(169 days)
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.
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.
The Endura Guidewire is a medical device intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | Not explicitly stated, but implicitly passes performance testing | Passed |
| Torque Strength | Not explicitly stated, but implicitly passes performance testing | Passed |
| Torque Response (Torqueability) | Not explicitly stated, but implicitly passes performance testing | Passed |
| Guidewire Support Profile | Not explicitly stated, but implicitly passes performance testing | Passed |
| Tip Load (Tip Flexibility) | Not explicitly stated, but implicitly passes performance testing | Passed |
| Fracture Resistance | Not explicitly stated, but implicitly passes performance testing | Passed |
| Flex Resistance | Not explicitly stated, but implicitly passes performance testing | Passed |
| Hydrophilic Coating Particulate (Coating Adherence/Integrity) | Not explicitly stated, but implicitly passes performance testing | Passed |
| PTFE Coating Adhesion (Coating Adherence/Integrity) | Not explicitly stated, but implicitly passes performance testing | Passed |
| Corrosion Resistance | Not explicitly stated, but implicitly passes performance testing | Passed |
| Track Force | Not explicitly stated, but implicitly passes performance testing | Passed |
| Friction Force (HPC and PTFE) | Not explicitly stated, but implicitly passes performance testing | Passed |
| Fluoroscopy Visualization | Not explicitly stated, but implicitly passes performance testing | Passed |
| Length Extension | Not explicitly stated, but implicitly passes performance testing | Passed |
| Cytotoxicity (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Sensitization (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Irritation/Intracutaneous Reactivity (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Systemic Toxicity (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Pyrogenicity (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Hemocompatibility (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Sterility | Sterility Assurance Level (SAL) 10-6 via Ethylene Oxide (EO) sterilization | Achieved SAL 10-6 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each individual performance test or biocompatibility test. It mentions that "device samples" passed the biocompatibility tests and that the design was "verified through the following tests." The data provenance can be inferred as originating from Vascular Solutions, Inc., USA, the manufacturer of the device, through prospective testing conducted to demonstrate the device's performance and safety.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This section is not applicable as the Endura Guidewire is a physical medical device. The "ground truth" for its performance and safety is established through laboratory and bench testing, as well as biocompatibility assessments, rather than expert interpretation of data or images.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, which is not the case for the pre-market testing of this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. An MRMC study is relevant for AI algorithms or diagnostic tools where human reader performance is being evaluated with and without AI assistance. The Endura Guidewire is a physical interventional device, not a diagnostic or AI-powered system.
6. Standalone (Algorithm Only) Performance:
This section is not applicable. The Endura Guidewire is a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply.
7. Type of Ground Truth Used:
The ground truth for the Endura Guidewire's performance is based on:
- Engineering specifications and test methodologies: Each performance test (e.g., tensile strength, torque response, flexibility, coating adherence) has predefined engineering benchmarks and standards that the device must meet.
- Biocompatibility standards: Compliance with ISO 10993-1 guidelines for biological evaluation of medical devices.
- Sterilization standards: Achieving a Sterility Assurance Level (SAL) of 10-6.
8. Sample Size for the Training Set:
This section is not applicable. The Endura Guidewire is a physical medical device and does not involve AI or machine learning, therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable as there is no training set for this device.
{0}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 otherinterventional 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.
§ 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.