The Glidesheath Slender consists of an introducer (sheath and a dilator), which are packaged together with an entry needle, mini guide wire and guide wire inserter. The Glidesheath Slender devices (all sheath sizes) are used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in either the stainless steel (SS) entry needle version or the Surflo (SR) IV catheter (which includes a needle). There are two different types of stainless-steel entry needles that are available in various gauges and lengths. The two needle types are referenced in the documentation as TPC and TRI. These initials are only used in internal Terumo documents.

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in three versions made out of three materials, either a stainless-steel spring coil model (stainless steel), a nitinol model with palladium tip (nitinol) or a polyurethane plastic model with a nitinol core (plastic).

During either a diagnostic or interventional catheterization procedure, a physician will perform the following procedure. The mini guide wire is inserted through a cannula placed in the patient's blood vessel. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. Following guide wire insertion, the cannula is removed, and the sheath and dilator are 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 The mini guide wire is then withdrawn from the vessel.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 during insertion. Once the sheath is situated in the vessel, the dilator is removed, and an appropriate catheter can then be inserted through the sheath.

The entry needle, the mini guide wire and the guide wire inserter are all accessories to the Glidesheath Slender sheath/dilator. The accessories for a given product code are provided with the Glidesheat Slender sheath/dilator in an individual package and sterilized together.

AI/ML Overview

The acceptance criteria and study proving the device meets them are detailed for the Glidesheath Slender. The device is a catheter introducer for radial artery access.

Here's a breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comprehensive list of performance tests conducted on various components of the Glidesheath Slender. The "Reported Device Performance" column implicitly states that the "Glidesheath Slender tested met the predetermined acceptance criteria and results support a determination of substantial equivalence." This means that for each test item listed, the device's performance fell within the acceptable parameters defined by the cited standards (ISO, ASTM, in-house) or internal requirements.

