Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on physical components and mechanical performance, with no mention of AI/ML algorithms or data processing.

Therapeutic

No

Explanation: The device is an introducer sheath system used to facilitate the placement of a catheter, but it does not directly treat or diagnose a disease or condition. It is an accessory to a procedure.

Diagnostic

No

The device is an introducer sheath system that facilitates the placement of a catheter into the radial artery for either diagnostic or interventional catheterization procedures. It does not perform any diagnostic function itself, but rather aids in a procedure that can be diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple physical components including a sheath, dilator, entry needle, mini guide wire, and guide wire inserter. It is a physical medical device used for catheter placement.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "facilitate placing a catheter through the skin into the radial artery." This is a procedural device used for accessing a blood vessel, not for performing tests on samples taken from the body.
Device Description: The description details a physical device (sheath, dilator, needle, guide wire) used for a medical procedure. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Measuring analytes or biomarkers

The device is a medical device used for a procedural purpose (vascular access), not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

DYB

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

radial artery

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142183

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K152173

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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.

1

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Image /page/3/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green, block letters. The red line appears to be a stylized representation of movement or progress.

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

4

Image /page/4/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters "TE". The font is bold and sans-serif. The logo is simple and modern.

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))

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

5

Image /page/5/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green. The font is sans-serif and the letters are bold.

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.

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

6

Image /page/6/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red arc above the company name, which is written in green, block letters. The arc is positioned above and to the left of the word "TERUMO".

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 a
catheter through the skin into the radial artery	Same
Operation Principle	Operated manually or by a manual
process:	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 of
the proposed device are not available in kits for the predicate
TC Glidesheath Slender (K142183), they are identical to the
Guide Wire (Nitinol) and TRI Stainless Steel Entry Needle
used in the reference Glidesheath (K152173).
Materials	Sheath Assembly:
Ethylene-Tetrafluoroethylene(ETFE) copolymer
Bismuth trioxide
Colorant
Dimethylacrylamide-glycidyl methacrylate copolymer
Silicone oil
Polypropylene
Silicone Rubber
Stainless Steel
Styrene-ethylene-butylene-styrene block copolymer
Polybutadiene
Polycarbonate
Polyethylene
Colorant

Dilator Assembly:
Polypropylene
Bismuth subcarbonate
Colorant
Silicone oil
Stainless Steel | Same, except for:
3WSC and Silicone Lubricant of the proposed device have
same material types with minor differences, but they are
identical to the 3WSC and Silicone Lubricant used in the
reference Glidesheath (K152173).

7

Image /page/7/Picture/1 description: The image shows the Terumo logo. The logo consists of a red curved line above the word "TERUMO" in green. The red curved line is positioned above and to the left of the word "TERUMO", creating a sense of motion or direction.

8

Image /page/8/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word, creating a dynamic and modern look.

Terumo Medical Corporation, USA

9

Image /page/9/Picture/1 description: The image shows the Terumo logo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word, creating a sense of motion or progress.

10

Image /page/10/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red curved line above the word. The red curved line starts above the "T" and extends to the right, above the "E".

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 4.5
ASTM 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 D
ISO 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 4.5
ASTM 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 C
ISO 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

11

Image /page/11/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh appears to be a stylized representation of movement or progress.

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.

12

Image /page/12/Picture/1 description: The image shows the Terumo logo. The logo consists of a red curved line above the word "TERUMO" in green. The red curved line is positioned above and to the left of the word "TERUMO", creating a sense of motion or direction.

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