The GT Leggiero Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities and all coronary vessels. The GT Leggiero Catheter is also intended for drug infusion in intraarterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.

Device Description

The GT Leggiero™ Catheter is a multilayer single-lumen catheter 100-150cm in length with a maximum injection pressure of 450 psi. The catheter shaft is reinforced the entire length by helically-cut stainless steel piping. The distal 15cm is fine-worked for high flexibility. The catheter is 2.9Fr. size (~0.96mm in outer diameter) and can be used with a guiding catheter 0.047" (1.20mm) or larger inner diameter. The catheter shaft has an inner diameter of ~0.6mm to admit a 0.018" or smaller sized guide wire. The catheter has a hydrophilic polymer coating on the outer surface with the exception of 30cm from its proximal end. A radiopaque marker (~0.8mm) is incorporated in the catheter tip for increased radiopacity.

AI/ML Overview

The provided text describes the GT Leggiero Catheter, a medical device, and its substantial equivalence to a predicate device. This submission focuses on the physical and performance attributes of the catheter itself, not on an "AI device" or diagnostic software. Therefore, many of the requested points, such as sample size for test sets (as there are no "images" or "cases"), number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, etc., are not applicable in this context.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for an AI device's performance does not directly apply here. Instead, the GT Leggiero Catheter's performance was evaluated against the predicate device through a series of physical and functional tests to demonstrate substantial equivalence. The "specifications" table below shows key dimensional characteristics of the device and its predicate. The performance section lists the types of tests conducted.

Feature/Metric	GT Leggiero (Reported Performance)	Predicate Device (Terumo Angiographic Catheter K915414)
Intended Use	Infusion of contrast media, drug infusion, infusion of embolic materials in peripheral, cervical, lower/upper extremity, and coronary vessels (not cerebral).	Same
Material/Design	Multilayer single-lumen catheter; 100-150cm length; helically-cut stainless steel reinforced; distal 15cm fine-worked; hydrophilic polymer coating (except 30cm proximal); radiopaque marker.	Similar (Differences in materials raise no new safety/effectiveness issues)
Outer Diameter	2.9Fr. (0.96mm)	3.0Fr. (1.00mm)
Inner Diameter	0.60mm	0.70mm
Catheter Length	100-150cm	100cm & 130cm
Maximum Injection Pressure	450 psi	Not explicitly stated for predicate in this document, but implies equivalence.
Compatibility	Usable with guiding catheter 0.047" (1.20mm) or larger; accepts 0.018" or smaller guide wire.	Implied equivalence.
Performance Tests Conducted	Flexibility Test, Tensile Strength, Maximum Pressure Test, Flow Rate Test	Implied equivalent performance to predicate.
Sterilization	Validated according to AAMI guidelines, SAL 10-6	Implied equivalent.
Ethylene Oxide Residuals	Will not exceed maximum residue limits	Implied equivalent.
Biocompatibility	Blood contacting materials tested per ISO-10993, found biocompatible.	Implied equivalent.
Expiration Dating	24 months	Implied equivalent.

Note: The acceptance criteria here are implicitly achieving performance comparable or superior to the predicate device in the specified tests, and meeting relevant regulatory and safety standards (e.g., AAMI, ISO-10993 for biocompatibility).

2. Sample Size for the Test Set and Data Provenance

As this is a physical medical device (catheter) and not an AI or diagnostic tool processing data, there is no "test set" in the context of images or patient data. The tests conducted were physical and functional performance tests on samples of the manufactured catheters. The document does not specify the exact number of catheters tested for each performance criterion (e.g., N=X for Flexibility Test).

Sample Size for Test Set: Not specified for individual tests, but refers to physical samples of the GT Leggiero Catheter.
Data Provenance: The 'data' refers to the results of physical device testing. The testing would have been conducted by the manufacturer, Terumo Medical Corporation, likely in their labs in the USA (Elkton, MD) where the company is located. This is effectively prospective testing of manufactured devices.

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

This question is not applicable. The "ground truth" for a physical device like a catheter is established through objective engineering measurements and industry standards (e.g., tensile strength in Newtons, flow rate in mL/min, biocompatibility as per ISO standards). There is no "ground truth" established by human experts in the way it applies to diagnostic image interpretation.