Component	Test Item	Reference	Acceptance Criteria	Reported Device Performance
Sheath	Fluoroscopy	ISO 11070:2014, Section 4.5ASTM F640-12	(Implicit: Device must be visible under fluoroscopy as per standards)	Met predetermined acceptance criteria.
	Sheath visual inspection	In-house standard	(Implicit: Visual quality meets internal specifications)	Met predetermined acceptance criteria.
	Sheath Effective Length	In-house standard	(Implicit: Length within specified tolerances)	Met predetermined acceptance criteria.
	Side Tube Length	In-house standard	(Implicit: Length within specified tolerances)	Met predetermined acceptance criteria.
	Sheath Tip ID	In-house standard	(Implicit: Inner diameter at tip within specified tolerances)	Met predetermined acceptance criteria.
	Sheath, Hemostatic Valve Leak	ISO 11070:2014, Annex E	(Implicit: Hemostatic valve must prevent leakage as per standard)	Met predetermined acceptance criteria.
	Sheath Pressure Test	ISO 11070:2014, Annex DISO 11070:2013, Annex C	(Implicit: Withstands specified pressure without failure as per standards)	Met predetermined acceptance criteria.
	Sheath Penetration	In-house standard	(Implicit: Achieves appropriate penetration characteristics)	Met predetermined acceptance criteria.
	Visual inspection after penetration testing	ISO 11070:2014 - Annex A section A3	(Implicit: No significant damage or alteration after penetration as per standard)	Met predetermined acceptance criteria.
	Sheath Tip Rollback Test	ISO 11070:2014 - Annex A section A3	(Implicit: Tip integrity maintained during rollback as per standard)	Met predetermined acceptance criteria.
	Dilator Hub to Sheath Hub Snap Fit Strength	In-house standard	(Implicit: Connection strength meets internal specifications)	Met predetermined acceptance criteria.
	Valve Mobility Resistance	In-house standard	(Implicit: Valve operates smoothly within specified resistance)	Met predetermined acceptance criteria.
	Sheath Kink resistance	ISO 11070:2014 Annex A section A.1	(Implicit: Resists kinking under specified conditions as per standard)	Met predetermined acceptance criteria.
	Sheath Tubing/Housing Joint Strength	ISO 11070:2014, Section 7.6	(Implicit: Joint strength meets specified requirements as per standard)	Met predetermined acceptance criteria.
	Cap to Housing Joint Strength	In-house standard	(Implicit: Connection strength meets internal specifications)	Met predetermined acceptance criteria.
	Sheath Support to Housing Strength	In-house standard	(Implicit: Support strength meets internal specifications)	Met predetermined acceptance criteria.
	Sheath Tubing Tensile Strength	ISO 11070:2014, Section 7.6	(Implicit: Tensile strength meets specified requirements as per standard)	Met predetermined acceptance criteria.
	Sheath Lubricity and Durability	In-house standard	(Implicit: Maintains lubricity and durability over intended use)	Met predetermined acceptance criteria.
	Particle capture during simulated use	FDA PTCA Guidance	(Implicit: Particle generation during simulated use is within acceptable limits as per FDA guidance)	Met predetermined acceptance criteria.
	Coating integrity after simulated use	In-house standard	(Implicit: Hydrophilic coating maintains integrity after simulated use)	Met predetermined acceptance criteria.
Dilator	Fluoroscopy	ISO 11070:2014, Section 4.5ASTM F640-12	(Implicit: Device must be visible under fluoroscopy as per standards)	Met predetermined acceptance criteria.
	Dilator visual inspection	In-house standard	(Implicit: Visual quality meets internal specifications)	Met predetermined acceptance criteria.
	Dilator Useable Length	In-house standard	(Implicit: Length within specified tolerances)	Met predetermined acceptance criteria.
	Dilator Tip ID	In-house standard	(Implicit: Inner diameter at tip within specified tolerances)	Met predetermined acceptance criteria.
	Dilator OD at Sheath Tip	In-house standard	(Implicit: Outer diameter at sheath tip within specified tolerances)	Met predetermined acceptance criteria.
	Dilator Penetration	In-house standard	(Implicit: Achieves appropriate penetration characteristics)	Met predetermined acceptance criteria.
	Visual inspection after penetration testing	ISO 11070:2014 - Annex A section A3	(Implicit: No significant damage or alteration after penetration as per standard)	Met predetermined acceptance criteria.
	Dilator Tip Rollback Test	ISO 11070:2014 - Annex A section A3	(Implicit: Tip integrity maintained during rollback as per standard)	Met predetermined acceptance criteria.
	Dilator to Hub Tensile	ISO 11070:2014, Annex CISO 11070:2013, Annex B	(Implicit: Tensile strength of dilator to hub connection meets specified requirements as per standards)	Met predetermined acceptance criteria.
	Dilator Hub to Sheath Hub Snap Fit Strength	In-house standard	(Implicit: Connection strength meets internal specifications)	Met predetermined acceptance criteria.
	Particle capture during simulated use	FDA PTCA Guidance	(Implicit: Particle generation during simulated use is within acceptable limits as per FDA guidance)	Met predetermined acceptance criteria.
Biocompatibility	Cytotoxicity	EN ISO 10993-1, FDA Guidance	(Implicit: No cytotoxic effects detected)	Met predetermined acceptance criteria.
	Sensitization	EN ISO 10993-1, FDA Guidance	(Implicit: No sensitization detected)	Met predetermined acceptance criteria.
	Intracutaneous Reactivity	EN ISO 10993-1, FDA Guidance	(Implicit: No significant intracutaneous reaction)	Met predetermined acceptance criteria.
	Systemic Toxicity (Acute)	EN ISO 10993-1, FDA Guidance	(Implicit: No acute systemic toxicity)	Met predetermined acceptance criteria.
	Pyrogenicity	EN ISO 10993-1, FDA Guidance	(Implicit: No pyrogenic response)	Met predetermined acceptance criteria.
	Hemocompatibility	EN ISO 10993-1, FDA Guidance	(Implicit: Compatible with blood, does not cause adverse hematological effects)	Met predetermined acceptance criteria.
Sterilization	Sterility Assay	ISO 11135:2014	Sterility Assurance Level (SAL) of 10-6	Achieved SAL of 10-6.
	Residual Ethylene Oxide (EO)	EN ISO 10993-7:2008	Not exceeding an average daily dose of 4 mg after 24 hours of heated aeration	Met predetermined acceptance criteria.
	Residual Ethylene Chlorohydrin (ECH)	EN ISO 10993-7:2008	Not exceeding an average daily dose of 9 mg after 24 hours of heated aeration	Met predetermined acceptance criteria.
Shelf Life	Shelf life validation	(Implied in submission)	(Implicit: Device maintains performance and safety for 30 months)	Demonstrated 30 months shelf life, with performance maintained throughout.

2. Sample Size for the Test Set and Data Provenance:

The document describes non-clinical performance testing, which typically involves testing of device units according to engineering standards rather than a "test set" of patient data. The specific number of units tested for each performance test item is not provided in this summary. The data provenance is internal to the manufacturer (Terumo Medical Corporation) and follows recognized international and in-house standards. This is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the usual sense for clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This information is not applicable as the document explicitly states: "This 510(k) does not include data from clinical tests." The performance testing described is engineering and biocompatibility testing, where "ground truth" is established by adherence to specified physical and chemical properties and compliance with recognized standards.

