Wattson Temporary Pacing Guidewire

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January 15, 2020 Vascular Solutions Nancy Frame Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369 Re: K192454 Trade/Device Name: Wattson Temporary Pacing Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 18, 2019 Received: December 20, 2019 Dear Nancy Frame: 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, Hetal Patel Assistant Director Implantable Electrophysiology Devices Team Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices 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) K192454 #### Device Name Wattson™ temporary pacing guidewire #### Indications for Use (Describe) The Wattson™ temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| | Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> | |----------------------------------------------|-------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Below the square is the text "Vascular" in a bold, serif font, with the word "SOLUTIONS" in a smaller, sans-serif font underneath. # 510(k) Summary [As required by 21 CFR 807.92] 510(k) NUMBER: K192454 ### SUBMITTER Vascular Solutions 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Phone: 763.656.4230 (direct) Fax: 763.251.0363 Contact Person: Nancy Frame, Sr. Regulatory Product Specialist Date Prepared: September 5, 2019 ### DEVICE Name of Device: Wattson™ temporary pacing guidewire Common or Usual Name: Catheter Guidewire Classification Name: Catheter Guidewire (21 CFR 870.1330) Regulatory Class: II Primary Product Code: DQX Secondary Product Code: LDF ### PREDICATE DEVICES ### Primary Predicate: Manufacturer: Medtronic Device Name: Confida™ /Breaker Guidewire 510(k) No: K181001 (cleared May 3, 2018), Class II, Product Code DQX; classified per 21 CFR 870.1330 {4}------------------------------------------------ ### Secondary Predicate: Manufacturer: Bard Device Name: Bard® Temporary Pacing Electrode Catheter 510(k) No: K800298 (cleared April 16, 1980). Class II, Product Code LDF; classified per 21 CFR 870.3680 # DEVICE DESCRIPTION The Wattson temporary pacing guidewire is a dual-purpose 0.035" guidewire designed for the delivery of devices and for temporary rapid pacing of the heart. The distal end of the device has an atraumatic pigtail shape. The shaft of the device has a silicone lubricant applied to the outer surface. Rapid pacing is achieved through a bipolar electrode configuration integrated in the shaft of the guidewire. The electrodes terminate in a single positive electrode at the distal tip of the device and three discrete negative electrodes located proximal to the tip within the pigtail section. The entire device is visible using standard fluoroscopic methods. The device is packaged with a proprietary adapter that locks on to the proximal end of the guidewire and converts it to discrete positive and negative terminal pins. The terminal pins of the adapter are compatible with standard external pulse generators. The Wattson temporary pacing guidewire is sterilized with ethylene oxide. # INDICATIONS FOR USE The Wattson temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure. # COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES This submission is seeking the clearance of the Wattson temporary pacing guidewire which has similar uses, fundamental technologies, principals of operation and performance as the identified predicate devices. The Wattson temporary pacing guidewire is similar to the Confida Brecker wire in that it is used to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart. It is similar to the Bard Temporary Pacing catheter in that it is used to transmit an electrical signal from an external pulse generator to the heart. Where there are technological differences, results of bench and animal tests confirm that the Wattson temporary pacing guidewire is substantially equivalent to the predicate devices. A comparison of the technological characteristics for the Wattson temporary pacing guidewire against the predicate devices is as follows: {5}------------------------------------------------ ### Substantial Equivalence Comparison | Characteristic | Subject Device | Primary Predicate<br>Device | Secondary Predicate<br>Device | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Wattson temporary<br>pacing guidewire | Confida Guidewire | Temporary Pacing<br>Electrode Catheter | | 510(k) | K19XXXXX | K181001 | K800298 | | Manufacturer | Vascular Solutions | Medtronic | Bard | | Product Class | II | II | II | | Product<br>Classification | 870.1330 | 870.1330 | 870.3680 | | Product Code | DQX; LDF | DQX | LDF | | Indications for Use | The WattsonTM<br>temporary pacing<br>guidewire is intended to<br>introduce and position<br>catheters and other<br>interventional devices<br>within the chambers of<br>the heart, including<br>those used within<br>transcatheter aortic<br>valve replacement<br>(TAVR) procedures and<br>balloon aortic<br>valvuloplasty (BAV),<br>while transmitting an<br>electrical signal from an<br>external pulse generator<br>to the heart. The<br>temporary pacing<br>guidewire is not<br>intended to remain in<br>place following the<br>clinical procedure. | The Medtronic<br>ConfidaTM Brecker<br>guidewire is intended<br>for use to introduce<br>and position catheters<br>during diagnostic and<br>interventional<br>procedures within the<br>chambers of the heart,<br>including transcatheter<br>aortic valve<br>replacement (TAVR). | Bard® Temporary Pacing<br>Catheters are designed to<br>transmit an electrical<br>signal from an external<br>pulse generator to the<br>heart or from the heart to<br>a monitoring device.