Spectre guidewire

K163444 · Vascular Solutions, Inc. · DQX · Jan 6, 2017 · Cardiovascular

Device Facts

• Record ID: K163444
• Device Name: Spectre guidewire
• Applicant: Vascular Solutions, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 6, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

Device Story

Spectre guidewire is a 0.014" diameter, straight-tip device available in 190 cm and 300 cm lengths; used in percutaneous procedures to introduce and position catheters/interventional devices within coronary and peripheral vasculature. Construction includes bi-metal stainless steel and nitinol core wire, distal radiopaque coil, distal hydrophilic coating, and proximal PTFE coating. Operated by physicians in clinical settings (e.g., cath lab) to navigate vasculature; provides mechanical support and guidance for interventional tools. Benefits include facilitated access to target anatomy during minimally invasive procedures.

Clinical Evidence

Bench testing only. Verification testing included track force and guidewire support profile. Results met all specified acceptance criteria.

Technological Characteristics

Core: Nitinol and stainless steel. Tip: 3 cm radiopaque coil. Coatings: Distal hydrophilic, proximal PTFE. Dimensions: 0.014" O.D., 190/300 cm lengths. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Connectivity: None (mechanical device).

Indications for Use

Indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature in patients requiring such interventions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Endura guidewire (K161702)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2017

Vascular Solutions, Inc. Beka Vite Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K163444

Trade/Device Name: Spectre Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 7, 2016 Received: December 9, 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 (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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando Aguel
Fernando Aguel
-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) K163444

Device Name Spectre guidewire

Indications for Use (Describe)

The Spectre guidewire is intended for use in percutaneous procedures to introduce and position cather 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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#### 2 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: December 7, 2016 K163444 510(k) Number:

## Submit t er'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: [phone] Fax: [phone]

## General Information

| Trade Name | Spectre guidewire |
|---------------------|-------------------------------------------|
| Common / Usual Name | Guidewire |
| Classification Name | 21 CFR 870.1330, Catheter Guidewire (DQX) |
| Predicate Device | K161702 – Endura guidewire (VSI) |

## Device Description

The Spectre guidewire is a straight tip guidewire with a maximum outer diameter of 0.014" available in 190 cm and 300 cm lengths. The Spectre guidewire consists of a bi-metal stainless steel and nitinol core wire covered on the distal end by a radiopaque coil at the distal tip. The distal end of the Spectre 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 Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

## Technological Characteristics Comparison

The table below compares the technological characteristics of the Spectre guidewire.

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| | Subject Device | Predicate Device |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Characteristic | Spectre Guidewire | Endura Guidewire<br>(K161702, VSI) |
| Indications for Use | Intended for use in percutaneous<br>procedures to introduce and position<br>catheters and other interventional<br>devices within the coronary and/or<br>peripheral vasculature. | Same |
| Anatomical Location | Coronary and peripheral vasculature | Same |
| Dimensions | Maximum O.D.: 0.014"<br>Length: 190 cm and 300 cm | Same |
| Core Wire | Nitinol and Stainless Steel | Same |
| Distal Tip | 3 cm radiopaque coil | Same |
| Lubricious Coatings | Hydrophilic (distal end) and PTFE<br>(proximal end) | Same |
| Sterility | Ethylene Oxide (EO) – Sterility<br>Assurance Level (SAL) 10-6 | Same |

## Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence that the Spectre guidewire is substantially equivalent to the predicate device. The Spectre 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:

- . Track Force
- Guidewire Support Profile

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the modified Spectre guidewire is substantially equivalent to the predicate device.