PINNACLE ROII INTRODUCER SHEATH

K082847 · Terumo Medical Corp. · DYB · Oct 29, 2008 · Cardiovascular

Device Facts

• Record ID: K082847
• Device Name: PINNACLE ROII INTRODUCER SHEATH
• Applicant: Terumo Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 29, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Pinnacle® ROII Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

Device Story

Pinnacle® ROII Introducer Sheath facilitates percutaneous catheter placement into veins or arteries. System includes introducer sheath, dilator, mini guide wire, and RADIFOCUS obturator. Sheath features radiopaque marker band for fluoroscopic visualization. Operation: Mini guide wire inserted via cannula; sheath/dilator assembly advanced over wire; wire withdrawn; dilator removed for catheter insertion. Obturator provides occlusion and wall support for indwelling sheath. Used in clinical settings by healthcare professionals. Bismuth content in components ensures radiopacity. Benefits include vessel access and maintenance of access site integrity during procedures.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

ETFE tubing construction; radiopaque marker band (bismuth-loaded) for fluoroscopy; sizes 4Fr-9Fr; lengths 4-110 cm; guide wire OD 0.021"-0.038". Sterilized per ANSI/AAMI/ISO 11135-1994. Biocompatible per ISO 10993.

Indications for Use

Indicated for facilitating catheter placement into a patient's vein or artery. Includes accessory Mini Guide Wire for sheath placement and RADIFOCUS Obturator for vessel occlusion and sheath support.

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® ROII (K003424)

Submission Summary (Full Text)

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KOR2847

1

# SECTION II. 510(K) SUMMARY

| A. | Device Name | 17 |
|----|-------------------------------------|----|
| B. | Predicate Device | 17 |
| C. | Intended Use | 17 |
| D. | Description | 17 |
| E. | Principle of Operation / Technology | 17 |
| F. | Design / Materials | 19 |
| G. | Specifications | 19 |
| H. | Performance | 19 |
| I. | Additional Safety Information | 20 |
| J. | Substantial Equivalence | 20 |
| K. | Submitter Information | 21 |

.

:

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# SECTION II. 510(K) SUMMARY

#### A. DEVICE NAME

| Proprietary Name: | Pinnacle® ROII Introducer Sheath |
|----------------------|----------------------------------|
| Classification Name: | Introducer, Catheter |
| Common Name: | Introducer Sheath |

#### B. PREDICATE DEVICE

The predicate device is the Pinnacle® ROII, which is manufactured by Terumo Medical Corporation. The Pinnacle® ROII is cleared through the premarket notification process (K003424).

# C. INTENDED USE

The Pinnacle® ROII Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

Note: This is the same intended use as the Pinnacle® ROII, K003424.

#### D. DESCRIPTION

The PINNACLE R/O II Introducer Sheath is comprised of an introducer sheath and a dilator. The introducer sheath has a radiopaque marker that is highly visible under fluoroscopy. The marker is a band that is located approximately 5 mm from the sheath's distal tip.

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The introducer sheath consists of 2 pieces of ETFE tubing -- a long segment and a short tip segment. The band is sandwiched between the two segments and fused together. The band is completely encapsulated within the tubing wall.

The PINNACLE R/O II Introducer Sheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the device. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.

The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The PINNACLE R/O II Introducer Sheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Dilator maintains the integrity of the Sheath and dilates the blood vessel while the Introducer Sheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted.

The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed.

The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

# E. PRINCIPLE OF OPERATION / TECHNOLOGY

The Pinnacle® ROII Introducer Sheaths operated manually or by a manual process.

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# F. Design / Materials

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The Pinnacle® ROII Introducer Sheath uses the same materials and design as the predicate device. There are no new issues of safety and effectiveness related to design or materials.

# ் SPECIFICATIONS

| Sheath Sizes: | 4Fr. (0.055" nominal lumen size)<br>5Fr. (0.068" nominal lumen size)<br>9Fr. (0.122" nominal lumen size) |
|-----------------|----------------------------------------------------------------------------------------------------------|
| Sheath Length: | 4-110 cm |
| Dilator Length: | 5-110 cm |
| Guide Wire OD: | 0.021"-0.038" |

# H. Performance

The performance of the Pinnacle® ROII Introducer Sheath is substantially equivalent to the performance of the predicate device K003424. The equivalence was shown through bench 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°.

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® ROII Introducer Sheath is categorized as "Externally Communicating Device, Circulating Blood, Prolonged Contact (24hrs to 30 days)". The blood contacting materials were found to be biocompatible.

Expiration dating for the Pinnacle® ROII Introducer Sheath will be 30 months.

# J. SUBSTANTIAL EQUIVALENCE

The Pinnacle® ROII Introducer Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Pinnacle® ROII (K003424), which is also manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.

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Terumo Medical Corporation Special 510(k) - Pinnacle® ROII Introducer Sheath Section II. 510(k) Summary

# 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 September 25, 2008

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2008

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

Re: K082847

> Pinnacle ROII Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: September 25, 2008 Received: September 29, 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

R. Volmer

o 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):

K082847

Pinnacle® ROII Introducer Sheath Device Name:

Indications For Use:

The Pinnacle® ROII Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

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)

Donna R. Vachner

(Division Simn-Off) Division of Cardiovascular Devices

510(k) Number_KO82847