(69 days)
Not Found
No
The description focuses on the physical components and mechanical performance of a guide wire, with no mention of AI or ML.
No.
The device is a guide wire used for the introduction and placement of diagnostic or interventional devices, primarily to facilitate medical procedures rather than directly administering therapy itself.
No
The device is a steerable guide wire used for the introduction and placement of diagnostic or interventional devices, but it is not itself a diagnostic device. Its function is to facilitate the use of other devices, some of which may be diagnostic.
No
The device description clearly lists physical components like hypotube, core wire, spring, and forming member, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 guidance, not for testing samples outside the body.
- Device Description: The description details the physical components of a guide wire used for navigation within blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic testing.
Therefore, the GT2 Fusion Guide Wire is a medical device used for interventional and diagnostic procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GT2 Fusion 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. The GT2 Fusion Guide Wires are not intended for use in the cerebral vasculature. GT2 Fusion steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Product codes
74 DQX
Device Description
The major components of the device include the hypotube, core wire, spring, and forming member. The Medtronic® GT2 Fusion Guide Wire is similar in performance to the predicate devices. These wires will be available in: .014" diameter 180cm & 300 cm in length Straight and "J" tip configurations PTFE coating with Pro/Pel coating and PTFE coating with hydrophilic coating on the distal 60 cm.
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
In-vitro performance testing of the guidewire included dimensional inspection, tensile strength, torque strength, coating adhesion and durability, tip whip, tip stiffness and distal trackability. Test results verified that the Medtronic® GT2 Fusion Guide Wires meet all of the applicable specifications and are deemed adequate for the intended use. All appropriate biocompatibility tests, with the exception of sensitization, which will be available on July 12, 1999, were successfully performed on the materials used for the Medtronic® GT2 Fusion Guide Wires.
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
SEP 9 1999
992237
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990) 7/1/99
- Medtronic, Inc. Submitted by: 1. 37 A Cherry Hill Drive Danvers MA 01923
- Fred Boucher 2. Contact Name: Regulatory Affairs Manager (978) 777-0042
- Medtronic® GT2 Fusion Guide Wire. Trade or Proprietary Name: 3. Common/Classification Name: Catheter Guide Wire Name of Predicate Device: AVE GT1 Guide Wire Classification: Class II These wires will be available in: .014" diameter 180cm & 300 cm in length Straight and "J" tip configurations PTFE coating with Pro/Pel coating and PTFE coating with hydrophilic coating on the distal 60 cm.
- GT2 Fusion Guide Wires are steerable guide wires that are used for the introduction and placement of 4 diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The GT2 Fusion Guide Wires are not intended for use in the cerebral vasculature. GT2 Fusion steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
- 5 The major components of the device include the hypotube, core wire, spring, and forming member. The Medtronic® GT2 Fusion Guide Wire is similar in performance to the predicate devices.
- б All appropriate biocompatibility tests, with the exception of sensitization, which will be available on July 12, 1999, were successfully performed on the materials used for the Medtronic® GT2 Fusion Guide Wires.
- 7 In-vitro performance testing of the guidewire included dimensional inspection, tensile strength, torque strength, coating adhesion and durability, tip whip, tip stiffness and distal trackability. Test results verified that the Medtronic® GT2 Fusion Guide Wires meet all of the applicable specifications and are deemed adequate for the intended use. The Medtronic™ GT2 Fusion Guide Wire is considered to be substantially equivalent to the following devices:
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human face in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 9 1999
Mr. Fred Boucher Medtronic, Inc. 37 A Cherry Hill Drive Danvers, MA 01923
K992237 Re: Medtronic® GT2 Fusion Guide Wire Requlatory Class: II (two) Product Code: 74 DQX Dated: August 26, 1999 Received: August 27, 1999
Dear Mr. Boucher:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Fred Boucher
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
To be assigned by FDA 510(k) Number: Medtronic GT2 Fusion Guide Wire Device Name: GT2 Fusion Guide Wires are steerable guide wires that are Indications for Use: 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. The GT2 Fusion Guide Wires are not intended for use in the cerebral vasculature. GT2 Fusion steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
043
Christopher Alfor Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devi 510(k) Number