MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH

K062446 · Terumo Medical Corp. · DYB · Oct 23, 2006 · Cardiovascular

Device Facts

• Record ID: K062446
• Device Name: MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
• Applicant: Terumo Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 23, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Pinnacle® RO11 HiFlow 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

The Pinnacle R/O II HiFlow Introducer Sheath facilitates catheter placement into veins or arteries. The device consists of ETFE tubing with an encapsulated radiopaque band for fluoroscopic visibility. It is used with a Mini Guide Wire for initial vessel access and a Dilator to maintain vessel integrity during insertion. A RADIFOCUS Obturator may be inserted into the sheath to create an occlusion and provide structural support after catheter removal. The device is operated manually by clinicians in a clinical setting. It is designed for prolonged contact (24 hours to 30 days) with circulating blood. The device benefits patients by providing a stable, accessible conduit for catheter-based procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 and FDA G95-1. Sterilization validated per ANSI/AAMI/ISO 11135-1994.

Technological Characteristics

Materials: ETFE tubing, bismuth (radiopaque). Dimensions: 6Fr-8Fr lumen, 4-110 cm length. Principle: Manual insertion/dilatation. Connectivity: None. Sterilization: Validated per ANSI/AAMI/ISO 11135-1994 (SAL 10^-6).

Indications for Use

Indicated for patients requiring catheter placement into a vein or artery for diagnostic or interventional procedures.

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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K062446

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 radiofrequency (RF) welding is used to fuse the two segments together. The band is completely encapsulated within the tubing wall.

The PINNACLE R/O II HiFlow 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 HiFlow 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 slightly visible under fluoroscopy.

### E. PRINCIPLE OF OPERATION / TECHNOLOGY

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

#### F. DESIGN / MATERIALS

The Pinnacle® ROH Hill low Introducer 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.

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

#### ਾਂ SPECIFICATIONS

| Sheath Sizes: | 6Fr. (0.087" nominal lumen size)<br>7Fr. (0.100" nominal lumen size)<br>8Fr. (0.115" 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 HiFlow Introducer Sheath is substantially equivalent to the performance of the predicate device K003424. The equivalence was shown through bench testing.

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

#### I. ADDITIONAL SAFETY INFORMATION

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 Pinnacle® ROII HiFlow 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 HiFlow Introducer Sheath will be 30 months.

#### J. SUBSTANTIAL EQUIVALENCE

The Pinnacle® ROII HiFlow 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 HiFlow Introducer 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

August18, 2006

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2006

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

Re: K062446

Pinnacle® RO11 HiFlow Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: September 25, 2006 Received: September 26, 2006

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,

Dina R. Lochner

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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): _

Pinnacle® ROII HiFlow Introducer Sheath Device Name:

Indications For Use:

The Pinnacle® RO11 HiFlow 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 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. lahner

Division of Cardiovascular Devices

510(k) Number K 062