DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

K080415 · Terumo Medical Corp. · DYB · Mar 7, 2008 · Cardiovascular

Device Facts

• Record ID: K080415
• Device Name: DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
• Applicant: Terumo Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 7, 2008
• 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

Pinnacle® Destination® Peripheral Guiding Sheath functions as both guiding catheter and introducer sheath. Packaged with sheath, dilator, hemostatic valve, and dilator retaining clip. Operated manually by clinicians to facilitate access to human vasculature, specifically for lower extremity procedures via contralateral approach. Device provides conduit for interventional/diagnostic tools. Benefits include simplified vascular access. No electronic or software components; purely mechanical device.

Clinical Evidence

Bench testing only; no clinical data. Performance equivalence demonstrated through bench and vessel model testing.

Technological Characteristics

Catheter introducer; 6-7Fr sizes; 45-55 cm length; hydrophilic coating on distal 15-55 cm. Materials biocompatible per ISO 10993. Sterilized via Ethylene Oxide per EN ISO 11135-1. Manual operation.

Indications for Use

Indicated for introduction of interventional and diagnostic devices into 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)

Submission Summary (Full Text)

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K080415 Page 1 of

# 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).

#### 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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#### E. PRINCIPLE OF OPERATION / TECHNOLOGY

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.

#### (उ. SPECIFICATIONS

| Sheath Size: | 6-7Fr. |
|------------------------------|-----------------------|
| Nominal ID / OD: | 6Fr.: 0.087" / 0.109" |
| | 7Fr.: 0.100" / 0.122" |
| Sheath Length: | 45-55 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 unmodified Peripheral Guiding Sheath. The equivalence was shown through bench and vessel model testing.

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#### I. ADDITIONAL SAFETY INFORMATION

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), which is manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.

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#### K. SUBMITTER INFORMATION

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### 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

February 13, 2008

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 7 2008

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

Re: K080415

Pinnacle® Destination® Peripheral Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: February 13, 2008 Received: February 14, 2008

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 (OS) 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 Biometric's (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. bochner

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

6080415 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 (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)

Muna R. de Mines

Division Sign-Off) Division of Cardiovascular Devices

510(k) number K080415

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