(288 days)
No
The document describes a physical catheter and its performance characteristics, with no mention of software, algorithms, or AI/ML terms.
No.
The device is intended for the infusion of substances and not for treating or curing a medical condition.
No
The GT Leggiero Catheter is intended for the infusion of substances like contrast media, drugs, or embolic materials, which are interventional or therapeutic uses, not diagnostic.
No
The device description clearly details a physical catheter with specific dimensions, materials (stainless steel, polymer coating), and physical properties (flexibility, tensile strength, pressure rating). This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the infusion of substances (contrast media, drugs, embolic materials) directly into blood vessels. This is an in vivo procedure, meaning it's performed within a living organism.
- Device Description: The description details a catheter, which is a tool for accessing and delivering substances within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body for therapeutic and diagnostic imaging purposes (by delivering contrast).
N/A
Intended Use / 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 intraarterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities and all coronary vessels.
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
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
Note: This is the same intended use as the Terumo Angiographic Catheter) cleared under 510(k) K915414.
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.
Note:
The catheter will be supplied with a Y-Connector and Stainless Steel shaping Mandrel.
1
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 Angiographic
Catheter (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 |
2
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.
3
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
4
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
5
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
6
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)
OR
Over-The-Counter Use