DESTINATION CAROTID GUIDING SHEATH

K052185 · Terumo Medical Corp. · DYB · Sep 6, 2005 · Cardiovascular

Device Facts

• Record ID: K052185
• Device Name: DESTINATION CAROTID GUIDING SHEATH
• Applicant: Terumo Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 6, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

Device Story

Destination® Carotid Guiding Sheath functions as both guiding catheter and introducer sheath. Device facilitates introduction of interventional and diagnostic tools into human vasculature, specifically carotid arteries. System includes sheath, dilator, hemostatic valve, and optional dilator retaining clip. Operated manually by clinicians in clinical settings. Provides access pathway for secondary devices; enables diagnostic or interventional procedures. Benefits patient by allowing minimally invasive access to vasculature.

Clinical Evidence

No clinical data. Equivalence established through bench and cadaver testing.

Technological Characteristics

Sheath sizes 6-7Fr; lengths 80-110 cm. Hydrophilic coating on distal 15 cm. Distal shapes: straight or angled. Materials biocompatible per ISO 10993. Sterilization via ANSI/AAMI/ISO 11135-1994 (SAL 10^-6). Manual operation.

Indications for Use

Indicated for the introduction of interventional and diagnostic devices into the human vasculature, including carotid arteries.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Carotid Guiding Sheath (K012812)

Submission Summary (Full Text)

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Terumo Medical Corporation Special 510(k) Premarket Notification - Destination® Carotid Guiding Sheath Section II: 510(k) Summary

## SECTION II. 510(k) SUMMARY

#### A. DEVICE NAME

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Destination® Carotid Guiding Sheath Proprietary Name: Classification Name: Catheter Introducer Common Name: Guiding Sheath

#### B. PREDICATE DEVICE

The predicate device is the Carotid Guiding Sheath, which is manufactured by Terumo Medical Corporation. The Carotid Guiding Sheath is cleared through the premarket notification process (K012812).

#### C. INTENDED USE

The Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

Note: This is the same intended use as the Carotid Guiding Sheath, K012812.

#### D. DESCRIPTION

The Destination® Carotid Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Carotid Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (dilator retaining clip is only available with codes containing the touhy-borst valve).

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#### Principle of Operation / Technology E.

The Destination® Carotid Guiding Sheath is operated manually or by a manual process.

#### F. Design / Materials

The Destination® Carotid Guiding Sheath uses similar materials as the predicate device. Differences in materials between the two devices do not raise any new issues of safety and effectiveness.

#### G. SPECIFICATIONS

| Sheath Size: | 6-7Fr. |
|------------------------------|------------------------------------------------|
| Nominal ID / OD: | 6Fr.: 0.087" / 0.112"<br>7Fr.: 0.100" / 0.122" |
| Sheath Length: | 80-110 cm |
| Hydrophilic Coating: | Distal 15 cm |
| Distal Shape Configurations: | Straight, Angled |

#### H. PERFORMANCE

The performance of the Destination® Carotid Guiding Sheath.is substantially equivalent to the performance of the predicate device K012812. The equivalence was shown through bench and cadaver testing.

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#### I. ADDITIONAL SAFETY INFORMATION

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Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 10-6.

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 Destination® Carotid Guiding Sheath is categorized as "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". The blood contacting materials were found to be biocompatible.

Expiration dating for the Destination® Carotid Guiding Sheath will be 30 months.

#### J. SUBSTANTIAL EQUIVALENCE

The Destination® Carotid Guiding Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Carotid Guiding Sheath (K012812), which is manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.

Terumo's statement of substantial equivalence is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.

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K052185
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#### K. SUBMITTER INFORMATION

______________________________________________________________________________________________________________________________________________________________________________

Name and Address

Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921

### Contact Person

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

### Date Prepared

August 10, 2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

SEP - 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Medical Corporation c/o Mr. Mark Unterreiner Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921

Re: K052185

Destination® Carotid Guiding Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DYB Dated: August 10, 2005 Received: August 11, 2005

Dear Mr. Unterreiner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bection 910(x) presidentially equivalent (for the indications for relerenced above and nave decemined and seed predicate devices marketed in interstate commerce use stated in the encrosure/ to regary interest date of the Medical Device Amendments, or to devices that proof to May 26, 1770, the onecthers and the provisions of the Federal Food, Drug, and Cosmetic have occh recuired in asserval of a premarket approval application (PMA). You may, Act (Act) that do not require apprect to the general controls provisions of the Act. The general therefore, mailier the defree, backed we annual registration, listing of devices, good Controls provisions or allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to sam adon 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 Unterreiner

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Durna R. Valumer

\ 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):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Destination Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

Prescription Use × (Part 21 CFR 801 Subpart D)

:

ﺎ

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)

P. vochner

vision Sign-Off) ivision of Cardiovascular Devices

10(k) Number K052185

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