(169 days)
No
The description focuses on the physical properties and materials of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guidewire used for positioning catheters and other interventional devices for diagnostic or interventional purposes, not for direct therapeutic treatment.
No
Explanation: The device description and intended use clearly state that the Endura guidewire is used for introducing and positioning catheters and other interventional devices during percutaneous procedures. It acts as a tool for facilitating interventional procedures, not for diagnosing conditions.
No
The device description clearly outlines physical components like a core wire, radiopaque coil, and coatings (hydrophilic and PTFE), indicating it is a hardware device, not software-only.
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/or peripheral vasculature." This describes a device used within the body for a procedural purpose, not a device used outside the body to examine specimens from the body.
- Device Description: The description details a physical guidewire with specific materials and coatings, designed to be inserted into blood vessels. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This guidewire is a tool used during a medical procedure to facilitate the delivery of other devices.
N/A
Intended Use / Indications for Use
The Endura guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Endura guidewire is a straight tip guidewire with a maximum outer diameter of 0.014" available in 190 cm and 300 cm lengths. The Endura guidewire consists of a bi-metal stainless steel and nitinol core wire covered on the distal end by a radiopaque coil at the distal end of the Endura guidewire has a hydrophilic coating (HPC) and the proximal end is coated with polytetrafluoroethylene (PTFE). The 190 cm length model is compatible with a guidewire extension.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or 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 technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests and results did not raise new questions of safety or effectiveness. The device design has been verified through the following tests:
- Tensile Strength ●
- Torque Strength
- Torque Response (Torqueability) ●
- Guidewire Support Profile
- Tip Load (Tip Flexibility)
- Fracture Resistance
- Flex Resistance
- Hydrophilic Coating Particulate (Coating Adherence/Integrity)
- PTFE Coating Adhesion (Coating Adherence/Integrity)
- Corrosion Resistance
- Track Force
- Friction Force (HPC and PTFE) .
- Fluoroscopy Visualization
- Length Extension
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity
- Sensitization
- . Irritation/Intracutaneous Reactivity
- Systemic Toxicity
- Pyrogenicity
- Hemocompatibility
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues.
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.
K151234 - R350 guidewire (Vascular Solutions, Inc.)
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.
K063695 - Runthrough NS guidewire (Terumo Medical Corp.), K052339 - MiracleBros 6 (Asahi Intecc Co., Ltd.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2016
Vascular Solutions, Inc. Beka Vite Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K161702
Trade/Device Name: Endura Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 3, 2016 Received: November 4, 2016
Dear Beka Vite:
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, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely.
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Endura guidewire
Indications for Use (Describe)
The Endura guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or 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]
Date Prepared: December 2, 2016
510(k) Number: K161702
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 | Endura guidewire |
| Common / Usual Name | Guidewire |
| Classification Name | 21 CFR 870.1330, Catheter Guidewire (DQX) |
| Predicate Device | K151234 - R350 guidewire (Vascular Solutions, Inc.) |
| Reference Device | K063695 - Runthrough NS guidewire (Terumo Medical Corp.) |
| K052339 - MiracleBros 6 (Asahi Intecc Co., Ltd.) |
Device Description
The Endura guidewire is a straight tip guidewire with a maximum outer diameter of 0.014" available in 190 cm and 300 cm lengths. The Endura guidewire consists of a bi-metal stainless steel and nitinol core wire covered on the distal end by a radiopaque coil at the distal end of the Endura guidewire has a hydrophilic coating (HPC) and the proximal end is coated with polytetrafluoroethylene (PTFE). The 190 cm length model is compatible with a guidewire extension.
Intended Use
The Endura guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.
4
Technological Characteristics Comparison
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Endura Guidewire | R350 Guidewire | |
| (K151234, VSI) | ||
| Indications for Use | ...for use in percutaneous procedures to introduce and position catheters and other | |
| interventional devices within the coronary and/or peripheral vasculature. | ||
| Anatomical Location | Coronary and peripheral vasculature | |
| Dimensions | Maximum O.D.: 0.014" | |
| Length: 190 cm and 300 cm | Maximum O.D.: 0.013" | |
| Length: 350 cm | ||
| Core Wire | Nitinol and Stainless Steel | Nitinol |
| Distal Tip | 3 cm radiopaque coil | 5 cm radiopaque coil |
| Lubricious Coatings | Hydrophilic (distal end) and PTFE (proximal end) | |
| Sterility | Ethylene Oxide (EO) – Sterility Assurance Level (SAL) 10-6 |
The table below compares the technological characteristics of the Endura guidewire.
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests and results did not raise new questions of safety or effectiveness. The Endura guidewire is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
- Tensile Strength ●
- Torque Strength
- Torque Response (Torqueability) ●
- Guidewire Support Profile
- Tip Load (Tip Flexibility)
- Fracture Resistance
- Flex Resistance
- Hydrophilic Coating Particulate (Coating Adherence/Integrity)
- PTFE Coating Adhesion (Coating Adherence/Integrity)
- Corrosion Resistance
- Track Force
- Friction Force (HPC and PTFE) .
- Fluoroscopy Visualization
- Length Extension
5
The only evaluation that was not performed on the modified guidewire was package integrity as it is identical to the predicate device. Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity
- Sensitization
- . Irritation/Intracutaneous Reactivity
- Systemic Toxicity
- Pyrogenicity
- Hemocompatibility
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore the Endura guidewire, a modified version of the R350, is considered substantially equivalent to the predicate device.