Major components of the SUPER SHEATH (PROPOSED) are a sheath and a dilator. In addition, a guidewire is covered under this premarket notification. The guidewire is placed in the gudiewire case including inserter. The sheath for the SUPER SHEATH (PROPOSED) is named as the SUPER SHEATH (PROPOSED) Introducer Sheath and is available in 4F- 9F diameters and in lengths ranging from 7 to 25 cm. Some types of sheaths have radiopaque markers. The SUPER SHEATH (PROPOSED) are provided sterile and are intended for one procedure use only. The one-piece construction of the sheath shaft and hub allows smooth passage of concomitantly interventional medical devices. The sheath shaft and hub are made of Ethylene Tetrafluoro ethylene (ETFE) and polyamide. The hubs, color-coded by French size, contain a hemostatic valve to minimize 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. Some types of sheaths contain a marker band that is embedded in the shaft approximately 2.0 mm from the distal tip. The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. The dilator is inserted into the introducer sheath. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator facilitates and supports the entry of the sheath into the patient's vasculature. Once the sheath is in place the dilator is removed. There are two different dilator distal tip sizes, 0.038" and 0.035" guidewire compatible. The 4F dilators are only available with a 0.035" guidewire lumen dilator. The 5-9F dilators are available with a 0.035" or 0.038" guidewire lumen. The 4bes are made from Polypropylene (PP). The 9F dilator tubes are made of Fluorinated Ethylene Propylene (FEP). The dilator tubes are attached to the inner hub with a metal bush. The sheath hub and the dilator hub lock using a rotating motion. The SUPER SHEATH (PROPOSED) has a polypropylene suture wing which is 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. The uncoated guidewire is made of a stainless steel coil wrapped tightly around an inner mandrel that tapers at the distal tip. The flexible tip is J-shaped available in diameters of 0.035" and 0.038". The guidewire, with inserter, is available in 45 cm and 80 cm lengths. The inserter is used strictly for guiding the guidewire into a cannula or introducer.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "SUPER SHEATH (PROPOSED)," a catheter introducer. The submission aims to establish substantial equivalence to previously marketed predicate devices, "SUPER SHEATH (K052557)" and "3.3F SUPER SHEATH (K121504)."

The acceptance criteria are not explicitly stated as numerical performance targets (e.g., "sensitivity of 90%"). Instead, the acceptance criteria are implicitly met by demonstrating that the "SUPER SHEATH (PROPOSED)" device is substantially equivalent to its predicate devices through various bench tests and biocompatibility testing. The study's goal was to ensure the proposed device's safety and effectiveness amidst material changes to the sheath shaft and packaging modifications.

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

Since specific numerical acceptance criteria (e.g., target tensile strength, specific kink resistance values) are not provided in the document, the table below lists the types of tests performed and the general findings as the "reported device performance." The acceptance criteria, in this context, were that the proposed device would perform comparably to its predicate device or meet international/in-house requirements without raising new safety or effectiveness concerns.

