SUPER SHEATH XL INTRODUCER SHEATH by TOGO MEDIKIT CO., LTD.

The Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.

Device Description

The Medikit Super Sheath Introducer XL Sheaths and Super Sheath XL Introducer Sheath Sets are similar to the 4-9F sheaths with the addition of four French sizes to the sheath line. The Super Sheath XL Introducer Sheaths are available in 10F, 11F, 12F and 14F sizes and available in lengths ranging from 11 to 25 cm. The devices are provided sterile and are intended for one procedure use only. The Medikit Super Sheath XL Introducer Sheath is packaged with a dilator. The Super Sheath Introducer XL Sheath Set consists of a sheath, a dilator and a mini guidewire, with inserter. The mini guidewires with inserter were cleared to market in K052557 (January 17, 2006). The construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and hub are made of polyamide and fluorinated ethylene propylene FEP (Teflon). 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 side tube extension may be used for fluid and medication administration as well as blood sampling. The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire 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. The dilators are 0.038" and a 0.035" guidewire compatible. The dilator tubes are made of fluorinated ethylene propylene (FEP). The dilator tubes are attached to the dilator hub using an epoxy resin. The sheath hub and the dilator hub lock using a rotating motion.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (introducer sheaths) and does not describe acceptance criteria or a study that proves a device meets those criteria in the context of an AI/ML clinical validation study. Instead, it details the non-clinical (bench) testing performed to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested categories are not applicable to the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document describes several non-clinical tests but does not explicitly state acceptance criteria in a quantitative format or report performance against specific thresholds. It generally states that "Test results verified that the Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets are adequate for their intended use."

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Not explicitly stated in the document for each test. General goal: "meet product specification" and be "adequate for their intended use."	Verified as "adequate for their intended use."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for individual non-clinical tests.
Data Provenance: N/A (non-clinical bench testing, not human data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. Ground truth in this context would be test standards/specifications, not expert interpretation of data.

4. Adjudication method for the test set:

N/A. This is relevant for diagnostic studies, not bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

N/A. This document describes a medical device, not an AI/ML diagnostic system, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A. This is not an algorithm.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" would be the established engineering specifications and performance standards for introducer sheaths, which are not detailed in this summary but are referred to as "product specification."

8. The sample size for the training set:

N/A. No training set is applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established:

N/A. No training set.

Summary of Device-Specific Information from the Text:

The document describes the Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets, which are indicated for the introduction of diagnostic and interventional devices into the human vasculature.

Study Type: Non-clinical (bench) testing was performed to verify that the device met product specifications and to establish substantial equivalence to a predicate device (Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets, K052557).

Tests Performed:

Sheath Shaft Tensile test
Sheath Kink Test
Sheath Hub to Shaft Tensile Test
Hemostatic Valve Integrity/Sheath Pressure Test
Sheath Valve Integrity/Sheath Pressure Test
Dilator Shaft Tensile Test
Dilator Hub to Shaft Tensile Test
Real Time Product Shelf Lift Testing
(Also referenced from predicate device testing: Lubricity, radiopacity, sheath/dilator corrosion resistance testing, biocompatibility, and package test reports).

Conclusion of Testing: "Test results verified that the Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets are adequate for their intended use. Based on a comparison of intended use, design and the results of bench testing, Medikit 10F, 11F, 12F, and 14F Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets have been shown to be substantially equivalent to the predicate (K052557) device."

