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 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.

AI/ML Overview

The provided document describes the Wattson™ temporary pacing guidewire and its substantial equivalence to predicate devices, but it does not explicitly state specific quantifiable acceptance criteria for the device performance or present a table comparing such criteria with reported performance values.

Instead, the document focuses on demonstrating substantial equivalence through various types of testing. I will extract information related to the closest aspects of 'acceptance criteria' and 'reported device performance' based on the safety and effectiveness testing conducted.

Here's an attempt to answer your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantifiable acceptance criteria are not provided in the document, this table will summarize the types of tests and the outcomes as described for demonstrating substantial equivalence.

Test Category	Acceptance Criteria (Inferred/Qualitative)	Reported Device Performance (Qualitative Summaries)
Biocompatibility	Compliance with ISO 10993-1 for an externally communicating device in contact with circulating blood and tissue for limited duration (<24 hours), implying no unacceptable cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, or thrombogenicity.	Passed all required biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity).
Bench Performance	Device meets design specifications for physical and electrical properties, including dimensions, strength, friction, electrical continuity, and material integrity.	All listed 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) were performed and presumably met expectations for substantial equivalence.
Animal Performance	Similar performance to predicate devices in terms of adverse events, return to normal sinus rhythm post-pacing, and lack of histological differences. Ability to provide clinically significant blood pressure reduction, proper positioning, BAV device delivery, and connection to external pacing programmer.	Study 1: Performed similarly to control devices with regard to adverse events and animal health concerns. No sustained arrhythmia, all animals returned to normal sinus rhythm, no histological differences. Study 2: Similar performance and handling to control devices during simulated clinical use. Provided clinically significant BP reduction, proper positioning, successful BAV device delivery, and successful connection to external programmer. All animals returned to normal sinus rhythm and were free of concerning cardiac events post-procedure.
Clinical Performance	Predictable guidewire support, reliable bipolar pacing at low thresholds to allow safe transcatheter heart valve delivery.	The Wattson temporary pacing guidewire "offered predictable guidewire support with concomitant reliable bipolar pacing at low thresholds to allow safe transcatheter heart valve delivery." Performance indicates potential for a "more efficient procedure."

2. Sample Size and Data Provenance

Test Set (Clinical): 20 subjects.
Data Provenance (Clinical): Single-center, prospective study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting a U.S. study or a study compliant with U.S. regulatory standards.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not provided in the document. The clinical study describes the outcomes observed in patients undergoing TAVR procedures but does not detail the process of establishing a "ground truth" through expert consensus for a test set, as might be typical for diagnostic AI devices. The assessment of performance appears to be based on the observed clinical outcomes and utility during the procedures.

4. Adjudication Method (Test Set)

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted or reported. The document describes performance for the device itself, not an AI-assisted human reading scenario.

6. Standalone Performance Study

Yes, the studies described (bench, animal, and clinical) represent the standalone performance of the Wattson temporary pacing guidewire. There is no mention of human-in-the-loop performance; the device's efficacy is assessed directly.

7. Type of Ground Truth Used

Biocompatibility & Bench Testing: Established by adherence to recognized international standards (ISO 10993-1) and internal design specifications/engineering measurements.
Animal Studies: Established through direct observation of physiological responses, adverse events, histological findings, and procedural success in a porcine model, conducted under GLP. Comparison was made against predicate (control) devices.
Clinical Study: Established by observed clinical outcomes during TAVR procedures, including aspects like guidewire support, pacing efficacy (reliable bipolar pacing at low thresholds), and safe transcatheter heart valve delivery.

8. Sample Size for the Training Set

This information is not applicable / not provided. The Wattson temporary pacing guidewire is a physical medical device, not an AI model requiring a training set in the conventional sense. The "training" of the device is through its design and manufacturing process, and its "performance" is evaluated through the validation studies described.

9. How the Ground Truth for the Training Set was Established

This information is not applicable / not provided for the same reasons as (8).

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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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

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 PredicateDevice	Secondary PredicateDevice
	Wattson temporarypacing guidewire	Confida Guidewire	Temporary PacingElectrode Catheter
510(k)	K19XXXXX	K181001	K800298
Manufacturer	Vascular Solutions	Medtronic	Bard
Product Class	II	II	II
ProductClassification	870.1330	870.1330	870.3680
Product Code	DQX; LDF	DQX	LDF
Indications for Use	The WattsonTMtemporary pacingguidewire is intended tointroduce and positioncatheters and otherinterventional deviceswithin the chambers ofthe heart, includingthose used withintranscatheter aorticvalve replacement(TAVR) procedures andballoon aorticvalvuloplasty (BAV),while transmitting anelectrical signal from anexternal pulse generatorto the heart. Thetemporary pacingguidewire is notintended to remain inplace following theclinical procedure.	The MedtronicConfidaTM Breckerguidewire is intendedfor use to introduceand position cathetersduring diagnostic andinterventionalprocedures within thechambers of the heart,including transcatheteraortic valvereplacement (TAVR).	Bard® Temporary PacingCatheters are designed totransmit an electricalsignal from an externalpulse generator to theheart or from the heart toa monitoring device.When an internal lumenis present (other than theone used for ballooninflation), it may be usedfor fluid infusion,pressure monitoring, orblood sampling.
Contraindication	The guidewire iscontraindicated for usein the coronary arteriesand in thecerebrovasculature.	The MedtronicConfidaTM BreckerGuidewire iscontraindicated forpatients presentingwith an intolerance toanticoagulationtherapy and	None
Characteristic	Subject Device	Primary PredicateDevice	Secondary PredicateDevice
	Wattson temporarypacing guidewire	Confida Guidewire	Temporary PacingElectrode Catheter
		unheparinizedpatients. Theguidewire iscontraindicated for usein the coronary arteriesand in thecerebrovasculature.
Anatomical sites	Left Ventricle	Left Ventricle	Right Ventricle
Materials ofconstruction	Stainless Steel Wirewith fluoropolymerjacket and stainless-steelelectrodes	Stainless Steel wirewith fluoropolymercoating.	Woven or extrudedpolyurethane jacketedshaft with platinum orstainless-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 ofSterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Single Use orReusable	Single Use	Single Use	Single Use
Coating	Fluropolymer outerJacket (FEP) withSilicone Oil Lubricant.	Fluoropolymer (PTFE)coating	Polyurethane OuterJacket
Radiopacity	Yes	Yes	Yes
Tip Configuration	Pigtail	Preformed 360°curved tip (pigtail)	Straight, Preshapedangle tip
ExternalPacemakerConnections	Removable guidewireadapter terminating intwo shroudedpositive/negativeconnectors	N/A	Two incorporatedshroudedpositive/negativeconnectors.
Pulse Generatorcompatibility	Compatible withstandard external pulsegenerators	N/A	Compatible withstandard external pulsegenerators

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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.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
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.(b)
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.