The 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 of adult and pediatric patients of all ages.

Device Description

The Super Sheath Introducer Sheaths and Super Sheath Sets are similar to the 4F-9F with the addition of the 3.3 French sheath, compatible dilator and guidewire to the sheath line. The Super Sheath Introducer Sheath is available in 3.3F and lengths of 5 cm and 7 cm. The device is provided sterile and intended for one procedure use only.

The Super Sheath Introducer Sheath is packaged with one dilator. The Super Sheath Introducer Sheath Set consists of one sheath, one dilator, and one guidewire with inserter. The sheath shaft and hub are manufactured of polyamide and ethylene tetrafluoro ethylene; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains 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 to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The 3.3F Super Sheath Introducer Sheaths and provided dilator are compatible with a maximum recommended 0.025" guidewire. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.

AI/ML Overview

The provided text describes a medical device (Super Sheath Introducer Sheaths and Sets) and its equivalence to a predicate device, rather than the acceptance criteria and study results for a new AI or diagnostic device. As such, most of the requested information (sample sizes, expert qualifications, MRMC studies, ground truth types, training data, etc.) is not applicable or present in this document.

However, I can extract the information related to the functional testing conducted to establish the performance of this medical device.

Acceptance Criteria and Device Performance (Functional Testing)

The document states that "Functional testing was conducted to verify the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets met product specification." While specific numerical acceptance criteria are not provided, the types of tests performed indicate the performance characteristics that were evaluated and met.

Acceptance Criteria (Implied)	Reported Device Performance
Sheath Shaft Tensile Strength: Must withstand tensile forces.	Met product specification through testing.
Sheath Kink Resistance: Must resist kinking during use.	Met product specification through testing.
Connection Strength: Connections must be secure.	Met product specification through testing.
Hemostatic Valve Pressure Integrity: Valve must prevent blood leakage under pressure.	Met product specification through testing.
Sheath Valve Integrity / Sheath Pressure: Valve and sheath must maintain integrity under pressure.	Met product specification through testing.
Sheath Lubricity: Sheath must allow smooth passage.	Met product specification through testing.
Sheath Radiopacity: Sheath must be visible under fluoroscopy.(Note: Predicate had a marker, new device states "Not applicable" for marker. This implies the sheath material itself might be radiopaque or it's not a P.criterion for the 3.3F based on its intended use/size.)	Met product specification through testing.
Sheath / Dilator Corrosion Resistance: Must resist corrosion.	Met product specification through testing.
Dilator Tensile Strength: Dilator must withstand tensile forces.	Met product specification through testing.
Dilator Connection Strength: Dilator connections must be secure.	Met product specification through testing.
Guidewire Tensile Strength: Guidewire must withstand tensile forces.	Met product specification through testing.
Guidewire Radiopacity: Guidewire must be visible under fluoroscopy.	Met product specification through testing.
Guidewire Corrosion Resistance: Guidewire must resist corrosion.	Met product specification through testing.
Guidewire Torque Load: Guidewire must withstand torque.	Met product specification through testing.
Guidewire Torqueability: Guidewire must be steerable/torqueable.	Met product specification through testing.
Sterilization Efficacy: Device must be sterile.	Validated in accordance with ISO 11135-1:2007.
Biocompatibility: Device materials must be biocompatible.	Demonstrated by similarity to predicate in K052557.
Packaging Integrity: Packaging must maintain sterility and product integrity.	Demonstrated by similarity to predicate in K052557.
Product Shelf Life: Device must maintain performance over time.	Demonstrated by similarity to predicate in K052557 (3 years).

Study Details (for a medical device, not AI)

Sample size used for the test set and the data provenance: Not explicitly stated. The testing was functional/engineering testing of the device itself, not patient data. Therefore, "data provenance" in terms of country of origin or retrospective/prospective is not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were non-clinical, functional tests performed according to protocols. "Ground truth" in this context would refer to engineering specifications and international standards, not expert medical opinion.
Adjudication method for the test set: Not applicable. Results would be compared against established product specifications and standards.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
The type of ground truth used: Product Specifications, International Standards (e.g., ISO 11135-1:2007 for sterilization), and in-house requirements.
The sample size for the training set: Not applicable. This document describes the testing of a physical medical device, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

Page 1 of 5

Section 5. 510(k) Summary

Submission Correspondent Emergo Group, Inc.

www.emergogroup.com/

Address

611 West Fifth Street Third Floor Austin, TX 78701

Phone

(512) 327-9997

Fax

(512) 327-9998

Contact

Ms. Heather Crawford, RAC heather@emergogroup.com

Submission Sponsor

Togo Medikit Co. Ltd. 17148-6 Aza Kamekawa Oaza Hichiya Hyuga City, Miyazaki, Japan 883-0062 +81-982-53-8027 (Voice) +81-982-53-8008 (Fax)

