← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K091582 # GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 (K091582) _Medtronic Vascular · DQX · Dec 4, 2009 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K091582 ## Device Facts - **Applicant:** Medtronic Vascular - **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md) - **Decision Date:** Dec 4, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1330 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## 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. ## 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. ## Regulatory 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](/device/K001969.md)) - Radius PTCA Guidewire ([K970466](/device/K970466.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ . ## 510(k) Summary . · DEC - 4 2009 | Submitter: | Medtronic Vascular
37A Cherry Hill Drive | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Colleen Mullins
Senior Regulatory Affairs Specialist
Phone: (978) 739-3267
Fax: (978) 739-7380 | | Alternate Contact | Fred Boucher
Director of Regulatory Affairs
Phone: (978) 739-3116
Fax: (978) 739-7380 | | Date Prepared: | May 29, 2009 | | Trade Name: | GTX Guidewire | | Common Name: | PTCA Guidewire | | Classification
Name: | Wire, Guide, Cardiovascular | | Predicate Devices: | GT2 Fusion Guidewire (K001969)
Radius PTCA Guidewire (K970466) | | Device
Description: | The Medtronic GTX Guidewire are steerable guide wires
available in a variety of stiffnesses with available hydrophilic
and hydrophobic coatings, which allow for the introduction
and placement of diagnostic or interventional devices in the
coronary and peripheral vasculature. | | Statement of
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. | | Summary of
Technological
Characteristics: | The Medtronic Vascular GTX Guidewire consists of a
corewire covered with spring coils and terminated in a
hemispherical tip, which impart various characteristics to the | {1}------------------------------------------------ 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. {2}------------------------------------------------ ## 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. {3}------------------------------------------------ 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 (800) 638-2041 or (240) 276-3150 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 {4}------------------------------------------------ ## 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 Page 1 of | (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_K 69/ 58 C --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K091582](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K091582) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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