GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15

K091582 · Medtronic Vascular · DQX · Dec 4, 2009 · Cardiovascular

Device Facts

• Record ID: K091582
• Device Name: GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
• Applicant: Medtronic Vascular
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Device Story

GTX Guidewire is a steerable guidewire used by clinicians to navigate coronary and peripheral vasculature; facilitates introduction/placement of diagnostic or interventional devices; enables substitution of devices via exchange wire functionality. Device consists of corewire, spring coils, and hemispherical tip; features hydrophilic/hydrophobic coatings for lubricity; includes proximal markers for positioning relative to guiding catheter. Used in clinical settings; provides mechanical support and guidance for interventional procedures; benefits patient by enabling access to target lesions.

Clinical Evidence

No clinical investigation has been performed for this device. Bench testing only.

Technological Characteristics

Corewire with spring coils and hemispherical tip; hydrophilic and hydrophobic coatings; proximal markers for position gauging. Steerable design. No software or electronic components.

Indications for Use

Indicated for patients requiring introduction and placement of diagnostic or interventional devices in coronary and peripheral vasculature; may be used to reach and cross target lesions. Contraindicated for use in cerebral vasculature.

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

• GT2 Fusion Guidewire (K001969)
• Radius PTCA Guidewire (K970466)

Submission Summary (Full Text)

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## 510(k) Summary .

· DEC - 4 2009

| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Colleen Mullins<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Alternate Contact | Fred Boucher<br>Director of Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | May 29, 2009 |
| Trade Name: | GTX Guidewire |
| Common Name: | PTCA Guidewire |
| Classification<br>Name: | Wire, Guide, Cardiovascular |
| Predicate Devices: | GT2 Fusion Guidewire (K001969)<br>Radius PTCA Guidewire (K970466) |
| Device<br>Description: | The Medtronic GTX Guidewire are steerable guide wires<br>available in a variety of stiffnesses with available hydrophilic<br>and hydrophobic coatings, which allow for the introduction<br>and placement of diagnostic or interventional devices in the<br>coronary and peripheral vasculature. |
| Statement of<br>Intended Use: | Medtronic GTX guide wires are steerable guide wires that are<br>used for the introduction and placement of diagnostic or<br>interventional devices in the coronary and peripheral<br>vasculature and may be used to reach and cross a target lesion.<br>Medtronic guide wires are not intended for use in the cerebral<br>vasculature. Medtronic steerable exchange wires are used to<br>facilitate the substitution of one diagnostic or interventional<br>device for another. |
| Summary of<br>Technological<br>Characteristics: | The Medtronic Vascular GTX Guidewire consists of a<br>corewire covered with spring coils and terminated in a<br>hemispherical tip, which impart various characteristics to the |

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distal tip of the wire, such as tip stiffness. Wire coatings provide sufficient lubricity to reach and cross target lesions. Markers on the proximal portion of the corewire aid in gauging guide wire position relative to the guiding catheter tip.

Summary of Nonclinical Data:

The Medtronic GTX Gudiewire has successfully passed all verification testing.

Summary of Clinical Data: No clinical investigation has been performed for this device.

Conclusion from Data:

Medtronic has demonstrated that the GTX Guidewire is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three flowing lines representing its wings or feathers. The bird is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC - 4 2009

Medtronic Vascular c/o Ms. Colleen Mullins Senior Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923

Re: K091582

Trade/Device Name: GTX Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II (two) Product Code: DQX Dated: October 30, 2009 Received: November 2, 2009

Dear Ms. Mullins:

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.

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.

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Page 2 – Ms. Colleen Mullins

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

una R. Vicher

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 Kb91582

Device Name: GTX Guidewire

Indications for Use:

Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Wma P. de Lunes

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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_K 69/ 58 C