FINECROSS MG CORONARY MICRO-GUIDE CATHETER

K082519 · Terumo Medical Corp. · KRA · Sep 26, 2008 · Cardiovascular

Device Facts

• Record ID: K082519
• Device Name: FINECROSS MG CORONARY MICRO-GUIDE CATHETER
• Applicant: Terumo Medical Corp.
• Product Code: KRA · Cardiovascular
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The product (Finecross™ MG) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

Device Story

FINECROSS MG is a coronary micro-guide catheter used during percutaneous coronary intervention (PCI). The device is percutaneously introduced into blood vessels to support a guide wire and facilitate the injection of radiopaque contrast media for angiography. It features a reinforced braided mesh shaft for strength and anti-kink properties, with a gradual hardness transition from proximal to distal ends. The inner layer is composed of PTFE for mobility, and the outer surface is coated with a hydrophilic polymer for lubricity. The device is operated manually by a physician in a clinical setting. It provides mechanical support for guide wires and a conduit for contrast media, aiding in coronary procedures. Benefits include improved navigation and support within the vasculature during complex interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Catheter shaft with reinforcing braided mesh; PTFE inner layer; hydrophilic polymer outer coating; 1300/1500mm length; 1.8Fr distal/2.6Fr proximal diameter; 0.018-0.0221 inch inner diameter; 1 radiopaque marker. Sterilized via Ethylene Oxide per EN ISO 11135-1. Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for patients undergoing percutaneous coronary intervention (PCI) requiring guide wire support and/or angiography via injection of radiopaque contrast media.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Rapidtransit (K972518)
• Tornus (K051772)

Submission Summary (Full Text)

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# SEP 2 6 2008

Terumo Corporation Premarket Notification - FINECROSS™ MG Coronary Micro-Guide catheter Section II. 510(k) Summary

# SECTION II. 510(K) SUMMARY

#### A. DEVICE NAME

FINECROSS™ MG Coronary Micro-Guide catheter Proprietary Name: Classification Name: Catheter, Continuous Flush Common Name: Micro-Guide Catheter

#### B. PREDICATE DEVICE

The predicate devices are the Rapidtransit and Tornus, which are manufactured by Cordis Neurovascular Inc. and Asahi Intecc Co LTD, respectfully. The predicate devices have been cleared through the premarket notification process, Rapidtransit K972518 and Tornus K051772.

#### C. INTENDED USE

The product (Finecross™ MG) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

#### DESCRIPTION D.

FINECROSS MG consists of a catheter shaft, a hub and an anti-kink protector. The catheter shaft has reinforcing braided mesh, thus achieving the high shaft strength and anti-kink characteristics. The shaft has gradual hardness change from the proximal to the distal portion. This is achieved by joining outer layers of material with different hardness. By using polytetrafluoroethylene (PTFE) as the inner layer, high inner face mobility has been achieved. The outer surface of the catheter is coated with a hydrophilic polymer, therefore, it demonstrates a high lubricity upon moistening.

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### PRINCIPLE OF OPERATION / TECHNOLOGY E.

The FINECROSS™ MG Coronary Micro-Guide catheter is operated manually or by a manual process.

### F. DESIGN / MATERIALS

The FINECROSS™ MG Coronary Micro-Guide catheter uses similar materials as the predicate devices. Differences in materials between the devices do not raise any new issues of safety and effectiveness.

#### G SPECIFICATIONS

| Usable length of catheter: | 1300 and 1500mm |
|--------------------------------------------|-------------------------------------|
| Outer diameter of catheter (distal end): | 1.8Fr (0.60mm) |
| Outer diameter of catheter (proximal end): | 2.6Fr (0.870mm) |
| Inner diameter of catheter: | 0.018" (0.45mm) to 0.0221" (0.55mm) |
| Radiopaque markers: | 1 |

### H. PERFORMANCE

The performance of the FINECROSS™ MG Coronary Micro-Guide catheter is substantially equivalent to the performance of the predicate devices. The equivalence was shown through bench testing.

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#### ADDITIONAL SAFETY INFORMATION 1.

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." to provide a Sterility Assurance Level of 105.

Blood contacting materials were tested in accordance with the test recommendations in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993. "Biological Evaluation of Medical Devices - Part I: Evaluation and Testing." The FINECROSS MG Coronary Micro-Guide catheter is categorized as "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". The blood contacting materials were found to be biocompatible.

Expiration dating for the FINECROSS™ MG Coronary Micro-Guide catheter will be 2 years.

### SUBSTANTIAL EQUIVALENCE J.

The FINECROSS™ MG Coronary Micro-Guide catheter submitted in this 510(k) is substantially equivalent' in intended use, design, principle of operation / technology, materials and performance to the Rapidtransit and Tornus, which are manufactured by Cordis Neurovascular Inc. and Asahi Intecc Co LTD, respectfully. Differences between the devices do not raise any issues of safety or effectiveness.

¹ A statement of substantially equivalence to another product is required by 21CFR807.87, and relater the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " .. a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seq. (1977)

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### K. SUBMITTER INFORMATION

## Name and Address

Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921 USA

## Contact Person

Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist Ph: 410-392-7213 Fax: [phone] Email: [e-mail]

## Date Prepared

August 6, 2008

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

SEP 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Rc: K082519

> FINEVROSS MG Coronary Micro-Guide Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter Continuous Flush Regulatory Class: Class II Product Code: KRA Dated: September 23, 2008 Received: September 24, 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.

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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 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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

1682519 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The product (Finecross™ MG) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for the purpose of anglography.

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)

(Division Sign-Off) Division of Saldluvascular Devices 510(k) Number 160826