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 pacing of the heart. The distal end of the device has an atraumatic pigtail shape. The shaft of the device has a hydrophilic coating. Pacing is achieved through a bipolar electrode configuration integrated in 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. Unshrouded adaptor pins are provided to ensure compatibility with all connecter cable terminals. The Wattson temporary pacing guidewire is sterilized with ethylene oxide.

AI/ML Overview

This document is a 510(k) Summary for the Wattson Temporary Pacing Guidewire (Model 2250). It details the device's indications for use, its characteristics, and a comparison to a predicate device (K192454, also a Wattson temporary pacing guidewire). The summary also outlines the performance data gathered to support the claim of substantial equivalence.

Based on the provided text, the device is a medical guidewire used in cardiac procedures, specifically Transcatheter Aortic Valve Replacement (TAVR) and Balloon Aortic Valvuloplasty (BAV), which also has the capability to transmit an electrical signal for temporary cardiac pacing.

Here's an analysis of the acceptance criteria and study proving the device meets them, based solely on the provided text:

Important Note: The provided document is a 510(k) Summary, which is a regulatory submission for medical devices to demonstrate substantial equivalence to a legally marketed predicate device. It typically summarizes testing, but does not provide the full detailed study reports. Therefore, some information requested in your prompt (e.g., number of experts, specific effect sizes for MRMC studies, sample sizes for training sets for AI models) may not be present because this device is a traditional guidewire, not an AI/ML-driven diagnostic device. The questions you've asked are largely applicable to AI/ML device submissions, which is not what this document describes.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a physical medical device (guidewire) and not an AI/ML diagnostic tool, "acceptance criteria" are typically defined by engineering specifications, material biocompatibility, and functional performance benchmarks rather than diagnostic metrics like sensitivity/specificity. The document doesn't present a formal table of quantitative acceptance criteria and performance results in the way one would for an AI model.

However, the "Performance Data" section outlines the types of testing performed, which implicitly demonstrates "acceptance" based on successful completion of these tests.

Category	Acceptance Criteria (Implicit from testing type)	Reported Device Performance
Biocompatibility	Meets ISO 10993-1 standards for an externally communicating device in contact with circulating blood and tissue for limited time (<24 hours).	- Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Complement Activation, and Thrombogenicity tests were conducted. (Implies successful completion for acceptance).
Bench Performance	Device design verified for: Performance, Patient Safety, Structural Integrity, Infection, Microbial & Particulate Contamination, Device Interface.	- Device design was verified through these tests. (Implies successful completion against internal specifications).
Animal Study (GLP Safety)	Performance similar to predicate device, no new safety concerns, no sustained arrhythmia, return to normal sinus rhythm, no histological differences.	- Performed similarly to the predicate regarding adverse events and other animal health concerns. - No sustained arrhythmia in post-rapid pacing monitoring period. - All animals returned to normal sinus rhythm after rapid pacing was turned off. - No histological findings indicating differences from predicate.

2. Sample Sizes Used for the Test Set and Data Provenance

Animal Study (GLP Safety): The study was performed in a porcine model. The document states "No animals experienced sustained arrhythmia...", implying a cohort of animals, but the exact number of animals (sample size) is not specified.
Data Provenance: The animal study was a prospective GLP Safety study. The country of origin for the data is not specified but given the US FDA submission, it's likely a US-based study or conducted to US regulatory standards. Biocompatibility and Bench tests are laboratory-based and generally don't have "data provenance" in the same regional sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable to this device submission. The Wattson Temporary Pacing Guidewire is a physical medical device, not an AI-based diagnostic tool that relies on expert interpretation for "ground truth" to validate an algorithm's performance on image data. For an AI/ML device, ground truth would typically be established by expert radiologists or pathologists.

For this device, "ground truth" (or verification) is established through technical performance specifications, material science, and observed biological/physiological responses in animal models and bench testing.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this device is not an AI/ML diagnostic. Adjudication methods (like 2+1 or 3+1) are used in studies where multiple human readers interpret data to create a consensus "ground truth" for evaluating an AI algorithm. For a physical device, performance is measured against engineering specifications, biological responses, and comparative performance to a predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images with or without AI assistance). This submission is for a guidewire, which does not involve human readers interpreting images in a way that would necessitate an MRMC study for its primary function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm; it is a physical medical device. Therefore, the concept of "standalone performance" for an algorithm does not apply. The device's performance is inherently "standalone" in its primary function as a guidewire and pacing tool.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is based on:

Physiological/Biological Outcomes: Observed responses in the porcine model (e.g., return to normal sinus rhythm, absence of sustained arrhythmia, lack of adverse events, histological findings).
Bench Test Specifications: Performance against internal engineering parameters, safety margins, structural integrity, and material properties.
Biocompatibility Standards: Conformance to recognized ISO standards (ISO 10993-1).
Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is demonstrating that the study device performs "similarly" and raises "no new questions of safety or effectiveness" compared to the predicate device.

8. The Sample Size for the Training Set

Not applicable. As this device is a physical medical device and not an AI/ML algorithm, there is no "training set."

