GTX 12 GIDEWIRE

K100470 · Medtronic, Inc. · DQX · Apr 21, 2010 · Cardiovascular

Device Facts

• Record ID: K100470
• Device Name: GTX 12 GIDEWIRE
• Applicant: Medtronic, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 21, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

Medtronic GTX Guidewires 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

Steerable guidewire; used in coronary and peripheral vasculature; facilitates placement of diagnostic/interventional devices; enables device exchange. Features corewire with spring coils; hemispherical tip; PTFE, silicone, or hydrophilic coatings for lubricity; radiopaque distal segment; proximal markers for position gauging. Used by clinicians in interventional procedures; fluoroscopic visualization. Benefits patient by enabling navigation to and crossing of vascular lesions.

Clinical Evidence

No clinical investigation performed. Evidence based on in-vitro bench testing (dimensional, tip stiffness, torque energy transfer, tip integrity, radiopacity, coating adhesion, lubricity/durability, insertion/extraction force) and simulated use (animal study). Biocompatibility testing performed on predicate materials per ISO 10993-1.

Technological Characteristics

Corewire with spring coils; hemispherical tip. Coatings: PTFE, silicone, or hydrophilic. Radiopaque distal segment. Proximal markers. Dimensions: 180cm nominal, 300cm exchange. Biocompatibility per ISO 10993-1. Mechanical testing per FDA guidance.

Indications for Use

Indicated for introduction and placement of diagnostic or interventional devices in coronary and peripheral vasculature; used to reach and cross target lesions; facilitates device substitution. 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

• Medtronic GTX Guidewire (K091582)

Reference Devices

• Medtronic GTX 15 (K091523)
• Medtronic Cougar XT (K032899)
• Medtronic GT1 (K983927)

Submission Summary (Full Text)

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## 510(k) Summary

| Submitter: | Medtronic Vascular<br>35-37A Cherry Hill Drive<br>Danvers, MA 01923 | APR 21 2016 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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: | April 19th, 2010 | |
| Trade Name: | Medtronic GTX Guidewires | |
| Common Name: | PTCA Guidewire | |
| Classification<br>Name: | Wire, Guide, Cardiovascular<br>21 CFR 1330, Product Code DQX | |
| Predicate Devices: | Medtronic GTX Guidewire (K091582) | |
| Device<br>Description: | The Medtronic GTX 12 guidewires are available in<br>nominal 180cm length and 300cm exchange length. They<br>are available with PTFE, silicone or hydrophilic coatings.<br>A portion of the distal length is opaque to allow for<br>visualization under fluoroscopy and markers are etched on<br>the proximal segment of the guide wire to aid in gauging<br>guide wire position relative to the guiding catheter tip. | |
| Statement of<br>Intended Use: | Medtronic GTX Guidewires are steerable guide wires that<br>are 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<br>lesion. Medtronic guide wires are not intended for use in<br>the cerebral vasculature. Medtronic steerable exchange<br>wires are used to facilitate the substitution of one diagnostic<br>or interventional device for another. | |

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Summary of Technological Characteristics: The Medtronic Vascular GTX 12 Guidewire consists of a corewire covered with spring coils and terminated in a hemispherical tip, which impart various characteristics to the 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. The technological characteristics of the Medtronic GTX-12 guidewire are identical to that of the Medtronic GTX guidewires (K091523).

## Summary of Nonclinical Data:

In-vitro bench testing was conducted according to the recommendations from relevant FDA guidance to demonstrate that the GTX 12 guidewire met the acceptance criteria and performed similarly to the predicate devices. As noted below, in some cases a bracketing sample strategy was chosen to support the test requirements. The in-vitro tests that were conducted to evaluate the performance of the GX 12 guidewire include:

| In-vitro Bench Testing<br>Performed | Product Tested |
|--------------------------------------------------------------------------|------------------------------------------------------|
| Dimensional—Diameter | Medtronic GTX 1<br>(K091582) and GTX 15 |
| Dimensional—Diameter (GTX<br>guidewires with a 0.009" tip<br>joint only) | Medtronic GTX 15 |
| Dimensional—Overall Length | Medtronic GTX 1<br>(K091582) and GTX 15 |
| Dimensional—Radiopaque<br>Length | Medtronic GTX 1<br>(K091582) and<br>Medtronic GTX 15 |
| Tip Column Stiffness | Medtronic GTX 12 |
| Tortuous Torque Energy<br>Transfer | Medtronic GTX 12 |
| Tip Integrity-Torsional | Medtronic GTX 1<br>(K091582) and GTX 15 |
| Tip Integrity-Strength | Medtronic GTX 1<br>(K091582) and GTX 15 |
| Radiopacity-Distal & Proximal | Medtronic GTX 1<br>(K091582) and GTX 15 |
| PTFE Coating Adhesion | Medtronic Cougar XT<br>(K032899) |
| Lubricity/ Durability | Medtronic Cougar XT<br>(K032899) |
| DOC Insertion and Extraction<br>Force (180 cm only) | Medtronic GT1<br>(K983927) |
| DOC Crimp Wire Stiffness<br>(180cm only) | Medtronic GT1<br>(K983927) |

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Due to shared materials of construction, biocompatibility testing was performed on the predicate Medtronic GTX guidewires (K091582) to satisfy the requirements of ISO 10993-1 Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing. The following biocompatibility tests were performed:

- IS0 Cytotoxicity Study .
- IS0 Maximization Sensitization Study .
- IS0 Intracutaneous Study Extract (SC & SO) �
- ISO/USP Systemic Toxicity Study (SC & SO) �
- USP Material Mediated Pyrogen Study .
- ASTM Hemolysis Study .
- Compliment Activation (C3a & SC5b-9) .
- In-vivo Thromboresistance Study .
- Plasma Recalcification �

Simulated Use Testing (Animal Study) was also performed using the GTX 12 guidewire.

No new safety or effectiveness issues were raised during the testing.

| Summary of<br>Clinical Data: | No clinical investigation has been performed for this<br>device. |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion from<br>Data: | Medtronic has demonstrated that the GTX 12 Guidewire is<br>substantially equivalent to the predicate devices based on<br>its indications for use and fundamental scientific<br>technology. Testing demonstrates that the GTX 12<br>Guidewire device is safe, effective and performs as well or<br>better then the predicate devices. |

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

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

APR 2 1 2010

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

Re: K100470

Trade/Device Name: Medtronic Vascular GTX 12 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 23, 2010 Received: March 25, 2010

## 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. 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

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Page 2 - Ms. Colleen Mullins

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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Sincerely vours.

ina R. hohner

Image /page/4/Picture/8 description: The image contains a handwritten symbol on the left and the words "Bra" and "Di" on the right. The symbol appears to be a combination of curved and angular lines, possibly representing a stylized signature or mark. The text is in a simple, sans-serif font and is vertically aligned.

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_K100470

Device Name: Medtronic GTX-12 Guidewires

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)

NANCY R. VICKNER

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K100470

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