Wattson Temporary Pacing Guidewire

K192454 · Vascular Solutions · DQX · Jan 15, 2020 · Cardiovascular

Device Facts

• Record ID: K192454
• Device Name: Wattson Temporary Pacing Guidewire
• Applicant: Vascular Solutions
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Dual-purpose 0.035" guidewire; facilitates catheter delivery and temporary rapid cardiac pacing. Features distal pigtail shape; bipolar electrode configuration (distal tip positive, three proximal negative electrodes). Includes proprietary adapter converting proximal end to terminal pins for standard external pulse generator connection. Used in cardiac catheterization labs during TAVR/BAV procedures; operated by interventionalists. Provides guidewire support for device delivery; transmits pacing signals to induce rapid pacing (reducing blood pressure for valve placement). Fluoroscopically visible. Benefits include procedural efficiency by combining guidewire support and pacing functions in one device.

Clinical Evidence

Prospective, single-center study of 20 subjects undergoing TAVR. Primary endpoints: guidewire support and pacing reliability. Results: device provided predictable support and reliable bipolar pacing at low thresholds, facilitating successful heart valve delivery. No clinical complications reported.

Technological Characteristics

Stainless steel wire; fluoropolymer (FEP) jacket; stainless steel electrodes. 0.035" OD; 280 cm length. Bipolar electrode configuration. Ethylene oxide sterilization. Single-use. Radiopaque. Connects to external pulse generators via proprietary adapter.

Indications for Use

Indicated for patients undergoing TAVR or BAV procedures requiring catheter positioning and temporary cardiac pacing. Contraindicated for use in coronary arteries and cerebrovasculature.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Confida™ /Breaker Guidewire (K181001)
• Bard® Temporary Pacing Electrode Catheter (K800298)

Submission Summary (Full Text)

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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. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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

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# 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"/> |

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Image /page/3/Picture/0 description: The image shows the logo for Vascular Solutions. The logo features a square with a gradient of black squares above it, resembling a stylized image of smoke. 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: [phone] (direct) Fax: [phone] 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

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### 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:

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### 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 |

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### 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 ●

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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.