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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the GT1 Guide Wires, comparing them to the predicate Commander Series guide wires. The submission focuses on demonstrating substantial equivalence, primarily through material changes and subsequent bench testing and biocompatibility assessments, rather than clinical studies or evaluations of diagnostic accuracy typically associated with AI/ML devices. Therefore, much of the requested information (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable here.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of specific acceptance criteria with numerical targets and corresponding performance values in the way one might expect for a diagnostic or AI device. Instead, it states that the GT1 guide wires were evaluated against the "performance requirements" of their Commander Series counterparts and that their performance was either:

Statistically equivalent to
Better than
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.

For biocompatibility, the acceptance criterion was "biocompatible."

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical properties equivalent or superior to predicate devices	"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."
Biological safety (biocompatibility)	"GT1 guide wires were shown to be biocompatible."
Meeting established specifications (clinical acceptability)	"Performance was clinically acceptable in every case."

2. Sample Size for the Test Set and Data Provenance:

The document mentions "bench testing" was conducted on the GT1 Floppy and GT1 Hi-Per Flex guide wires as "representative samples." It does not specify the exact sample size (number of guide wires tested, or number of tests performed per guide wire) used for this bench testing.

Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. The origin of the data is internal to the manufacturer (Arterial Vascular Engineering Massachusetts, Inc.). The data is prospective in the sense that the tests were conducted specifically for this submission, but it's not a clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not applicable as the study was not a clinical or diagnostic study involving human subjects or expert interpretations. The "ground truth" for mechanical properties would be defined by the physical measurements and established engineering standards, rather than expert consensus on medical images or diagnoses. Biocompatibility assessment relies on standardized laboratory tests.

4. Adjudication Method for the Test Set:

This information is not applicable as the study was not a clinical or diagnostic study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable as the device is a guide wire, not an AI/ML diagnostic or assistive tool, and no MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is a guide wire, not an AI algorithm. Its performance is inherently "standalone" in its mechanical function, but this is not the context of AI standalone performance.

7. The Type of Ground Truth Used:

Mechanical Performance: The ground truth for mechanical performance was based on established performance requirements and specifications for guide wires, and comparative measurements against the predicate Commander Series guide wires. This is analogous to engineering specifications and comparative testing.
Biocompatibility: The ground truth for biocompatibility was established through standardized biocompatibility testing conducted according to recognized protocols (mentioned in NAMSA reports in Appendix 1, though not detailed in the provided text). This is based on scientific assay results.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a guide wire and does not involve AI/ML requiring a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as the device does not involve AI/ML requiring a training set.

Summary

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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:

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.

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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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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:

Contraindications:

No known contraindications.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
✓

(Per 21 CFR 801.109)

Over-the-Counter Use

un. Puy

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Regulation Number and Section

§ 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).