<br>When an internal lumen<br>is present (other than the<br>one used for balloon<br>inflation), it may be used<br>for fluid infusion,<br>pressure monitoring, or<br>blood sampling. | | Contraindication | The guidewire is<br>contraindicated for use<br>in the coronary arteries<br>and in the<br>cerebrovasculature. | The Medtronic<br>ConfidaTM Brecker<br>Guidewire is<br>contraindicated for<br>patients presenting<br>with an intolerance to<br>anticoagulation<br>therapy and | None | | Characteristic | Subject Device | Primary Predicate<br>Device | Secondary Predicate<br>Device | | | Wattson temporary<br>pacing guidewire | Confida Guidewire | Temporary Pacing<br>Electrode Catheter | | | | unheparinized<br>patients. The<br>guidewire is<br>contraindicated for use<br>in the coronary arteries<br>and in the<br>cerebrovasculature. | | | Anatomical sites | Left Ventricle | Left Ventricle | Right Ventricle | | Materials of<br>construction | Stainless Steel Wire<br>with fluoropolymer<br>jacket and stainless-steel<br>electrodes | Stainless Steel wire<br>with fluoropolymer<br>coating. | Woven or extruded<br>polyurethane jacketed<br>shaft with platinum or<br>stainless-steel electrodes | | Length | 280 cm | 260 cm | 100, 110, 115, 125 cm | | Wire OD | 0.035"/0.89 mm | 0.035"/0.89 mm | N/A | | Method of<br>Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | Single Use or<br>Reusable | Single Use | Single Use | Single Use | | Coating | Fluropolymer outer<br>Jacket (FEP) with<br>Silicone Oil Lubricant. | Fluoropolymer (PTFE)<br>coating | Polyurethane Outer<br>Jacket | | Radiopacity | Yes | Yes | Yes | | Tip Configuration | Pigtail | Preformed 360°<br>curved tip (pigtail) | Straight, Preshaped<br>angle tip | | External<br>Pacemaker<br>Connections | Removable guidewire<br>adapter terminating in<br>two shrouded<br>positive/negative<br>connectors | N/A | Two incorporated<br>shrouded<br>positive/negative<br>connectors. | | Pulse Generator<br>compatibility | Compatible with<br>standard external pulse<br>generators | N/A | Compatible with<br>standard external pulse<br>generators | {6}------------------------------------------------ {7}------------------------------------------------ Page 5 of 6 ### PERFORMANCE DATA ## Biocompatibility Testing The biocompatibility evaluation for the Wattson temporary pacing guidewire was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Wattson temporary pacing guidewire is considered an externally communicating device in contact with circulating blood and tissue for a limited period of time (<24 hours) during use. The battery of tests included the following: - Cytotoxicity - Sensitization - Irritation ● - Acute Systemic Toxicity ### Performance Testing- Bench The device design was verified through the following tests: - Dimensional Verification . - Visual Inspection ● - Tensile Strength - Track Force - Guidewire Support Profile - Distal Flex Force - Shaft Friction Force ● - Electrode Size - Electrode Location - Device Continuity ● - Particulate Evaluation ● - Corrosion Resistance ● - Radiopacity ● ### Performance Data – Animal: Animal testing was performed to demonstrate the substantial equivalence of the Wattson temporary pacing guidewire to the predicates Confida Breaker Guidewire and Bard Temporary Pacing Catheter in a porcine model. The testing was performed in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies. The subject Wattson temporary pacing guidewire shares the same fundamental scientific technology as the predicate devices. A GLP study demonstrated that the Wattson temporary pacing guidewire and the predicate (control) devices performed similarly with regard to adverse events and other animal health concerns. No animals experienced sustained arrhythmia in the post-rapid pacing monitoring period, all animals returned to normal sinus rhythm after rapid pacing was turned off, and there were no histological findings that indicate any differences between the test and control group. - - Pyrogenicity ● - . Hemolysis - Complement Activation ● - Thrombogenicity ● {8}------------------------------------------------ A second GLP study successfully demonstrated that the Wattson temporary pacing guidewire and the predicate (control) devices are similar in performance and handling during simulated clinical use in the swine model. In all cases: the Wattson wire provided a clinically significant reduction in blood pressure to adequately allow for successful BAV inflation; and the interventionalist was able to properly position the device, successfully deliver the BAV device and successfully connect to the external pacing programmer. Animals were monitored for 30 minutes post-procedure and demonstrated a return to normal sinus rhythm and were free of any concerning cardiac events. # Performance Testing - Clinical: Twenty subjects underwent TAVR procedures and were treated with the Wattson temporary pacing guidewire in a single-center, pre-market, prospective study. The Wattson temporary pacing guidewire offered predictable guidewire support with concomitant reliable bipolar pacing at low thresholds to allow safe transcatheter heart valve delivery in the treated cohort. In this experience the Wattson wire performance indicates the device has the potential to make TAVR a more efficient procedure in patients. # CONCLUSIONS The results of bench and animal tests confirm that the Wattson temporary pacing guidewire, subject of this 510(k), is substantially equivalent to the predicate devices. The Wattson temporary pacing guidewire is similar to the predicate devices in its indications for use and substantially equivalent in technology, materials, and performance to the predicates. Performance data demonstrates that the Wattson temporary pacing guidewire performs as well as the Confida Breaker Guidewire and Bard Temporary Pacing Catheter. Therefore, it can be concluded that the Wattson temporary pacing guidewire is substantially equivalent to the predicate devices.