Summary

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APR 4 ZUDE

Special 510(k) Notification Togo Medikit Co. LTD Introducer Sheaths and Introducer Sheath Sets

General Provisions

K 060190

. J

Section 7

7.1

Summary of Safety and Effectiveness

(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)

Submitter's Name and Address	Togo Medikit Co. Ltd.17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga CityMiyazaki Prefecture 883-0062Japan
Contact Name and Information	Toshimitsu HayashiQuality Assurance ManagerPhone: 81-982-53-8027Fax: 81-982-53-8008e-mail: toshimitsu.hayashi@togomedikit.co.jp
Applicant	Heidi M. EricksonSpecialist, Regulatory AffairsPhone: 763-694-3028Fax: 763-694-6966e-mail: ericksoh@bsci.com
Proprietary Name(s)	Super Sheath XL Introducer Sheath
Common Name	Catheter Introducer
Product Code	DYB
Classification of Device	Class II, 21 CFR Part 870.1340

7.2 Name of Predicate Device

Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets

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7.3 Device Description

The Medikit Super Sheath Introducer XL Sheaths and Super Sheath XL Introducer Sheath Sets are similar to the 4-9F sheaths with the addition of four French sizes to the sheath line.

The Super Sheath XL Introducer Sheaths are available in 10F, 11F, 12F and 14F sizes and available in lengths ranging from 11 to 25 cm. The devices are provided sterile and are intended for one procedure use only.

The Medikit Super Sheath XL Introducer Sheath is packaged with a dilator. The Super Sheath Introducer XL Sheath Set consists of a sheath, a dilator and a mini guidewire, with inserter. The mini guidewires with inserter were cleared to market in K052557 (January 17, 2006). The construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and hub are made of polyamide and fluorinated ethylene propylene FEP (Teflon). 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 side tube extension may be used for fluid and medication administration as well as blood sampling.

The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire 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. The dilators are 0.038" and a 0.035" guidewire compatible. The dilator tubes are made of fluorinated ethylene propylene (FEP). The dilator tubes are attached to the dilator hub using an epoxy resin. The sheath hub and the dilator hub lock using a rotating motion.

7.4 Intended Use

7.5 Summary of Technological Characteristics

The Medikit Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets are operated manually or by a manual process. The Medikit Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets use similar product design, packaging, sterilization methods and labeling when compared to the 4-9F sheaths (K052557). The similar indications for use and technological characteristics support a determination of substantial equivalence. Differences in materials do not raise any new issues of safety and effectivencss.

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7.6 Non-clinical Test Summary

Testing was conducted to verify that the Super Sheath XL Introducer Sheaths met product specification. The following testing was performed:

Sheath Shaft Tensile test
Sheath Kink Test ●
Sheath Hub to Shaft Tensile Test .
Hemostatic Valve Integrity/Sheath Pressure Test ●
Sheath Valve Integrity/Sheath Pressure Test
. Dilator Shaft Tensile Test
Dilator Hub to Shaft Tensile Test
. Real Time Product Shelf Lift Testing

Lubricity, radiopacity, sheath/dilator corrosion resistance testing, biocompatibility and package test reports were provided in K052557. The devices tested included the materials and packaging used in the devices included in this Special 510(k) notification. No new testing was conducted.

Test results verified that the Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets are adequate for their intended use. Based on a comparison of intended use, design and the results of bench testing, Medikit 10F, 11F, 12F, and 14F Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets have been shown to be substantially equivalent to the predicate (K052557) device.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 4 2006

TOGO Medikit Co., Ltd. c/o Boston Scientific 5905 Nathan Lane Mail Stop P-25 Plymouth, MN 55442 Attn: Ms. Heidi M. Erickson

Re: K060190 Super Sheath XL Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: March 15, 2006 Received: March 16, 2006

Dear Ms. Erickson:

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, EDA over 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

vvie R. Viclner

\ 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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Special 510(k) Notification Togo Medikit Co. LTD Introducer Sheaths and Introducer Sheath Sets

Section 5 Indications for Use

Kobo ic

510(k) Number (if known): Kobol 90

Device Name: Guide Sheaths and Guide Sheath Sets

Indications for Use: The Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted 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)

Duna R. de Line
(Division Sign-Off)

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Division of Cardiovascular Devices

510(k) Number ن ( ( ( 1 ) 0 ( 1 ) 0

Confidential

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).