(30 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a guidewire, with no mention of AI or ML capabilities.
No.
The device is a guidewire, which is used to facilitate the placement of other interventional devices, rather than directly providing therapy itself.
No
Explanation: The Warrior 14 guidewire is described as being used to introduce and position other devices, not to diagnose conditions. Its function is procedural (interventional), not diagnostic.
No
The device description clearly describes a physical guidewire made of stainless steel with coatings and specific dimensions, intended for physical insertion into the vasculature. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature." This describes a device used within the body during a medical procedure, not a device used to test samples outside the body.
- Device Description: The description details a physical guidewire with specific dimensions, coatings, and features designed for navigating blood vessels. This is consistent with an interventional medical device, not an IVD.
- Anatomical Site: The specified anatomical site is the "coronary and peripheral vasculature," which are locations within the human body. IVDs typically analyze samples taken from the body (like blood, urine, tissue) but don't operate directly within these anatomical sites.
- Performance Studies: The performance studies focus on biocompatibility and bench testing related to the physical properties and function of the guidewire (e.g., tensile strength, torqueability, coating adherence). These are relevant to the safety and effectiveness of a device used in a medical procedure, not the analytical performance of a diagnostic test.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This guidewire does not fit that description.
N/A
Intended Use / Indications for Use
The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature.
Product codes
DQX
Device Description
The Warrior 14 guidewire is a 0.014" diameter stainless steel core guidewire with a 0.009" diameter tapered distal tip. The distal 20cm of the guidewire has a spring coil, of which the distal 2.5cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. It is available in 190cm and 300cm lengths. The proximal end of the 190cm version has a guidewire extension feature. The Warrior 14 guidewire is intended for single use and sterilized with ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic methods
Anatomical Site
coronary and peripheral vasculature
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 Warrior 14 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 Warrior 14 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
February 16, 2018
Vascular Solutions. Inc % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K180128
Trade/Device Name: Warrior 14 guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: January 14, 2018 Received: January 17, 2018
Dear Mark Job:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Warrior 14 guidewire
Indications for Use (Describe)
The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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]
K180128 510(k) NUMBER:
SUBMITTER
Vascular Solutions 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Phone: 763-656-4300 Fax: 763-656-4253 Contact Person: Becky Astrup, Regulatory Product Specialist Date Prepared: December 8, 2017
DEVICE
Name of Device: Warrior 14 guidewire Common or Usual Name: Catheter Guidewire Classification Name: Catheter Guidewire (21 CFR 870.1330) Regulatory Class: II Product Code: DQX
PREDICATE/REFERENCE DEVICES
The legally marketed devices to which substantial equivalence is claimed is:
Vascular Solutions Spectre guidewire, K163444 (cleared January 6, 2017)
The Asahi Confianza Pro 12 guidewire, K041531 (cleared August 3, 2004) and the Vascular Solutions R350 guidewire, K151234 (cleared November 18, 2015) are included as reference devices for this submission.
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DEVICE DESCRIPTION
The Warrior 14 guidewire is a 0.014" diameter stainless steel core guidewire with a 0.009" diameter tapered distal tip. The distal 20cm of the guidewire has a spring coil, of which the distal 2.5cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. It is available in 190cm and 300cm lengths. The proximal end of the 190cm version has a guidewire extension feature. The Warrior 14 guidewire is intended for single use and sterilized with ethylene oxide.
INDICATIONS FOR USE
The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The table below compares the technological characteristics of the Warrior 14 guidewire and, Spectre guidewire predicate.
| Characteristic | Subject Device:
Warrior 14 | Predicate Device:
Spectre |
|------------------------------|-------------------------------|----------------------------------------|
| Maximum Diameter | 0.014'' | Identical |
| Lengths | 190cm, 300cm | Identical |
| Tip Configuration | Straight, Shapeable | Identical |
| Lubricious Coating- Distal | Hydrophilic | Identical |
| Lubricious Coating- Proximal | PTFE | Identical |
| Core Wire Material | Stainless Steel | Similar
Nitinol and Stainless Steel |
| Radiopaque Material | Platinum, Tungsten | Identical |
| Radiopaque Tip Length | 2.5cm | Equivalent
3cm |
| Tip O.D. | 0.009" | Similar
0.014" |
| Tip Load | 14g | Similar