(128 days)
Not Found
No
The description focuses on the mechanical and electrical properties of a guidewire for pacing and device delivery. There is no mention of data processing, algorithms, or learning capabilities.
Yes
The device is described as a "temporary pacing guidewire" that transmits an "electrical signal from an external pulse generator to the heart," directly indicating a therapeutic function of delivering electrical therapy.
No
The device is designed to introduce and position catheters and other interventional devices within the heart and transmit an electrical signal for temporary rapid pacing, not to identify or monitor a disease state.
No
The device description clearly outlines a physical guidewire with integrated electrodes, a silicone lubricant, and a proprietary adapter. It is a hardware device used for both device delivery and temporary pacing.
Based on the provided information, the Wattson™ temporary pacing guidewire is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for introducing and positioning catheters and other interventional devices within the heart and for transmitting an electrical signal for temporary pacing. This is a direct interaction with the patient's body for a therapeutic and procedural purpose.
- Device Description: The description details a physical guidewire with electrodes designed to be inserted into the heart.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The Wattson temporary pacing guidewire does not perform this function. It is an invasive medical device used directly within the patient's circulatory system for procedural support and temporary pacing.
N/A
Intended Use / 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.
Product codes
DQX, LDF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic
Anatomical Site
chambers of the heart, 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 Testing: The biocompatibility evaluation for the Wattson temporary pacing guidewire was conducted in accordance with the International Standard ISO 10993-1. The Wattson temporary pacing guidewire is considered an externally communicating device in contact with circulating blood and tissue for a limited period of time (
§ 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.
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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
1
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)
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) | |
|---|---|
| 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
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:
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Substantial Equivalence Comparison
| Characteristic | Subject Device | Primary Predicate
Device | Secondary Predicate
Device |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Wattson temporary
pacing guidewire | Confida Guidewire | Temporary Pacing
Electrode Catheter |
| 510(k) | K19XXXXX | K181001 | K800298 |
| Manufacturer | Vascular Solutions | Medtronic | Bard |
| Product Class | II | II | II |
| Product
Classification | 870.1330 | 870.1330 | 870.3680 |
| Product Code | DQX; LDF | DQX | LDF |
| Indications for Use | The WattsonTM
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 Medtronic
ConfidaTM Brecker
guidewire is intended
for use to introduce
and position catheters
during diagnostic and
interventional
procedures within the
chambers of the heart,
including transcatheter
aortic valve
replacement (TAVR). | Bard® Temporary Pacing
Catheters are designed to
transmit an electrical
signal from an external
pulse generator to the
heart or from the heart to
a monitoring device.
When an internal lumen
is present (other than the
one used for balloon
inflation), it may be used
for fluid infusion,
pressure monitoring, or
blood sampling. |
| Contraindication | The guidewire is
contraindicated for use
in the coronary arteries
and in the
cerebrovasculature. | The Medtronic
ConfidaTM Brecker
Guidewire is
contraindicated for
patients presenting
with an intolerance to
anticoagulation
therapy and | None |
| Characteristic | Subject Device | Primary Predicate
Device | Secondary Predicate
Device |
| | Wattson temporary
pacing guidewire | Confida Guidewire | Temporary Pacing
Electrode Catheter |
| | | unheparinized
patients. The
guidewire is
contraindicated for use
in the coronary arteries
and in the
cerebrovasculature. | |
| Anatomical sites | Left Ventricle | Left Ventricle | Right Ventricle |
| Materials of
construction | Stainless Steel Wire
with fluoropolymer
jacket and stainless-steel
electrodes | Stainless Steel wire
with fluoropolymer
coating. | Woven or extruded
polyurethane jacketed
shaft with platinum or
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
Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Single Use or
Reusable | Single Use | Single Use | Single Use |
| Coating | Fluropolymer outer
Jacket (FEP) with
Silicone Oil Lubricant. | Fluoropolymer (PTFE)
coating | Polyurethane Outer
Jacket |
| Radiopacity | Yes | Yes | Yes |
| Tip Configuration | Pigtail | Preformed 360°
curved tip (pigtail) | Straight, Preshaped
angle tip |
| External
Pacemaker
Connections | Removable guidewire
adapter terminating in
two shrouded
positive/negative
connectors | N/A | Two incorporated
shrouded
positive/negative
connectors. |
| Pulse Generator
compatibility | Compatible with
standard external pulse
generators | N/A | Compatible with
standard external pulse
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 (