PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

K051601 · Terumo Medical Corp. · DYB · Aug 4, 2005 · Cardiovascular

Device Facts

• Record ID: K051601
• Device Name: PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
• Applicant: Terumo Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

Device Story

The Pinnacle® Destination® Peripheral Guiding Sheath functions as both a guiding catheter and an introducer sheath. It is a manually operated device used by clinicians to facilitate the introduction of diagnostic or interventional instruments into the human vasculature. The system includes a sheath, dilator, hemostatic valve, and dilator retaining clip. By providing a stable conduit, it allows for the navigation and delivery of secondary devices to target sites, such as the lower extremities. The device is intended for use in a clinical setting.

Clinical Evidence

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

Technological Characteristics

Sheath sizes 6-7Fr; lengths 55-75 cm; hydrophilic coating on distal 15-55 cm; straight distal shape. Materials are biocompatible per ISO 10993 for externally communicating, circulating blood, limited contact (≤24hrs) devices. Sterilization via ANSI/AAMI/ISO 11135-1994.

Indications for Use

Indicated for patients requiring introduction of interventional and diagnostic devices into the human vasculature, including lower extremity access via a contralateral approach.

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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## SECTION II. 510(k) SUMMARY

| A. | Device Name | 11 |
|----|-------------------------------------|----|
| B. | Predicate Device | 11 |
| C. | Intended Use | 11 |
| D. | Description | 11 |
| E. | Principle of Operation / Technology | 12 |
| F. | Design / Materials | 12 |
| G. | Specifications | 12 |
| H. | Performance | 12 |
| I. | Additional Safety Information | 13 |
| J. | Substantial Equivalence | 13 |
| K. | Submitter Information | 14 |

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# SECTION II. 510(k) SUMMARY

#### DEVICE NAME A.

- Pinnacle® Destination® Peripheral Guiding Sheath Proprietary Name: Classification Name: Catheter Introducer Common Name: Guiding Sheath
#### PREDICATE DEVICE B.

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 Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

#### D. DESCRIPTION

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.

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The Pinnacle® Destination® Peripheral Guiding Sheath and the Carotid Guiding Sheath are operated manually or by a manual process.

#### F. DESIGN / MATERIALS

______________________________________________________________________________________________________________________________________________________________________________

The Pinnacle® Destination® Peripheral 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.

#### ్ర SPECIFICATIONS

| Sheath Size: | 6-7Fr. |
|------------------------------|-----------------------|
| Nominal ID / OD: | 6Fr.: 0.087" / 0.112" |
| | 7Fr.: 0.100" / 0.122" |
| Sheath Length: | 55-75 cm |
| Hydrophilic Coating: | Distal 15-55 cm |
| Distal Shape Configurations: | Straight |

#### H. PERFORMANCE

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

KOSIGOI

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#### ADDITIONAL SAFETY INFORMATION I.

Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 106

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 Pinnacle® Destination® Peripheral 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 Pinnacle® Destination® Peripheral Guiding Sheath will be 30 months.

#### J. SUBSTANTIAL EQUIVALENCE

The Pinnacle® Destination® Peripheral 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.

KOS1601

p. 4 of S

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#### SUBMITTER INFORMATION K.

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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

June 15, 2005

KOSI601 p. Soft

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/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 emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

AUG 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Medical Corporation c/o Mr. Mark Unterreiner Regulatory Affairs Specialist 950 Elkon Blvd. Elkton, MD 21921

Re: K051601

Pinnacle Destination Peripheral Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (Two) Product Code: DYB Dated: June 15, 2005 Received: June 16, 2005

Dear Mr. Unterreiner:

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 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,

Dmna R. Lochner

1Bram 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):_____________________________________________________________________________________________________________________________________________________

Pinnacle® Destination® Peripheral Guiding Sheath Device Name:

Indications For Use:

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

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)

Duna R. bochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_¥05|60 |

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