RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER

K082736 · Terumo Medical Corp. · DQO · Sep 24, 2008 · Cardiovascular

Device Facts

• Record ID: K082736
• Device Name: RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
• Applicant: Terumo Medical Corp.
• Product Code: DQO · Cardiovascular
• Decision Date: Sep 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.

Device Story

Radifocus Optitorque Angiographic Catheter; two-layer construction with stainless steel mesh between polyurethane polyamide elastomer layers; contains barium sulfate for fluoroscopic visibility; features flexible polyurethane 'soft-tip' to minimize vessel wall trauma. Used by physicians in clinical settings for cardiac and vascular procedures; manually operated to selectively engage arteries. Delivers radiopaque media, guide wires, catheters, and therapeutic agents to vascular sites. Benefits patient by enabling targeted diagnostic and therapeutic vascular access.

Clinical Evidence

No clinical data. Bench testing only, including risk/hazard analysis per EN ISO 14971, biocompatibility testing per ISO 10993, and sterilization validation per EN ISO 11135-1.

Technological Characteristics

Two-layer construction: stainless steel mesh between polyurethane polyamide elastomer layers. Barium sulfate additive for radiopacity. Sizes: 4-6 Fr; Length: 650-1200 mm. Max injection pressure: 750 psi (4 Fr) to 1000 psi (5, 6 Fr). Manual operation. Sterilized via Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for patients undergoing cardiac and vascular procedures requiring delivery of radiopaque media, guide wires, catheters, or therapeutic agents to selected vascular sites via femoral, radial, or brachial access.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Radifocus Optitorque Angiographic Catheter (K992051)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and letters. The sequence is "k082736". The characters are written in black ink on a white background.

SEP 2 4 2008 Terumo Corporation Premarket Notification - Radifocus® Optitorque™ Angiographic Catheter Section II. 510(k) Summary

# SECTION II. 510(K) SUMMARY

#### A. Device Name

| Proprietary Name: | Radifocus® Optitorque™ Angiographic Catheter |
|----------------------|----------------------------------------------|
| Classification Name: | Angiographic Catheter |
| Common Name: | Angiographic Catheter |

# B. Intended Use

The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to dcliver radiopaque media, guide wires, catheters, and therapeutic agents to sclected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.

# C. Device Description

The Radifocus Optitorque Angiographic Catheter is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft.

# D. Principle Of Operation / Technology

The Radifocus Optitorque Angiographic Catheter is operated manually or by a manual process.

# E. Design / Materials

The Radifocus Optitorque Angiographic Catheter in this submission is the same device that was cleared under K992051. There are no changes in the design or materials.

{1}------------------------------------------------

# F. Specifications

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Available Sizes | 4 - 6 Fr. |
|-------------------------------|--------------------------------------|
| Catheter Length | 650 – 1200 mm |
| Maximum Injection<br>Pressure | 4 Fr.: 750 psi<br>5, 6 Fr.: 1000 psi |

# G. Performance

A risk/hazard analysis was conducted according to EN ISO 14971 Medical Devices -Application of risk management to medical devices. Performance characteristics for this new indication for use were determined. Then it was justified that the performance of the Radifocus Optitorque Angiographic Catheter is substantially equivalent to the performance of the Radifocus Optitorque Angiographic Catheter cleared under K992051.

### H. Additional Safety Information

Manufacturing controls include visual, functional, dimensional 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".

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.

Sterilization conditions have been validated in accordance with EN 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 .

{2}------------------------------------------------

Terumo Corporation Premarket Notification - Radifocus® Optitorque™ Angiographic Catheter Section II. 510(k) Summary

#### H. Substantial Equivalence

The Radifocus Optitorque Angiographic Catheter is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Radifocus Optitorque Angiographic Catheter, cleared under K992051. Differences between the devices do not raise any significant issues of safety or effectiveness.

# I. Submitter Information

.

| Prepared By: | Mr. Mark Unterreiner |
|----------------|-------------------------------------------|
| | Sr. Regulatory Affairs Specialist |
| Prepared For: | Terumo Medical Corporation |
| | 950 Elkton Blvd. |
| | Elkton, MD 21921 |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Prepared: | August 29, 2008 |

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a person embracing another, representing health and human services.

SEP 2 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Corporation c/o Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K082736

Radifocus Optitorque Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: September 17, 2008 Received: September 18, 2008

Dear Mr. Job:

We have reviewed your Section 510(k) promarket 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 gencral 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 such 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.

{4}------------------------------------------------

Page 2 - Mr. Mark Job

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); good manufacturing 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Radifocus® Optitorque™ Angiographic Catheter Device Name:

Indications For Use:

The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery,

Prescription Use × (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)

ion Silan-Off) Division of Cardiovascular Devices 510(k) Number_ Kos