Test Category	Specific Bench Test Type	Implicit Acceptance Criteria (based on predicate equivalence/safety)	Reported Device Performance
Mechanical Performance (Sheath)	Sheath Shaft Tensile Test	The sheath shaft must maintain sufficient tensile strength to prevent breakage during use and be comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Sheath Kink Test	The sheath must resist kinking to ensure proper device insertion and functionality, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Sheath Hub to Shaft Tensile Test	The connection between the sheath hub and shaft must be strong enough to withstand forces during use, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Valve Integrity of Sheath	The hemostatic valve must effectively minimize blood leakage during a procedure, performing comparably to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Sheath Lubricity Test	The sheath must exhibit adequate lubricity for smooth insertion and removal, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Sheath Radiopacity Test	The sheath should be sufficiently radiopaque for visualization under fluoroscopy, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Cover Tube Durability Test	The cover tube must be durable enough for its intended purpose.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Hemostatic Valve Integrity/Sheath Pressure Test	The hemostatic valve and sheath must withstand internal pressure and maintain integrity.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Sheath/Dilator Corrosion Resistance Test	No significant corrosion should occur that could compromise functionality or patient safety, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
Mechanical Performance (Dilator)	Dilator Shaft Tensile Test	The dilator shaft must possess adequate tensile strength, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Dilator Hub to Shaft Tensile Test	The connection between the dilator hub and shaft must be strong enough to withstand forces during use, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
Mechanical Performance (Guidewire)	Guidewire Tensile Test	The guidewire must exhibit sufficient tensile strength to prevent breakage during manipulation, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Guidewire Combined Load Test	The guidewire must perform reliably under combined loads experienced during procedures, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Guidewire Torqueability Test	The guidewire must have acceptable torqueability for precise positioning, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Guidewire Radiopacity Test	The guidewire should be sufficiently radiopaque for visualization under fluoroscopy, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
	Guidewire Corrosion Resistance Test	No significant corrosion should occur that could compromise functionality or patient safety, comparable to the predicate device.	Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
Biocompatibility	Cytotoxicity	No unacceptable cytotoxic effects should be observed.	No biocompatibility concern was raised in the biocompatibility testing reports.
	Intracutaneous Reactivity	No unacceptable intracutaneous reactivity should be observed.	No biocompatibility concern was raised in the biocompatibility testing reports.
	Sensitization	No unacceptable sensitization (allergic reaction) should be observed.	No biocompatibility concern was raised in the biocompatibility testing reports.
	Acute Systemic Toxicity	No unacceptable acute systemic toxic effects should be observed.	No biocompatibility concern was raised in the biocompatibility testing reports.
	Hemocompatibility	The device should not cause adverse blood-material interactions (e.g., hemolysis, thrombosis).	No biocompatibility concern was raised in the biocompatibility testing reports.
	Pyrogen Test	The device should be non-pyrogenic to prevent fever reactions.	No biocompatibility concern was raised in the biocompatibility testing reports.
	LAL Test (Endotoxin)	Limits for endotoxins must be met.	No biocompatibility concern was raised in the biocompatibility testing reports.
Sterilization & Packaging	Packaging Integrity Test	The packaging must maintain a sterile barrier throughout the shelf-life.	Packaging integrity test and sterility test demonstrates the packaging works as a sterile barrier for the SUPER SHEATH (PROPOSED) and is substantial equivalent to the packaging of the 3.3F SUPER SHEATH (K121504).
	Sterility Test	The device must remain sterile until opened for use and meet requirements for ethylene oxide sterilization.	Packaging integrity test and sterility test demonstrates the packaging works as a sterile barrier for the SUPER SHEATH (PROPOSED) and is substantial equivalent to the packaging of the 3.3F SUPER SHEATH (K121504).
	Shelf-Life Testing	The device components and sterile barrier must remain stable and functional for the stated shelf-life (2 years for the proposed device), comparable to the predicate devices (3 years for predicates, although proposed is 2 years, this difference in shelf-life is not highlighted as a concern).	Bench testing including shelf-life testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).

Regarding the study proving the device meets the acceptance criteria:

The study described is a series of bench tests and biocompatibility tests designed to demonstrate that the "SUPER SHEATH (PROPOSED)" is substantially equivalent to its predicate devices, despite a material change in the sheath shaft and changes in packaging.

2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of devices or samples used for each bench test or biocompatibility test. It simply states that "bench testing" and "biocompatibility testing" were performed.
- Data Provenance: The tests were conducted by TOGO MEDIKIT CO., LTD., a Japanese company. The data would therefore originate from their internal testing processes. The document does not specify if the tests were retrospective or prospective, but typically such verification tests are performed prospectively on newly manufactured devices or components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. This premarket notification is for a physical medical device (catheter introducer) and its performance is evaluated through objective physical and chemical testing (bench tests, biocompatibility tests). There is no "ground truth" established by human experts in the way that an AI diagnostic device would require (e.g., radiologist consensus on images). The "ground truth" for these tests are objective measurements against established engineering standards or comparative performance against predicate devices.
4. Adjudication method for the test set:
- This question is not applicable for the reasons stated above. There is no human interpretation or adjudication of "cases" as would be seen in an AI study. The results of the physical and chemical tests are objectively measured.
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:
- This question is not applicable. This is not an AI/software device that involves human interpretation of diagnostic data. It is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This is not an AI/software device. The performance is of the physical device components.
7. The type of ground truth used:
- The "ground truth" in this context refers to the objective performance criteria derived from engineering specifications, international standards, and the established performance of the predicate devices. For biocompatibility, the ground truth is the absence of adverse biological reactions/toxicity as defined by ISO standards for biocompatibility.
8. The sample size for the training set:
- This question is not applicable. This submission does not involve an AI algorithm; therefore, there is no "training set." The device is a physical product.
9. How the ground truth for the training set was established:
- This question is not applicable. As there is no AI algorithm, there is no training set or associated ground truth.