Date Prepared

20 June 2012

Trade Name

Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Set

Classification Name

Catheter Introducer

Regulation Number

870.1340

Product Code

DYB

Classification Panel Cardiovascular

SEP 27 2012

{1}------------------------------------------------

Device Class

Class II

Predicate Device

K052557: Super Sheath Introducer Sheath and Introducer Sheath Sets, 4F-9F

Togo Medikit Co., Ltd. previously submitted Special 510(k) K060190 Super Sheath XL Introducer Sheath to add sizes 10F, 11F, 12F and 14F to the range previously cleared under predicate device premarket notification number K052557. Special 510(k) K060190 was determined substantially equivalent on 04 April 2006 and added sizes 10F, 11F, 12F and 14F.

Indications for Use

The Super Sheath Introducer Sheaths and Super Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.

Device Description

{2}------------------------------------------------

Technological Characteristics and Substantial Equivalence

The following table compares the Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets to the predicate device with respect to intended use and technological characteristics, providing more detailed information regarding the basis for the determination of substantial equivalence.

Parameter	Super Sheath (3.3F)Additional Size	Super Sheath (4F-9F)Predicate Device
510(k)	To be assigned	K052557
Device Trade Name	Super Sheath IntroducerSheaths and Super SheathIntroducer Sheath Sets	Super Sheath IntroducerSheaths and Super SheathIntroducer Sheath Sets
Indications for Use	The Super Sheath IntroducerSheaths and Super SheathIntroducer Sheath Sets areindicated for use in theintroduction of diagnostic andinterventional devices insertedinto the human vasculature ofadult and pediatric patients ofall ages.	Introducer Sheaths andIntroducer Sheath Sets areintended for use in theintroduction of diagnostic andinterventional devicesinserted into the humanvasculature.
Regulation Number	870.1340	870.1310
FDA Product Code	DYB	DRE
Prescription / OTC Use	Prescription	Prescription
Single-Use / Reusable	Single-Use	Single-Use
Sheath
French Sizes Available	3.3F	4F - 9F
Effective Length	5 cm – 7 cm(50 mm – 70 mm)	7 cm – 25 cm(70 mm – 250 mm)
Radiopaque Marker	Not applicable	Tantalum
Guidewire and Inserter
Guidewire Tip Shape	Straight type	J-tip
Guidewire RecommendedMaximum OD (OuterDiameter)	0.025"	0.035", 0.038"
Inserter	Available	Available
Sterilization and Shelf Life
Sterilization Method	Ethylene oxide	Ethylene oxide
Sterile Package	Pouch	Pouch
Shelf Life (Use By Date)	Three (3) years	Three (3) years

Table 5-1. Device Comparison Table

{3}------------------------------------------------

Summary of Non-Clinical Data Submitted

Functional testing was conducted to verify the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets met product specification. Testing was conducted according to protocols based on international standards and in-house requirements, and included:

-Sheath Shaft Tensile Test
-Sheath Kink Test
Connection Strength Test י
Hemostatic Valve Pressure Test -
Sheath Valve Integrity / Sheath Pressure Test ー
Sheath Lubricity Test -
-Sheath Radiopacity Test
Sheath / Dilator Corrosion Resistance Test
Dilator Tensile Test -
Dilator Connection Strength Test -
ﮯ Guidewire Tensile Test
Guidewire Radiopacity Test
-Guidewire Corrosion Resistance Test
-Guidewire Torque Load Test
-Guidewire Torqueability Test

Additionally the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets were adopted into the existing ethylene oxide sterilization cycle for sheath products, which was validated in accordance with ISO 11135-1:2007.

Biocompatibility, packaging and product shelf life testing was provided in K052557. The devices tested included materials and packaging used in the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets included in this Special 510(k) premarket notification. Additional testing was not conducted.

Safety and Effectiveness

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

lt has been shown in this 510(k) submission that the differences between the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets and predicate devices do not raise any questions regarding its safety and effectiveness. The 3.3F Super Sheath Introducer Sheaths

{4}------------------------------------------------

and Super Sheath Introducer Sheath Sets, as designed and manufactured, therefore are determined to be substantially equivalent to the referenced predicate devices.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 27 2012

Togo Medikit Co., Ltd. c/o Ms. Heather Crawford, RAC Sr. Quality and Regulatory Consultant, Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701

Re: K121504

Trade/Device Name: Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets

Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II Product Code: DYB Dated: August 14, 2012 Received: August 16, 2012

Dear Ms. Crawford:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{6}------------------------------------------------

Page 2 - Ms. Heather Crawford

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Brain D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name:

Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets

Indications for Use:

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 IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)Division of Cardiovascular Devices	Page 1 of 1

K 12,504

510(k) Number

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).