4. Adjudication Method for the Test Set:

This information is not applicable as clinical data or expert review of cases is not part of this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This 510(k) does not include data from clinical tests." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.

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

This is not applicable as the device is a physical medical instrument (catheter introducer), not an AI algorithm or software.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is established by:

International Standards: ISO 11070:2014, ASTM F640-12, ISO 11135:2014, EN ISO 10993-1, EN ISO 10993-7:2008.
FDA Guidance: FDA PTCA Guidance, FDA Guidance on Use of International Standard ISO 10993-1.
In-house standards: Internal specifications developed by Terumo Medical Corporation.

These standards and guidances define acceptable physical, mechanical, chemical, and biological properties for device components.

8. The Sample Size for the Training Set:

This is not applicable as the device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

May 8, 2018

Terumo Medical Corporation Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd Elkton, Maryland 21921

Re: K173831

Trade/Device Name: Glidesheath Slender Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 13, 2018 Received: April 16, 2018

Dear Liang Lu:

We have reviewed vour 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 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh - S

for

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)

K173831

Device Name Glidesheath Slender

Indications for Use (Describe)

The Glidesheath Slender is indicated to facilitate placing a catheter through the skin into the radial artery.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

A. SUBMITTER INFORMATION (807.92(a)(1))

Prepared by:

Liang Lu Senior Regulatory Affairs Specialist Terumo Medical Corporation Tel. (410) 392-7321 Fax (410) 398-6079

Prepared for: Owner/Operator Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873, USA Owner/Operator Number: 9003933

Manufacturer (510(k) Applicant)

Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Registration Number: 1118880

Sterilization Facility

STERIS AST 3459 South Clinton Ave South Plainfield, NJ 07080 Registration Number: 2246552

Contact Person: Liang Lu Senior Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: liang.lu@terumomedical.com

Date prepared: April 27, 2018

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B. DEVICE NAME (807.92(a)(2))

Proprietary Name: Common Name: Classification Name: Classification Panel: Regulation: Product Code: Classification:

Glidesheath Slender Introducer Sheath Introducer, Catheter Cardiovascular 21 CFR 870.1340 DYB Class II

C. PREDICATE DEVICE (807.92(a)(3))

The legally marketed device(s) to which substantial equivalence is claimed are:

Predicate Device: K142183 Glidesheath Slender, manufactured by Terumo ● Corporation, Japan
Reference Device: K152173 Glidesheath, manufactured by Terumo Medical . Corporation. USA

D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted for the Glidesheath Slender, manufactured by Terumo Medical Corporation, for the purposes of establishing substantial equivalence to a legally marketed predicate device.

E. DEVICE DESCRIPTION (807.92(a)(4))

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in insertion of the mini guide wire into the cannula. Following guide wire insertion, the cannula is removed, and the sheath and dilator are 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 during insertion. Once the sheath is situated in the vessel, the dilator is removed, and an appropriate catheter can then be inserted through the sheath.

F. INDICATIONS FOR USE (807.92(a)(5))

The Glidesheath Slender is indicated to facilitate placing a catheter through the skin into the radial artery.

G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))

The Glidesheath Slender, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the predicate device, manufactured by Terumo Corporation.

A comparison of the technological characteristics is summarized on the table below.

