(126 days)
Not Found
No
The summary describes a physical medical device (guide wires) and its intended use and performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No
The device is described as a steerable guide wire used for the introduction and placement of diagnostic or interventional devices, not for direct therapeutic action.
No
The device description clearly states that these guide wires are "used for the introduction and placement of diagnostic or interventional devices," indicating they are tools for other devices, not diagnostic devices themselves.
No
The device description clearly identifies the device as "steerable guide wires," which are physical, hardware components used in medical procedures. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes the AVE guide wires as devices used for the "introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature." They are physical tools used within the body to facilitate procedures.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze biological samples or provide diagnostic information based on such analysis.
The device described is an invasive medical device used for procedural guidance and support within the vascular system.
N/A
Intended Use / Indications for Use
The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support 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 GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are not intended for use in the cerebral vasculature.
Product codes
DQT
Device Description
The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support 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 GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are not intended for use in the cerebral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted on the GT1 Floppy and GT1 Hi-Per Flex guide wires and compared to the predicate devices. This bench testing supports the effectiveness of the GT1 guide wires. Biocompatibility testing was conducted on guide wires that contain the same materials of construction as the GT1 guide wires. All GT1 guide wires have the same materials of construction. The performance requirements for the GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support guide wires are identical to their Commander Floppy, Commander Hi-Per Flex, and Commander SR-1 Light Support counterparts. Testing was conducted on the GT1 Floppy and GT1 Hi-Per Flex quide wires as representative samples to support this 510(k). The performance of the GT1 Floppy and GT1 Hi-Per Flex guide wires was statistically equivalent to, better than, or between the performances of the currently sold Commander Series guide wire counterparts or was found to meet specification (i.e. the performance was clinically acceptable) in every case. In terms of biocompatibility, the GT1 guide wires were shown to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1370 Catheter tip occluder.
(a)
Identification. A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows a logo for AVE, which stands for Axial Vascular Engineering. The letters AVE are in a bold, sans-serif font, with the letters connected to each other. The words "Axial Vascular Engineering" are written in a smaller, less bold font below the letters AVE. The logo is in black and white.
VI. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION_
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
| Name: | Arterial Vascular Engineering Massachusetts, Inc. |
|---|---|
| Address: | (978) 667-2511 extension 4261 |
| Fax: | (978) 670-1863 |
| Contact Person: | Deborah L. Herrington |
| Regulatory Affairs Manager | |
| Date of Preparation: | December 1, 1998 |
| B. Device Name | |
| Trade Name: | GT1 Floppy guide wire |
| GT1 Hi-Per Flex guide wire | |
| GT1 Light Support guide wire | |
| Common Name: | Guide Wire |
| Classification Name: | Guide Wire for PTCA Catheter |
A. Submitter Information:
C. Predice Des Cestre P
Commander Series Guide Wirey
Commander Floppy Commander Hi-Per Flex Commander Light Support
AVE Massachusetts, Inc.
. Concord Road Amendment to K983927 - 510(k) Premarket Notification for the AVE GT1 Guide Wires Billerica, MA 0 ØBêc �f�ber 1, 1998
Tel: 978 667-2511
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D. Device Description & Intended Use:
The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support 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 GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are not intended for use in the cerebral vasculature.
E. Technological Characteristics Summary
The GT1 guide wires, covered under this 510(k), are very similar to their Commander Series guide wire counterparts regarding materials and construction. They utilize the same packaging materials and method of sterilization as the Commander Series guide wires.
The indications for use are the same for both the GT1 and Commander Series guide wires: GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support 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 GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are not intended for use in the cerebral vasculature.
2
The new devices (GT1 quide wires) are compared to marketed devices (Commander Series quide wires).
Does the New Device Have the Same Indication Statements? 1.
Yes. The proposed GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support 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 GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are not intended for use in the cerebral vasculature. This indication statement is the same as the indication statement for the Commander Series guide wires.
The new devices have the same Intended Use and May be "Substantially Equivalent".
2. Does the New Device Have the Same Technological Characteristics, e.g., Design, Materials. Etc.?
No. Although the overall design of the GT1 quide wires is similar with respect to the components and dimensional properties, there have been modifications to some of the materials of construction. The new materials have been qualified through biocompatibility testing and bench testina.
3. Could the New Characteristics Affect Safety or Effectiveness?
Yes. The effect on safety and effectiveness is due to the material differences. The differences in materials are unlikely to affect safety as biocompatibility was verified through testing (see summary in Section III and results in Appendix 1). The effectiveness of the guide wire, however, can be affected by changes to materials since these material differences could affect the quide wires mechanical properties. Bench testing was conducted on the GT1 Floppy and GT1 Hi-Per Flex guide wires and compared to the predicate devices. This bench testing supports the effectiveness of the GT1 guide wires. The proposed GT1 guide wires have the same performance requirements as their Commander Series guide wire counterparts (see below and Appendix 2).
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3
Do the New Characteristics Raise New Types of Safety or Effectiveness 4. Questions?
No. The minor material differences do not raise new types of safety or effectiveness questions as the same biocompatibility and mechanical properties questions need to be addressed as for the predicate devices.
Do Accepted Scientific Methods Exist for Assessing Effects of the New 5. Characteristics?
Yes. The necessary biocompatibility and mechanical properties tests have been used based on the required properties of guide wires as discussed in the Principles of Operation in Section IIIE are well-established.
6. Are Performance Data Available to Assess Effects of New Characteristics?
Yes. The GT1 Floppy and GT1 Hi-Per Flex guide wires were tested for safety and performance based on the required properties of guide wires as discussed in Section IIIE, Principles of Operation. Biocompatibility testing was conducted on guide wires that contain the same materials of construction as the GT1 guide wires. All GT1 guide wires have the same materials of construction. The performance requirements for the GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support guide wires are identical to their Commander Floppy, Commander Hi-Per Flex, and Commander SR-1 Light Support counterparts. Testing was conducted on the GT1 Floppy and GT1 Hi-Per Flex quide wires as representative samples to support this 510(k). A summary of this testing is provided in Part C below. Results for the performance testing may be found in Appendix 2; results for the biocompatibility tests are summarized in Section III and the NAMSA reports are presented in Appendix 1.
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Do Performance Data Demonstrate Equivalence? 7.
Yes. The performance of the GT1 Floppy and GT1 Hi-Per Flex guide wires was statistically equivalent to, better than, or between the performances of the currently sold Commander Series guide wire counterparts or was found to meet specification (i.e. the performance was clinically acceptable) in every case. In terms of biocompatibility, the GT1 guide wires were shown to be biocompatible.
A summary of all testing may be found below. More in depth protocols and results may be found in Appendix 2 (bench testing) and in Appendix 1 (biocompatibility testing).
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 1 1999
Fred L. Boucher, R.A.C. QA/RA Manager AVE Massachusetts, Inc. 129 Concord Road Billerica, MA 01821-0566
Re: K983927 Trade Name: GT1 Guide Wires Requlatory Class: II Product Code: DQT Dated: March 3, 1999 Received: March 4, 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 Regulation (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
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Page 2 - Mr. Fred L. Boucher
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.
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) 594-4586. 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" (21CFR 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. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Device Name: GT1 Guide Wires
Indications for Use:
AVE 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. AVE guide wires are not intended for use in the cerebral vasculature. AVE steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Contraindications:
No known contraindications.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
✓
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
un. Puy
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number