Summary

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

January 15, 2015

Togo Medikit Co., Ltd. Izumi Maruo Senior Consultant 4-1-17 Hongo Bunkyo-ku, 113-0033 JA

Re: K141070 Trade/Device Name: Super Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DRE Dated: December 8, 2014 Received: December 12, 2014

Dear Izumi Maruo,

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

Bram D. Zuckerman, M.D. For 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) K141070

Device Name SUPER SHEATH

Indications for Use (Describe)

The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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TOGO MEDIKIT CO., LTD.

17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City
Miyazaki Prefecture 883-0062, Japan
TELEPHONE: +81-982-53-8027
FACSIMILE: +81-982-53-8008

510(k) Summary

a. Owner/Company name, address TOGO MEDIKIT CO., LTD. 17148-6 Aza Kamekawa, Oaza Hichiya Hyuga City, Miyazaki Prefecture, 883-0062, Japan
Daisuke Nagamizu Manager, Regulatory Affairs Section, Quality Assurance Department Phone: 011-81-982-53-8000 011-81-982-53-8008 Fax: Email: qc@togomedikit.co.jp

b. Contact/Application Correspondent

Izumi Maruo Senior Consultant MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan

Phone: 011-81-3-3818-8577 011-81-3-3818-8573 Fax: Email: maruo@mici.co.jp

c. Date prepared

April 18, 2014

d. Name of device

Trade Name:	SUPER SHEATH
Common Name:	Introducer, Catheter
Classification Name:	Catheter Introducer
Classification Regulation:	21 CFR 870.1340
Product Code:	DYB
Classification Panel:	Cardiovascular

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e. Predicate devices

The SUPER SHEATH is substantially equivalent to the following legally marketed devices:

510(k):	K052557
Trade name:	Super Sheath Introducer Sheath and Introducer Sheath Sets, 4F-9F
Regulation Number:	21 CFR 870.1310
Product code:	DRE
510(k):	K121504
Trade name:	Super Sheath Introducer Sheath and Introducer Sheath Sets, 3.3F
Regulation Number:	21 CFR 870.1340
Product code:	DYB

Since the same name as predicate device is used, the new device under application is hereinafter called "the SUPER SHEATH (PROPOSED)" and the predicate devices are called "the SUPER SHEATH (K052557)" and "the 3.3F SUPER SHEATH (K121504)", respectively, for convenience of discussion in this application.

We are claiming substantial equivalence to product codes DRE and DYB.

f. Description of the device

The sheath for the SUPER SHEATH (PROPOSED) is named as the SUPER SHEATH (PROPOSED) Introducer Sheath and is available in 4F- 9F diameters and in lengths ranging from 7 to 25 cm. Some types of sheaths have radiopaque markers. The SUPER SHEATH (PROPOSED) are provided sterile and are intended for one procedure use only.

The one-piece construction of the sheath shaft and hub allows smooth passage of concomitantly interventional medical devices. The sheath shaft and hub are made of Ethylene Tetrafluoro ethylene (ETFE) and polyamide.

The hubs, color-coded by French size, contain a hemostatic valve to minimize 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. Some types of sheaths contain a marker band that is embedded in the shaft approximately 2.0 mm from the distal tip.

The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. The dilator is inserted into the introducer sheath. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator facilitates and supports the entry of the sheath into the patient's vasculature. Once the sheath is in place the dilator is removed. There are two different dilator distal tip sizes, 0.038" and 0.035" guidewire compatible. The 4F dilators are only available with a 0.035" guidewire lumen dilator. The 5-9F dilators are available with a

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0.035" or 0.038" guidewire lumen. The 4bes are made from Polypropylene (PP). The 9F dilator tubes are made of Fluorinated Ethylene Propylene (FEP). The dilator tubes are attached to the inner hub with a metal bush. The sheath hub and the dilator hub lock using a rotating motion.

The SUPER SHEATH (PROPOSED) has a polypropylene suture wing which is 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.

