TERUMO SUPPORT CATHETER

K110540 · Terumo Medical Corp. · DQY · May 13, 2011 · Cardiovascular

Device Facts

• Record ID: K110540
• Device Name: TERUMO SUPPORT CATHETER
• Applicant: Terumo Medical Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

Percutaneous catheter used during interventional or diagnostic procedures; provides conduit for guidewire support, wire exchange, and delivery of saline or contrast media. Three-layer construction (stainless steel braid between polyester elastomer layers); distal portion contains tungsten for fluoroscopic visibility; hydrophilic coating enhances lubricity. Operated manually by physicians in clinical settings. Device inserted over guidewire through hemostasis valve of guiding catheter/sheath; advanced to target vessel. Output is physical support for guidewire and fluid delivery path. Benefits include improved access to vasculature and procedural efficiency during wire exchanges.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via mechanical testing: force at break, leakage, radio detectability, burst pressure, bending stiffness, flexibility/kink strength, torque transmission, sliding characteristics, wire-support, flow rate, and simulated use. Biocompatibility testing per ISO-10993 (cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, thrombogenicity, complement activation) performed on aged and non-aged devices.

Technological Characteristics

Three-layer catheter: stainless steel braid, polyester elastomer layers. Platinum alloy radiopaque markers. Hydrophilic coating. 4Fr size. 0.035 inch guidewire compatibility. Max injection pressure 750 psi. Sterilized via Ethylene Oxide per ANSI/AAMI/ISO 11135-1.

Indications for Use

Indicated for patients requiring vascular access for guidewire support, wire exchange, or delivery of saline/diagnostic contrast agents during interventional or diagnostic procedures.

Regulatory Classification

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.

Predicate Devices

• QUICK CROSS CATHETERS (K033678)
• QUICK CROSS EXTREME SUPPORT CATHETERS (K092396)

Submission Summary (Full Text)

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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 CROSS<br>CATHETERS | QUICK CROSS<br>EXTREME SUPPORT<br>CATHETERS | Terumo<br>Support Catheter |
|----------|------------------------------------|--------------------------|---------------------------------------------|----------------------------|
| | | K033678 | K092396 | - |
| Design | Construction | Single layer | Three layers | Three layers |
| | Number of<br>Radiopaque<br>markers | 3 | 3 | 3 |
| Material | Inner layer | Polyethylene | PTFE | Polyester elastomer |
| | Braid | - | Stainless steel | Stainless steel |
| | Outer layer | - | Polyamide elastomer | Polyester elastomer |
| | Radiopaque<br>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<br>CATHETERS | QUICK CROSS<br>EXTREME SUPPORT<br>CATHETERS | Terumo<br>Support Catheter |
|---------------------------------|--------------------------|---------------------------------------------|----------------------------|
| Effective lengths | 65, 90, 135, 150 cm | 65, 90, 135, 150 cm | 65, 90, 135, 150 cm |
| Number of Radiopaque<br>markers | 3 | 3 | 3 |
| Radiopaque marker<br>spacing | 15mm, 50mm | 50mm | 40mm, 60mm |
| Guidewire Compatibility | 0.014, 0.018, 0.035 inch | 0.035 inch | 0.035 inch |
| Maximum Injection<br>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 |

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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:

- 1) Surface
- 2) Product dimension (ID, OD, effective length)
- 3) Fitting strength of strain relief to hub
- 4) Hub pull test
- 5) Tip pull test
- 6) Coating Integrity
- 7) 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 Unterreiner<br>Sr. Regulatory Affairs Specialist |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared For: | Terumo Medical Corporation<br>950 Elkton Blvd.<br>Elkton, MD 21921<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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 [phone] or [phone] 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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