(77 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Terumo Support Catheter, which aims to demonstrate substantial equivalence to predicate devices. This type of submission does not typically involve the rigorous clinical trials or complex statistical analyses that would be found in a PMA (Premarket Approval) application for novel, high-risk devices. Therefore, many of the requested elements regarding acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, and standalone performance for AI/ML devices are not applicable.
The "acceptance criteria" for a 510(k) device primarily revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise any new questions of safety or effectiveness. This is achieved through a combination of design, materials, specifications, and performance testing, often comparing the new device directly to the predicate.
Here's an attempt to extract and present the information based on the provided document, addressing the requested points where possible, and noting when information is not applicable to this type of submission.
Acceptance Criteria and Device Performance for Terumo Support Catheter
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, "acceptance criteria" are generally framed as demonstrating substantial equivalence to predicate devices across various attributes. The performance tests conducted are to ensure the new device meets specifications comparable to or better than the predicates. The text states:
"The Terumo Support Catheter met all performance specifications."
While specific numerical acceptance criteria for each test (e.g., minimum force at break, maximum allowable leakage) are not explicitly detailed in the provided summary, the overarching acceptance criterion is successful completion of all listed performance tests, demonstrating substantial equivalence to the predicate devices. The reported device performance is that it met all specifications.
| Acceptance Criterion (Implicitly "Substantial Equivalence to Predicate") | Reported Device Performance |
|---|---|
| Mechanical Performance Tests | |
| 1. Force at break (shaft, hub, tip) | Met specifications (performed successfully) |
| 2. Freedom from leakage | Met specifications (performed successfully) |
| 3. Radio detectability | Met specifications (performed successfully) |
| 4. Catheter burst/leakage pressure | Met specifications (performed successfully) |
| 5. Breakage strength of catheter shaft | Met specifications (performed successfully) |
| 6. Bending stiffness of catheter shaft | Met specifications (performed successfully) |
| 7. Flexibility/Kink strength of catheter shaft | Met specifications (performed successfully) |
| 8. Torque transmission property | Met specifications (performed successfully) |
| 9. Interior sliding characteristics | Met specifications (performed successfully) |
| 10. Exterior sliding characteristics | Met specifications (performed successfully) |
| 11. Wire-support characteristics | Met specifications (performed successfully) |
| 12. Flow rate | Met specifications (performed successfully) |
| 13. Simulated use testing | Met specifications (performed successfully) |
| 14. Torque strength testing | Met specifications (performed successfully) |
| Device Integrity & Dimensional Tests | |
| 1. Surface | Met specifications (performed successfully) |
| 2. Product dimension (ID, OD, effective length) | Met specifications (performed successfully) |
| 3. Fitting strength of strain relief to hub | Met specifications (performed successfully) |
| 4. Hub pull test | Met specifications (performed successfully) |
| 5. Tip pull test | Met specifications (performed successfully) |
| 6. Coating Integrity | Met specifications (performed successfully) |
| 7. Particulate Evaluation | Met specifications (performed successfully) |
| Biocompatibility Tests (Non-aged Device) | |
| Cytotoxicity | Passed (biocompatible) |
| Maximization | Passed (biocompatible) |
| Intracutaneous Reactivity | Passed (biocompatible) |
| Acute Systemic Toxicity | Passed (biocompatible) |
| Hemolysis | Passed (biocompatible) |
| Pyrogen test | Passed (biocompatible) |
| Thrombogenicity Study in Dogs | Passed (biocompatible) |
| Complement Activation Assay | Passed (biocompatible) |
| Biocompatibility Tests (Aged Device) | |
| Physiochemical Profile | Passed (biocompatible) |
| Cytotoxicity | Passed (biocompatible) |
| Hemolysis | Passed (biocompatible) |
| Sterilization Validation | Validated to SAL of 10^-6 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of catheters tested) for each performance or biocompatibility test. It indicates that "Testing was performed on nonaged and aged Terumo Support Catheters vs the Spectranetics QUICK CROSS CATHETERS and the Spectranetics QUICK CROSS EXTREME SUPPORT CATHETERS." This implies a comparison study, but the specific N for each test article is not disclosed.
The "data provenance" mentioned in the context of AI/ML (country of origin, retrospective/prospective) is not applicable here as this is a physical medical device. The data comes from in vitro (laboratory) and in vivo (Thrombogenicity Study in Dogs) testing of device prototypes.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This section is not applicable. The evaluations are based on objective physical, chemical, and biological tests, not expert interpretation of diagnostic images or patient outcomes. The "ground truth" for parameters like "force at break" is a direct measurement, not an expert consensus.
