended use, same indications for use, same target population, same operating principle, same fundamental scientific technology, same sterility assurance level and method of sterilization, same performance bench testing with same acceptance criteria, same biocompatibility requirements, same packaging configurations, and same materials. The WavelinQ™ EndoAVF System includes minor design modifications when compared to the WavelinQ™ 4F EndoAVF System predicate device. The WavelinQ™ EndoAVF System includes one additional radiopaque rotational indicator to both the venous and arterial catheters and the addition of 24 magnets each to both the arterial and venous catheters. The minor design modifications have been verified and validated through appropriate non clinical performance data. There are no changes with respect to manufacturing, materials and their processing compared to the predicate WavelinQ™ 4F EndoAVF System. Magnet Array Force Coaptation Testing and S-Turn Tortuosity Coaptation and Alignment Comparison Testing were introduced as a verification tests in order to compare the subject device to the predicate device and confirm that minor modifications of the WavelinQ™ EndoAVF System maintain or exceed performance requirements previously established with the predicate WavelinQ™ 4F EndoAVF System. In order to address the performance requirements previously validated by end users which are potentially impacted by the minor design modifications, repeat validation testing was performed on the subject WavelinQ™ EndoAVF System to confirm design outputs continue to satisfy the design inputs and user needs. The repeat design validation provides confirmation that design outputs satisfy those design inputs that may not otherwise be evaluated through design verification testing. ### Performance Data: #### Non Clinical Performance Data: To demonstrate that the subject device WavelinQ™ EndoAVF System is as safe and effective as the predicate device WavelinQ™ 4F EndoAVF System, the technological characteristics and performance criteria were evaluated. Using internal risk assessment procedures, tests of the following characteristics and performance criteria were performed on the subject device: {6}------------------------------------------------ - Electrical Safety per IEC 60601 ● - Electromagnetic Compatibility (EMC) Testing - Design Validation Cadaver Study ● - . Magnet Array Force Coaptation Testing - S-Turn Tortuosity Coaptation and Alignment Comparison Testing . ### Conclusions: The subject device, WavelinQ™ EndoAVF System, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The subject device and the predicate device share the same characteristics: intended use, indications for use, target populations for use, and fundamental scientific technology. Therefore, Bard Peripheral Vascular, Inc. concludes that the subject device WavelinQ™ EndoAVF System is substantially equivalent to the legally marketed predicate device WavelinQ™ 4F EndoAVF System.