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

Not applicable. Since there is no AI/ML algorithm and therefore no training set, the concept of establishing ground truth for a training set does not apply.

Summary

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May 5, 2023

Vascular Solutions Vite Beka Regulatory Manager 6464 Sycamore Court North Maple Grove, Minnesota 55369

Re: K230637

Trade/Device Name: Wattson Temporary Pacing Guidewire (2250) Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX, LDF Dated: March 7, 2023 Received: March 7, 2023

Dear Vite Beka:

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.

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ce determination does not mean that FDA

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 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 (QS) 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.

Digitally signed
Sara M. by Sara M. Royce
-S
Royce -S Date: 2023.05.05
19:34:49 -04'00'

for Hetal Odobasic Assistant Director 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

Submission Number (if known)

K230637

Device Name

Wattson temporary pacing guidewire (2250)

Indications for Use (Describe)

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)

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510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: May 5, 2023

510(k) Number: K230637

Submitter's Name / Contact Person

Manufacturer Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812

Contact Person Beka Vite Regulatory Manager Tel: 612.441.0914 (direct)

General Information

Trade Name	Wattson™ temporary pacing guidewire
Common / Usual Name	Catheter Guidewire
Classification Name	21 CFR 870.1330, Catheter Guidewire, DQX, Class IISecondary Product Code: LDF
Predicate Device	K192454, Wattson temporary pacing guidewire (Vascular Solutions LLC

Device Description

Pacing is achieved through a bipolar electrode configuration integrated in 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. Unshrouded adaptor pins are provided to ensure compatibility with all connecter cable terminals.

The Wattson temporary pacing guidewire is sterilized with ethylene oxide.

Indications for Use

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Comparison of Technological Characteristics with the Predicate Device

A comparison of the technological characteristics between the Wattson temporary pacing guidewire and the predicate device are provided in the following table.

Comparison of Technological Characteristics
Characteristic	Subject Device	Primary Predicate Device
	Wattson temporary pacingguidewire	Wattson temporary pacingguidewire
Indications for Use	The Wattson™ temporary pacingguidewire is intended tointroduce and position cathetersand other interventional deviceswithin the chambers of theheart, including those usedwithin transcatheter aortic valvereplacement (TAVR) proceduresand balloon aortic valvuloplasty(BAV), while transmitting anelectrical signal from an externalpulse generator to the heart. Thetemporary pacing guidewire isnot intended to remain in placefollowing the clinical procedure.	The Wattson™ temporary pacingguidewire is intended to introduceand position catheters and otherinterventional devices within thechambers of the heart, includingthose used within transcatheteraortic valve replacement (TAVR)procedures and balloon aorticvalvuloplasty (BAV), whiletransmitting an electrical signalfrom an external pulse generatorto the heart. The temporary pacingguidewire is not intended toremain in place following theclinical procedure.
Contraindication	The guidewire is contraindicatedfor use in the coronary arteriesand in the cerebrovasculature.	The guidewire is contraindicatedfor use in the coronary arteriesand in the cerebrovasculature.
Anatomical sites	Left Ventricle	Left Ventricle
Materials of construction	Stainless Steel Wire withfluoropolymer outer jacket (FEP)and stainless-steel electrodes	Stainless Steel Wire withPolyetheretherketone outer jacket(PEEK) and stainless-steelelectrodes
Length	280 cm	280 cm
Wire OD	0.035"/0.89 mm	0.035"/0.89 mm
Method of Sterilization	Ethylene Oxide	Ethylene Oxide
Single Use or Reusable	Single Use	Single Use
Coating	Silicone Oil Lubricant	Hydrophilic coating
Radiopacity	Yes	Yes
Comparison of Technological Characteristics
Characteristic	Subject Device	Primary Predicate Device
	Wattson temporary pacingguidewire	Wattson temporary pacingguidewire
Tip Configuration	Pigtail	Pigtail
External PacemakerConnections	Removable guidewire adapterterminating in two shroudedpositive/negative connectors	Removable guidewire adapterterminating in two shroudedpositive/negative connectors andtwo unshrouded adapter pins
Pulse Generatorcompatibility	Compatible with standardexternal pulse generators	Compatible with standard externalpulse generators

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Performance Data

Biocompatibility

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
Intracutaneous Reactivity
Acute Systemic Toxicity ●
Pyrogenicity
Hemolysis
Complement Activation
Thrombogenicity

Performance Data - Bench

The device design was verified through performance, patient safety, structural integrity, infection, microbial and particulate contamination, and device interface tests.

Performance Data - Animal:

A Good Laboratory Practice (GLP) Safety study was performed to demonstrate the substantial equivalence of the Wattson temporary pacing guidewire in comparison to the predicate Wattson temporary pacing guidewire 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 device.

The GLP Safety study demonstrated that the Wattson temporary pacing guidewire performed similarly to the predicate with regard to adverse events and other animal health concerns. No animals

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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 subject device and its predicate.

Conclusion

Results of biocompatibility, benchtop, and animal studies performed on the Wattson temporary pacing guidewire did not raise any new questions of safety or effectiveness compared to the predicate device. The Wattson temporary pacing guidewire is substantially equivalent to the predicate device.

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.