(185 days)
Not Found
No
The 510(k) summary describes a physical medical device (guidewire) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The description focuses on the mechanical properties and materials of the guidewire.
No
The device is a steerable guide wire used to introduce and place diagnostic or interventional devices, not to provide therapy itself.
No
The device is a guidewire used to introduce and place diagnostic or interventional devices, not to diagnose conditions itself.
No
The device description clearly describes a physical guide wire with corewire, spring coils, tip, coatings, and markers, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guide wires are used for the "introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature." This describes a device used within the body for procedural purposes, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details the physical components of the guide wire (corewire, spring coils, tip, coatings, markers) and their function in facilitating the placement of other devices within the vasculature. This aligns with an interventional or procedural device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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