K Number

Device Name

Wattson temporary pacing guidewire (2250)

Manufacturer

Vascular Solutions LLC

Date Cleared

2023-05-05

(59 days)

Product Code

DQX DOX LDF

Regulation Number

870.1330

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K192454

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical design, materials, and electrical function of a guidewire for pacing and device delivery. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

Yes
The device is described as "temporary pacing guidewire," and its function includes "transmitting an electrical signal from an external pulse generator to the heart" and "temporary pacing of the heart," which are therapeutic interventions.

Diagnostic

The device is designed for pacing the heart and delivering other interventional devices, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly details a physical guidewire with integrated electrodes, a hydrophilic coating, and a proprietary adapter, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Wattson temporary pacing guidewire is an invasive medical device used within the body to guide other devices and provide temporary electrical pacing to the heart. It does not analyze samples taken from the body.
Intended Use: The intended use clearly describes its function in introducing and positioning catheters and providing electrical pacing within the heart.
Device Description: The description details its physical characteristics, materials, and how it interacts with an external pulse generator, all related to its function as an invasive device.

Therefore, the Wattson temporary pacing guidewire falls under the category of an invasive therapeutic or interventional device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DQX, LDF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Left Ventricle

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 (

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

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

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 II
Secondary Product Code: LDF
Predicate Device	K192454, Wattson temporary pacing guidewire (Vascular Solutions LLC

Device Description

The Wattson temporary pacing guidewire is sterilized with ethylene oxide.

Indications for Use

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 pacing
guidewire	Wattson temporary pacing
guidewire
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.	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.
Contraindication	The guidewire is contraindicated
for use in the coronary arteries
and in the cerebrovasculature.	The guidewire is contraindicated
for use in the coronary arteries
and in the cerebrovasculature.
Anatomical sites	Left Ventricle	Left Ventricle
Materials of construction	Stainless Steel Wire with
fluoropolymer outer jacket (FEP)
and stainless-steel electrodes	Stainless Steel Wire with
Polyetheretherketone outer jacket
(PEEK) and stainless-steel
electrodes
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 pacing
guidewire	Wattson temporary pacing
guidewire
Tip Configuration	Pigtail	Pigtail
External Pacemaker
Connections	Removable guidewire adapter
terminating in two shrouded
positive/negative connectors	Removable guidewire adapter
terminating in two shrouded
positive/negative connectors and
two unshrouded adapter pins
Pulse Generator
compatibility	Compatible with standard
external pulse generators	Compatible with standard external
pulse generators

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 (