SUPER SHEATH INTRODUCER SHEATH

K052557 · Togo Medikit Co., Ltd. · DRE · Jan 17, 2006 · Cardiovascular

Device Facts

• Record ID: K052557
• Device Name: SUPER SHEATH INTRODUCER SHEATH
• Applicant: Togo Medikit Co., Ltd.
• Product Code: DRE · Cardiovascular
• Decision Date: Jan 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are intended for the introduction of diagnostic and interventional devices into the human vasculature.

Device Story

Super Sheath Introducer Sheath and Sets facilitate percutaneous access to human vasculature for diagnostic and interventional procedures. System components include a sheath (polyamide/Teflon), dilator (polypropylene or FEP), and optional mini guidewire (stainless steel coil). Sheath features include a hemostatic valve to prevent blood leakage, side tube with three-way stopcock for site management, and optional radiopaque markers. Dilator facilitates sheath entry; removed once sheath is positioned. Used in clinical settings by healthcare professionals. Device provides a conduit for medical instruments; benefits include controlled vascular access and reduced risk of blood loss during device exchange.

Clinical Evidence

Bench testing only. Testing included sheath shaft tensile, kink, hub-to-shaft tensile, hemostatic valve integrity, sheath pressure, lubricity, radiopacity, and corrosion resistance. Dilator and guidewire functional testing (tensile, torqueability, corrosion) and biocompatibility/shelf-life testing were performed. Results verified adequacy for intended use.

Technological Characteristics

Materials: Polyamide, Teflon, Polypropylene (PP), Fluorinated Ethylene Propylene (FEP), stainless steel. Components: Sheath with hemostatic valve, dilator, mini guidewire. Dimensions: 4F-9F diameters, 7-25 cm lengths. Operation: Manual. Sterilization: Sterile, single-use. No software or energy source.

Indications for Use

Indicated for the introduction of diagnostic and interventional devices into the human vasculature. No specific patient population, age, or gender restrictions are stated.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Terumo Pinnacle Introducer Sheaths (K954234)

Submission Summary (Full Text)

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JAN 1 7 2006

Image /page/0/Picture/1 description: The image shows a black and white logo of a person standing in front of a globe. The globe is represented by a grid of lines, and the person is standing with their arms outstretched. The logo is simple and iconic, and it could be used to represent a variety of concepts, such as global unity, human connection, or international cooperation. The person is centered in the image.

## TOGO MEDIKIT CO., LTD.
17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City

Miyazaki Prefecture 883-0062, Japan

57

## 510(k) Summary per 21 CFR §807.92

| Submitter's Name<br>and Address | Togo Medikit Co. Ltd.<br>17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City<br>Miyazaki Prefecture 883-0062<br>Japan | | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------|
| Contact Name and<br>Information | Toshimitsu Hayashi<br>Quality Assurance Assistant Manager<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | |
| Applicant | Heidi M. Erickson<br>Specialist, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | |
| Date Prepared | September 15, 2005 | | |
| Proprietary<br>Name(s) | Super Sheath Introducer Sheath | | |
| Common Name | Catheter Introducer | | |
| Product Code | DYB | | |
| Classification of<br>Device | Class II, 21 CFR Part 870.1340 | | |
| Predicate Device | Terumo Pinnacle<br>Introducer<br>Sheaths | K954234 | November 27, 1995 |

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The Super Sheath Introducer Sheaths are available in-4F-Device Description 9F diameters and available in lengths ranging from 7 to 25 cm. Some sheaths may be ordered with a suture wing and some sheaths have radiopaque markers. The devices are provided sterile and are intended for one procedure use only.