The uncoated guidewire is made of a stainless steel coil wrapped tightly around an inner mandrel that tapers at the distal tip. The flexible tip is J-shaped available in diameters of 0.035" and 0.038". The guidewire, with inserter, is available in 45 cm and 80 cm lengths. The inserter is used strictly for guiding the guidewire into a cannula or introducer.

g. Indications for Use

Indication for Use

The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.

h. Statement of substantial equivalence

The main body of the SUPER SHEATH (PROPOSED) was essentially modified from the SUPER SHEATH (K052557). Thus, most of the characteristics of the SUPER SHEATH (PROPOSED) are similar to those of the SUPER SHEATH (K052557). Regarding packaging, the packaging materials and configuration are the same as the 3.3F SUPER SHEATH (K121504).

Comparison table of technological characteristics is as follows;

Feature	SUPER(PROPOSED)	SHEATH	SUPER(K052557)	SHEATH	3.3F SUPER SHEATH(K121504)
Indications for Use	The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.		Introducer Sheaths and Introducer Sheath Sets are intended for use in the introduction of diagnostic and interventional devices into the human vasculature.		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.
Regulation	870.1340		870.1310		870.1340

			Comparison table of technological characteristics
Number
FDA Product Code	DYB	DRE	DYB
Prescription/OTC Use	Prescription	Prescription	Prescription
Single-use/Reusab le	Single-use	Single-use	Single-use
Sheath
French Sizes Available	4F- 9F	4F- 9F	3.3F
Effective Length	7 cm - 25 cm	7 cm - 25 cm	5 cm - 7 cm
Sheath Shaft Inner Diameter (ID)	1.58 mm - 3.23 mm	1.58 mm - 3.23 mm	1.30 mm
Sheath Shaft Outer Diameter (OD)	1.98 mm - 3.69 mm	1.98 mm - 3.69 mm	1.70 mm
Sheath Shaft Materials	Ethylene tetrafluoro ethylene (Neoflon® ETFE EP-526):90%Barium Sulfate: 10%	Ethylene tetrafluoro ethylene (Neoflon® ETFE EP-522):85%Barium Sulfate: 15%	Ethylene tetrafluoro ethylene (Neoflon® ETFE EP-522):85%Barium Sulfate: 15%
Cover Tube Material	Ethylene tetrafluoro ethylene (Neoflon® ETFE EP-526)	Ethylene tetrafluoro ethylene (Neoflon® ETFE EP-522)	Not Applicable
Radiopaque Marker	Tantalum	Tantalum	Not Applicable
Dilator
Dilator Tube Materials	4F -8F:Polypropylene9F: Fluorinated ethylene propylene	4F -8F:Polypropylene9F: Fluorinated ethylene propylene	Polypropylene
Dilator Tube Inner Diameter (ID)	4F-8F 0.92 mm – 1.00 mm (0.035" )1.02 mm– 1.10 mm (0.038" )9F 0.95 mm – 1.05 mm (0.035" )1.05 mm– 1.15 mm (0.038" )	4F-8F 0.92 mm – 1.00 mm (0.035" )1.02 mm– 1.10 mm (0.038" )9F 0.95 mm – 1.05 mm (0.035" )1.05 mm– 1.15 mm (0.038" )	0.65 mm – 0.75 mm

Dilator TubeOuter Diameter(OD)	1.38 mm – 3.09 mm	1.38 mm – 3.09 mm	1.23 mm
Dilator TubeEffective Length	13 cm – 31 cm(130 mm – 310 mm)	13 cm – 31 cm(130 mm – 310 mm)	10.5 cm to 12.5 cm(105 mm – 125 mm)
Dilator Distal Tip	0.035”0.038”	0.035” 0.038”	0.018”0.021”0.025”
Guidewire and Inserter
GuidewireTipShape	J-tip	J-tip	Straight type
Outer Diameter	0.035”, 0.038”	0.035”, 0.038”	0.025”
Inserter	Available	Available	Available
Sterilization and Shelf-life
Sterilizationmethod	Ethylene oxide	Ethylene oxide	Ethylene oxide
Sterile Package	Pouch	Blister package	Pouch
Shelf-Life	Two (2) years	Three (3) years	Three (3) years

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OGO MEDIKIT CO., LT 7148-6. Aza Kamekawa. Oaza Hichiya. Hyuga City

Miyazaki Prefecture 883-0062, Japan TELEPHONE : +81-982-53-8027 FACSIMILE : +81-982-53-8008

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Image /page/7/Picture/0 description: The image shows a logo with a stylized human figure standing in front of a globe. The globe is represented by a grid of lines, suggesting a network or global reach. The human figure is simplified, with arms raised, creating a sense of connection or outreach. The logo appears to be designed to convey a message of global unity, human connection, or international cooperation.