4. Adjudication Method for the Test Set

This question is not applicable as there's no diagnostic uncertainty to adjudicate. Test results are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This question is not applicable because the device is a physical catheter, not an AI system for diagnostic interpretation. There are no "human readers" interpreting "cases" with or without "AI assistance."

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

This question is not applicable. The device is a physical catheter, not an algorithm. Its performance is inherent to its physical properties and design.

7. Type of Ground Truth Used

For the GT Leggiero Catheter, the "ground truth" for its performance is based on:

Objective Engineering Measurements: Results from tests like flexibility, tensile strength, maximum pressure, and flow rate.
Adherence to Standards: Compliance with recognized industry and regulatory standards for sterilization (AAMI) and biocompatibility (ISO-10993).
Comparison to Predicate Device: The performance and specifications are deemed acceptable if they are substantially equivalent to the legally marketed predicate device (Terumo Angiographic Catheter K915414), which has an established safety and effectiveness profile.

8. Sample Size for the Training Set

This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are developed through engineering R&D, not by training an algorithm on a dataset.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as point 8.

Summary

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SECTION II Summary and Certification

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Proprietary Device Name: GT LEGGIERO

Classification Name: Catheter, Angiographic

INTENDED USE

Note: This is the same intended use as the Terumo Angiographic Catheter) cleared under 510(k) K915414.

DESCRIPTION

Note:

The catheter will be supplied with a Y-Connector and Stainless Steel shaping Mandrel.

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SUBSTANTIAL EQUIVALENCE

The GT Leggiero™ Catheter submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Angiographic Catheter (SP Catheter) K915414.

PRINCIPLE OF OPERATION/TECHNOLOGY

The GT Leggiero and Terumo Angiographic Catheter (SP Catheter) are operated manually or by a manual process.

DESIGN/MATERIALS

Differences in materials between the GT Leggiero and the Terumo Angiographic Catheter (SP Catheter) raise no new issues of safety and effectiveness.

SPECIFICATIONS

Parts	GT Leggiero	Cleared Terumo AngiographicCatheter (SP Catheter) K915414
Outer diameter	2.9Fr. (0.96mm)	3.0Fr. (1.00mm)
Inner diameter	0.60mm	0.70mm
Catheter Length	100-150cm	100cm & 130cm

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PERFORMANCE

The performance of the GT Leggiero is substantially equivalent to the performance of the cleared Terumo Angiographic Catheter (SP Catheter) K915414.

The following tests were performed demonstrating the substantial equivalence of the GT Leggiero submitted in this 510(k) to the cleared Terumo Angiographic Catheter) K915414.

· Flexibility Test
· Tensile Strength
· Maximum Pressure Test
· Flow Rate Test

ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated according to the AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10 to the negative sixth.

Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal register of June 23, 1978 (or as finalized or amended).

Manufacturing control test methods include: functional, extraction and sterility tests.

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤24 hours) contact duration). The blood contacting materials were found to be biocompatible.

The expiration dating for the GT Leggiero will be 24 months.

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CONCLUSION

The Terumo GT Leggiero submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Angiographic Catheter (SP Catheter) K915414. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Phone (410) 392-7375 or (410) 392-7231

Date Prepared April 9, 1998 Prepared by Keith M. Smith Senior Regulatory Affairs Associate Regulatory Affairs Terumo Medical Corporation Prepared for 125 Blue Ball Road Elkton, MD 21921

Fax (410) 398-6079

012

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 1999

Ms. Yuk-Ting Lewis Senior Regulatory Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921

K981359 Re: GT Leggiero Catheter Trade Name: Requlatory Class: II Product Code: DQY Dated: October 23, 1998 Received: October 29, 1998

Dear Ms. Lewis:

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 to A substantially equivalent determination assumes compliance with 895. 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 obligation

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Paqe 2 - Ms. Yuk-Ting Lewis

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 requlations.

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 qeneral 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. CallaMan, 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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revised Jan. 19, 1999

510(k) Number (if known): K981359

GT Leggiero Catheter Device Name:

Indications For Use:

The GT Leggiero Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities and all coronary vessels. The GT Leggiero Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ohrstopher M. Ali - for RTC

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

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).