(77 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a support catheter, with no mention of AI or ML capabilities.
No.
The device is intended to guide and support a guidewire, allow for wire exchanges, and provide a conduit for delivery of saline or diagnostic contrast agents, which are procedural support functions rather than therapeutic actions.
No
The device is a support catheter used to guide and support a guidewire, allow for wire exchanges, and deliver saline or contrast agents. While it can be used in "diagnostic procedures," its primary function is not to diagnose a condition itself, but rather to facilitate other diagnostic or interventional actions.
No
The device description clearly details a physical catheter with material composition, construction, and physical performance testing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents." This describes a device used in vivo (within the body) for interventional or diagnostic procedures.
- Device Description: The description details the physical construction of a catheter designed for insertion into the vasculature.
- Anatomical Site: The anatomical site is the "Vasculature," which is within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform tests on samples in vitro.
The device is an interventional or diagnostic catheter used within the body, not an IVD.
N/A
Intended Use / Indications for Use
Terumo Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
Product codes
DOY
Device Description
The Terumo Support Catheter is a three-layer construction comprised of a stainless steel braid sandwiched between two layers of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The most distal tip contains no braid and the tip is available in either straight or curved shapes. The device has three radiopaque markers, the distal one is embedded in the tip wall while the more proximal two are swaged to the outer surface of the catheter. There is a hydrophilic coating on the distal portion of the catheter to enhance lubricity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
The Terumo Support Catheter submitted in this 510(k), and the Spectranetics QUICK CROSS CATHETERS cleared under K033678 and the Spectranetics QUICK CROSS EXTREME SUPPORT CATHETERS cleared under K092396 have similar performance characteristics. The following performance tests were conducted on these catheters. Testing was performed on nonaged and aged Terumo Support Catheters vs the Spectranetics QUICK CROSS CATHETERS and the Spectranetics QUICK CROSS EXTREME SUPPORT CATHETERS.
- Force at break (shaft, hub, tip) 1)
- Freedom from leakage 2)
- Radio detectability 3)
- Catheter burst/leakage pressure 4)
- Breakage strength of catheter shaft 5)
- Bending stiffness of catheter shaft 6)
- Flexibility/Kink strength of catheter shaft 7)
- Torque transmission property 8)
- Interior sliding characteristics 9)
- Exterior sliding characteristics 10)
- Wire-support characteristics 11)
- Flow rate 12)
- Simulated use testing 13)
- Torque strength testing 14)
In addition, the following tests were performed on the Terumo Support Catheter to assure proper performance:
-
- Surface
-
- Product dimension (ID, OD, effective length)
-
- Fitting strength of strain relief to hub
-
- Hub pull test
-
- Tip pull test
-
- Coating Integrity
-
- Particulate Evaluation
The Terumo Support Catheter met all performance specifications.
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
MAY 1 3 2011
SECTION II. 510(K) SUMMARY
Device Name A.
| Proprietary Name: | Terumo Support Catheter |
|---|---|
| Classification Name: | Percutaneous catheter |
| Common Name: | Percutaneous catheter |
Intended Use B.
Terumo Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
C. Device Description
The Terumo Support Catheter is a three-layer construction comprised of a stainless steel braid sandwiched between two layers of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The most distal tip contains no braid and the tip is available in either straight or curved shapes. The device has three radiopaque markers, the distal one is embedded in the tip wall while the more proximal two are swaged to the outer surface of the catheter. There is a hydrophilic coating on the distal portion of the catheter to enhance lubricity.
Principle Of Operation / Technology D.
The Terumo Support Catheter is operated manually or by a manual process.
During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing a guide wire and introducer within a vessel. Then a guiding catheter or sheath would be advanced over the guide wire. Next, the Terumo Support Catheter would be inserted over the guide wire and through the hemostasis valve of the guiding catheter or sheath. The guide wire and Terumo Support Catheter would then be advanced to the target vessel. The Terumo Support Catheter can then be used for injection of contrast media or for support and exchange of guide wires.