Table 5.1: Summary of Substantial Equivalence

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Device Characteristic	Subject Device:	Predicate Device:
	Glidesheath Slender	Glidesheath Slender (K142183)
Manufacturer	Terumo Medical Corporation (Elkton, MD)	Terumo Corporation, (Ashitaka, Japan)
Intended Use /Indications for Use	The Glidesheath Slender is indicated to facilitate placing acatheter through the skin into the radial artery	Same
Operation Principle	Operated manually or by a manualprocess:	Same
Design / Construction	Sheath,Dilator,Guide Wires (Plastic, Stainless Steel, Nitinol),Surflo IV Catheter,Stainless Steel Entry Needle	Same, except for:Guide Wire (Nitinol) and TRI Stainless Steel Entry Needle ofthe proposed device are not available in kits for the predicateTC Glidesheath Slender (K142183), they are identical to theGuide Wire (Nitinol) and TRI Stainless Steel Entry Needleused in the reference Glidesheath (K152173).
Materials	Sheath Assembly:Ethylene-Tetrafluoroethylene(ETFE) copolymerBismuth trioxideColorantDimethylacrylamide-glycidyl methacrylate copolymerSilicone oilPolypropyleneSilicone RubberStainless SteelStyrene-ethylene-butylene-styrene block copolymerPolybutadienePolycarbonatePolyethyleneColorantDilator Assembly:PolypropyleneBismuth subcarbonateColorantSilicone oilStainless Steel	Same, except for:3WSC and Silicone Lubricant of the proposed device havesame material types with minor differences, but they areidentical to the 3WSC and Silicone Lubricant used in thereference Glidesheath (K152173).Same, except for:Silicone Lubricant of the proposed device has same materialtypes with minor differences, but it isidentical to the Silicone Lubricant used in the referenceGlidesheath (K152173).
Device Characteristic	Subject Device:	Predicate Device:
	Glidesheath Slender	Glidesheath Slender (K142183)
	Guide Wire (Plastic Jacket):	Same
	Nickel-Titanium alloy
	Polyurethane
	Tungsten
	Silicone oil

	Guide Wire (Stainless Steel):	Same
	Stainless Steel
	Guide Wire (Nitinol):	Guide Wire (Nitinol) of the proposed device is not available
	Nickel-Titanium alloy	in kits for the predicate TC Glidesheath Slender (K142183),
	Palladium	but it is identical to the Guide Wire (Nitinol) used in the
	Epoxy adhesive	reference Glidesheath (K152173).
	Guide Wire Inserter:	Same
	Polyethylene
	Colorant
	Surflo IV Catheter:	Same
	Ethylene-Tetrafluoroethylene (ETFE) copolymer
	Colorant
	Barium sulfate
	Dispersant
	Silicone oil
	Polypropylene
	Stainless Steel
	Sorbitan fatty acid ester
	PolycarbonatePolystyrenePolyester-Chlorinated polyvinyl chloride
	Entry Needle (TPC):	Same
	Stainless Steel
	Silicone oil
	PolycarbonateAcrylic resin containing colorant
Device Characteristic	Subject Device:Glidesheath Slender	Predicate Device:Glidesheath Slender (K142183)
	Entry Needle (TRI):	Same, except for:
	Stainless SteelSilicone oilStyrene-buadieneAcrylic resin heat transcription foil	TRI Stainless Steel Entry Needle (21G x 38mm) of theproposed device is not available in kits for the predicate TCGlidesheath Slender (K142183), but it is identical to theentry needle used in the reference Glidesheath (K152173).
Package	Tyvek, Polyester-polyethylene laminated film,High Impact Polystyrene	Same
Specifications	Sheath	Sheath
	Size: 5, 6, 7 Fr.Length: 10, 16 cm	Same
	DilatorSize (Applicable to GW Outer Diameter):0.021, 0.025 inchLength: 15.7, 21.7 cm	DilatorSize (Applicable to GW Outer Diameter):0.018, 0.021, 0.025, 0.035 inchLength: 15.5, 21.5 cm
	Guide Wire (Plastic)OD: 0.021, 0.025 inchGuide Wires Length: 45, 80 cm	Guide Wire (Plastic)OD: 0.018, 0.021, 0.025, 0.035 inchGuide Wires Length: Same
	Guide Wire (Stainless Steel)OD: 0.021, 0.025 inchGuide Wires Length: 45, 80 cm	Guide Wire (Stainless Steel)OD: 0.018, 0.021, 0.025, 0.035 inchGuide Wires Length: Same
	Guide Wire (Nitinol)OD: 0.021 inchGuide Wires Length: 43 cm	Guide Wire (Nitinol)None
	Surflo IV CatheterType: 20, 22 GLength: 25, 32 mm (1", 1 1/4")	Surflo IV CatheterType: 18, 20, 22 GLength: 25, 32, 51, 64 mm (1", 1 1/4", 2", 2 1/2")
Device Characteristic	Subject Device:	Predicate Device:
	Glidesheath Slender	Glidesheath Slender (K142183)
	Entry Needle (TPC)	Entry Needle (TPC)
	Type: 20, 21 G	Same
	Length: 35 mm

	Entry Needle (TRI)	Entry Needle (TRI)
	Type: 21 G	None
	Length: 38 mm	TRI Stainless Steel Entry Needle (21G x 38mm) of the
		proposed device is not available in kits for the predicate TC
		Glidesheath Slender (K142183), but it is identical to the
		entry needle used in the reference Glidesheath (K152173).
Sterilization	Ethylene Oxide (validated in accordance with ANSI / AAMI / ISO 11135-1 to achieve SAL 10-6)	Same

Shelf life	30 months	Same
Disposable Single Use	Yes	Same

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Terumo Medical Corporation, USA

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H. NON-CLINICAL TESTS (807.92(b)(1))

Performance

Performance testing was conducted to ensure that the Glidesheath Slender met the applicable design and performance requirements throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.