> The Medikit Super Sheath Introducer Sheath is packaged with a dilator. The Super Introducer Sheath Sets consists of a sheath, a dilator and a mini guidewire, with Inserter, as described in this submission or a US commercially available mini guidewire meeting Medikit specifications. The one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and hub are made of polyamide and Ethylene shart and mac mac the (Teflon). Some sheaths have radiopaque markers that are embedded into the shaft 1.5 mm from the distal tip. The hubs, color-coded by French size, contain a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The sidetube extension is used for site management

> The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. It is inserted into the introducer sheath and facilitates and supports the entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. Once the sheath is in place the dilator is removed. There are two different dilators, 0.038" and a 0.035" guidewire compatible. The 4-8F-dilator tubes are made from Polypropylene (PP). The 9F dilator tubes are made of Fluorinated Ethylene Propylene (FEP). The dilator tubes are pressed into the dilator hub with a bushing. The sheath hub and the dilator hub lock using a rotating motion.

Super Sheaths can be ordered with a Polypropylene suture wing color coded by French size. The suture wing is a small projection near the hub with a hole in it for correct placement of the sheath using sutures.

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| Device Description<br>continued | The uncoated mini guidewire is made of a stainless steel<br>coil wrapped tightly around an inner mandrel that tapers at<br>the distal tip. The flexible tip is J-shaped available in<br>diameters of 0.035" and 0.038". The mini guidewire (with<br>Inserter) is available in 45cm and 80cm lengths. The<br>Inserter does not contact blood and is used strictly for<br>guiding the guidewire into a cannula or introducer. A US<br>commercially available mini guidewire (meeting Medikit<br>specifications) may be used in the sets or the mini<br>guidewire that is described in this submission. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of<br>Device | Super Sheath Introducer Sheaths and Super Sheath<br>Introducer Sheath Sets are intended for the introduction of<br>diagnostic and interventional devices into the human<br>vasculature. |
| Non-Clinical Test<br>Summary | Functional testing for the Super Sheath consisted of sheath<br>shaft tensile, sheath kink, sheath hub to shaft tensile,<br>hemostatic valve integrity/sheath pressure, valve integrity<br>of sheath, sheath lubricity, sheath radiopacity, and<br>sheath/dilator corrosion resistance testing. Dilator<br>functional testing consisted of dilator shaft tensile and<br>dilator hub to shaft tensile testing. Mini Guidewire<br>functional testing included tensile, combined load,<br>torqueability, radiopacity and corrosion resistance.<br>Biocompatibility, packaging and product shelf life testing<br>has also been conducted. Test results verified that the<br>Super Sheath Introducer Sheaths and Super Sheath<br>Introducer Sheath Sets are adequate for their intended use.<br>Based on a comparison of intended use, design and the<br>results of bench testing, Medikit Super Sheath Introducer<br>Sheaths and Super Sheath Introducer Sheath Sets have<br>been shown to be substantially equivalent to the predicate<br>Terumo Pinnacle Introducer Sheaths (K954234) and are<br>therefore deemed suitable for their intended use. |

·

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Technological Characteristics The Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets and the Terumo Pinnacle Introducer Sheaths (K954234) are operated manually or by a manual process. The Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets use similar product design, packaging, sterilization methods and labeling when compared to Terumo Pinnacle Sheaths (the predicate device). The similar indications for use and technological characteristics support a determination of substantial equivalence. Differences in materials or manufacturing methods do not raise any new issues of safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 17 2006

Togo Medikit Co., Ltd. c/o Boston Scientific Corporation Ms. Heidi M. Erickson Specialist, Regulatory Affairs 5905 Nathan Lane P-25 Plymouth, MN 55442

K052557 Re: Super Sheath Introducer Sheath Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: II Product Code: DRE Dated: December 27, 2005 Received: December 29, 2005

Dear Ms. Erickson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assessed in the encreated of to trg. 25 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 adultcration.

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 -- Ms. Heidi M. Erickson

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 vours.

Dulla R. Vines

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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Traditional 510(k) Notification

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Togo Medikit Co. LTD. Introducer Sheaths and Introducer Sheath Sets

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## Section 4: Indications for Use Statement

## Indications for Use

のお気になる。

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K052557 510(k) Number (if known):

Device Name: Super Sheath Introducer Sheath

Indications for Use: Introducer Sheaths and Introducer Sheath Sets are intended for use in the introduction of diagnostic and interventional devices into the human vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dina R. Vidiner

(Division Sign-Off) Division of Cardiovascular Devices

10(k) Number_K052557

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