1
E. Design / Materials
The Terumo Support Catheter in this submission uses similar materials as the predicate devices. Differences in materials between the devices do not raise any new issues of safety and effectiveness. Below is a table with a comparison of the materials used in the Terumo Support Catheter and the predicate devices:
| | | QUICK CROSS
CATHETERS | QUICK CROSS
EXTREME SUPPORT
CATHETERS | Terumo
Support Catheter |
|----------|------------------------------------|--------------------------|---------------------------------------------|----------------------------|
| | | K033678 | K092396 | - |
| Design | Construction | Single layer | Three layers | Three layers |
| | Number of
Radiopaque
markers | 3 | 3 | 3 |
| Material | Inner layer | Polyethylene | PTFE | Polyester elastomer |
| | Braid | - | Stainless steel | Stainless steel |
| | Outer layer | - | Polyamide elastomer | Polyester elastomer |
| | Radiopaque
marker | Platinum | Platinum | Platinum alloy |
F. Specifications
The Terumo Support Catheter submitted in this 510(k), the Spectranetics QUICK CROSS CATHETERS cleared under K033678 and the Spectranetics QUICK CROSS EXTREME SUPPORT CATHETERS cleared under K092396 have similar device specifications. Differences in specifications between the devices do not raise any new issues of safety and effectiveness.
| Item | QUICK CROSS
CATHETERS | QUICK CROSS
EXTREME SUPPORT
CATHETERS | Terumo
Support Catheter |
|---------------------------------|--------------------------|---------------------------------------------|----------------------------|
| Effective lengths | 65, 90, 135, 150 cm | 65, 90, 135, 150 cm | 65, 90, 135, 150 cm |
| Number of Radiopaque
markers | 3 | 3 | 3 |
| Radiopaque marker
spacing | 15mm, 50mm | 50mm | 40mm, 60mm |
| Guidewire Compatibility | 0.014, 0.018, 0.035 inch | 0.035 inch | 0.035 inch |
| Maximum Injection
Pressure | 300psi | 500psi | 750psi |
| Inner diameter | 1.13mm | 0.98mm | 1.05mm |
| Outer diameter | 1.60mm | 1.50mm | 1.39mm |
| French size | 5Fr | 5Fr | 4Fr |
| Tip design/ shape | Straight | Angle | Straight/Angle |
2
·
G Performance
The Terumo Support Catheter submitted in this 510(k), and the Spectranetics QUICK CROSS CATHETERS cleared under K033678 and the Spectranetics QUICK CROSS EXTREME SUPPORT CATHETERS cleared under K092396 have similar performance characteristics. The following performance tests were conducted on these catheters. Testing was performed on nonaged and aged Terumo Support Catheters vs the Spectranetics QUICK CROSS CATHETERS and the Spectranetics QUICK CROSS EXTREME SUPPORT CATHETERS.
- Force at break (shaft, hub, tip) 1)
- Freedom from leakage 2)
- Radio detectability 3)
- Catheter burst/leakage pressure 4)
- Breakage strength of catheter shaft ર)
- Bending stiffness of catheter shaft ()
- Flexibility/Kink strength of catheter shaft 7)
- Torque transmission property 8)
- Interior sliding characteristics 9)
- Exterior sliding characteristics 10)
- Wire-support characteristics 11)
- Flow rate 12)
- Simulated use testing 13)
- Torque strength testing 14)
The performance of the Terumo Support Catheter is substantially equivalent to the performance of the predicate devices.
In addition, the following tests were performed on the Terumo Support Catheter to assure proper performance:
-
- Surface
-
- Product dimension (ID, OD, effective length)
-
- Fitting strength of strain relief to hub
-
- Hub pull test
-
- Tip pull test
-
- Coating Integrity
-
- Particulate Evaluation
The Terumo Support Catheter met all performance specifications.
3
H. Additional Safety Information
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".
The catheter is classified as Externally Communicating Devices, Circulating Blood, limited Contact (