The following Table 5.2 provides a list of the performance tests that were performed on the proposed Glidesheath Slender.

Component	Test Item	Reference
Sheath	Fluoroscopy	ISO 11070:2014, Section 4.5ASTM F640-12
	Sheath visual inspection	In-house standard
	Sheath Effective Length	In-house standard
	Side Tube Length	In-house standard
	Sheath Tip ID	In-house standard
	Sheath, Hemostatic Valve Leak	ISO 11070:2014, Annex E
	Sheath Pressure Test	ISO 11070:2014, Annex DISO 11070:2013, Annex C
	Sheath Penetration	In-house standard
	Visual inspection after penetration testing	ISO 11070:2014 - Annex A section A3
	Sheath Tip Rollback Test	ISO 11070:2014 - Annex A section A3
	Dilator Hub to Sheath Hub Snap Fit Strength	In-house standard
	Valve Mobility Resistance	In-house standard
	Sheath Kink resistance	ISO 11070:2014 Annex A section A.1
	Sheath Tubing/Housing Joint Strength	ISO 11070:2014, Section 7.6
	Cap to Housing Joint Strength	In-house standard
	Sheath Support to Housing Strength	In-house standard
	Sheath Tubing Tensile Strength	ISO 11070:2014, Section 7.6
	Sheath Lubricity and Durability	In-house standard
	Particle capture during simulated use	FDA PTCA Guidance
	Coating integrity after simulated use	In-house standard
Dilator	Fluoroscopy	ISO 11070:2014, Section 4.5ASTM F640-12
	Dilator visual inspection	In-house standard
	Dilator Useable Length	In-house standard
	Dilator Tip ID	In-house standard
	Dilator OD at Sheath Tip	In-house standard
	Dilator Penetration	In-house standard
	Visual inspection after penetration testing	ISO 11070:2014 - Annex A section A3
	Dilator Tip Rollback Test	ISO 11070:2014 - Annex A section A3
	Dilator to Hub Tensile	ISO 11070:2014, Annex CISO 11070:2013, Annex B
	Dilator Hub to Sheath Hub Snap Fit Strength	In-house standard
	Particle capture during simulated use	FDA PTCA Guidance

Table 5.2: Summary of Performance Testing

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The Glidesheath Slender tested met the predetermined acceptance criteria and results support a determination of substantial equivalence. There are no new issues of safety and effectiveness in the performance of the device.

Biocompatibility

Glidesheath Slender is categorized as an external communicating device, circulating blood with limited contact duration (up to 24 hours). The biological evaluation of Glidesheath Slender was performed per EN ISO 10993-1 and FDA Guidance on Use of International Standard ISO 10993-1.

The proposed Glidesheath Slender product will have the same materials, processing, and sterilization as the existing Glidesheath (non-slender) product manufactured at TMC with the exception of the carrier solvent (manufacturing material) used for the hydrophilic coating of the sheath.

Due to the change in the carrier solvent used for the hydrophilic coating of the sheath, biocompatibility testing was performed on the Glidesheath Slender (sheath and dilator) to cover biological endpoints for the device categorization:

Cytotoxicity
Sensitization
Intracutaneous Reactivity ●
Systemic Toxicity (Acute)
Pyrogenicity ●
Hemocompatibility

Results of the testing demonstrate biocompatibility of the finished Glidesheath Slender. The Glidesheath Slender is considered to be biocompatible for the indicated use.

Sterilization

The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014. Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

The sterilization process was validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6.

Glidesheath Slender is a limited exposure device. After 24 hours of heated aeration, the level of residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) shall not exceed an average daily dose of 4 mg and 9 mg respectively per EN ISO 10993-7:2008.

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I. CLINICAL TESTS (807.92(b)(2))

This 510(k) does not include data from clinical tests.

J. CONCLUSION (807.92(b)(3))

In summary, the Glidesheath Slender, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device(s):

Predicate Device: K142183 Glidesheath Slender, manufactured by Terumo ● Corporation, Japan
Reference Device: K152173 Glidesheath, manufactured by Terumo Medical ● Corporation, USA

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).