TOGO MEDIKIT CO., LTD.

7148-6, Aza Kamekawa, Oaza Hichiya, Hyuga Ci
Miyazaki Prefecture 883-0062, Japan
TELEPHONE : +81-982-53-8027

Note*: There are two different dilator distal tip sizes, 0.038" and 0.035" guidewire compatible. Note that the 4F dilators are only available with a 0.035"guidewire lumen dilator. The 5-9F dilators are available with a 0.035" or 0.038" guidewire lumen.

SUPER SHEATH (K052557) referenced regulation number 870.1310 and product code DRE. However 3.3F SUPER SHEATH (K121504) for additional sizes utilized regulation number 870.1340 and product code DYB, which are referenced by the current submission. Citation of 870.1340 /DYB is presumably the most current regulatory practice as evidenced by 3.3F SUPER SHEATH (K121504).

Regarding the main body of the SUPER SHEATH (PROPOSED), major components are a sheath and a dilator. In addition, a guidewire is covered under this premarket notification. The guidewire is placed in the Gudiewire case including inserter. The only difference from the SUPER SHEATH (K052557) is the modifications of material change of the sheath shaft.

In order to evaluate any effects of the above changes on safety and effectiveness for the main body, biocompatibility testing and bench testing including shelf-life testing were performed.-Biocompatibility testing demonstrated that the SUPER SHEATH (PROPOSED) does

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Image /page/8/Picture/0 description: The image shows a logo with a globe-like structure. The globe is made of vertical and horizontal lines, creating a grid-like pattern. In the center of the globe, there is a stylized human figure with its arms raised. The figure appears to be integrated into the globe's structure, suggesting a connection between humanity and the world.

TOGO MEDIKIT CO., LTD.
17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City
Miyazaki Prefecture 883-0062, Japan
TELEPHONE: +81-982-53-8027
FACSIMILE: +81-982-53-8008

not raise any biocompatibility concern. testing including shelf-life testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).

Regarding packaging of the SUPER SHEATH (PROPOSED), packaging integrity test and sterility test demonstrates the packaging works as a sterile barrier for the SUPER SHEATH (PROPOSED) and is substantial equivalent to the packaging of the 3.3F SUPER SHEATH (K121504).

Based on above, we concluded that the modification did not raise any new safety or effectiveness concerns compared to the SUPER SHEATH (K052557) for main body and the 3.3F SUPER SHEATH (K121504) for packaging.

i. Bench Testing

The following bench tests were performed to ensure the safety and effectiveness of the SUPER SHEATH (PROPOSED), verify conformity to the international standards and in-house requirements, and demonstrate substantial equivalence to the SUPER SHEATH (K052557).

Sheath Shaft Tensile Test
Sheath Kink Test
Sheath Hub to Shaft Tensile Test
Valve Integrity of Sheath
Sheath Lubricity Test
Sheath Radiopacity Test
Cover Tube Durability Test
Hemostatic Valve Integrity/Sheath Pressure Test
Sheath/Dilator Corrosion Resistance Test
Dilator Shaft Tensile Test
. . . . . . . . . . . . . Dilator Hub to Shaft Tensile Test
Guidewire Tensile Test
Guidewire Combined Load Test
Guidewire Torqueability Test
Guidewire Radiopacity Test
Guidewire Corrosion Resistance Test

Biocompatibility Testing i.

We performed following biocompatibility tests because of material change of the sheath shaft;

Cytotoxicity
Intracutaneous reactivity
Sensitization
.... Acute Systemic Toxicity
Hemocompatibility
Pyrogen test
LAL test

SUPER SHEATH APRIL 18, 2014

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TOGO MEDIKIT CO., LTD.

17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City
Miyazaki Prefecture 883-0062, Japan
TELEPHONE: +81-982-53-8027
FACSIMILE: +81-982-53-8008

In the biocompatibility testing reports, no biocompatibility concern was raised.

k. Conclusion

Based on the above discussion and enclosed sections regarding substantial equivalence to predicate devices, TOGO MEDIKIT concludes that the SUPER SHEATH (PROPOSED) is substantially equivalent to the SUPER SHEATH (K052557) and the 3.3F SUPER SHEATH (K121504) , and the SUPER SHEATH (PROPOSED) does not raise any new questions regarding safety or effectiveness.

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
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.(b)
Classification. Class II (performance standards).