4. Adjudication Method for the Test Set
This section is not applicable, as there's no subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This is typically relevant for diagnostic imaging AI tools, not for a physical medical device like a catheter seeking 510(k) clearance based on substantial equivalence.
6. If a Standalone Performance Study (Algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is not an algorithm or AI device. The performance tests evaluate the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests (e.g., force at break, burst pressure, flow rate, dimensions) is established through direct physical measurements and standardized test methods. For biocompatibility, the ground truth is determined by the results of specific biological assays (e.g., cytotoxicity, hemolysis, pyrogenicity) against established safety thresholds as per ISO-10993. For sterilization, the ground truth is the demonstration of sterility to a specific SAL (Sterility Assurance Level) through validated processes in accordance with relevant ISO standards.
8. The Sample Size for the Training Set
This section is not applicable. There is no AI/ML model being "trained" for this device. The development process involves design, prototyping, testing, and refinement, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set was Established
This section is not applicable, as there is no training set in the context of this device's development or regulatory submission.
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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.
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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 CROSSCATHETERS | QUICK CROSSEXTREME SUPPORTCATHETERS | TerumoSupport Catheter | ||
|---|---|---|---|---|
| K033678 | K092396 | - | ||
| Design | Construction | Single layer | Three layers | Three layers |
| Number ofRadiopaquemarkers | 3 | 3 | 3 | |
| Material | Inner layer | Polyethylene | PTFE | Polyester elastomer |
| Braid | - | Stainless steel | Stainless steel | |
| Outer layer | - | Polyamide elastomer | Polyester elastomer | |
| Radiopaquemarker | 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 CROSSCATHETERS | QUICK CROSSEXTREME SUPPORTCATHETERS | TerumoSupport Catheter |
|---|---|---|---|
| Effective lengths | 65, 90, 135, 150 cm | 65, 90, 135, 150 cm | 65, 90, 135, 150 cm |
| Number of Radiopaquemarkers | 3 | 3 | 3 |
| Radiopaque markerspacing | 15mm, 50mm | 50mm | 40mm, 60mm |
| Guidewire Compatibility | 0.014, 0.018, 0.035 inch | 0.035 inch | 0.035 inch |
| Maximum InjectionPressure | 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 |
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·
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.
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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 (<24 hrs). Results of the testing demonstrate that the blood contacting materials are biocompatible. The Terumo Support Catheter successfully passed all of the following biocompatibility tests:
Biocompatibility Test Reports - Non-aged Device:
Cytotoxicity Maximization Intracutaneous Reactivity Acute Systemic Toxicity Hemolysis Pyrogen test Thrombogenicity Study in Dogs Complement Activation Assay
Biocompatibility Test Reports - Aged Device: Physiochemical Profile Cytotoxicity Hemolysis
Sterilization conditions have been validated in accordance with ANSVAAMI/ISO 11135-1, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10 °.
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I. Substantial Equivalence
The Terumo Support Catheter submitted in this 510(k) is substantially equivalent in the general intended use, design, technology/principles of operation, materials, and performance to the Spectranetics QUICK CROSS CATHETERS cleared under K033678 or the Spectranetics QUICK CROSS EXTREME SUPPORT CATHETERS cleared under K092396. Differences between the devices do not raise any new issues of safety or effectiveness.
J. Submitter Information
| Prepared By: | Mr. Mark UnterreinerSr. Regulatory Affairs Specialist |
|---|---|
| Prepared For: | Terumo Medical Corporation950 Elkton Blvd.Elkton, MD 21921Phone: (410) 392-7213Fax: (410) 398-6079Email: mark.unterreiner@terumomedical.com |
| Date Prepared: | January 28, 2011 |
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Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Terumo Medical Corporation c/o Mr. Mark Job Regulatory Technology Services, LLC . 1394 25th Street, NW Buffalo, MN 55313
MAY 1 3 2011
Re: K110540
Trade/Device Name: Terumo Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: April 22, 2011 Received: April 25, 2011
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
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Page 2 - Mr. Mark Job
practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barry D. Zuckerman, M.D.
Bram D. Zugkerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
14110540 510(k) Number (if known):
Terumo Support Catheter Device Name:
Indications For Use:
Terumo Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(DWision Sign-Off)
Division of Cardiovascular Devices
510(k) Number 110 540
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§ 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).