PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

K091329 · Terumo Medical Corp. · DYB · May 29, 2009 · Cardiovascular

Device Facts

• Record ID: K091329
• Device Name: PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
• Applicant: Terumo Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: May 29, 2009
• Decision: SESE
• Submission Type: Special
• 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 consists of a sheath, dilator, hemostatic valve, and a dilator retaining clip. It is used in clinical settings to provide vascular access, specifically for lower extremity procedures via a contralateral approach. By providing a stable conduit, it assists the physician in navigating interventional devices to the target site, thereby enabling minimally invasive vascular interventions.

Clinical Evidence

No clinical data. Equivalence demonstrated through bench testing and vessel model testing.

Technological Characteristics

8Fr sheath size; 45-110 cm length; distal hydrophilic coating (15-60 cm); straight distal shape configuration. Materials are biocompatible per ISO 10993. Sterilization via Ethylene Oxide per EN ISO 11135-1 to SAL 10^-6.

Indications for Use

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

• Pinnacle® Destination® Peripheral Guiding Sheath (K051601)
• Pinnacle® Destination® Peripheral Guiding Sheath (K080415)

Submission Summary (Full Text)

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.K091329 page 1 of 4

MAY 2 9 2009

# SECTION II. 510(k) SUMMARY

#### A. DEVICE NAME

| Proprietary Name: | Pinnacle® Destination® Peripheral Guiding Sheath |
|----------------------|--------------------------------------------------|
| Classification Name: | Catheter Introducer |
| Common Name: | Guiding Sheath |

#### B. PREDICATE DEVICE

The predicate device is the Pinnacle® Destination® Peripheral Guiding Sheath, which is manufactured by Terumo Medical Corporation. The Pinnacle® Destination® Peripheral Guiding Sheath is cleared through the premarket notification process (K051601 and K080415).

#### 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 (Devices with TBV Valve only).

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#### PRINCIPLE OF OPERATION / TECHNOLOGY E.

The Pinnacle® Destination® Peripheral Guiding Sheath is 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.

#### G SPECIFICATIONS

| Sheath Size: | 8Fr. |
|------------------------------|-----------------|
| Sheath Length: | 45-110 cm |
| Hydrophilic Coating: | Distal 15-60 cm |
| Distal Shape Configurations: | Straight |

#### H. PERFORMANCE

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

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#### ADDITIONAL SAFETY INFORMATION I.

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 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 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 Pinnacle® Destination® Peripheral Guiding Sheath (K051601 and K080415), which is manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.

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K091329 page 4 of 4

Terumo Medical Corporation Terumo Medical Corporation® Peripheral Guiding Sheath Section II. 510(k) Summary

#### SUBMITTER INFORMATION K.

## Name and Address

Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921

### Contact Person

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

### Date Prepared

May 1, 2009

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2009

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

Re: K091329

Pinnacle® Destination® Peripheral Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: May 1, 2009 Received: May 5, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

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): K0241329

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)

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