(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 guidewire is used to introduce and position other devices, not to treat a condition itself.
No
The device is a guidewire used to introduce and position other medical devices, not to diagnose a condition.
No
The device description clearly describes a physical guidewire made of stainless steel and other materials, with specific dimensions and coatings. The performance studies listed are also related to the physical properties and biocompatibility of a hardware device.
Based on the provided information, 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 for medical procedures, not a device used to examine specimens outside the body to diagnose conditions.
- Device Description: The description details a physical guidewire with coatings and a radiopaque coil, designed for insertion into blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Raider guidewire is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DOX
Device Description
The Raider guidewire is a stainless steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 190 cm and 300 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
The device design has been verified through the following tests:
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Coating Adherence/Integrity
- Catheter Compatibility
- Dimensional Analysis
- Radiopacity
- Corrosion
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemolysis
- Complement Activation
- Thrombogenicity
Performance data demonstrate that the Raider guidewire is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Spectre Guidewire (K163444 - Vascular Solutions, Inc.; January 6, 2017)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Hi-Torque Pilot 200 (K101116 – Abbott Vascular; June 23, 2010), R350 Guidewire (K151234 - Vascular Solutions, Inc.; November 18, 2015)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
December 15, 2017
Vascular Solutions, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K173532
Trade/Device Name: Raider Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: November 13, 2017 Received: November 15, 2017
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 Mav 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, 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 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 (QS) regulation (21 CFR Part 820);
1
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 mediation-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 Raider guidewire
Indications for Use (Describe)
The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
| 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 |
| | 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: October 20, 2017
510(k) Number: __K173532
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Beka Vite Sr. Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-656-4253
General Information
| Trade Name | Raider guidewire |
|---|---|
| Common / Usual Name | Guidewire |
| Classification Name | 21 CFR 870.1330 |
| Predicate Device | Spectre Guidewire (K163444 - Vascular Solutions, Inc.; January 6, 2017) |
| Reference Device | Hi-Torque Pilot 200 (K101116 – Abbott Vascular; June 23, 2010) |
| R350 Guidewire (K151234 - Vascular Solutions, Inc.; November 18, 2015) |
Device Description
The Raider guidewire is a stainless steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 190 cm and 300 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.
Intended Use
The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
Technological Characteristics Comparison
The table below compares the technological characteristics of the Raider guidewire and the predicate device.
| Characteristic | Raider Guidewire | Predicate Device |
|---|---|---|
| Maximum Diameter | 0.014" | Same |
| Lengths | 190 cm, 300 cm | Same |
| Core Wire Material | Stainless Steel with Distal | |
| Polymer Jacket | Nitinol and Stainless Steel | |
| Distal Tip | Radiopaque Coil | Same |
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| Characteristic | Raider Guidewire | Predicate Device |
|---|---|---|
| Lubricious Coatings | Hydrophilic (Distal) | |
| PTFE (Proximal) | Same |
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of substantial equivalence for the Raider guidewire. The device design has been verified through the following tests:
- Tensile Strength
- Torque Strength
- Torqueability
- . Tip Flexibility
- . Coating Adherence/Integrity
- Catheter Compatibility
- Dimensional Analysis
- Radiopacity
- Corrosion
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- . Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- . Material Mediated Pyrogenicity
- Hemolysis
- Complement Activation
- . Thrombogenicity
The Raider guidewire is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The minor technological and material differences between the Raider guidewire and the predicate device raise no new questions of safety or effectiveness. Performance data demonstrate that the Raider guidewire is as safe, as effective, and performs as well as the predicate device. Therefore, it can be concluded that the Raider guidewire is substantially equivalent to the predicate device.