RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)

K090040 · Terumo Medical Corp. · DQO · Feb 6, 2009 · Cardiovascular

Device Facts

• Record ID: K090040
• Device Name: RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
• Applicant: Terumo Medical Corp.
• Product Code: DQO · Cardiovascular
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.

Device Story

Diagnostic intravascular catheter; two-layer construction with stainless steel mesh between polyurethane polyamide elastomer layers; contains barium sulfate for fluoroscopic visibility; hydrophilic coating on distal portion. Operated manually by clinicians during angiographic procedures. Delivers radiopaque contrast media and therapeutic agents to specific vascular sites; facilitates navigation of guide wires or catheters. Used in clinical settings; provides visualization and access for vascular interventions. Benefits include improved navigation and site-specific delivery of agents.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed per ISO 10993; sterilization validated per EN ISO 11135-1; risk management conducted per EN ISO 14971.

Technological Characteristics

Two-layer construction: stainless steel mesh between polyurethane polyamide elastomer layers. Contains barium sulfate for radiopacity. Hydrophilic coating on distal end. Sizes: 4 & 5 Fr; lengths: 30-150 cm. Max injection pressure: 750 psi (4 Fr) / 1000 psi (5 Fr). Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected vascular sites and to guide wires or catheters to target sites in patients requiring vascular 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

• Terumo Angiographic Catheter (K915414)

Submission Summary (Full Text)

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FEB = 6 2009

## SECTION II. 510(K) SUMMARY

#### A. Device Name

| Proprietary Name: | RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) |
|----------------------|---------------------------------------------------|
| Classification Name: | Diagnostic Intravascular Catheter |
| Common Name: | Angiographic Catheter |

#### B. Intended Use

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.

#### C. Device Description

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) 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. There is a hydrophilic coating on the distal portion of the device. The length of the coating is determined by the product code number.

#### D. Principle of Operation / Technology

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is operated manually or by a manual process.

#### E. Design / Materials

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) in this submission is the same device that was cleared under K915414, the Terumo Angiographic Catheter. There are no changes in the design or materials.

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Terumo Corporation Premarket Notification - RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) Section II. 510(k) Summary

## F. Specifications

| Available Sizes | 4 & 5 Fr. |
|-------------------------------|-----------------------------------|
| Catheter Length | 30 - 150 cm |
| Maximum Injection<br>Pressure | 4 Fr.: 750 psi<br>5 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® Glidecath® (or RADIFOCUS Glidecath XP) is substantially equivalent to the performance of the Terumo Angiographic Catheter cleared under K915414.

#### 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°.

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Terumo Corporation Premarket Notification - RADIFOCUs® Glidecath® (or RADIFOCUS Glidecath XP) Section II. 510(k) Summary ・

#### H. Substantial Equivalence

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Terumo Angiographic Catheter, cleared under K915414. Differences between the devices do not raise any significant issues of safety or effectiveness.

#### I. 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 |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Prepared: | December 22, 2008 |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

FEB = 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090040

> Trade/Device Name: RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) Common Name: Diagnostic intravascular catheter Regulation Number: 21 CFR 870.1200 Regulatory Class: II Product Code: DQO Dated: January 23, 2008 Received: January 26, 2008

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 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.

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

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#### Page 2 - Mr. Mark Job

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. product rainline in 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 entitled, "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 yours,

R-vichner

Bram D. Zuckerman, 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

510(k) Number (if known): K090040

RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) Device Name:

Indications For Use:

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.

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)

R. Vi. Lunes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ko 900 40