(69 days)
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
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.
The provided text describes a 510(k) summary for the Medtronic® GT2 Fusion Guide Wire, a medical device for use in the coronary and peripheral vasculature. The information primarily focuses on the device's technical specifications and a comparison to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria.
Therefore, many of the requested details, such as the use of experts, adjudication methods, multi-reader multi-case studies, and ground truth for training sets, are not applicable or not provided in this document as they are typically associated with performance evaluation of diagnostic or AI-driven devices. This document refers to in-vitro performance testing rather than clinical or AI-related studies.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests/Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Biocompatibility tests (except sensitization) | All appropriate tests successfully performed on materials. (Sensitization results pending as of July 12, 1999) |
| Physical Dimensions | Dimensional inspection | Met all applicable specifications. |
| Mechanical Strength | Tensile strength | Met all applicable specifications. |
| Torque strength | Met all applicable specifications. | |
| Coating Integrity | Coating adhesion | Met all applicable specifications. |
| Coating durability | Met all applicable specifications. | |
| Distal Performance | Tip whip | Met all applicable specifications. |
| Tip stiffness | Met all applicable specifications. | |
| Distal trackability | Met all applicable specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the in-vitro performance testing. The document states "In-vitro performance testing of the guidewire included..." but does not give specific numbers of units tested for each criterion.
- Data Provenance: The tests were "in-vitro," meaning conducted in a laboratory setting, not on patient data. There is no mention of country of origin for any data or whether it was retrospective or prospective, as these terms are relevant for clinical or observational studies on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This document describes engineering performance tests for a physical device, not a diagnostic or AI device requiring expert-established ground truth from, for example, medical images.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically for image-based diagnostic evaluations. This is not mentioned as part of the in-vitro performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is a type of clinical study used to evaluate the performance of diagnostic tests (often involving human readers and AI systems). This document focuses on the in-vitro physical and mechanical performance of a guide wire, not a diagnostic or AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm. The tests are for a physical guide wire.
7. The Type of Ground Truth Used
- Engineering Specifications/Standards: The "ground truth" for the in-vitro tests would be the pre-defined engineering specifications and performance standards that the guide wire was designed to meet (e.g., a specific tensile strength value, acceptable range for tip whip). The report states, "Test results verified that the Medtronic® GT2 Fusion Guide Wires meet all of the applicable specifications."
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
{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
§ 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.